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This Rome Foundation Working Team Report reflects the consensus of an international interdisciplinary team of experts regarding the use of behavioral interventions, specifically brain-gut behavior therapies (BGBTs), in patients with disorders of gut-brain interaction (DGBIs). The committee members reviewed the extant scientific literature and, when possible, addressed gaps in this literature through the lens of their clinical and scientific expertise. The Delphi method was used to create consensus on the goals, structure, and framework before writing the report. The report is broken into 5 parts: 1) definition and evidence for BGBT, 2) the gut-brain axis as the mechanistic basis for BGBT, 3) targets of BGBTs, 4) common and unique therapeutic techniques seen in BGBT, and 5) who and how to refer for BGBT. We chose to not only review for the reader the 5 existing classes of BGBT and their evidence, but to connect DGBI-specific behavioral targets and techniques as they relate directly, or in some cases indirectly, to the gut-brain axis. In doing so, we expect to increase gastrointestinal providers' confidence in identifying and referring appropriate candidates for BGBT and to support clinical decision making for mental health professionals providing BGBT. Both gastrointestinal medical providers and behavioral health providers have an opportunity to optimize care for DGBIs through a collaborative integrated approach that begins with an effective patient-provider relationship, thoughtful communication about the brain-gut axis and, when appropriate, a well communicated referral to BGBT. The Rome Foundation's Working Team Report on Brain-Gut Behavior Therapies empowers gastroenterologists to effectively communicate the scientific rationale for and the approach to brain-gut behavior therapies as part of integrated care. [ABSTRACT FROM AUTHOR]

Reports on cross-sectional and longitudinal associations between health-related quality of life (HRQoL), psychological distress, and irritable bowel syndrome (IBS) in the adolescent and young adult general population are few. We aimed to describe cross-sectional associations between HRQoL and IBS in adolescence and young adulthood, and examine bidirectional gut-brain interactions in the transition from childhood to adulthood. We included 3391 subjects from a prospective birth cohort study, with data on IBS at 16 years of age and 24 years of age. IBS was assessed using the pediatric Rome III (16 years of age) and the adult Rome IV (24 years of age) diagnostic questionnaires. HRQoL and psychological distress were assessed through EQ-5D. Sex-adjusted logistic regression models were used to examine associations between overall HRQoL/psychological distress at 16 years of age and new-onset IBS at 24 years of age (brain-gut) and between IBS at 16 years of age and new-onset psychological distress at 24 years of age (gut-brain). In subjects with vs without IBS at 16 and 24 years of age, overall HRQoL (EQ visual analog scale, EQ-5D index value) was lower, and it was more common reporting problems in 4 of 5 EQ-5D dimensions (all P <.05). EQ-5D index value at 16 years of age was inversely associated (odds ratio [OR], 0.1, 95% confidence interval [CI], 0.01–0.6), and psychological distress at 16 years of age was positively associated (OR, 1.6; 95% CI, 1.2–2.3), with new-onset IBS at 24 years of age. Having any abdominal pain–related disorder of gut-brain interaction at 16 years of age was associated with new-onset psychological distress at 24 years of age (OR, 1.7; 95% CI, 1.2–2.5). Adolescents and young adults with IBS in the general population have impaired HRQoL. Bidirectional gut-brain interactions are relevant for symptom generation in abdominal pain–related disorders of gut-brain interaction, and for HRQoL impairment and psychological distress in the transition from childhood to adulthood. [ABSTRACT FROM AUTHOR]

Avoidant/restrictive food intake disorder (ARFID) symptoms are common (up to 40%) among adults with functional dyspepsia (FD), a disorder of gut-brain interaction characterized by early satiation, post-prandial fullness, epigastric pain, and/or epigastric burning. Using an 8-session exposure-based cognitive-behavioral treatment (CBT) for adults with FD + ARFID compared to usual care (UC) alone, we aim to: (1) determine feasibility, (2) evaluate change in clinical outcomes in, and (3) explore possible mechanisms of action. We will randomize adults with FD who meet criteria for ARFID with ≥5% weight loss (N = 50) in a 1:1 ratio to CBT (with continued UC) or to UC alone. A priori primary benchmarks will be: ≥75% eligible participants enroll; ≥75% participants complete assessments; ≥70% participants attend 6/8 sessions; ≥70% of sessions have all content delivered; ≥70% participants rate Client Satisfaction Questionnaire scores above scale midpoint. We will also examine the size of changes in FD symptom severity and related quality of life within and between groups, and explore possible mechanisms of action. Findings from this trial will inform next steps with treatment development or evaluation—either for further refinement or for next-step efficacy testing with a fully-powered clinical trial. [ABSTRACT FROM AUTHOR]

We investigated the occurrence and effects of sudden gains in internet-based cognitive behavioral therapy (ICBT) for obsessive-compulsive disorder (OCD). As secondary analysis, we studied whether sudden gains are moderated by D-Cycloserine (DCS). Using data from a recent trial (N = 128), we assessed sudden gains based on weekly symptom change on the self-rated Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Treatment outcome was assessed using the clinician-administered Y-BOCS. We compared treatment outcomes for sudden gainers vs. non-sudden gainers and gradual gainers at post-treatment and 3, 12 and 24-month follow-up. Thirty-eight percent of the patients experienced a sudden gain. Sudden gainers showed significantly larger improvements on the clinician-administered Y-BOCS than non-sudden gainers at post-treatment (d = 1.11), as well as at 3-month (d = 1.06), 12-month (d = 0.88) and 24-month follow-up (d = 0.77). Sudden gainers also showed significantly less severe OCD symptoms than gradual gainers at post-treatment (d = 0.50), as well as 3-month (d = 0.55) and 12-month follow-up (d = 0.57). In addition, patients receiving DCS showed a significantly higher rate of sudden gains. Sudden gains are common in ICBT for OCD and are associated with favorable short and long-term treatment outcomes. • We investigated sudden gains in internet-based CBT for OCD. • Sudden gains were common. • Sudden gains were associated with greater symptom improvements during treatment. • Sudden gains were associated with better short- and long-term treatment outcomes. • Patients receiving D-Cycloserine showed a higher frequency of sudden gains. [ABSTRACT FROM AUTHOR]

Fibromyalgia (FM) is a prevalent and debilitating chronic pain disorder associated with a substantial economic burden. Although there are several studies investigating the effectiveness of psychological treatments such as cognitive-behavioral therapy for FM, studies on cost-effectiveness are scarce. The aim of the present study was to investigate the cost-effectiveness of Internet-delivered exposure therapy (iExp) for FM. We used health economic data from a recently conducted randomized, controlled trial, where 140 participants were randomized to either iExp or a waitlist control (WLC) condition. Economic data were collected at pre-treatment, post-treatment, and at the 1-year follow-up. Treatment effectiveness in relation to costs were analyzed using both a societal perspective (including all direct and indirect costs) and a health care unit perspective (including only the direct treatment costs). Bootstrapped net benefit regression analyses were also conducted, comparing the difference in costs and effects between iExp and WLC, within different willingness-to-pay scenarios. Results showed that the incremental cost-effectiveness ratio was -$15,295, indicating that iExp was highly cost-effective as each successfully treated case (treatment responder) was associated with a substantial net reduction in costs. The robustness of the results was tested in 2 different sensitivity analyses, where iExp remained cost-effective, even in a willingness-to-pay-scenario of $0. We conclude that iExp is a cost-effective treatment that generates large societal cost savings. PERSPECTIVE: Health-economic evaluations of psychological interventions for FM are scarce. This study is a cost-effectiveness analysis of Internet-delivered exposure therapy for patients with FM. Results showed that iExp was highly cost-effective compared with no treatment, where each successfully treated case generated a substantial societal cost saving. [ABSTRACT FROM AUTHOR]

Severe health anxiety (SHA) shares features with obsessive-compulsive disorder (OCD) and in recent years there has been a debate as to whether the two disorders may represent two facets of the same condition. Few studies have however investigated the overlap and differences in symptom profiles between the disorders. The primary aim of the present study was to investigate these aspects using one sample of participants with a principal diagnosis of SHA and one sample of participants with a principal OCD diagnosis. The second aim was to examine differences in improvement trajectories on measures of health anxiety and OCD symptoms in patients with SHA receiving treatment with exposure and response prevention. We compared persons participating in clinical trials with a principal diagnosis of SHA ( N = 290) to persons with a principal diagnosis of OCD ( n = 95) on measures of health anxiety, OCD symptoms, and depressive symptoms. A subsample of SHA participants ( n = 99) received exposure and response prevention (ERP) for SHA over 12 weeks and was assessed at baseline and post-treatment. The results showed large and significant differences between SHA and OCD patients on measures of health anxiety ( d s = 2.99–3.09) and OCD symptoms ( ds = 1.64–2.14), while they had equivalent levels of depressive symptoms ( d = 0.19, 95% CI [−0.04, 0.43]). In the SHA sample 7.6% had comorbid OCD, and in the OCD sample 9.5% had SHA. For participants with a principal diagnosis of SHA, ERP led to large reductions of health anxiety, but effects on OCD symptoms were small to moderate. Among participants with comorbid OCD, effect sizes were large on measures of health anxiety and moderate to large on OCD measures. We conclude that SHA and OCD are separate psychiatric disorders with limited overlap in symptom profiles. [ABSTRACT FROM AUTHOR]

Background Cognitive behaviour therapy (CBT) has been shown to be an effective treatment for anxiety disorders in children, but few affected seek or receive treatment. Internet-delivered CBT (ICBT) could be a way to increase the availability of empirically supported treatments. Aims A randomised controlled trial was conducted to evaluate ICBT for children with anxiety disorders. Method Families (N = 93) with a child aged 8–12 years with a principal diagnosis of generalised anxiety disorder, panic disorder, separation anxiety, social phobia or specific phobia were recruited through media advertisement. Participants were randomised to 10 weeks of ICBT with therapist support, or to a waitlist control condition. The primary outcome measure was the Clinician Severity Rating (CSR) and secondary measures included child- and parent-reported anxiety. Assessments were made at pre-treatment, post-treatment and at three-month follow-up. Results At post-treatment, there were significant reductions on CSR in the treatment group, with a large between-group effect size (Cohen's d = 1.66). Twenty per cent of children in the treatment group no longer met criteria for their principal diagnosis at post-treatment and at follow-up this number had increased to 50%. Parent-reported child anxiety was significantly lower in the treatment group than in the waitlist group at post-treatment, with a small between-group effect size (Cohen's d = 0.45). There were no significant differences between the groups regarding child-ratings of anxiety at post-treatment. Improvements were maintained at three-month follow-up, although this should be interpreted cautiously due to missing data. Conclusions Within the limitations of this study, results suggest that ICBT with therapist support for children with anxiety disorders can reduce clinician- and parent-rated anxiety symptoms. Trial registration Clinicaltrials.gov: NCT01533402 . [ABSTRACT FROM AUTHOR]

Background The Health Anxiety Inventory (HAI), the Illness Attitude Scales (IAS), and the Whiteley Index (WI) are three of the most widely used health anxiety measures, but their psychometric properties have not been investigated when administered via the Internet. Methods We investigated the three instruments' test–retest reliability, internal consistency, convergent, and discriminant validity and sensitivity to change using one sample ( n = 111) of participants with severe health anxiety and one sample of healthy controls ( n = 92). Results The HAI, IAS, and WI showed high test–retest reliability ( r s ≥ .80), good convergent, and discriminant validity and were sensitive to detect change. The HAI and IAS ( α s ≥ .85), but not the WI ( α s ≤ .60) demonstrated high internal consistency. Conclusions The HAI, IAS, and WI have good psychometric properties, except for the low internal consistency of WI, when used as Internet-administered measures of health anxiety. Using these measures over the Internet offers highly important advantages such as increased ease of administration, reduced attrition, and cost-efficient treatment evaluation. [ABSTRACT FROM AUTHOR]

Obsessive-compulsive disorder (OCD) is a common and disabling disorder. Although evidence-based psychological treatments exists, such as cognitive behavior therapy (CBT), the cost-effectiveness of CBT has not been properly investigated. In this trial, we used health economic data from a recently conducted randomized controlled trial, where 101 OCD patients were allocated to either internet-based CBT (ICBT) or control condition (online support therapy). We analyzed treatment effectiveness in relation to costs, using both a societal- (including all direct and indirect costs) and a health care unit perspective (including only the direct treatment costs). Bootstrapped net benefit regression analyses were also conducted, comparing the difference in costs and effects between ICBT and control condition, with different willingness-to-pay scenarios. Results showed that ICBT produced one additional remission for an average societal cost of $931 and this figure was even lower ($672) when narrowing the perspective to treatment costs only. The cost-utility analysis also showed that ICBT generated one additional QALY to an average price of $7186 from a societal perspective and $4800 when just analyzing the treatment costs. We conclude that ICBT is a cost-effective treatment and the next step in this line of research is to compare the cost-effectiveness of ICBT with face-to-face CBT. [ABSTRACT FROM AUTHOR]

Cognitive behavior therapy (CBT) is an effective treatment for OCD when delivered face-to-face, in group-format and also via the internet. However, despite overall large effect sizes, a considerable amount of the patients relapse. One intervention that has the potential to reduce these relapse rates is booster programs, but if booster program is a cost-effective method of preventing relapse is still unknown. We used health economical data from a recent randomized controlled trial, where patients who had undergone an internet-based CBT were randomly allocated to receive an additional booster program. Assessment points were 4-, 7-, 12- and 24-month. Health economical data were primarily analyzed using a societal perspective. Results showed that the booster program was effective in preventing relapse, and the cost of one avoided relapse was estimated to $1066–1489. Cost-effectiveness acceptability curves showed that the booster program had a 90% probability of being cost-effective given a willingness to pay of $1000–1050 the first year, but this figure grew considerably after two years ($2500–5500). We conclude that internet-based booster programs are probably a cost-effective alternative within one-year time frame and that more treatment may be needed to maintain adequate cost-effectiveness up to two years. [ABSTRACT FROM AUTHOR]

Internet-based cognitive behavior therapy (ICBT) for obsessive–compulsive disorder (OCD) has shown efficacy in randomized trials but many patients do not respond to the treatment, we therefore need to find predictors and moderators of treatment response. In this study, we analyzed predictors of ICBT response using both post-treatment as well as 24-month outcome data. As half of the participants were randomized to receive an Internet-based booster program as an adjunct to ICBT, we also investigated moderators of ICBT with or without booster. Results showed that more severe baseline OCD symptoms predicted worse end state outcome but also higher degree of change. Furthermore, high degree of working alliance predicted better outcome but patients with primary disgust emotions had worse treatment effects. The moderator analysis also indicated that scoring high on the obsessing subscale on the Obsessive–Compulsive Inventory-Revised predicted worse treatment outcome in the booster group. In conclusion, there are some possible predictors and moderators of ICBT for OCD but more research is needed with larger and clinically representative samples. [ABSTRACT FROM AUTHOR]

Abstract: An internet-delivered cognitive behavioral treatment (ICBT) based on systematic exposure exercises has previously shown beneficial effects for patients with irritable bowel syndrome (IBS). Exposure exercises may be perceived as difficult for patients to perform because of the elicited short-term distress and clinicians may be reluctant to use these interventions. The aim of this study was to compare ICBT with the same protocol without systematic exposure (ICBT-WE) to assess if exposure had any incremental value. This randomized controlled dismantling study included 309 participants diagnosed with IBS. The treatment interventions lasted for 10 weeks and included online therapist contact. ICBT-WE comprised mindfulness, work with life values, acceptance, and encouraged reduced avoidance behaviors, while ICBT also included systematic exposure to IBS symptoms and related situations. Severity of IBS symptoms was measured with the Gastrointestinal Symptom Rating Scale – IBS version (GSRS-IBS). The between-group Cohen's d on GSRS-IBS was 0.47 (95% CI: 0.23–0.70) at post-treatment and 0.48 (95% CI: 0.20–0.76) at 6-month follow-up, favoring ICBT. We conclude that the systematic exposure included in the ICBT protocol has incremental effects over the other components in the protocol. This study provides evidence for the utility of exposure exercises in psychological treatments for IBS. [Copyright &y& Elsevier]

Abstract: We conducted a follow-up of a previously reported study of internet-delivered cognitive behavior therapy (CBT) for IBS, based on exposure and mindfulness exercises (Ljótsson et al. (2010). Internet-delivered exposure and mindfulness based therapy for irritable bowel syndrome – a randomized controlled trial. Behaviour Research and Therapy, 48, 531–539). Seventy-five participants from the original sample of 85 (88%) reported follow-up data at 15–18 months (mean 16.4 months) after completing treatment. The follow-up sample included participants from both the original study’s treatment group and waiting list after it had been crossed over to treatment. Intention-to-treat analysis showed that treatment gains were maintained on all outcome measures, including IBS symptoms, quality of life, and anxiety related to gastrointestinal symptoms, with mainly large effect sizes (within-group Cohen’s d =0.78–1.11). A total of fifty participants (59% of the total original sample; 52% of the original treatment group participants and 65% of the original waiting list participants) reported adequate relief of symptoms. Improvements at follow-up were more pronounced for the participants that had completed the full treatment and maintenance of improvement did not seem to be dependent on further treatment seeking. This study suggests that internet-delivered CBT based on exposure and mindfulness has long-term beneficial effects for IBS-patients. [ABSTRACT FROM AUTHOR]

Abstract: We conducted a study of a group therapy based on exposure and mindfulness in the treatment of irritable bowel syndrome (IBS). Out of 49 outpatients, most of whom were referred from gastroenterological clinics, 34 entered into the 10-week treatment. Patients were assessed before, immediately after and 6 months after treatment. The assessments consisted of a gastrointestinal symptom diary, self-report questionnaires covering quality of life, gastrointestinal specific anxiety, general functioning, and a psychiatric interview. At post-treatment, the mean reduction in symptoms was 41% and 50% of patients showed clinically significant improvement in symptom level. Patients also showed marked improvement on other outcome measures. Treatment gains were maintained at follow-up. The results support the use of exposure and mindfulness based strategies in the treatment of IBS, but further randomised studies are needed to confirm the efficacy of the treatment. [Copyright &y& Elsevier]

Abstract: The Internet has become increasingly popular as a way to administer self-report questionnaires, especially in the field of Internet delivered psychological treatments. Collecting questionnaire data over the Internet has advantages, such as ease of administration, and automated scoring. However, psychometric properties cannot be assumed to be identical to the paper-and-pencil versions. The aim of this study was to test the equivalence of paper-and-pencil and Internet administered versions of self-report questionnaires used in social phobia research. We analyzed data from two trials in which samples were recruited in a similar manner. One sample (N =64) completed the paper-and-pencil version of questionnaires and the second sample (N =57) completed the same measures online. We included the Liebowitz Social Anxiety Scale-self-assessment (LSAS-SR), the Social Interaction and Anxiety Scale (SIAS), and the Social Phobia Scale (SPS) as measures of social anxiety. Also included were the Montgomery Åsberg Depression Rating Scale-self-assessment (MADRS-S), the Beck Anxiety Inventory (BAI), and the Quality of Life Inventory (QOLI). Results showed equivalent psychometric properties across administration formats. Cronbach’s α ranged between 0.77 and 0.94. There was an indication of a somewhat higher construct validity when participants filled out questionnaires using paper-and-pencil. We conclude that the LSAS-SR, SIAS, and SPS can be administered via the Internet with maintained psychometric properties. [Copyright &y& Elsevier]

Abstract: The aim of this study was to investigate if cognitive behavior therapy (CBT) based on exposure and mindfulness exercises delivered via the Internet would be effective in treating participants with irritable bowel syndrome (IBS). Participants were recruited through self-referral. Eighty-six participants were included in the study and randomized to treatment or control condition (an online discussion forum). One participant was excluded after randomization. The main outcome measure was IBS-symptom severity and secondary measures included IBS-related quality of life, GI-specific anxiety, depression and general functioning. Participants were assessed at pre-treatment, post-treatment and 3 month follow-up (treatment condition only). Four participants (5% of total sample) in the treatment condition did not participate in post-treatment assessment. Participants in the treatment condition reported a 42% decrease and participants in the control group reported a 12% increase in primary IBS-symptoms. Compared to the control condition, participants in the treatment group improved on all secondary outcome measures with a large between group effect size on quality of life (Cohen’s d = 1.21). We conclude that CBT-based on exposure and mindfulness delivered via the Internet can be effective in treating IBS-patients, alleviating the total burden of symptoms and increasing quality of life. [Copyright &y& Elsevier]

Structured education can reduce symptoms in patients with irritable bowel syndrome (IBS), but the availability of such interventions is limited and online formats could facilitate their dissemination. We compared the effectiveness of Internet-delivered vs face-to-face education in patients with IBS, hypothesizing that the online format would not be inferior. We conducted 2 trials of Internet-delivered vs face-to-face group education (3 weeks) at a gastroenterology outpatient clinic in Sweden. In the first trial, 141 patients with IBS were assigned randomly (1:1) to either Internet-delivered or face-to-face education, from August 2016 through June 2017. In the second trial, 155 patients with IBS were allowed to choose whether to receive education via the Internet or face to face, from August 2017 through September 2018. Patients completed questionnaires before, during, and after education. The primary outcome measure was the irritable bowel syndrome severity scoring system, which measures IBS severity on a scale from 0 to 500, based on abdominal pain, bloating, dissatisfaction with bowel habits, and interference with life. The primary test of noninferiority adhered to the intent-to-treat principle and concerned the difference in change up to 6 months after education, tested using the 1-sided CI for the time by group interaction in a linear mixed model fitted on data from the randomized controlled trial. A secondary per-protocol analysis used data from all treatment completers in both trials. The noninferiority margin was 40 points on the irritable bowel syndrome severity scoring system. In the primary analysis, patients who received face-to-face education had an average reduction in irritable bowel syndrome severity score that was 12.2 points more than that of patients who received Internet education (1-sided 95% CI upper bound, 38.4). In the per-protocol analysis, patients who received face-to-face education reduced their average irritable bowel syndrome severity score by 14.7 points more than patients who received Internet education (95% CI upper bound, 35.5). Face-to-face education had significantly higher credibility and produced a significantly larger increase in self-rated knowledge, although most patients preferred Internet-delivered education. Between-group effects on secondary symptoms were small. Based on the comparison of Internet-delivered vs face-to-face education for IBS, the upper bound of the CI for the difference in change up to 6 months after education was within the noninferiority margin of 40 points. We therefore conclude that Internet-delivered education is noninferior to face-to-face education. Future research should focus on increasing within-group effects. ClinicalTrials.gov no: NCT03466281. [ABSTRACT FROM AUTHOR]

There is controversy about whether psychological factors (anxiety and depression) increase health care seeking by patients with irritable bowel syndrome (IBS). We investigated whether psychological factors increase health care seeking by patients with IBS and the effects of extragastrointestinal (extra-GI) symptoms. We performed a population-based prospective study of health care use over a 12-year period in Sweden. From 2002 through 2006, 1244 subjects were selected randomly for an examination by a gastroenterologist and to complete questionnaires, including the Rome II modular questionnaire. Psychological factors were measured with the valid Hospital Anxiety and Depression scale and extra-GI symptoms were measured with a symptom checklist. Responses from 1159 subjects (57% female; mean age, 48.65 y) were matched with health records in 2016 (164 were classified as having IBS based on Rome II criteria). The overall association between depression or anxiety and health care use varied in subjects with and without IBS at baseline. The presence of extra-GI symptoms strengthened the relationship between anxiety and depression and prospective psychiatric visits for subjects with IBS and without IBS (incidence rate ratio, 1.14–1.26). Extra-GI symptoms did not alter the association of anxiety or depression with use of GI or extra-GI health care. In a population-based study in Sweden, we found that individuals with high baseline anxiety or depression were more likely to seek psychiatric health care, but not GI or extra-GI health care, in the presence of extra-GI symptoms at baseline. Patients with IBS might benefit from more thorough assessments that examine extra-GI and psychological symptoms, to reduce health care utilization. [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]

Atrial fibrillation (AF) is often associated with troubling symptoms leading to impaired quality of life (QoL) and high health care use. Symptom preoccupation, that is, fear of cardiac-related symptoms and avoidance behavior, potentially contributes to disability in AF but is not targeted by current interventions. We sought to evaluate the effect of online cognitive behavior therapy (AF-CBT) on QoL in patients with symptomatic paroxysmal AF. Patients with symptomatic paroxysmal AF (n = 127) were randomly assigned to receive AF-CBT (n = 65) or standardized AF education (n = 62). Online AF-CBT lasted 10 weeks and was therapist guided. The main components were exposure to cardiac-related symptoms and reduction of AF-related avoidance behavior. Patients were evaluated at baseline, posttreatment, and at the 3-month follow-up. Primary outcome was AF-specific QoL as assessed by the Atrial Fibrillation Effect on Quality of Life summary score (range: 0-100) at the 3-month follow-up. Secondary outcomes included AF-specific health care consumption and AF burden assessed by 5-day continuous electrocardiogram recording. The AF-CBT group was followed for 12 months. AF-CBT led to large improvements in AF-specific QoL (Atrial Fibrillation Effect on Quality of Life summary score) by 15.0 points (95% CI: 10.1-19.8; P < 0.001). Furthermore, AF-CBT reduced health care consumption by 56% (95% CI: 22-90; P = 0.025). The AF burden remained unchanged. Results on self-assessed outcomes were sustained 12 months after treatment. In patients with symptomatic paroxysmal AF, online CBT led to large improvements in AF-specific QoL and reduced health care use. If these results are replicated, online CBT may constitute an important addition to AF management. (Internet-Delivered Cognitive Behavior Therapy for Atrial Fibrillation; NCT03378349) [Display omitted] [ABSTRACT FROM AUTHOR]

LGBTQ-affirmative cognitive-behavioral therapy (CBT) addresses minority stress to improve sexual minority individuals' mental and behavioral health. This treatment has never been tested in high-stigma contexts like China using online delivery. Chinese young sexual minority men (n = 120; ages 16–30; HIV-negative; reporting depression and/or anxiety symptoms and past-90-day HIV-transmission-risk behavior), were randomized to receive 10 sessions of culturally adapted asynchronous LGBTQ-affirmative internet-based CBT (ICBT) or weekly assessments only. The primary outcome included HIV-transmission-risk behavior (i.e., past-30-day condomless anal sex). Secondary outcomes included HIV social-cognitive mechanisms (e.g., condom use self-efficacy), mental health (e.g., depression), and behavioral health (e.g., alcohol use), as well as minority stress (e.g., acceptance concerns), and universal (e.g., emotion regulation) mechanisms at baseline and 4- and 8-month follow-up. Moderation analyses examined treatment efficacy as a function of baseline stigma experiences and session completion. Compared to assessment only, LGBTQ-affirmative ICBT did not yield greater reductions in HIV-transmission-risk behavior or social-cognitive mechanisms. However, LGBTQ-affirmative ICBT yielded greater improvements in depression (d = −0.50, d = −0.63) and anxiety (d = −0.51, d = −0.49) at 4- and 8-month follow-up, respectively; alcohol use (d = −0.40) at 8-month follow-up; and certain minority stress (e.g., internalized stigma) and universal (i.e., emotion dysregulation) mechanisms compared to assessment only. LGBTQ-affirmative ICBT was more efficacious for reducing HIV-transmission-risk behavior for participants with lower internalized stigma (d = 0.42). Greater session completion predicted greater reductions in suicidality and rumination. LGBTQ-affirmative ICBT demonstrates preliminary efficacy for Chinese young sexual minority men. Findings can inform future interventions for young sexual minority men in contexts with limited affirmative supports. • LGBTQ-affirmative internet-based CBT was tested among sexual minority men in China. • LGBTQ-affirmative ICBT yielded greater mental health effects than assessment-only. • Treatment impact on HIV risk was stronger for those with lower internalized stigma. • Identity-focused treatments might be most efficacious in high-stigma settings. [ABSTRACT FROM AUTHOR]

Abstract: Objective: A sudden gain is defined as a large and stable individual improvement occurring between two consecutive treatment sessions. Sudden gains have been shown to predict better long-term improvement in several treatment studies, including cognitive behavioural therapy for depression and anxiety disorders, but have not been studied in the treatment of health anxiety or any form of internet-based cognitive behavioural therapy. The aim of this study was to investigate the role of sudden gains in internet-based cognitive behavioural therapy for severe health anxiety. Method: We examined the occurrence and significance of sudden gains in measures of health anxiety in 81 participants receiving internet-based cognitive behavioural therapy. We compared patients with sudden gains, patients without sudden gains, and patients with gradual gains. Results: Thirteen participants (16%) experienced one sudden gain in health anxiety with individual sudden gains distributed across the treatment. As expected, patients with a sudden gain showed larger improvements than patients without a sudden gain at post-treatment (d = 1.04) and at one-year follow-up (d = 0.91) on measures of health anxiety. Conclusions: Consistent with previous studies, sudden gains in internet-based cognitive behavioural therapy are associated with significantly larger and stable treatment effects up to one-year follow-up. [Copyright &y& Elsevier]

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]

Abstract: Social anxiety disorder (SAD) is highly prevalent and associated with a substantial societal economic burden, primarily due to high costs of productivity loss. Cognitive behavior group therapy (CBGT) is an effective treatment for SAD and the most established in clinical practice. Internet-based cognitive behavior therapy (ICBT) has demonstrated efficacy in several trials in recent years. No study has however investigated the cost-effectiveness of ICBT compared to CBGT from a societal perspective, i.e. an analysis where both direct and indirect costs are included. The aim of the present study was to investigate the cost-effectiveness of ICBT compared to CBGT from a societal perspective using a prospective design. We conducted a randomized controlled trial where participants with SAD were randomized to ICBT (n =64) or CBGT (n =62). Economic data were assessed at pre-treatment, immediately following treatment and six months after treatment. Results showed that the gross total costs were significantly reduced at six-month follow-up, compared to pre-treatment in both treatment conditions. As both treatments were equivalent in reducing social anxiety and gross total costs, ICBT was more cost-effective due to lower intervention costs. We conclude that ICBT can be more cost-effective than CBGT in the treatment of SAD and that both treatments reduce societal costs for SAD. [Copyright &y& Elsevier]

Functional abdominal pain (FAP) and functional dyspepsia (FD) are common in adolescents and associated with low quality of life. Exposure-based cognitive-behavioral therapy (CBT) is efficient for adult and adolescent irritable bowel syndrome (IBS), but has never been evaluated for adolescent FAP/FD. The aim of this study was to evaluate the feasibility and potential efficacy of a novel disorder-specific Internet-delivered CBT (Internet-CBT) for adolescents with FAP or FD, using an uncontrolled open pilot including 31 adolescents. The Internet-CBT consisted of 10 weekly online modules, which focused mainly on exposure to abdominal symptoms. Parents received modules to help them reduce unhelpful parental behaviors. Participants reported the treatment to be credible, and an overall satisfaction with the treatment. Data attrition rate was low (7%) and adherence to treatment was acceptable. We saw a significant and large effect on the primary outcome, pain intensity, at posttreatment (d = 1.20, p < .001) that was further improved after 6 months (d = 1.69, p < .001). Participants also made significant and large improvements on gastrointestinal symptoms (d = 0.84, p < .001) and quality of life (d = 0.84, p < .001) that were sustained or further improved at follow-up 6 months after treatment. This study demonstrated that exposure-based Internet-CBT, tailored for adolescents with FAP or FD, is a feasible treatment that potentially improves pain intensity, gastrointestinal symptoms, and quality of life. [ABSTRACT FROM AUTHOR]

LGBTQ-affirmative cognitive-behavioral therapy (CBT) addresses the adverse impacts of minority stress. However, this treatment has rarely been tested in randomized controlled trials with LGBTQ youth and never using an asynchronous online platform for broad reach. This study examined the feasibility, acceptability, preliminary efficacy, and multi-level stigma moderators of LGBTQ-affirmative internet-based CBT (ICBT). Participants were 120 LGBTQ youth (ages 16–25; 37.5% transgender or non-binary; 75.8% assigned female at birth; 49.2% non-Latino White) living across 38 U.S. states and reporting depression and/or anxiety symptoms. Participants were randomized to receive 10 sessions of LGBTQ-affirmative ICBT or only complete 10 weekly assessments of mental and behavioral health and minority stress; all completed measures of psychological distress, depression, anxiety, suicidal thoughts, alcohol use, and HIV-transmission-risk behavior at baseline and 4 and 8 months post-baseline; 20 LGBTQ-affirmative ICBT participants completed a qualitative interview regarding intervention acceptability. Participants randomized to LGBTQ-affirmative ICBT completed, on average, 6.08 (SD = 3.80) sessions. Participants reported that LGBTQ-affirmative ICBT was helpful and engaging and provided suggestions for enhancing engagement. Although most outcomes decreased over time, between-group comparisons were small and non-significant. LGBTQ-affirmative ICBT was more efficacious in reducing psychological distress than assessment-only for participants in counties high in anti-LGBTQ bias (b = −1.73, p = 0.001, 95% CI [-2.75, −0.70]). Session dosage also significantly predicted reduced depression and anxiety symptoms. LGBTQ-affirmative ICBT represents a feasible and acceptable treatment. Future research can identify more efficacious approaches and modalities for engaging LGBTQ youth, especially those living under stigmatizing conditions, who might benefit most. • This study tests LGBTQ-affirmative internet-based cognitive behavioral therapy (ICBT). • LGBTQ youth find LGBTQ-affirmative ICBT to be feasible and acceptable. • Effect sizes were small comparing LGBTQ-affirmative ICBT to weekly assessment-only. • LGBTQ youth in high-stigma locales particularly benefited from LGBTQ-affirmative ICBT. [ABSTRACT FROM AUTHOR]

Irritable bowel syndrome (IBS) is common in adolescents with a pronounced negative impact on quality of life. A pattern of avoidance behavior is commonly seen in the IBS population, which is associated with more gastrointestinal (GI) symptoms. Exposure-based cognitive behavior therapy (CBT) targets the avoidance behavior to reduce symptoms, but it is unknown whether reduced avoidance is a mediator of symptom improvement in adolescent IBS. Stress has been suggested to play a key role in worsening GI symptoms and is also a potential mediator of the treatment effect in IBS. This study was based on data from a randomized controlled trial (N = 101) that evaluated exposure-based internet-delivered CBT (Internet-CBT) compared with a wait-list for adolescents with IBS. We investigated whether avoidance behavior and perceived stress mediated the improvement in global GI symptoms due to treatment. We found that a change in avoidance behavior, but not perceived stress, mediated the effect of exposure-based Internet-CBT on GI symptoms. The decrease in avoidance behavior explained a large portion (67%) of the total treatment effect. Moreover, a unidirectional relationship over time was observed between avoidance behavior and GI symptoms. Our conclusion is that exposure-based CBT in adolescent IBS reduces avoidance and, consequently, reduces GI symptoms. [ABSTRACT FROM AUTHOR]

For children with oppositional defiant disorder (ODD), Parent Management Training (PMT) is a recommended treatment in addition to child Cognitive Behavioral Therapy (child-CBT). There is however a lack of studies investigating the additive effect of group-based child-CBT to PMT for children between 8 and 12 years. The current study investigated the incremental effect of group-based child-CBT, based on the Coping Power Program, when added to the Swedish group-based PMT program KOMET. Outcomes were child behavior problems, child prosocial behavior, parenting skills and the moderating effect of child characteristics. One hundred and twenty children 8–12 years with ODD or Disruptive Behavioral Disorder NOS and their parents were randomized either to combined child-CBT and PMT (n = 63) or to PMT only (n = 57) in Swedish Child- and Adolescent Psychiatric settings. Participants were assessed pre- and post-treatment using semi-structured interviews and child- and parent ratings. After treatment, behavior problems were reduced in both groups. Prosocial behavior were significantly more improved in the combined treatment. Parenting skills were improved in both groups. In moderator analyses, behavior problems and prosocial behavior improved significantly more in the combined treatment compared to PMT only in the group of children with high levels of ODD symptoms. [ABSTRACT FROM AUTHOR]

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]