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Background Owing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to specialized treatment. Guided self-help cognitive behavioral therapy–enhanced (CBT-E) may have great advantages for patients if its efficacy can be established. Objective The aim of this study was to examine the efficacy of guided self-help CBT-E compared with that of a delayed-treatment control condition. Methods A single-blind 2-arm randomized controlled trial was designed to evaluate guided self-help CBT-E according to an intention-to-treat analysis. A total of 180 patients were randomly assigned to guided self-help CBT-E (n=90, 50%) or the delayed-treatment control condition (n=90, 50%) for which guided self-help CBT-E was provided after the initial 12-week delay. The primary outcome was reduction in binges. The secondary outcome was full recovery at the end of treatment, as measured using the Eating Disorder Examination during the last 4 weeks of treatment. A linear mixed model analysis was performed to compare treatment outcomes at the end of treatment. A second linear mixed model analysis was performed to measure between- and within-group effects for up to 24 weeks of follow-up. The Eating Disorder Examination–Questionnaire and clinical impairment assessment were conducted before and after treatment and during follow-up. In addition, dropout rates were assessed in both conditions. Results During the last 4 weeks of treatment, objective binges reduced from an average of 19 (SD 16) to 3 (SD 5) binges, and 40% (36/90) showed full recovery in the guided self-help CBT-E group. Between-group effect size (Cohen d) was 1.0 for objective binges. At follow-up, after both groups received treatment, there was no longer a difference between the groups. Of the 180 participants, 142 (78.9%) completed treatment. The overall treatment dropout appeared to be associated with gender, level of education, and number of objective binges at baseline but not with treatment condition. Conclusions This is the first study to investigate the efficacy of guided self-help CBT-E. Guided self-help CBT-E appeared to be an efficacious treatment. This study’s findings underscore the international guidelines recommending this type of treatment for binge eating disorder. Trial Registration Netherlands Trial Registry (NTR) NL7994; https://trialsearch.who.int/Trial2.aspx?TrialID=NL7994 International Registered Report Identifier (IRRID) RR2-10.1186/s12888-020-02604-1

Background There has been a recent rise in the use of eHealth treatments for a variety of psychological disorders, including eating disorders. Objective This meta-analysis of randomized controlled trials is the first to evaluate the efficacy of eHealth interventions specifically for the treatment of binge eating disorder (characterized by compulsive overconsumption of food, in a relatively short period, and without compensatory behaviors such as purging or fasting). Methods A search on the electronic databases PubMed, Web of Science, Embase, MEDLINE, and CINAHL was conducted for randomized controlled trials that compared the efficacy of eHealth treatment interventions with waitlist controls. Results From the databases searched, 3 studies (298 participants in total) met the inclusion criteria. All interventions were forms of internet-based guided cognitive behavioral therapy. The results of the analysis demonstrated that when compared with waitlist controls, individuals enrolled in eHealth interventions experienced a reduction in objective binge episodes (standardized mean difference [SMD] −0.77, 95% CI −1.38 to −0.16) and eating disorder psychopathology (SMD −0.71, 95% CI −1.20 to −0.22), which included shape (SMD −0.61, 95% CI −1.01 to −0.22) and weight concerns (SMD −0.91, 95% CI −1.33 to −0.48). There was no significant difference in BMI between the eHealth interventions and controls (SMD −0.01, 95% CI −0.40 to 0.39). Conclusions These findings provide promising results for the use of internet-based cognitive behavioral therapy for binge eating disorder treatment and support the need for future research to explore the efficacy of these eHealth interventions.

Background Eating disorders are serious conditions associated with an impaired health-related quality of life and increased healthcare utilization and costs. Despite the existence of evidence-based treatments, access to treatment is often delayed due to insufficient health care resources. Internet-based self-help interventions may have the potential to successfully bridge waiting time for face-to-face outpatient treatment and, thus, contribute to overcoming treatment gaps. However, little is known about the feasibility of implementing such interventions into routine healthcare. The aim of this study is to analyze the effects and feasibility of an Internet-based self-help intervention (everyBody Plus) specifically designed for patients with Bulimia Nervosa, Binge Eating Disorder and other specified feeding and eating disorders (OSFED) on a waiting list for outpatient face-to-face treatment. The aim of this paper is to describe the study protocol. Methods A multi-country randomized controlled trial will be conducted in Germany and the UK. N = 275 female patients awaiting outpatient treatment will be randomly allocated either to the guided online self-help intervention “everyBody Plus” or a waitlist control group condition without access to the intervention. everyBody Plus comprises eight weekly sessions that cover topics related to eating and exercise patterns, coping with negative emotions and stress as well as improving body image. Participants will receive weekly individualized feedback based on their self-monitoring and journal entries. Assessments will take place at baseline, post-intervention as well as at 6- and 12-months follow up. In addition, all participants will be asked to monitor core eating disorder symptoms weekly to provide data on the primary outcome. The primary outcome will be number of weeks after randomization until a patient achieves a clinically relevant improvement in core symptoms (BMI, binge eating, compensatory behaviors) for the first time. Secondary outcomes include frequency of core symptoms and eating disorder related attitudes and behaviors, as well as associated psychopathology. Additional secondary outcomes will be the participating therapists' confidence in treating eating disorders as well as perceived benefits of everyBody Plus for patients. Discussion To the best of our knowledge, this is the first randomized controlled trial examining the effects of Internet-based self-help for outpatients with eating disorders awaiting face-to-face outpatient treatment. If proven to be effective and successfully implemented, Internet-based self-help programs might be used as a first step of treatment within a stepped-care approach, thus reducing burden and cost for both patients and health care providers., Highlights • Patients with eating disorders are often confronted with long and stressful waiting times. • Internet-based self-help interventions used as a first step of treatment may have the potential to overcome treatment gaps. • We will evaluate an Internet-based self-help intervention used to bridge waiting times in a randomized controlled trial. • We hope to reduce the time until a patient achieves a clinically relevant improvement in core symptoms for the first time.

Binge-eating disorder (BED) is characterized by recurrent episodes of loss of control over eating and is related to a higher prevalence of other mental disorders and somatic consequences associated with overweight and obesity. In community-based samples, 2–4% of women and 1–3% men are diagnosed with BED. Psychotherapeutic interventions focusing on maintenance factors of disturbed eating behavior have proven to be effective. However, treatment access is limited for a considerable number of patients with BED. A lack of specialized institutions and treatment resources, but also long distances to treatment facilities for people living in remote or rural areas are often causes of insufficient care. Internet-based guided self-help (GSH) programs have the potential to fill this gap. This project aims to develop and evaluate an Internet-based treatment for BED derived from an evidence-based manualized cognitive behavioral therapy (CBT). The primary goal is to test feasibility and suitability of the Internet-based program and to evaluate the treatment outcome in comparison to a pure and a placebo-inspired waitlist control group (i.e. reduction of binge-eating episodes and eating disorder pathology as primary outcome variables). In total, 60 women and men aged 18–70 years with a BED diagnosis will be recruited. The Internet-based GSH treatment comprises eight sessions followed by three booster sessions. The placebo-inspired waitlist control group receives weekly messages containing information increasing positive expectations regarding the treatment effects during the four-week waiting period. The pure waitlist control group receives weekly messages simply asking patients to fill in a short questionnaire. The access to evidence-based treatments for BED might be made easier using an Internet-based GSH approach. The present study protocol presents a randomized controlled trial. As well as evaluating the suitability and efficacy of the Internet-based GSH treatment, there will also be a prelimarily investigation on the influence of positive expectations (placebo) for a therapeutic intervention on core symptoms. German Clinical Trials Register, DRKS00012355 . Registered on 14 September 2017.

Background Only a small proportion of older patients with generalized anxiety disorder (GAD) seek professional help. Difficulties in accessing treatment may contribute to this problem. Guided self-help based on the principles of cognitive-behavioral therapy (GSH-CBT) is one way of promoting access to psychological treatment. Moreover, because the therapist’s role in GSH-CBT is limited to supporting the patient, this role could be assumed by trained and supervised lay providers (LPs) instead of licensed providers. The main goal of this study is to evaluate the efficacy of GSH-CBT guided by LPs for primary threshold or subthreshold GAD in older adults. Methods We will conduct a multisite randomized controlled trial comparing an experimental group receiving GSH-CBT guided by LPs (n = 45) to a wait-list control group (n = 45). Treatment will last 15 weeks and will be based on a participant’s manual. Weekly telephone sessions with LPs (30 min maximum) will be limited to providing support. Data will be obtained through clinician evaluations and self-assessment questionnaires. Primary outcomes will be the tendency to worry and severity of GAD symptoms. Secondary outcomes will be anxiety symptoms, sleep difficulties, functional deficit, diagnosis of GAD, and cognitive difficulties. For the experimental group, measurements will take place at pre- and post-treatment and at 6 and 12 months post-treatment. For the control group, three evaluations are planned: two pre-treatment evaluations (before and after the waiting period) and after receiving treatment (post-treatment). The efficacy of GSH-CBT will be established by comparing the change in the two groups on the primary outcomes. Discussion This project will provide evidence on the efficacy of a novel approach to treat GAD in older adults. If effective, it could be implemented on a larger scale and provide many older adults with much needed mental health treatment through an expanded workforce. Trial registration The trial was registered at ClinicalTrials.gov, number NCT03768544, on December 7, 2018.

Currently one-third of children in the United States have overweight or obesity (OW/OB). The goal of Healthy People 2020 is to reduce the proportion of children with OW/OB and increase the proportion of primary care visits that include nutrition and weight-related counseling. Unfortunately, many health care providers find it difficult to offer effective weight-related counseling and treatment in the primary care setting. Therefore, new models of care are needed that allow a greater proportion of children with OW/OB and their parents to access care and receive quality weight management treatment. The current paper describes the GOT Doc study which is designed to test the effectiveness of a Guided Self-Help (GSH) model of obesity treatment that can be delivered in the primary care setting compared to a traditional Family-Based Behavioral weight loss treatment (FBT) delivered at an academic center. We will assess the impact of this program on attendance (access to care) and changes in child BMI percentile/z-score. We will also examine the impact of this treatment model on change in child lifestyle behaviors, parent support behaviors, and parent self-efficacy and empowerment to make behavior change. Finally, we will assess the cost-effectiveness of this model on changes in child BMI percentile/z-score. We believe the GSH intervention will be a cost-effective model of obesity management that can be implemented in community practices around the country, thereby increasing access to treatment for a broader proportion of our population and decreasing rates of childhood obesity., Highlights • Effective childhood obesity treatment is not widely available or easily accessible. • Guided Self-Help (GSH) model of treatment has been developed for pediatric obesity. • GSH is easier to implement and can be delivered in the primary care setting. • GSH can increase access to much needed treatment. • Evaluation of its effectiveness in the primary care setting is needed.

Compared to conventional face-to-face psychological treatments, internet-based cognitive-behavioral therapy (iCBT) presents an innovative alternative that has been found to be effective in the treatment of anxiety disorders. The current study provides a meta-analysis investigating the efficacy of disorder-specific guided self-help (Gsh) iCBT compared to various active and inactive control conditions, with focus on adult panic disorder sufferers with or without agoraphobia (PD/A). Systematic literature search yielded 13 randomized controlled trials (RCTs) (N = 1214) that met the eligibility criteria for this study. We found no statistically significant differences between Gsh iCBT and various active CBT interventions in reducing PD/A symptoms at both post-test (g = 0.015, k = 10) and follow-up (g = 0.113, k = 6) levels. Also, comorbid anxiety and depression were reduced equivalently at post-test (g = 0.004, k = 6) and follow-up (g = 0.004, k = 6). Quality of life was equally improved at post-test (g = −0.100, k = 5) and follow-up (g = 0.074, k = 2). When compared to inactive controls, we found large effect sizes in PD/A (g = −0.892, k = 9) and comorbid anxiety and depression (g = −0.723, k = 9) symptoms, and moderate change in quality of life (g = −0.484, k = 3) at post-test. There was no difference between Guided self-help iCBT and Self-help iCBT in PD/A (g = −0.025, k = 3) and comorbid anxiety and depression (g = −0.025, k = 3) at post-test. Baseline severity, country of original research and adherence to the treatment in form of initial uptake were identified as statistically significant moderators of the iCBT treatment., Highlights • Disorder-specific Gsh iCBT is equally effective in treating panic disorder with or without agoraphobia (PD/A), comorbid anxiety and depression symptoms, and improving quality of life, when compared to various active CBT interventions at post-test and follow-up • Gsh iCBT is highly effective in treating PD/A and comorbid anxiety and depression, and moderately effective in improving quality of life, when compared to inactive controls • Gsh iCBT is equally effective when compared to Sh iCBT in PD/A and comorbid anxiety and depression at post-test • Clinical significance, initial login into the treatment, adherence and attrition is equal in Gsh iCBT and psychological treatments with CBT elements • Baseline severity, country of original research and initial uptake to the treatment are moderators of the iCBT treatment effect

Background Aging is a social concern. The increased incidence of depression in older populations in China poses a challenge to the health care system. Older adults who are depressed often suffer from a lack of motivation. Behavioral activation treatment, an evidence-based guided self-help treatment, is effective in reducing anhedonia and amotivation in depression; however, the efficacy of guided self-help behavioral activation in older adults with depression is not yet known. Objective The aim of this study is to pilot a self-help guided intervention for the treatment of depression in older adults. Methods This study has been designed as a pilot randomized controlled trial with inpatients (n=60; to be randomly allocated 1:1) between the ages of 60 and 70 and who have major depressive disorder. Patients attending clinical psychological clinics at the Mental Health Center of Chongqing will be randomized to either receive guided self-help behavioral activation (intervention) or to be on a 6-week waiting list (control). Participants in the treatment group will receive 6 sessions of guided self-help behavioral activation delivered over the telephone. The waiting list control group will receive the intervention after a period of 6 weeks. Exclusion criteria will be individuals who are at significant risk of harming themselves or others, who have a primary mental health disorder other than depression, or who have an intellectual disability that would hamper their ability to participate in the intervention. Effects of the treatment will be observed using outcomes in 3 domains: (1) clinical outcomes (symptom severity, recovery rate), (2) process variables (patient satisfaction, attendance, dropout), and (3) economic outcomes (cost and resource use). We will also examine mediators of outcomes in terms of patient variables (behavioral activation or inhibition motivation). We hypothesize that guided self-help behavioral activation will have a beneficial effect. Results The study was approved by the research ethics committee of the Mental Health Center of Chongqing in November 2019. As of July 2020, recruitment had not yet begun. Data collection is expected to be completed by December 2020. Data analysis is expected to be completed by June 2021. Results will then be disseminated to patients, to the public, to clinicians, and to researchers through publications in journals and presentations at conferences. Conclusions This will be the first study in China to investigate guided self-help interventions for patients who are older adults and who are depressed, a group which is currently underrepresented in mental health research. The intervention is modular and adapted from an empirically supported behavioral activation treatment for depression. The generalizability and broad inclusion criteria are strengths. Trial Registration Chinese Clinical Trial Register ChiCTR1900026066; http://www.chictr.org.cn/showprojen.aspx?proj=43548 International Registered Report Identifier (IRRID) PRR1-10.2196/18259

Background Binge eating disorder is characterized by recurrent episodes of binge eating accompanied by a sense of lack of control. Of the different treatments available, Cognitive Behavioral Therapy-Enhanced and guided self-help treatment are recommended. As online treatment offers several additional advantages, we have developed a CBT-Enhanced online guided self-help intervention. The aim of this study is to determine whether this intervention reduces eating disorder pathology and increases the amount of binge free days in adults classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder, compared to an untreated waiting list condition. The experimental condition is hypothesized to be superior to the waiting list condition. Methods The efficacy of an online guided self-help intervention for binge eating disorder will be assessed by conducting a randomized controlled trial. The trial will target adult individuals classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder with a body mass index between 19.5 and 40, referred to an eating disorder treatment center. Dual arm allotment will be performed in a 1:1 ratio stratified for BMI above or below 30. Randomization will be blinded to the online intervention (n = 90), or to the control waiting list condition (n = 90). Assessors will be blinded and assessments will be administered at baseline, week 5, at end-of-treatment, and at 12 and 24 weeks follow-up. Primary outcome will be eating disorder pathology, operationalized as number of days on which binge eating occurred between the two conditions during the period of the intervention. Secondary outcome measures will be differences in other eating disorder pathology, clinical impairment and in quality of life, while therapeutic alliance, demographic characteristics and followed treatment module will serve as effect moderators. Several types of costs will be assessed. Discussion This paper presents an online guided self-help Cognitive Behavioral Therapy- Enhanced study protocol for individuals classified with binge eating disorder or other specified feeding or eating disorder. Efficacy will be examined through a Randomized Controlled Trial. Trial registration The study protocol is registered with the Netherlands Trial Registry NTR (NTR 7994) since 6 September 2019.

Background:\ud Depression is a common antenatal mental disorder associated with significant maternal morbidity and adverse fetal outcomes. However, there is a lack of research on the effectiveness or cost-effectiveness of psychological interventions for antenatal depression.\ud \ud Methods:\ud A parallel-group, exploratory randomised controlled trial across five hospitals. The trial compared Guided Self-Help, modified for pregnancy, plus usual care with usual care alone for pregnant women meeting DSM-IV criteria for mild-moderate depression. The trial objectives were to establish recruitment/follow-up rates, compliance and acceptability, and to provide preliminary evidence of intervention efficacy and cost-effectiveness. The primary outcome of depressive symptoms was assessed by blinded researchers using the Edinburgh Postnatal Depression Scale at 14-weeks post-randomisation.\ud \ud Results:\ud 620 women were screened, 114 women were eligible and 53 (46.5%) were randomised. 26 women received Guided Self-Help – 18 (69%) attending ≥4 sessions - and 27 usual care; n = 3 women were lost to follow-up (follow-up rate for primary outcome 92%). Women receiving Guided Self-Help reported fewer depressive symptoms at follow-up than women receiving usual care (adjusted effect size −0.64 (95%CI: −1.30, 0.06) p = 0.07). There were no trial-related adverse events. The cost-effectiveness acceptability curve showed the probability of Guided Self-Help being cost-effective compared with usual care ranged from 10 to 50% with a willingness-to-pay range from £0 to £50,000.\ud \ud Conclusions and Limitations:\ud Despite intense efforts we did not meet our anticipated recruitment target. However, high levels of acceptability, a lack of adverse events and a trend towards improvements in symptoms of depression post-treatment indicates this intervention is suitable for talking therapy services.

Background Mental well-being could be promoted and protected by positive psychology (PP) based interventions. Such interventions may be appealing for people at risk of anxiety and depressive disorders, but health-economic evaluations are scarce. The aim was to examine the cost-effectiveness of a PP intervention. Methods Participants with suboptimal levels of mental well-being were randomly assigned to an email guided PP-intervention (n = 137) or a wait-list control group (n = 138) with access to usual care (UC). At baseline and 6 months follow-up, data were collected on health care costs. Outcomes of interest were flourishing mental health and treatment response on anxiety and depressive symptoms. Results Bootstrapped mean incremental cost-effectiveness ratios were €2359 ($2899) for flourishing, €2959 ($3637) for anxiety and €2578 ($3168) for depression, suggesting appreciable health gains for low additional costs. At a willingness to pay ceiling of €10,000 ($12,290) for a treatment response, the probability that the intervention is deemed cost-effective ranged between 90 and 93%. Conclusions The guided PP intervention appears to be a promising strategy as seen from both a public health and a health-economic perspective, especially when there is some willingness to pay. When the PP-intervention is scaled up, then outcome monitoring is recommended to better guarantee the longer term cost-effectiveness of the intervention. Trial registration The Netherlands National Trial Register NTR4297. Registered on 29 November 2013. The NTR is part of the WHO Primary Registries.

Introduction: Depression is highly prevalent and often accompanied by comorbid anxiety disorder. Internet-based interventions have shown to be one effective treatment modality; however, comorbidities are often not targeted. Transdiagnostic tailored internet- and mobile-based interventions (IMIs) might be promising to overcome such issues. Aim: This study aims to evaluate the efficacy, moderators and cost-effectiveness of a transdiagnostic tailored internet- and mobile-based guided intervention for depression and comorbid anxiety in individuals with major depressive disorder (MDD). Method: Two-hundred participants with MDD will be randomly assigned to an eight-week guided self-help internet intervention (IC) or a six-month wait-list control group (WLC). Participants of the IC will receive weekly content-focused feedback on module completion as well as monitored adherence reminders from an eCoach. The primary outcome is clinician-rated depression severity (QIDS-C) at post-assessment assessed by diagnostic raters blind to study condition. Secondary outcomes include, e.g. change in diagnostic status (MDD and anxiety disorders), remission and response rates, disorder symptom severity, health related quality of life, incongruence related to needs and values, and behavioral activation. Assessments will take place at baseline (T1), post-assessment (T2), six-month follow-up (T3), and twelve-month follow-up in the IC. Data will be analyzed on an intention-to-treat basis and per protocol. A large number of a priori defined moderators of treatment outcome will be assessed at baseline and tested in predicting treatment outcome. Cost-effectiveness will be evaluated from a societal perspective. Discussion: The present study will provide evidence on the efficacy, potential cost-effectiveness, and moderators of a transdiagnostic tailored guided internet- and mobile-based treatment protocol. Trial registration: German Register of Clinical Studies DRKS00011690 (https://www.drks.de/drks_web/).

Source at https://doi.org/10.1186/s12888-018-1644-8. Licensed CC BY-NC-ND 4.0. Background: Evidence shows that internet-based self-help interventions are effective in reducing symptoms for a wide range of mental disorders. To date, online interventions treating psychotic disorders have been scarce, even though psychosis is among the most burdensome disorders worldwide. Furthermore, the implementation of cognitive-behavioral therapy (CBT) for psychosis in routine health care is challenging. Internet-based interventions could narrow this treatment gap. Thus, a comprehensive CBT-based online self-help intervention for people with psychosis has been developed. The aim of this study is the evaluation of the feasibility and efficacy of the intervention compared with a waiting list control group. Methods: The intervention includes modules on delusion, voice hearing, social competence, mindfulness, and seven other domains. Participants are guided through the program by a personal moderator. Usage can be amended by an optional smartphone app. In this randomized controlled trial, participants are allocated to a waiting list or an intervention of eight weeks. Change in positive psychotic symptoms of both groups will be compared (primary outcome) and predictors of treatment effects will be assessed. Discussion: To our knowledge, this project is one of the first large-scale investigations of an internet-based intervention for people with psychosis. It may thus be a further step to broaden treatment options for people suffering from this disorder. Trial registration: NCT02974400 (clinicaltrials.gov), date of registration: November 28th 2016.

There is good evidence that trauma-focused therapies for Post-Traumatic Stress Disorder are effective. However, they are not always feasible to deliver due a shortage of trained therapists and demands on the patient. An online trauma-focused Guided Self-Help (GSH) programme which could overcome these barriers has shown promise in a pilot study. This study will be the first to evaluate GSH against standard face-to-face therapy to assess its suitability for use in the NHS. The study is a large-scale multi-centre pragmatic randomised controlled non-inferiority trial, with assessors masked to treatment allocation. One hundred and ninety-two participants will be randomly allocated to receive either face-to-face trauma-focused cognitive behaviour therapy (TFCBT) or trauma-focused online guided self-help (GSH). The primary outcome will be the severity of symptoms of PTSD over the previous week as measured by the Clinician Administered PTSD Scale for DSM5 (CAPS-5) at 16 weeks post-randomisation. Secondary outcome measures include PTSD symptoms over the previous month as measured by the CAPS-5 at 52 weeks plus the Impact of Event Scale – revised (IES-R), Work and Social Adjustment Scale (WSAS), Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder-7 (GAD-7), Alcohol Use Disorders Test (AUDIT-O), Multidimensional Scale for Perceived Social Support (MSPSS), short Post-Traumatic Cognitions Inventory (PTCI), Insomnia Severity Index (ISI) and General Self Efficacy Scale (GSES) measured at 16 and 52 weeks post-randomisation. Changes in health-related quality of life will be measured by the EQ-5D and the level of healthcare resource utilisation for health economic analysis will be determined by an amended version of the Client Socio-Demographic and Service Receipt Inventory European Version. The Client Satisfaction Questionnaire (CSQ) will be collected at 16 weeks post-randomisation to evaluate treatment satisfaction. This study will be the first to compare online GSH with usual face-to-face therapy for PTSD. The strengths are that it will test a rigorously developed intervention in a real world setting to inform NHS commissioning. The potential challenges of delivering such a pragmatic study may include participant recruitment, retention and adherence, therapist retention, and fidelity of intervention delivery. ISRCTN13697710 registered on 20/12/2016.

Computer-based interventions target improvement of physical and emotional functioning in patients with chronic pain and functional somatic syndromes. However, it is unclear to what extent which interventions work and for whom. This systematic review and meta-analysis (registered at PROSPERO, 2016: CRD42016050839) assesses efficacy relative to passive and active control conditions, and explores patient and intervention factors. Controlled studies were identified from MEDLINE, EMBASE, PsychInfo, Web of Science, and Cochrane Library. Pooled standardized mean differences by comparison type, and somatic symptom, health-related quality of life, functional interference, catastrophizing, and depression outcomes were calculated at post-treatment and at 6 or more months follow-up. Risk of bias was assessed. Sub-group analyses were performed by patient and intervention characteristics when heterogeneous outcomes were observed. Maximally, 30 out of 46 eligible studies and 3,387 participants were included per meta-analysis. Mostly, internet-based cognitive behavioral therapies were identified. Significantly higher patient reported outcomes were found in comparisons with passive control groups (standardized mean differences ranged between -.41 and -.18), but not in comparisons with active control groups (SMD = -.26 - -.14). For some outcomes, significant heterogeneity related to patient and intervention characteristics.To conclude, there is a minority of good quality evidence for small positive average effects of computer-based (cognitive) behavior change interventions, similar to traditional modes. These effects may be sustainable. Indications were found as of which interventions work better or more consistently across outcomes for which patients. Future process analyses are recommended in the aim of better understanding individual chances of clinically relevant outcomes.

Objective Eating disorders and subclinical eating disorders are serious and disabling diseases with high prevalence rates on college campuses. Many symptomatic students are never screened nor formally diagnosed with an eating disorder and do not receive mental health treatment. Method This pilot study examines the feasibility, acceptability, and short-term efficacy of a 10-week online intervention, StudentBodies-Eating Disorders , designed to reduce eating disorder symptoms, related psychopathology, and weight and shape concerns. A total of 65 participants were randomized to the online intervention or waitlist control. Results Results indicate that for study completers, the intervention had large effects for reduction of eating-related psychopathology ( d =1.5), weight concerns ( d =.7), and psychosocial impairment ( d =.7). Those who completed it rated the program very acceptable. This pilot study suggests the potential efficacy of StudentBodies-Eating Disorders as a self-help intervention for subclinical eating disorders in a non-clinical setting.

Aim To evaluate if internet-delivered Cognitive Behavioral Therapy for insomnia (ICBT-i) with brief therapist support outperforms an active control treatment. Method Adults diagnosed with insomnia were recruited via media (n = 148) and randomized to either eight weeks of ICBT-i or an active internet-based control treatment. Primary outcome was the insomnia severity index (ISI) assessed before and after treatment, with follow-ups after 6 and 12 months. Secondary outcomes were use of sleep medication, sleep parameters (sleep diary), perceived stress, and a screening of negative treatment effects. Hierarchical Linear Mixed Models were used for intent-to-treat analyses and handling of missing data. Results ICBT-i was significantly more effective than the control treatment in reducing ISI (Cohen's d = 0.85), sleep medication, sleep efficiency, sleep latency, and sleep quality at post-treatment. The positive effects were sustained. However, after 12 months the difference was no longer significant due to a continuous decrease in ISI among controls, possibly due to their significantly higher utilization of insomnia relevant care after treatment. Forty-six negative effects were reported but did not differ between interventions. Conclusions Supported ICBT-i is more effective than an active control treatment in reducing insomnia severity and treatment gains remain stable one year after treatment.

Purpose of review – This systematic review sought to compare available evidence-based clinical treatment guidelines for all specific eating disorders. Recent findings – Nine evidence-based clinical treatment guidelines were located through a systematic search. The international comparison demonstrated notable commonalities and differences among current evidence-based clinical guidelines for eating disorders. Consistency across guidelines was greatest for treatments with a larger evidence base, while those with a lower evidence base had recommendations that varied considerably. Summary – Evidence-based clinical guidelines represent an important step toward the dissemination and implementation of evidence-based treatments into clinical practice. Despite advances in clinical research on eating disorders, a growing body of literature demonstrates that individuals with eating disorders often do not receive an evidence-based treatment for their disorder. Regarding the dissemination and implementation of evidence-based treatments, current guidelines do endorse the main empirically validated treatment approaches with considerable agreement, but additional recommendations are largely inconsistent. An increased evidence base is critical in offering clinically reliable and consistent guidance for the treatment of eating disorders. Because developing and updating clinical guidelines is time-consuming and complex, an international coordination of guideline development, for example, across the European Union, would be desirable.

Background Low mood is a common mental health problem with significant health consequences. Studies have shown that cognitive behavioural therapy (CBT) is an effective treatment for low mood and anxiety when delivered one-to-one by an expert practitioner. However, access to this talking therapy is often limited and waiting lists can be long, although a range of low-intensity interventions that can increase access to services are available. These include guided self-help materials delivered via books, classes and online packages. This project aims to pilot a randomized controlled trial of an online CBT-based life skills course with community-based individuals experiencing low mood and anxiety. Methods Individuals with elevated symptoms of depression will be recruited directly from the community via online and newspaper advertisements. Participants will be remotely randomized to receive either immediate access or delayed access to the Living Life to the Full guided online CBT-based life skills package, with telephone or email support provided whilst they use the online intervention. The primary end point will be at 3 months post-randomization, at which point the delayed-access group will be offered the intervention. Levels of depression, anxiety, social functioning and satisfaction will be assessed. Discussion This pilot study will test the trial design, and ability to recruit and deliver the intervention. Drop-out rates will be assessed and the completion and acceptability of the package will be investigated. The study will also inform a sample size power calculation for a subsequent substantive randomized controlled trial. Trial registration ISRCTN ISRCTN12890709

BackgroundThe development of widely accessible, effective psychological interventions for depression is a priority. This randomized trial provides the first controlled data on an innovative cognitive bias modification (CBM) training guided self-help intervention for depression.MethodOne hundred and twenty-one consecutively recruited participants meeting criteria for current major depression were randomly allocated to treatment as usual (TAU) or to TAU plus concreteness training (CNT) guided self-help or to TAU plus relaxation training (RT) guided self-help. CNT involved repeated practice at mental exercises designed to switch patients from an unhelpful abstract thinking habit to a helpful concrete thinking habit, thereby targeting depressogenic cognitive processes (rumination, overgeneralization).ResultsThe addition of CNT to TAU significantly improved depressive symptoms at post-treatment [mean difference on the Hamilton Rating Scale for Depression (HAMD) 4.28, 95% confidence interval (CI) 1.29–7.26], 3- and 6-month follow-ups, and for rumination and overgeneralization post-treatment. There was no difference in the reduction of symptoms between CNT and RT (mean difference on the HAMD 1.98, 95% CI −1.14 to 5.11), although CNT significantly reduced rumination and overgeneralization relative to RT post-treatment, suggesting a specific benefit on these cognitive processes.ConclusionsThis study provides preliminary evidence that CNT guided self-help may be a useful addition to TAU in treating major depression in primary care, although the effect was not significantly different from an existing active treatment (RT) matched for structural and common factors. Because of its relative brevity and distinct format, it may have value as an additional innovative approach to increase the accessibility of treatment choices for depression.

It is not clear if treatments for depression targeting repetitive negative thinking (RNT: rumination, worry and content-independent perseverative thinking) have a specific effect on RNT resulting in better outcomes than treatments that do not specifically target rumination. We conducted a systematic search of PsycINFO, PubMed, Embase and the Cochrane library for randomized trials in adolescents, adults and older adults comparing CBT treatments for (previous) depression with control groups or with other treatments and reporting outcomes on RNT. Inclusion criteria were met by 36 studies with a total of 3307 participants. At post-test we found a medium-sized effect of any treatment compared to control groups on RNT (g = 0.48; 95% CI: 0.37–0.59). Rumination-focused CBT: g = 0.76, Mindfulness-based Cognitive Therapy: g = 0.42, p effect sizes than other types of treatment (i.e., anti-depressant medication, light therapy, engagement counseling, life review, expressive writing, yoga) (g = 0.14) compared to control groups. Effects on RNT at post-test were strongly associated with the effects on depression severity and this association was only significant in RNT-focused CBT. Our results suggest that in particular RNT-focused CBT may have a more pronounced effect on RNT than other types of interventions. Further mediation and mechanistic studies to test the predictive value of reductions in RNT following RNT-focused CBT for subsequent depression outcomes are called for.

Background Although mild to moderate mental health problems are common and often debilitating, treatment options in primary care settings in New Zealand are often severely limited for patients with these conditions. Previously, we developed an ultra-brief intervention (UBI) to address mild to moderate psychological concerns, designed to be delivered by primary care clinicians. Recent feasibility testing, including an adaptation for Māori individuals (the indigenous people of New Zealand), showed that the brief intervention was feasible and acceptable to both clinicians and their patients. This protocol describes a large pragmatic randomized controlled trial of our UBI in primary care settings across the greater Wellington region, compared with practice as usual. Methods/Design We are using a two-arm cluster randomized controlled trial, with primary care practices randomized to exclusively deliver either the UBI or practice as usual to all their recruited participants. The structured, guided self-help UBI is delivered in three brief general practitioner (GP) appointments over a five week period. Participants are invited into the study based on partner primary health organization access criteria (youth, people with low income, or people with Māori or Pacific Island heritage). Improvements in mental health from baseline to post-treatment will be compared between the intervention and control groups using a mixed-models application of analysis of covariance. Data analysis will be on an intention-to-treat basis, to increase the real-world relevance of UBI and to meet the study's objective of releasing UBI to primary care clinicians nationwide. Discussion The UBI is a first-line intervention tool for GPs that models the stepped care approach advocated in New Zealand, against a background of limited access to treatments for often-overlooked patient groups. It is proposed to be accessible to clinicians and patients alike, with the potential to be relevant to primary care clinicians across New Zealand. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12613000041752.

Background Efficacy of self-help internet-based cognitive behavior therapy (ICBT) for anxiety disorders has been confirmed in several randomized controlled trials. However, the amount and type of therapist guidance needed in ICBT are still under debate. Previous studies have shown divergent results regarding the role of therapist guidance and its impact on treatment outcome. This issue is central to the development of ICBT programs and needs to be addressed directly. The present study aims to compare the benefits of regular therapist guidance via online real-time audio-video communication (i.e. Skype) to no therapist guidance during a 12-week Romanian self-help ICBT program for Panic Disorder. Both treatments are compared to a waiting-list control group. Methods/Design A parallel group randomized controlled trial is proposed. The participants, 192 Romanian adults fulfilling diagnostic criteria for panic disorder according to a diagnostic interview, conducted via secured Skype or telephone, are randomly assigned to one of the three conditions: independent use of the internet-based self-help program PAXonline, the same self-help treatment with regular therapist support via secured Skype, and waiting-list control group. The primary outcomes are severity of self-report panic symptoms (PDSS-SR) and diagnostic status (assessors are blind to group assignment), at the end of the intervention (12 weeks) and at follow-up (months 3 and 6). The secondary measures address symptoms of comorbid anxiety disorders, depression, quality of life, adherence and satisfaction with ICBT. Additional measures of socio-demographic characteristics, personality traits, treatment expectancies, catastrophic cognitions, body vigilance and working alliance are considered as potential moderators and/ or mediators of treatment outcome. Discussion To the best of our knowledge, the present study is the first effort to investigate the efficacy of a self-help internet-based intervention with therapist guidance via real-time video communication. A direct comparison between therapist guided versus unguided self-directed intervention for panic disorder will also be addressed for the first time. Findings from this study will inform researchers and practitioners about the added value of online video-therapy guidance sessions and the type of patients who may benefit the most from guided and unguided ICBT for Panic disorder. Trial registration ACTRN12614000547640 (Australian New Zealand Clinical Trials Registry). Registered 22/05/2014.

Background\ud Mental health problems such as anxiety and depression are known to be higher in those who are unemployed. Cognitive behavioural therapy (CBT) is a recognised support for people with such problems and can improve the ability of people to get back to work.\ud \ud Methods/design\ud Participants with symptoms of low mood will be recruited from the disability employment service, Remploy. Participants will receive either immediate or delayed access to an online CBT-based life skills intervention, the “Living Life” package. The primary end point will be at 3 months when the delayed group will be offered the intervention. This feasibility study will test the trial design and assess recruitment, retention, acceptability and adherence, as well as providing efficacy data.\ud \ud Discussion\ud The study will inform the design and sample size for a future full randomised controlled trial (RCT) which will be carried out to determine the effectiveness of the online package in improving mood and employment status.

Background Cognitive behavioural therapy (CBT) is recommended for the treatment of depression and anxiety. However, access is limited. Low-intensity approaches such as guided CBT self-help (bibliotherapy) can increase access to treatment and is recommended by UK guidelines. No previous research has explored the provision of group-based guidance/support for a bibliotherapy approach for depression and anxiety in community settings. The objective was to carry out a pilot study of a group guided self-help intervention, using community based recruitment methods. Method A randomised controlled trial comparing an 8 week CBT group guided self-help intervention to usual care. Recruitment and the delivery of the intervention were carried out in Glasgow and Derry/Londonderry in partnership with national depression charities. Fifty-three people were randomised, however we refer only to the forty-six participants who provided baseline data: 16 males and 30 females, aged 16 or over, with a PHQ-9 score of ≥ 5, were recruited from the community. The mean age of the sample was 43.7 (sd = 13) and 93.5% of participants had suffered from low mood for a year or more. Results There was effective recruitment, randomisation, uptake and adherence with 21 Immediate Access (IA) and 25 Delayed Access Control (DAC) participants. The intervention was highly acceptable to participants attending on average 4.46 of the 8 sessions (sd 3.06), 65.2% attended more than half of all sessions. The mean satisfaction on the Client Satisfaction Questionnaire was 28 out of 32 (sd 4.8). The provisional results in the pilot suggest the intervention may improve both anxiety and depression. At three months, data collection was achieved from 74% of participants. The trial successfully provided estimates of the sample size needed for the future planned trial. Conclusions Low-intensity group-based classes may offer an alternative method of managing depression and anxiety and warrant further research. Trial registration Current Controlled Trials ISRCTN84893887. Registered 3 November 2011.

Background:\ud Low mood is a common mental health problem affecting up to 121 million people worldwide and is common in students, particularly international students. Cognitive behavioural therapy (CBT) is known to be effective as a treatment for low mood and anxiety when delivered one to one by an expert practitioner, however this can be expensive and many services have waiting lists and delayed access. A range of additional ways of increasing access to services includes the offer of online courses such as computerised CBT as a possible additional pathway for care. This project aims to test the feasibility of a pilot randomised controlled trial of an online CBT-based life skills course with Chinese-speaking international students experiencing low mood and anxiety.\ud \ud Methods/design:\ud Chinese-speaking international students with symptoms of low mood and/or anxiety will be recruited from the University of Glasgow, Scotland. Participants will be remotely randomised to receive either immediate access (IA) or delayed access (DA) to a guided/supported online CBT-based life skills package, the “Living Life” package (Chinese version). Participants will be randomly assigned to IA or DA to the intervention. The primary end point will be at 3 months when the delayed group will be offered the intervention. Levels of depression, anxiety, social functioning and satisfaction will be assessed.\ud \ud Discussion:\ud This pilot study will test the trial design, ability to recruit, gather completed questionnaires, test drop-out rates and investigate completion and acceptability of the package. The study aims to reduce uncertainties about the delivery of a future substantive study and will also inform a sample size calculation for that subsequent substantive randomised controlled trial (RCT) which will be carried out to determine the effectiveness of the online package in improving low mood and anxiety in the Chinese-speaking student population.

Background: We describe the theoretical rationale and protocol for Self-Help And Recovery guide for Eating Disorders (SHARED), a trial investigating whether a guided self-care intervention (Recovery MANTRA) is a useful addition to treatment as usual for individuals with anorexia nervosa. Recovery MANTRA, a 6-week self-care intervention supplemented by peer mentorship, is a module extension of the Maudsley Model of Treatment for Adults with Anorexia Nervosa and targets the maintenance factors identified by the cognitive-interpersonal model of the illness. Methods: Patients accessing outpatient services for anorexia nervosa are randomized to either treatment as usual or treatment as usual plus Recovery MANTRA. Outcome variables include change in body weight at the end of the intervention (primary) and changes in body weight and eating disorder symptoms at immediate and extended follow-up (6-months; secondary). Change is also assessed for the domains identified by the theoretical model, including motivation, hope, confidence to change, positive mood, cognitive flexibility, therapeutic alliance and social adjustment. Feedback from peer mentors is gathered to understand the impact on their own well-being of providing guidance. Discussion: Results from this exploratory investigation will determine whether a larger clinical trial is justifiable and feasible for this affordable intervention, which has potential for high reach and scalability. Trial registration: ClinicalTrials.gov NCT02336841.