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Background: Despite the wide‐ranging negative consequences of nonsuicidal self‐injury (NSSI), there are few evidence‐based treatments for NSSI among adolescents and little is known about what treatments that work best for whom. The objective of this study was to investigate moderators (i.e., for whom a specific treatment works) and predictors (i.e., factors associated with treatment outcome independent of treatment type) of treatment outcome in a randomized clinical trial comparing internet‐delivered emotion regulation individual therapy for adolescents (IERITA) plus treatment as usual (TAU) to TAU alone. Methods: Adolescents (N = 166; mean [SD] age = 15.0 [1.2] years) with NSSI disorder were randomized to IERITA plus TAU (n = 84) or TAU‐only (n = 82). Adolescent emotion regulation difficulties, suicidality, NSSI frequency, depressive symptoms, sleep difficulties, global functioning, and age, and parental invalidation, were measured pre‐treatment and investigated as moderators and predictors of treatment outcome (i.e., NSSI frequency during treatment and for 4 weeks post‐treatment). A zero‐inflated negative binomial generalized linear mixed effects regression model was used to estimate the rate of NSSI change as a function of both treatment condition and moderator/predictor. Results: No significant moderators of treatment outcome were found. Parental invalidation was a significant predictor of treatment outcome regardless of treatment condition, such that high levels of parental invalidation pre‐treatment were associated with a less favorable NSSI frequency. Conclusions: We did not find evidence of a differential treatment effect as a function of any of the examined client factors. Future research should investigate moderation in larger samples and with sufficient statistical power to detect moderation effects of smaller magnitude. Results suggest that parental invalidation may have a negative impact on treatment response and highlight the importance of further investigating parental invalidation in the context of NSSI treatments. [ABSTRACT FROM AUTHOR]

Background and Aims: Most alcohol‐dependent people have a moderate level of dependence. General practitioners (GPs) hesitate to engage in this area, and need to have access to treatment they find applicable and feasible to use. The aim of this present study was to test if an open‐ended internet‐based cognitive–behavioral therapy (iCBT) program added to treatment‐as‐usual (TAU) is more effective than TAU‐only for alcohol‐dependent patients in primary care. Design, Setting and Participants: The present study was a two‐group, parallel, randomized controlled superiority trial comparing iCBT+TAU versus TAU‐only at 3‐ and 12‐month follow‐ups. TAU was delivered at 14 primary care centers in Stockholm, Sweden. A total of 264 patients (mean age 51 years, of whom 148 were female and 116 were male) with alcohol dependence and hazardous alcohol consumption were enrolled between September 2017 and November 2019. Measurements: Participants were randomized at a ratio of 1:1 to iCBT, as a self‐help intervention added to TAU (n = 132) or to TAU‐only (n = 132). The GPs gave participants in both treatment arms feedback on the assessments and biomarkers and offered TAU at the primary care center. Primary outcome was weekly alcohol consumption in g/week at 12‐month follow‐up, analyzed according to intention‐to‐treat (n = 132 + 132). The per‐protocol analysis included participants who completed at least one module of iCBT (n = 102 + 132). Findings There was no significant difference in weekly alcohol consumption between iCBT+TAU and TAU in the intention‐to‐treat (ITT) analysis at 12‐month follow‐up [iCBT+TAU = 133.56 (95% confidence interval, CI = 100.94–166.19) and TAU = 176.20 (95% CI = 144.04–208.35), P = 0.068, d = 0.23]. In the per‐protocol analysis, including only those who initiated iCBT, the iCBT+TAU group showed lower mean weekly alcohol consumption compared with TAU [iCBT+TAU = 107.46 (95% CI = 71.17–143.74), TAU = 176.00 (95% CI = 144.21–207.80), P = 0.010, d = 0.42]. Conclusions: In Sweden, an internet‐based cognitive–behavioral program added to treatment‐as‐usual to reduce alcohol consumption showed weak evidence of a benefit at 12 months in the intention‐to‐treat analysis and good evidence of a benefit in the per‐protocol analysis. [ABSTRACT FROM AUTHOR]

Aim: This study piloted a digital self-help intervention facilitating healthy lifestyle for patients with mental health problems in primary care. Background: Patients with mental health problems show more unhealthy lifestyle behaviors than the general population and prior research indicates that healthy lifestyle behaviors can improve mental health. Methods: This pilot study assessed use of a self-help digital intervention for healthy lifestyle promotion and included an embedded randomized recruitment trial, where all patients were randomized to digital self-help plus treatment as usual (TAU) or to TAU only. Patients seeking help for mental health problems were recruited from two primary care clinics in Stockholm, Sweden, and offered participation in a healthy lifestyle promotion study via digital self-help. Outcome measures included use-related assessment of inclusion and follow-up rates at both clinics, participant characteristics, and intervention adherence. Secondary outcomes included depression (the Patient Health Questionnaire-9) and anxiety (the GAD-7) up to 10 weeks, and changes in alcohol and tobacco use, physical activity, and diet. Results: The study included 152 patients. The recruitment rate, initially low, increased after involving the clinicians more and maintaining more frequent contact with the patients. The 10-week missing data rate was 33/152 (22%). Participants were 70% (106/152) women, with a mean age of 42 years (SD = 14); fewer than half (38%, n = 58/152) had one or more high-risk unhealthy behaviors at inclusion. Psychiatric symptoms were moderate at baseline and declined in both groups after 10 weeks (d = 0.57–0.75). No between-group effects over time occurred on depression (b = 0.3 [95% CI −1.6, 2.2]; d = 0.06), anxiety (b = −0.7 [−2.5, 1.2]; d = 0.13), or lifestyle behaviors (b = 0.01 [−0.3, 0,3]; d = −0.01). Conclusions: Recruitment routines seemed to be decisive for reaching as many patients as possible. The relatively low rate of unhealthy lifestyle behaviors and small effect sizes suggests that the intervention may only suit patients at risk. Trial registration: ClinicalTrials.gov NCT03691116 (01/10/2018), focusing on the embedded trial. Retrospectively registered for the first clinic and prospectively for the second clinic. [ABSTRACT FROM AUTHOR]

Previous studies have found an association between excessive worrying and negative beliefs about worry. It is unclear if change in these beliefs mediate worry reduction. This study aimed to examine (1) if a simplified online metacognitive intervention can reduce worry, (2) whether changes in negative beliefs about worry mediate changes in worry severity, and (3) moderated mediation, i.e., if the mediating effect is more pronounced in individuals with a high degree of negative beliefs about worry at baseline. Adult excessive worriers (N = 108) were randomized to 10-weeks of the online metacognitive intervention (MCI) aimed at reducing negative beliefs about worry, or to wait-list (WL). Outcomes, mediation, and moderated mediation were examined via growth curve modelling. Results indicated a significant reduction in the MCI group (d = 1.6). Reductions in negative beliefs about worry and depressive symptoms separately mediated changes in worry severity during the intervention, but in a multivariate test only the former remained significant. Sensitivity analysis indicated that the hypothesized mediation was robust to possible violations of mediator-outcome confounding. The moderated mediation hypothesis was not supported. The results from this randomized trial add to the growing literature suggesting that negative beliefs about worry play a key role in worry-related problems. ClinicalTrials.gov Identifier: NCT03393156 [ABSTRACT FROM AUTHOR]

Background: Health anxiety is common, disabling and costly due to patients' extensive use of health care services. Internet-delivered treatment may overcome barriers of accessibility to specialized treatment. We aimed to evaluate the efficacy of internet-delivered acceptance and commitment therapy (iACT). Methods: A randomized, controlled trial of iACT versus an internet-delivered discussion forum (iFORUM), performed in a Danish university hospital setting. Patients self-referred and underwent video-diagnostic assessment. Eligible patients (≥18 years) with health anxiety were randomized to 12 weeks of intervention. The randomization was blinded for the assessor. The primary outcome was between-group unadjusted mean differences in health anxiety symptoms measured by the Whiteley-7 Index (WI-7, range 0–100) from baseline to 6-month follow-up (6-MFU) using intention to treat and a linear mixed model. The study is registered at clinicaltrials.gov, number NCT02735434. Results: A total of 151 patients self-referred, and 101 patients were randomized to iACT (n = 53) or iFORUM (n = 48). A mean difference in change over time of 19.0 points [95% confidence interval (CI) 10.8–27.2, p < 0.001] was shown on the WI-7, and a large standardized effect size of d = 0.80 (95% CI 0.38–1.23) at 6-MFU. The number needed to treat was 2.8 (95% CI 1.8–6.1, p < 0.001), and twice as many patients in iACT were no longer clinical cases (35% v. 16%; risk ratio 2.17, 95% CI 1.00–4.70, p = 0.050). Adverse events were few and insignificant. Conclusions: iACT for health anxiety led to sustained effects at 6-MFU. The study contributes to the development of easily accessible treatment options and deserves wider application. [ABSTRACT FROM AUTHOR]

Background: Excessive worry is a common phenomenon. Our research group has previously developed an online intervention for excessive worry based on operant principles of extinction (IbET; internet-based extinction therapy) and tested it against a waiting-list. The aim of this study was to evaluate IbET against an active control comparator (CTRL). Methods: A 10-week parallel participant blind randomised controlled trial with health-economical evaluation and mediation analyses. Participants (N = 311) were randomised (ratio 4.5:4.5:1) to IbET, to CTRL (an internet-based stress-management training program) or to waiting-list. The nation-wide trial included self-referred adults with excessive worry. The primary outcome was change in worry assessed with the Penn State Worry Questionnaire from baseline to 10 weeks. Results: IbET had greater reductions in worry compared to CTRL [−3.6 point difference, (95% CI −2.4 to −4.9)] and also a significantly larger degree of treatment responders [63% v. 51%; risk ratio = 1.24 (95% CI 1.01–1.53)]. Both IbET and CTRL made large reductions in worry compared to waiting-list and effects were sustained up to 1 year. Treatment credibility, therapist attention, compliance and working alliance were equal between IbET and CTRL. Data attrition was 4% at the primary endpoint. The effects of IbET were mediated by the hypothesized causal mechanism (reduced thought suppression) but not by competing mediators. Health-economical evaluation indicated that IbET had a 99% chance of being cost-effective compared to CTRL given societal willingness to pay of 1000€. Conclusions: IbET is more effective than active comparator to treat excessive worry. Replication and extensions to real-world setting are warranted. [ABSTRACT FROM AUTHOR]

Background: Irritable bowel syndrome (IBS) is a debilitating and costly disorder. Cognitive behavior therapy (CBT) is effective in the treatment of IBS, both when delivered over the internet and in face-to-face settings. CBT consists of different components and little is known about their relative importance. We have in an earlier study showed that inclusion of exposure in the CBT for IBS makes it even more effective. In the present study we wanted to evaluate the economic effects for society of inclusion vs exclusion of exposure in an internet delivered CBT for IBS.Methods: We used data from a previous study with 309 participants with IBS. Participants were randomized to internet delivered CBT with (ICBT) or without exposure (ICBT-WE). We compared direct and indirect costs at baseline, after treatment, and 6 months after treatment (primary endpoint; 6MFU). Data was also collected on symptom severity and time spent by therapists and participants. The relative Incremental Cost Effectiveness Ratio (ICER) was calculated for the two treatment conditions and the return on investment (ROI).Results: Results showed that ICBT cost $213.5 (20%) more than ICBT-WE per participant. However, ICBT was associated with larger reductions regarding both costs and symptoms than ICBT-WE at 6MFU. The ICER was - 301.69, meaning that for every point improvement on the Gastrointestinal Symptom Rating Scale-IBS version in ICBT, societal costs would be reduced with approximately $300. At a willingness to pay for a case of clinically significant improvement in IBS symptoms of $0, there was an 84% probability of cost-effectiveness. ROI analysis showed that for every $1 invested in ICBT rather than ICBT-WE, the return would be $5.64 six months after treatment. Analyses of post-treatment data showed a similar pattern although cost-savings were smaller.Conclusions: Including exposure in Cognitive Behavior Treatment for IBS is more cost-effective from a societal perspective than not including it, even though it may demand more therapist and patient time in the short term.Trial Registration: This study is reported in accordance with the CONSORT statement for non-pharmacological trials [1]. Clinicaltrials.gov registration ID: NCT01529567 (14/02/2013). [ABSTRACT FROM AUTHOR]

Importance: Health anxiety is a common and often chronic mental health problem associated with distress, substantial costs, and frequent attendance throughout the health care system. Face-to-face cognitive behavior therapy (CBT) is the criterion standard treatment, but access is limited.Objective: To test the hypothesis that internet-delivered CBT, which requires relatively little resources, is noninferior to face-to-face CBT in the treatment of health anxiety.Design, Setting, and Participants: This randomized noninferiority clinical trial with health economic analysis was based at a primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care. Recruitment began in December 10, 2014, and the last treatment ended on July 23, 2017. Follow-up data were collected up to 12 months after treatment. Analysis began October 2017 and ended March 2020.Interventions: Patients were randomized (1:1) to 12 weeks of internet-delivered CBT or to individual face-to-face CBT.Main Outcomes and Measures: Change in health anxiety symptoms from baseline to week 12. Analyses were conducted from intention-to-treat and per-protocol (completers only) perspectives, using the noninferiority margin of 2.25 points on the Health Anxiety Inventory, which has a theoretical range of 0 to 54.Results: Overall, 204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period. Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50%) were randomized to face-to-face CBT. The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25). The between-group effect was not moderated by initial symptom level, recruitment path, or patient treatment preference. Therapists spent 10.0 minutes per patient per week in the online treatment vs 45.6 minutes for face-to-face CBT. The net societal cost was lower in the online treatment (treatment period point difference: $3854). There was no significant group difference in the number of adverse events, and no serious adverse event was reported.Conclusions and Relevance: In this trial, internet-delivered CBT appeared to be noninferior to face-to-face CBT for health anxiety, while incurring lower net societal costs. The online treatment format has potential to increase access to evidence-based treatment for health anxiety.Trial Registration: ClinicalTrials.gov Identifier: NCT02314065. [ABSTRACT FROM AUTHOR]

Background: Alcohol dependence is a common disorder with a continuum regarding severity. Most alcohol-dependent persons have a moderate level of dependence and live under socially orderly conditions. Treatment-seeking in this group is low, mainly due to stigma and because treatment options are seen as unappealing. Alcohol is a relevant topic to discuss in many primary care (PC) consultations and PC is less stigmatizing to visit compared to addiction care units for people with alcohol problems. However, general practitioners (GPs) hesitate to engage in treating alcohol problems due to time constraints and lack of knowledge. Screening and brief interventions are effective for high consumers but there are few studies on dependence.Methods: This is a two-group, parallel, randomized controlled trial (RCT). The aim is to study whether an Internet-based Cognitive Behavioral Treatment (iCBT) when added to treatment as usual (TAU) is more effective than TAU only for alcohol dependence in PC. Two hundred and sixty adults with alcohol dependence will be included. Participants are randomized to iCBT and TAU or TAU only. The primary study outcome is alcohol consumption in grams per week and heavy-drinking days. Secondary outcomes include alcohol-related problem severity, number of diagnostic criteria for alcohol dependence, depression and anxiety symptoms, health-related quality of life and biochemical markers for high consumption and liver pathology. Data will be analyzed using mixed-effect models.Discussion: Internet-based interventions are attractive to, and have been shown to reach, people with alcohol problems. Yet there are no studies investigating the efficacy of Internet treatment of alcohol dependence in PC. In this study we hypothesize that iCBT when added to TAU will improve treatment outcome for alcohol dependence in PC, compared to TAU only. If effective, iCBT can be distributed to the public to a low cost for a stakeholder and has the opportunity to reduce both short-term and long-term public health costs.Trial Registration: ISRCTN69957414. Retrospectively registered on 7 June 2018. [ABSTRACT FROM AUTHOR]

Sick leave due to common mental disorders (CMDs) increase rapidly and present a major societal challenge. The overall effect of psychological interventions to reduce sick leave and symptoms has not been sufficiently investigated and there is a need for a systematic review and meta-analysis of the field. The aim of the present meta-analysis was to calculate the effect size of psychological interventions for CMDs on sick leave and psychiatric symptoms based on all published randomized controlled trials. Methodological quality, the risk of bias and publication bias were also assessed. The literature searches gave 2240 hits and 45 studies were included. The psychological interventions were more effective than care as usual on both reduced sick leave (g = 0.15) and symptoms (g = 0.21). There was no significant difference in effect between work focused interventions, problem-solving therapy, cognitive behavioural therapy or collaborative care. We conclude that psychological interventions are more effective than care as usual to reduce sick leave and symptoms but the effect sizes are small. More research is needed on psychological interventions that evaluate effects on sick leave. Consensual measures of sick leave should be established and quality of psychotherapy for patients on sick leave should be improved. [ABSTRACT FROM AUTHOR]

Background: Prolonged exposure to stress can lead to substantial suffering, impairment and societal costs. However, access to psychological treatment is limited. Internet-based cognitive behavioral therapy (ICBT) can be effective in reducing symptoms of stress, but little is known of its effects in clinical samples. The aim of this study was to investigate the efficacy of ICBT for patients suffering from chronic stress, operationalized as adjustment disorder (AD) and exhaustion disorder (ED).Methods: A total of 100 adults diagnosed with AD or ED were randomly assigned to a 12-week ICBT (n = 50) or waitlist control condition (n = 50). Primary outcome was the level of perceived stress (PSS). Secondary outcomes included several mental health symptom domains as well as functional impairment and work ability. All outcomes were assessed at baseline, after treatment and at the 6-month follow-up. The study was preregistered at Clinicaltrials.gov: NCT02540317.Results: Compared to the control condition, patients in the ICBT group made large and significant improvements on the PSS (d = 1.09) and moderate to large improvements in secondary symptom domains. Effects were maintained at the 6-month follow-up. There was no significant between-group effect on functional impairment or work ability.Conclusions: A relatively short ICBT is indicated to be effective in reducing stress-related symptoms in a clinical sample of patients with AD and ED, and has the potential to substantially increase treatment accessibility. Results must be replicated, and further research is needed to understand the relationship between symptom reduction, functional impairment and work ability. [ABSTRACT FROM AUTHOR]

Background: Common mental disorders (CMD) cause large suffering and high societal costs. Cognitive behavioural therapy (CBT) can effectively treat CMD, but access to treatment is insufficient. Guided self-help (GSH) CBT, has shown effects comparable with face-to-face CBT. However, not all patients respond to GSH, and stepping up non-responders to face-to-face CBT, could yield larger response rates. The aim was to test a stepped care model for CMD in primary care by first evaluating the effects of GSH-CBT and secondly, for non-responders, evaluating the additional effect of face-to-face CBT. Methods: Consecutive patients (N = 396) with a principal disorder of depression, anxiety, insomnia, adjustment or exhaustion disorder were included. In Step I, all patients received GSH-CBT. In Step II, non-responders were randomized to face-to-face CBT or continued GSH. The primary outcome was remission status, defined as a score below a pre-established cutoff on a validated disorder-specific scale. Results: After GSH-CBT in Step I, 40% of patients were in remission. After Step II, 39% of patients following face-to-face CBT were in remission compared with 19% of patients after continued GSH (p = 0.004). Using this stepped care model required less than six therapy sessions per patient and led to an overall remission rate of 63%. Conclusions: Stepped care can be effective and resource-efficient to treat CMD in primary care, leading to high remission rates with limited therapist resources. Face-to-face CBT speeded up recovery compared with continued GSH. At follow-ups after 6 and 12 months, remission rates were similar in the two groups. [ABSTRACT FROM AUTHOR]

During the last two decades, Internet-delivered cognitive behavior therapy (ICBT) has been tested in hundreds of randomized controlled trials, often with promising results. However, the control groups were often waitlisted, care-as-usual or attention control. Hence, little is known about the relative efficacy of ICBT as compared to face-to-face cognitive behavior therapy (CBT). In the present systematic review and meta-analysis, which included 1418 participants, guided ICBT for psychiatric and somatic conditions were directly compared to face-to-face CBT within the same trial. Out of the 2078 articles screened, a total of 20 studies met all inclusion criteria. Results showed a pooled effect size at post-treatment of Hedges g = .05 (95% CI, −.09 to .20), indicating that ICBT and face-to-face treatment produced equivalent overall effects. Study quality did not affect outcomes. While the overall results indicate equivalence, there have been few studies of the individual psychiatric and somatic conditions so far, and for the majority, guided ICBT has not been compared against face-to-face treatment. Thus, more research, preferably with larger sample sizes, is needed to establish the general equivalence of the two treatment formats. [ABSTRACT FROM PUBLISHER]

Objective: Self-rated health (SRH) has been shown to be a stable predictor of illness and mortality. Improvement in SRH, even in the absence of change in objective health, predicts better health and reduced mortality. Severe health anxiety (SHA) is characterized by fear of illness and distorted health perception. The objective of the present study was to investigate if exposure-based cognitive behavior therapy (CBT) for SHA can lead to improvement in SRH and whether this improvement is mediated by reduced health anxiety.Methods: Data were collected from a randomized controlled trial where participants with SHA were allocated to 12weeks of exposure-based CBT (n=99) for SHA or to a no treatment control condition (n=33). The mediation analysis was based on SRH- and health anxiety data collected weekly during the treatment phase.Results: Linear mixed effects models analysis showed a significant interaction effect of group and time indicating superior improvements in SRH in exposure-based CBT compared to the control condition (Z=2.69, p=0.007). The controlled effect size was moderately large (d=0.64) and improvements were stable at 1-year follow-up. Reduced health anxiety was a significant mediator of improvement in SRH.Conclusions: 12weeks of exposure-based CBT for SHA can lead to significant improvements in SRH. Considering the previously established importance of SRH as a predictor for disease and mortality, exposure-based CBT for severe health anxiety may lead to improvements on several important health parameters, possibly even increasing the likelihood of longevity. [ABSTRACT FROM AUTHOR]

Fibromyalgia is a chronic pain condition associated with substantial suffering and societal costs. Traditional cognitive behavior therapy (T-CBT) is the most evaluated psychological treatment, but exposure therapy (Exp-CBT) has shown promise with a pronounced focus on the reduction of pain-related avoidance behaviors. In a recent randomized controlled trial (N = 274), we found that Exp-CBT was not superior to T-CBT (d = −0.10) in reducing overall fibromyalgia severity. This study investigated pain-related avoidance behaviors, pain catastrophizing, hypervigilance, pacing, overdoing and physical activity as potential mediators of the treatment effect. Mediation analyses were based on parallel process growth models fitted on 11 weekly measurement points, and week-by-week time-lagged effects were tested using random intercepts cross-lagged panel models. Results indicated that a reduction in avoidance behaviors, pain catastrophizing, and hypervigilance were significant mediators of change in both treatments. An increase in pacing and a reduction in overdoing were significant mediators in T-CBT only. Physical activity was not a mediator. In the time-lagged analyses, an unequivocal effect on subsequent fibromyalgia severity was seen of avoidance and catastrophizing in Exp-CBT, and of overdoing in T-CBT. Exposure-based and traditional CBT for fibromyalgia appear to share common treatment mediators, namely pain-related avoidance behavior, catastrophizing and hypervigilance. • Mediators in exposure-based and traditional CBT for fibromyalgia were studied. • Three of them were significant mediators in both treatments. • These were pain-related avoidance behavior, hypervigilance and pain catastrophizing. • Pacing and overdoing were mediators in traditional CBT only. • Exposure-based and traditional CBT for fibromyalgia appear to share common mediators. [ABSTRACT FROM AUTHOR]

Fibromyalgia is a debilitating pain condition for which treatment effects are typically modest. The most evaluated psychological treatment is traditional cognitive behavior therapy (T-CBT), but promising effects have recently been seen in exposure-based cognitive behavior therapy (Exp-CBT). We investigated whether Exp-CBT was superior to T-CBT in a randomized controlled trial. Self-referred participants with fibromyalgia (N = 274) were randomized (1:1) to 10 weeks of Exp-CBT or T-CBT. Treatments were delivered online and presented as "CBT for fibromyalgia." Participants were assessed at baseline, weekly during treatment, posttreatment, and at 6- and 12-month follow-up. Primary outcome was the difference in reduction in fibromyalgia severity as measured using the Fibromyalgia Impact Questionnaire (FIQ) over 11 assessment points from baseline to posttreatment, modelled within an intention-to-treat framework using linear mixed effects models fitted on multiple imputed data. Approximately 91% of weekly FIQ scores were collected over the main phase. There was no significant difference between Exp-CBT and T-CBT in the mean reduction of fibromyalgia severity from pretreatment to posttreatment (b = 1.3, 95% CI -3.0 to 5.7, P = 0.544, d = -0.10). Minimal clinically important improvement was seen 60% in Exp-CBT vs 59% in T-CBT. Effects were sustained up to 12 months posttreatment. This well-powered randomized trial indicated that Exp-CBT was not superior to T-CBT for fibromyalgia. Both treatments were associated with a marked reduction in fibromyalgia severity, and the online treatment format might be of high clinical utility. T-CBT can still be regarded a reference standard treatment that remains clinically relevant when compared to novel treatment approaches. [ABSTRACT FROM AUTHOR]

Evidence supporting the effectiveness of cognitive behavior therapy (CBT) for stress-related illness is growing, but little is known about its mechanisms of change. The aim of this study was to investigate potential mediators of CBT for severe stress in form of clinical burnout, using an active psychological treatment as comparator. We used linear mixed models to analyze data from patients (N = 82) with clinical burnout who received either CBT or another psychological treatment in a randomized controlled trial. Potential mediators (i.e., sleep quality, behavioral activation, perceived competence, and therapeutic alliance) and outcome (i.e., symptoms of burnout) were assessed weekly during treatment. The results showed that the positive treatment effects on symptoms of burnout favoring CBT (estimated between-group d = 0.93) were mediated by improvements in sleep quality, ab = -0.017, 95% CIasymmetric [-0.037, -0.002], and increase in perceived competence, ab = -0.037, 95% CIasymmetric [-0.070, -0.010]. Behavioral activation, ab = -0.004 [-0.016, 0.007], and therapeutic alliance, ab = 0.002 [-0.006, 0.011], did not significantly mediate the difference in effects between the treatments. Improving sleep quality and increasing perceived competence may thus constitute important process goals in order to attain symptom reduction in CBT for clinical burnout. [ABSTRACT FROM AUTHOR]

Strategies to increase the availability of cognitive behaviour therapy (CBT) for severe health anxiety (SHA) are needed, and this study investigated the cost-effectiveness and long-term efficacy of three forms of minimal-contact CBT for SHA. We hypothesised that therapist-guided internet CBT (G-ICBT), unguided internet CBT (U-ICBT), and cognitive behavioural bibliotherapy (BIB-CBT) would all be more cost-effective than a waiting-list condition (WLC), as assessed over the main phase of the trial. We also hypothesised that improvements would remain stable up to one-year follow-up. Adults ( N  = 132) with principal SHA were randomised to 12 weeks of G-ICBT, U-ICBT, BIB-CBT, or WLC. The primary measure of cost-effectiveness was the incremental cost-effectiveness ratio, or the between-group difference in per capita costs divided by the between-group difference in proportion of participants in remission. The Health anxiety inventory (HAI) was the primary efficacy outcome. G-ICBT, U-ICBT, and BIB-CBT were more cost-effective than the WLC. Over the follow-up period, the G-ICBT and BIB-CBT groups made further improvements in health anxiety, whereas the U-ICBT group did not change. As expected, all three treatments were cost-effective with persistent long-term effects. CBT without therapist support appears to be a valuable alternative to G-ICBT for scaling up treatment for SHA. [ABSTRACT FROM AUTHOR]

The aim of this study was to investigate insomnia symptom severity as a putative mediator of treatment response in therapist-guided internet-based cognitive behavioral therapy (ICBT) for chronic stress, using data from a randomized controlled trial. Participants (N = 100) were randomized to 12 weeks of ICBT or to a waitlist control condition (WLC). Insomnia severity was assessed weekly with the Insomnia Severity Index (ISI), as were the stress-related outcomes the Perceived Stress Scale (PSS) and the Shirom-Melamed Burnout Questionnaire (SMBQ). Latent growth models indicated that ICBT (vs. WLC) predicted a decrease in insomnia severity (α-path), and that growth in insomnia severity was predictive of growth in perceived stress and exhaustion (β-paths). Most importantly, there were also significant indirect effects (αβ products) such that the beneficial effects of ICBT on perceived stress and exhaustion were mediated by a reduction in insomnia symptom severity (PSS: αβ = −0.44, 95% CI [-0.92, −0.14]; SMBQ: αβ = −0.08, 95% CI [-0.15, −0.04]). Explorative analysis of moderated mediation showed that more severe insomnia symptoms at baseline were associated with larger mediated effects. We conclude that reducing insomnia severity could be of importance for achieving successful treatment outcomes in ICBT for chronic stress. • Internet-based cognitive behavior therapy (ICBT) is efficacious for chronic stress. • Little is known about how ICBT works and for whom. • In this RCT, based on weekly assessments, we analyzed insomnia as a mediator. • We found that insomnia mediates effect of ICBT on exhaustion and perceived stress. • More insomnia at baseline was associated with larger mediated effects. [ABSTRACT FROM AUTHOR]