Quality of Life and Bidirectional Gut-Brain Interactions in Irritable Bowel Syndrome From Adolescence to Adulthood.

BACKGROUNDS AND AIMS: 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. METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.

Internet delivered exposure based cognitive behavior therapy for IBS - A clinical effectiveness study.

OBJECTIVES: IBS is a common and debilitating disorder. When dietary and pharmacological interventions are not satisfactory, psychological treatment may produce good results. But the access to such treatment is scarce and therefore it is of importance to make use of technical solutions. In the present study we wanted to investigate the real-world effectiveness of an internet-delivered exposure based cognitive behavioral treatment (ECBT) for IBS and to replicate an earlier finding regarding the working mechanism of the treatment. METHODS: 309 consecutively recruited patients from the Internet Psychiatry Clinic in Stockholm received ECBT for 12 weeks. The patients' IBS symptoms, quality of life, avoidance behaviors and gastro-intestinal symptom-specific anxiety (GSA) were monitored and we used a bivariate cross-lagged panel model to investigate time-related change in symptoms and avoidance behaviors. RESULTS: IBS symptoms, measured with The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS) were reduced from 48.06 (SD = 11.26) pre-treatment to 33.06 (SD=10.81) 6 month after treatment (p<.001). The effect size was (Cohens d) 1.30 [1.08-1.51]. There was a significant (p<.001) cross-lagged effect from reduction in avoidance behavior to reduction in symptoms but not in the reversed direction, indicating that the treatment effect is mediated by behavioral change. CONCLUSIONS: We conclude that ECBT is effective under real world conditions, also when delivered via the internet, and that an important treatment mechanism is the reduction of avoidance behaviors.

Association between expectations and clinical outcomes in online v. face-to-face therapy - an individual participant data meta-analysis.

BACKGROUND: Online treatments are increasing in number and are currently available for a wide range of clinical problems. To date little is known about the role of treatment expectations and other placebo-like mechanisms in online settings compared to traditional face-to-face treatment. To address this knowledge gap, we analyzed individual participant data from randomized clinical trials that compared online and face-to-face psychological interventions. METHODS: MEDLINE (Ovid) and PsycINFO (Ovid) were last searched on 2 February 2021. Randomized clinical trials of therapist guided online v. face-to-face psychological interventions for psychiatric or somatic conditions using a randomized controlled design were included. Titles, abstracts, and full texts of studies were independently screened by multiple observers. The Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline was followed. Authors of the matching trials were contacted for individual participant data. Ratings from the Credibility and Expectancy Questionnaire and the primary outcome measure from each trial were used to estimate the association between expectation ratings and treatment outcomes in online v. face-to-face interventions, using a mixed-effects model. RESULTS: Of 7045 screened studies, 62 full-text articles were retrieved whereof six studies fulfilled the criteria and provided individual participant data (n = 491). Overall, CEQ ratings predicted clinical outcomes (ß = 0.27) at end of treatment with no moderating effect of treatment modality (online v. face-to-face). CONCLUSIONS: Online treatment appears to be equally susceptible to expectancy effects as face-to-face therapy. This furthers our understanding of the importance of placebo-like factors in online treatment and may aid the improvement of healthcare in online settings.

Cognitive-behavioral therapy for avoidant/restrictive food intake disorder: A proof-of-concept for mechanisms of change and target engagement.

BACKGROUND: Cognitive-behavioral therapy for avoidant/restrictive food intake disorder (ARFID; CBT-AR) theoretically targets three prototypic motivations (sensory sensitivity, lack of interest/low appetite, fear of aversive consequences), aligned with three modularized interventions. As an exploratory investigation, we: (1) evaluated change in candidate mechanisms in relationship to change in ARFID severity, and (2) tested if assignment (vs. not) to a module resulted in larger improvements in the corresponding mechanism. METHOD: Males and females (N = 42; 10-55 years) participated in an open trial of CBT-AR. RESULTS: Decreases in scaled scores for each candidate mechanism had medium to large correlations with decreases in ARFID severity-sensory sensitivity: -0.7 decrease (r = .42, p = .01); lack of interest/low appetite: -0.3 decrease (r = .60, p < .0001); and fear of aversive consequences: -1.1 decrease (r = .33, p = .05). Linear mixed models revealed significant weekly improvements for each candidate mechanism across the full sample (ps < .0001). There were significant interactions for the sensory and fear of aversive consequences modules-for each, participants who received the corresponding module had significantly larger decreases in the candidate mechanism than those who did not receive the module. DISCUSSION: Sensory sensitivity and fear of aversive consequences improved more if the CBT-AR module was received, but lack of interest/low appetite may improve regardless of receipt of the corresponding module. Future research is needed to test target engagement in CBT-AR with adaptive treatment designs, and to identify valid and sensitive measures of candidate mechanisms. PUBLIC SIGNIFICANCE: The mechanisms through which components of CBT-AR work have yet to be elucidated. We conducted an exploratory investigation to test if assignment (vs. not) to a CBT-AR module resulted in larger improvements in the corresponding prototypic ARFID motivation that the module intended to target. Measures of the sensory sensitivity and the fear of aversive consequences motivations improved more in those who received the corresponding treatment module, whereas the lack of interest/low appetite measure improved regardless of if the corresponding module was received.

A Rome Working Team Report on Brain-Gut Behavior Therapies for Disorders of Gut-Brain Interaction.

BACKGROUND AND AIMS: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Development of a brief cognitive-behavioral treatment for avoidant/restrictive food intake disorder in the context of disorders of gut-brain interaction: Initial feasibility, acceptability, and clinical outcomes.

BACKGROUND: Avoidant/restrictive food intake disorder (ARFID) symptoms are common (up to 40%) among adults with disorders of gut-brain interaction (DGBI), but treatments for this population (DGBI + ARFID) have yet to be evaluated. We aimed to identify initial feasibility, acceptability, and clinical effects of an exposure-based cognitive-behavioral treatment (CBT) for adults with DGBI + ARFID. METHODS: Patients (N = 14) received CBT as part of routine care in an outpatient gastroenterology clinic. A two-part investigation of the CBT included a retrospective evaluation of patients who were offered a flexible (8-10) session length and an observational prospective study of patients who were offered eight sessions. Feasibility benchmarks were ≥75% completion of sessions, quantitative measures (for treatment completers), and qualitative interviews. Acceptability was assessed with a benchmark of ≥70% patients reporting a posttreatment satisfaction scores ≥3 on 1-4 scale and with posttreatment qualitative interviews. Mixed model analysis explored signals of improvement in clinical outcomes. RESULTS: All feasibility and acceptability benchmarks were achieved (and qualitative feedback revealed high satisfaction with the treatment and outcomes). There were improvements in clinical outcomes across treatment (all p's < .0001) with large effects for ARFID fear (-52%; Hedge's g = 1.5; 95% CI = 0.6, 2.5) and gastrointestinal-specific anxiety (-42%; Hedge's g = 1.0; 95% CI = 0.5, 16). Among those who needed to gain weight (n = 10), 94%-103% of expected weight gain goals were achieved. DISCUSSION: Initial development and testing of a brief 8-session CBT protocol for DGBI + ARFID showed high feasibility, acceptability, and promising clinical improvements. Findings will inform an NIH Stage 1B randomized control trial. PUBLIC SIGNIFICANCE: While cognitive-behavioral treatments (CBTs) for ARFID have been created in outpatient feeding and eating disorder clinics, they have yet to be developed and refined for other clinic settings or populations. In line with the recommendations for behavioral treatment development, we conducted a two-part investigation of an exposure-based CBT for a patient population with high rates of ARFID-adults with disorders of gut-brain interaction (also known as functional gastrointestinal disorders). We found patients had high satisfaction with treatment and there were promising improvements for both gastrointestinal and ARFID outcomes. The refined treatment includes eight sessions delivered by a behavioral health care provider and the findings reported in this article will be studied next in an NIH Stage 1B randomized controlled trial.

Work-Focused Versus Generic Internet-Based Interventions for Employees With Stress-Related Disorders: Randomized Controlled Trial.

BACKGROUND: In recent decades, stress-related disorders have received more attention, with an increasing prevalence, especially within the working population. The internet provides new options for broad dissemination, and a growing body of evidence suggests that web-based interventions for stress might be effective. However, few studies have examined the efficacy of interventions in clinical samples and work-related outcomes. OBJECTIVE: The aim of this study was to evaluate the efficacy of an internet-based cognitive behavioral intervention for stress-related disorders integrating work-related aspects (work-focused and internet-based cognitive behavioral therapy [W-iCBT]), compared with a generic internet-based cognitive behavioral therapy (iCBT) group and a waitlist control (WLC) group. METHODS: In this trial, 182 employees, mainly employed in the health care, IT, or educational sector, who fulfilled the criteria for a stress-related disorder, were randomized to a 10-week W-iCBT (n=61, 33.5%), generic iCBT (n=61, 33.5%), or WLC (n=60, 33%). Self-rated questionnaires on perceived stress, burnout, exhaustion, and other mental health- and work-related outcomes were administered before and after the treatment and at 6- and 12-month follow-ups. RESULTS: Compared with the WLC group, participants of the W-iCBT and iCBT groups showed an equal and significant reduction in the primary outcome (Shirom-Melamed Burnout Questionnaire [SMBQ]) from pretreatment to posttreatment assessment (Cohen d=1.00 and 0.83, respectively) and at the 6-month follow-up (Cohen d=0.74 and 0.74, respectively). Significant moderate-to-large effect sizes were also found in the secondary health- and work-related outcomes. The W-iCBT was the only group that exhibited significant effects on work ability and short-term sickness absence. Short-term sickness absence was 445 days lower than the WLC group and 324 days lower than the iCBT intervention group. However, no significant differences were found in terms of work experience or long-term sick leave. CONCLUSIONS: The work-focused and generic iCBT interventions proved to be superior compared with the control condition in reducing chronic stress and several other mental health-related symptoms. Interestingly, effects on work ability and short-term sickness absence were only seen between the W-iCBT intervention and the WLC groups. These preliminary results are promising, indicating that treatments that include work aspects may have the potential to accelerate recovery and reduce short-term sickness absence because of stress-related disorders. TRIAL REGISTRATION: ClinicalTrials.gov NCT05240495; https://clinicaltrials.gov/ct2/show/NCT05240495 (retrospectively registered).

Examining predictors of treatment effect in digital Acceptance and Commitment Therapy for chronic pain.

Digitally delivered behavioral interventions for chronic pain have been encouraging with effects similar to face-to-face treatment. Although many chronic pain patients benefit from behavioral treatment, a substantial proportion do not improve. To contribute to more knowledge about factors that predict treatment effects in digitally delivered behavioral interventions for chronic pain, the present study analyzed pooled data (N = 130) from three different studies on digitally delivered Acceptance and Commitment Therapy (ACT) for chronic pain. Longitudinal linear mixed-effects models for repeated measures were used to identify variables with significant influence on the rate of improvement in the main treatment outcome pain interference from pre- to post-treatment. The variables were sorted into six domains (demographics, pain variables, psychological flexibility, baseline severity, comorbid symptoms and early adherence) and analysed in a stepwise manner. The study found that shorter pain duration and higher degree of insomnia symptoms at baseline predicted larger treatment effects. The original trials from which data was pooled are registered at clinicaltrials.gov (registration number: NCT03105908 and NCT03344926).

Psychological treatments for irritable bowel syndrome: a comprehensive systematic review and meta-analysis.

A wide range of psychological treatments have been found to reduce the symptoms of irritable bowel syndrome (IBS) but their relative effects are unclear. In this systematic review and meta-analysis, we determined the effects of psychological treatments for IBS, including subtypes of cognitive behavior therapy, versus attention controls. We searched 11 databases (March 2022) for studies of psychological treatments for IBS, reported in journal articles, books, dissertations, and conference abstracts. The resulting database comprised 9 outcome domains from 118 studies published in 1983-2022. Using data from 62 studies and 6496 participants, we estimated the effect of treatment type on improvement in composite IBS severity using random-effects meta-regression. In comparison with the attention controls, there was a significant added effect of exposure therapy (g = 0.52, 95% CI = 0.17-0.88) and hypnotherapy (g = 0.36, 95% CI = 0.06-0.67) when controlling for the pre- to post-assessment duration. When additional potential confounders were included, exposure therapy but not hypnotherapy retained a significant added effect. Effects were also larger with a longer duration, individual treatment, questionnaire (non-diary) outcomes, and recruitment outside of routine care. Heterogeneity was substantial. Tentatively, exposure therapy appears to be a particularly promising treatment for IBS. More direct comparisons in randomized controlled trials are needed. OSF.io identifier: 5yh9a.

Brief scales for the measurement of target variables and processes of change in cognitive behaviour therapy for major depression, panic disorder and social anxiety disorder.

BACKGROUND: The measurement of process variables derived from cognitive behavioural theory can aid treatment development and support the clinician in following treatment progress. Self-report process measures are ideally brief, which reduces the burden on patients and facilitates the implementation of repeated measurements. AIMS: To develop 13 brief versions (3-6 items) of existing cognitive behavioural process scales for three common mental disorders: major depression, panic disorder, and social anxiety disorder. METHOD: Using data from a real-world teaching clinic offering internet-delivered cognitive behavior therapy (n=370), we drafted brief process scales and then validated these scales in later cohorts (n=293). RESULTS: In the validation data, change in the brief process scales significantly mediated change in the corresponding domain outcomes, with standardized coefficient point estimates in the range of -0.53 to -0.21. Correlations with the original process scales were substantial (r=.83-.96), internal consistency was mostly adequate (α=0.65-0.86), and change scores were moderate to large (|d|=0.51-1.18). For depression, the brief Behavioral Activation for Depression Scale-Activation subscale was especially promising. For panic disorder, the brief Agoraphobic Cognitions Questionnaire-Physical Consequences subscale was especially promising. For social anxiety disorder, the Social Cognitions Questionnaire, the Social Probability and Cost Questionnaire, and the Social Behavior Questionnaire-Avoidance and Impression Management subscales were all promising. CONCLUSIONS: Several brief process scales showed promise as measures of treatment processes in cognitive behaviour therapy. There is a need for replication and further evaluation using experimental designs, in other clinical settings, and preferably in larger samples.

Exposure based cognitive behavioral group therapy for IBS at a gastroenterological clinic - a clinical effectiveness study.

BACKGROUND: Patients with irritable bowel syndrome (IBS) may benefit from psychological treatment when diet changes and medications do not sufficiently reduce symptoms. Our research team has developed an exposure based cognitive behavioral therapy protocol (ECBT), which has been shown to be effective in several randomized controlled trials. AIM: To investigate the effectiveness of ECBT in clinical routine care at a gastroenterological clinic in Stockholm and to find predictors for treatment outcome. METHOD: A ten session ECBT based on our protocol was given face to face by licensed psychologists in groups of 4-6 patients. A total of 129 patients provided information regarding IBS symptoms, quality of life, gastrointestinal symptom-specific anxiety (GSA), and depression pre and post-treatment. We used linear regression analyses to identify patient characteristics that predicted treatment outcome. RESULTS: The primary outcome was symptom severity measured with The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS). Average pre-and post-treatment GSRS-IBS scores were 49.24 (SD = 11.54) and 37.03 (SD = 10.03), corresponding to a 34.0% reduction in symptom severity (p < .001). Reductions were also found in GSA, 43.9% (p < .001) and depression, 38.6% (p < .001). IBS-related quality of life was on average increased by 68.2% (p < .001). The effect sizes were large and varied between (Cohen's d) 0.95 and 1.84. None of the patients' pre-treatment characteristics predicted outcome. CONCLUSION: We conclude that ECBT for IBS delivered face-to-face in a group-format is very effective, also in a routine care setting. We did not find any reliable predictors for treatment outcome. The trial was registered at Clinicaltrials.gov with ID: NCT04756414.

Validation of child-adapted short scales for measuring gastrointestinal-specific avoidance and anxiety.

AIM: To validate child-adapted shortened versions of the Irritable Bowel Syndrome-Behavioural Responses Questionnaire (IBS-BRQ; short scale denoted BRQ-C) and the Visceral Sensitivity Index (VSI; short scale denoted VSI-C) for children with functional abdominal pain disorders (FAPDs). METHODS: A child psychologist supervised by a child gastroenterologist was responsible for shortening the scales (BRQ-C, 11 items; and VSI-C, 7 items). Then, a sample of 89 children aged 8-12 years with FAPDs was used in the validation. Construct validity was assessed with correlations. Measures included gastrointestinal symptoms, quality of life, pain intensity and anxiety. Also, internal consistency, test-retest reliability, administration time and factor structure were assessed. RESULTS: Internal consistency for the BRQ-C and the VSI-C was α = 0.84 and α = 0.80, respectively. Correlations with related scales were similar between child-adapted scales and original scales, indicating construct validity equivalence. Correlations between short scales and original scales were high. Mean administration time was reduced by 47% (BRQ-C) and 42% (VSI-C), compared with original scales. Test-retest reliability was r = 0.72 for BRQ-C and r = 0.83 for VSI-C. BRQ-C had two factors (Avoidance and Bowel control). VSI-C had a unifactorial structure. CONCLUSION: The BRQ-C and the VSI-C were found to be time-saving, reliable and valid for children with FAPDs.

Therapist-guided online metacognitive intervention for excessive worry: a randomized controlled trial with mediation analysis.

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.

Online Education Is Non-Inferior to Group Education for Irritable Bowel Syndrome: A Randomized Trial and Patient Preference Trial.

BACKGROUND & AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Targeting excessive worry with internet-based extinction therapy: a randomised controlled trial with mediation analysis and economical evaluation.

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.

Brief Online Cognitive Behavioural Intervention for Dysfunctional Worry Related to the COVID-19 Pandemic: A Randomised Controlled Trial.

INTRODUCTION: Worries about the immediate and long-term consequences of the COVID-19 pandemic may for some individuals develop into pervasive worry that is disproportionate in its intensity or duration and significantly interferes with everyday life. OBJECTIVE: The aim of this study was to investigate if a brief self-guided, online psychological intervention can reduce the degree of dysfunctional worry related to the COVID-19 pandemic and associated symptoms. METHODS: 670 adults from the Swedish general population reporting daily uncontrollable worry about CO-VID-19 and its possible consequences (e.g., illness, death, the economy, one's family) were randomised (1:1 ratio) to a 3-week self-guided, online cognitive behavioural intervention targeting dysfunctional COVID-19 worry and associated symptoms, or a waiting list of equal duration. The primary outcome measure was a COVID-19 adapted version of the Generalised Anxiety Disorder 7-item scale administered at baseline and weeks 1-3 (primary endpoint). Follow-up assessments were conducted 1 month after treatment completion. The trial was registered on ClinicalTrials.gov (NCT04341922) before inclusion of the first participant. RESULTS: The main pre-specified intention-to-treat analysis indicated significant reductions in COVID-19-related worry for the intervention group compared to the waiting list (ß = 1.14, Z = 9.27, p < 0.001), corresponding to a medium effect size (bootstrapped d = 0.74 [95% CI: 0.58-0.90]). Improvements were also seen on all secondary measures, including mood, daily functioning, insomnia, and intolerance of uncertainty. Participant satisfaction was high. No serious adverse events were recorded. CONCLUSIONS: A brief digital and easily scalable self-guided psychological intervention can significantly reduce dysfunctional worry and associated behavioural symptoms related to the COVID-19 pandemic.

Return on investment of internet delivered exposure therapy for irritable bowel syndrome: a randomized controlled trial.

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).

Long-term outcomes of internet-delivered cognitive behaviour therapy for paediatric anxiety disorders: towards a stepped care model of health care delivery.

Internet-delivered cognitive behaviour therapy (ICBT) is emerging as a powerful tool to fill the gap between demand and availability of evidence-based treatment for paediatric anxiety disorders. However, it is still unclear how to best implement it in routine clinical care. 123 children (8-12 years) with anxiety disorders underwent a 12-week ICBT programme with limited therapist support. Participants were assessed 3- and 12-month post-ICBT (3MFU and 12MFU, respectively). Non-remitters who still fulfilled diagnostic criteria for their principal anxiety disorder at 3MFU were offered additional manualised "face-to-face" (F2F) CBT. The aim of the study was to emulate a stepped-care model of health care delivery, where the long-term treatment gains of ICBT as well as the potential benefit of proving addition treatment to non-remitters of ICBT were evaluated. Remitters of ICBT (n = 73) continued to improve throughout the study period (pre-ICBT to 12MFU; Cohen's d = 2.42). At 12MFU, 89% (n = 65) were free from their principal anxiety disorder. Of all the participants classed as non-remitters at 3MFU (n = 37), 48.6% (n = 18) accepted the offer to receive additional F2F CBT. These participants also improved with a large effect from pre-ICBT to 12MFU (Cohen's d = 2.27), with the largest effect occurring during F2F CBT. At 12MFU, 83% (n = 15) were free from their principal anxiety disorders. The majority of non-remitters declining additional F2F CBT (63.2%; n = 12) did so due to already receiving treatment at their local CAMHS, prior to 3MFU. The effects of ICBT for anxiety disorders are durable at least up to 1 year after the end of treatment. Patients who fail to fully benefit from ICBT improved further with additional F2F sessions at our clinic, suggesting that it may be feasible to implement ICBT within a stepped-care model of health care delivery.

Even mild catastrophic thinking is related to pain intensity in individuals with painful temporomandibular disorders.

AIMS: Temporomandibular disorders (TMD) are often associated with psychological comorbidities. One such comorbidity is pain catastrophising, that is, exaggeration of negative consequences of a painful event. The aim was to investigate catastrophising in individuals with painful TMD compared to controls and the association between catastrophising and pain intensity, number of pain sites and functional limitations. METHODS: A community-based sample of 110 individuals (83 women; 20-69 yrs) with painful TMDs (myalgia/arthralgia as per Diagnostic Criteria for TMD) and 190 age- and gender-matched controls (119 women; 20-69 yrs) from the Public Dental services in Västerbotten, Sweden, participated. Associations between catastrophising and functional jaw limitations, respectively, and painful TMD were evaluated with ordinal regression adjusted for the effect of gender and age. Associations (Spearman's correlation) of the Pain catastrophising Scale (PCS) with Jaw Functional Limitation Scale (JFLS-20), pain site number (whole-body pain map), and characteristic pain intensity (CPI) and intergroup comparisons (Mann-Whitney U test) of these variables were also calculated. RESULTS: Levels of catastrophising were associated with TMD pain (OR 1.6, 95%CI 1.1-2.6). Among individuals with painful TMD, catastrophising was correlated to pain intensity (r=0.458, p<0.01) and functional limitations (r=0.294-0.321, p≤0.002), but not to number of pain sites. CONCLUSION: Compared to controls, community-based individuals with painful TMD demonstrated higher levels of pain catastrophising, and this catastrophising was associated with increased pain intensity and jaw dysfunction. The relatively low scores of pain catastrophising suggest that even mild catastrophic thinking is associated with pain perception and jaw function, and should be considered in patient management.

Two randomized controlled trials of the efficacy of acceptance and commitment therapy-based educational course for body shape dissatisfaction.

The main aim of this project was to explore the efficacy of Acceptance and Commitment Therapy (ACT)-based educational course in different formats (i.e., pure and guided self-help with different durations, and guided self-help with and without access to a discussion forum) for body shape dissatisfaction. Two randomized controlled studies (RCT) were carried out. In the first RCT, the participants were randomized to a 12- or 16-week guided self-help, a 16-week pure self-help, or a waitlist control condition. In the second RCT, the efficacy of 12-week guided self-help with or without access to a discussion forum was investigated. ACT-based self-help resulted in promising improvements in body shape dissatisfaction, and modest effects on general health indicators (i.e., symptom of depression, self-esteem, satisfaction with life, and quality of life). The findings also showed no additional effects of support, access to the online discussion forum, and longer duration of self-help, suggesting the 12-week self-help with or without support is a viable option for reducing body shape dissatisfaction.