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.

A Transdisciplinary Framework to Unlock the Potential Benefits of Green Spaces for Urban Communities Under Changing Contexts.

New urban models increasingly seek to create more sustainable, livable, and healthier cities by reinvigorating green space. In this article, we highlight and briefly review several main but disconnected areas of study in which the factors that frame human-environment interactions and therefore also influence the potential well-being outcomes of those interactions are studied. We then use the intersection of affordance theory and socio-institutional programming to provide a conceptual framework that ties together these spheres of research, and we discuss some critical keys for enabling different positive green space experiences. Urban communities are not homogeneous, and accounting for the intersection between individual differences and landscape programming opens up more diverse pathways for affording positive human-environment interactions and different well-being outcomes.

Condensed Internet-delivered prolonged exposure provided soon after trauma: a randomised trial.

BACKGROUND: Exposure to trauma is common and can have a profoundly negative impact on mental health. Interventions based on trauma-focused cognitive behavioural therapy have shown promising results to facilitate recovery. The current trial evaluated whether a novel, scalable and digital early version of the intervention, Condensed Internet-Delivered Prolonged Exposure (CIPE), is effective in reducing post-traumatic stress symptoms. METHOD: A single-site randomised controlled trial with self-referred adults (N = 102) exposed to trauma within the last 2 months. The participants were randomised to 3 weeks of CIPE or a waiting list (WL) for 7 weeks. Assessments were conducted at baseline, week 1-3 (primary endpoint), week 4-7 (secondary endpoint) and at 6-month follow-up. The primary outcome measure was PTSD Checklist for DSM-5 (PCL-5). RESULTS: The main analysis according to the intention-to-treat principle indicated statistically significant reductions in symptoms of post-traumatic stress in the CIPE group as compared to the WL group. The between-group effect size was moderate at week 3 (bootstrapped d = 0.70; 95% CI 0.33-1.06) and large at week 7 (bootstrapped d = 0.83; 95% CI 0.46-1.19). Results in the intervention group were maintained at the 6-month follow-up. No severe adverse events were found. CONCLUSIONS: CIPE is a scalable intervention that may confer early benefits on post-traumatic stress symptoms in survivors of trauma. The next step is to compare this intervention to an active control group and also investigate its effects when implemented in regular care.

The Fear of Asthma Symptoms Scale and the Asthma Behavior Checklist: preliminary validity of two novel patient reported outcome measures.

Objective: The aim of this study was to investigate the preliminary validity of two novel scales, the Fear of Asthma Symptoms scale (FAS) and the Asthma Behavior Checklist (ABC). Methods: Using cross-sectional design, data was collected online from 188 adult participants (Age 18-71 years) with a diagnosis of asthma and self-reported anxiety related to asthma, recruited through social media. Confirmatory factor analysis, internal consistency and test-retest reliability were ascertained to address validity.Results: The confirmatory factor analysis demonstrated convergent validity for both the FAS (average variance extracted; AVE=.57) and the item-reduced ABC-8 (AVE=.61) as well as divergent validity for both scales. Both scales demonstrated high internal consistency (FAS: α = 0.94; ABC-8: α = 0.92). Test-retest reliability assessed after 1 week was good (FAS: r=.85; ABC-8: r=.88).Conclusions: We observed promising psychometric properties of the FAS and the ABC-8. The two novel scales could be useful to identify excessive fear and avoidance in patients with asthma and to investigate putative mechanisms in clinical research on anxiety related to asthma. Further evaluation of psychometric properties in independent samples are needed.

Physiological responses and performance factors for double-poling and diagonal-stride treadmill roller-skiing time-trial exercise.

PURPOSE: To compare physiological responses between a self-paced 4-min double-poling (DP) time-trial (TTDP) versus a 4-min diagonal-stride (DS) time-trial (TTDS). The relative importance of peak oxygen uptake ([Formula: see text]O2peak), anaerobic capacity, and gross efficiency (GE) for projection of 4-min TTDP and TTDS roller-skiing performances were also examined. METHODS: Sixteen highly trained male cross-country skiers performed, in each sub-technique on separate occasions, an 8 × 4-min incremental submaximal protocol, to assess individual metabolic rate (MR) versus power output (PO) relationships, followed by a 10-min passive break and then the TTDP or TTDS, with a randomized order between sub-techniques. RESULTS: In comparison to TTDS, the TTDP resulted in 10 ± 7% lower total MR, 5 ± 4% lower aerobic MR, 30 ± 37% lower anaerobic MR, and 4.7 ± 1.2 percentage points lower GE, which resulted in a 32 ± 4% lower PO (all P < 0.01). The [Formula: see text]O2peak and anaerobic capacity were 4 ± 4% and 30 ± 37% lower, respectively, in DP than DS (both P < 0.01). The PO for the two time-trial (TT) performances were not significantly correlated (R2 = 0.044). Similar parabolic pacing strategies were used during both TTs. Multivariate data analysis projected TT performance using [Formula: see text]O2peak, anaerobic capacity, and GE (TTDP, R2 = 0.974; TTDS, R2 = 0.848). The variable influence on projection values for [Formula: see text]O2peak, anaerobic capacity, and GE were for TTDP, 1.12 ± 0.60, 1.01 ± 0.72, and 0.83 ± 0.38, respectively, and TTDS, 1.22 ± 0.35, 0.93 ± 0.44, and 0.75 ± 0.19, respectively. CONCLUSIONS: The results show that a cross-country skier's "metabolic profile" and performance capability are highly sub-technique specific and that 4-min TT performance is differentiated by physiological factors, such as [Formula: see text]O2peak, anaerobic capacity, and GE.

Inter- and intra-observer variability in the echocardiographic evaluation of wall motion abnormality in patients with ST-elevation myocardial infarction or takotsubo syndrome - A novel approach.

INTRODUCTION AND OBJECTIVES: Using existing transthoracic echocardiographic indices to quantify left ventricular wall motion abnormalities (WMAs) can be difficult due to the variations in the location of the abnormalities within the left ventricle, the quality of examinations, and the inter-/intra-observer variability of available indices. This study aimed to evaluate a new approach for measuring the extent of WMA by calculating the percentage of abnormal wall motion and comparing it to the wall motion score index (WMSI). The study also sought to assess inter- and intra-observer variability. METHODS: The study included 140 echocardiograms from 54 patients presenting with ST-elevation myocardial infarction or Takotsubo syndrome. All patients underwent an echocardiographic examination according to a standard protocol and the images were used to measure the extent of akinesia (proportion akinesia, PrA), akinesia and hypokinesia (proportion akinesia/hypokinesia, PrAH), and WMSI. The inter-observer variability between the two operators was analyzed. The intra-observer analysis was performed by one observer using the same images at least 1 month after the first measurement. The agreement was analyzed using the Pearson correlation coefficient and Bland-Altman plots. RESULTS: Inter- and intra-observer variability for PrA and PrAH were low and comparable to those for WMSI. CONCLUSION: PrA and PrAH are reliable and reproducible echocardiographic methods for the evaluation of left ventricular wall motion.

An online self-guided cognitive intervention for unwanted intrusive thoughts about harming infants in new parents: initial randomised controlled trial with mediation analysis.

Approximately one-fifth of new parents struggle with unwanted intrusive thoughts (UITs) about intentionally harming their child. This study evaluated the initial efficacy, feasibility and acceptability of a novel online self-guided cognitive intervention for new parents with distressing UITs. Self-recruited parents (N = 43, 93% female, age 23-43 years) of children 0-3 years reporting daily distressing and impairing UITs were randomized to the 8-week self-guided online cognitive intervention or to waiting-list. The primary outcome was change on the Parental Thoughts and Behaviour Checklist (PTBC) from baseline to week 8 (post-intervention). The PTBC and negative appraisals (mediator) were assessed at baseline, weekly, post-intervention and at the 1-month follow-up. Results showed that the intervention led to statistically significant reductions in distress and impairment associated with UITs at post-intervention (controlled between-group d = 0.99, 95% CI 0.56 to 1.43), which were maintained at the 1-month follow-up (controlled between-group d = 0.90, 95% CI 0.41 to 1.39). The intervention was deemed to be feasible and acceptable by the participants. Change in negative appraisals mediated reductions in UITs but the model was sensitive to mediator-outcome confounders. We conclude that this novel online self-guided cognitive intervention can potentially reduce the distress and impairment associated with UITs in new parents. Large-scale trials are warranted.Abbreviations: UITs: Unwanted Intrusive Thoughts PTBC: Parental Thoughts and Behaviour Checklist.

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.

The Cost of Obsessive-Compulsive Disorder in Swedish Youth.

The economic impact of pediatric obsessive-compulsive disorder (OCD) on society is unknown. We compared a wide range of individual-level cost data of children 7-17 years with OCD (n = 152) with a control group from the general population in Sweden (n = 768). The total annual cost in the OCD group was M = 11941€ (95%CI [9915-13966]), compared to the control group M = 6380 € (95%CI [5461-7299]), corresponding to an estimated marginal mean cost of OCD of 5560 € per person and year (z = 4.99, p < .001). OCD was associated with significantly higher healthcare costs, parental absence from work and school productivity loss. OCD symptom severity was positively associated with higher costs. The total societal burden of pediatric OCD in Sweden was estimated to be 94.3 € million per year (95%CI [56.9-131.8]). These results have important implications for policy makers and for the allocation of healthcare resources. Similar studies are needed in other countries in order to estimate the global cost of the disorder.

Systemic Inflammation in Preclinical Ulcerative Colitis.

BACKGROUND & AIMS: Preclinical ulcerative colitis is poorly defined. We aimed to characterize the preclinical systemic inflammation in ulcerative colitis, using a comprehensive set of proteins. METHODS: We obtained plasma samples biobanked from individuals who developed ulcerative colitis later in life (n = 72) and matched healthy controls (n = 140) within a population-based screening cohort. We measured 92 proteins related to inflammation using a proximity extension assay. The biologic relevance of these findings was validated in an inception cohort of patients with ulcerative colitis (n = 101) and healthy controls (n = 50). To examine the influence of genetic and environmental factors on these markers, a cohort of healthy twin siblings of patients with ulcerative colitis (n = 41) and matched healthy controls (n = 37) were explored. RESULTS: Six proteins (MMP10, CXCL9, CCL11, SLAMF1, CXCL11 and MCP-1) were up-regulated (P < .05) in preclinical ulcerative colitis compared with controls based on both univariate and multivariable models. Ingenuity Pathway Analyses identified several potential key regulators, including interleukin-1ß, tumor necrosis factor, interferon-gamma, oncostatin M, nuclear factor-κB, interleukin-6, and interleukin-4. For validation, we built a multivariable model to predict disease in the inception cohort. The model discriminated treatment-naïve patients with ulcerative colitis from controls with leave-one-out cross-validation (area under the curve = 0.92). Consistently, MMP10, CXCL9, CXCL11, and MCP-1, but not CCL11 and SLAMF1, were significantly up-regulated among the healthy twin siblings, even though their relative abundances seemed higher in incident ulcerative colitis. CONCLUSIONS: A set of inflammatory proteins are up-regulated several years before a diagnosis of ulcerative colitis. These proteins were highly predictive of an ulcerative colitis diagnosis, and some seemed to be up-regulated already at exposure to genetic and environmental risk factors.

Operational Definitions of Treatment Response and Remission in Obsessive-Compulsive Disorder Capture Meaningful Improvements in Everyday Life.

INTRODUCTION: The operational definitions of treatment response, partial response, and remission in obsessive-compulsive disorder (OCD) are widely used in clinical trials and regular practice. However, the clinimetric sensitivity of these definitions, that is, whether they identify patients that experience meaningful changes in their everyday life, remains unexplored. OBJECTIVE: The objective was to examine the clinimetric sensitivity of the operational definitions of treatment response, partial response, and remission in children and adults with OCD. METHODS: Pre- and post-treatment data from five clinical trials and three cohort studies of children and adults with OCD (n = 1,528; 55.3% children, 61.1% female) were pooled. We compared (1) responders, partial responders, and non-responders and (2) remitters and non-remitters on self-reported OCD symptoms, clinician-rated general functioning, and self-reported quality of life. Remission was also evaluated against post-treatment diagnostic interviews. RESULTS: Responders and remitters experienced large improvements across validators. Responders had greater improvements than partial responders and non-responders on self-reported OCD symptoms (Cohen's d 0.65-1.13), clinician-rated functioning (Cohen's d 0.53-1.03), and self-reported quality of life (Cohen's d 0.63-0.73). Few meaningful differences emerged between partial responders and non-responders. Remitters had better outcomes across most validators than non-remitters. Remission criteria corresponded well with absence of post-treatment diagnosis (sensitivity/specificity: 93%/83%). Using both the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and the Clinical Global Impression Scale yielded more conservative results and more robust changes across validators, compared to only using the Y-BOCS. CONCLUSIONS: The current definitions of treatment response and remission capture meaningful improvements in the everyday life of individuals with OCD, whereas the concept of partial response has dubious clinimetric sensitivity.

Anaerobic work capacity in cycling: the effect of computational method.

PURPOSE: To compare the anaerobic work capacity (AnWC, i.e., attributable anaerobic mechanical work) assessed using four different approaches/models applied to time-trial (TT) cycle-ergometry exercise. METHODS: Fifteen male cyclists completed a 7 × 4-min submaximal protocol and a 3-min all-out TT (TTAO). Linear relationships between power output (PO) and submaximal metabolic rate were constructed to estimate TT-specific gross efficiency (GE) and AnWC, using either a measured resting metabolic rate as a Y-intercept (7 + YLIN) or no measured Y-intercept (7-YLIN). In addition, GE of the last submaximal bout (GELAST) was used to estimate AnWC, and critical power (CP) from TTAO (CP3´AO) was used to estimate mechanical work above CP (W', i.e., "AnWC"). RESULTS: Average PO during TTAO was 5.43 ± 0.30 and CP was 4.48 ± 0.23 W∙kg-1. The TT-associated GE values were ~ 22.0% for both 7 + YLIN and 7-YLIN and ~ 21.1% for GELAST (both P < 0.001). The AnWC were 269 ± 60, 272 ± 55, 299 ± 61, and 196 ± 52 J∙kg-1 for the 7 + YLIN, 7-YLIN, GELAST, and CP3´AO models, respectively (7 + YLIN and 7-YLIN versus GELAST, both P < 0.001; 7 + YLIN, 7-YLIN, and GELAST versus CP3´AO, all P < 0.01). For the three pair-wise comparisons between 7 + YLIN, 7-YLIN, and GELAST, typical errors in AnWC values ranged from 7 to 11 J∙kg-1, whereas 7 + YLIN, 7-YLIN, and GELAST versus CP3´AO revealed typical errors of 55-59 J∙kg-1. CONCLUSION: These findings demonstrate a substantial disagreement in AnWC between CP3´AO and the other models. The 7 + YLIN and 7-YLIN generated 10% lower AnWC values than the GELAST model, whereas 7 + YLIN and 7-YLIN generated similar values of AnWC.

A breathing mask attenuates acute airway responses to exercise in sub-zero environment in healthy subjects.

PURPOSE: Cold air exposure is associated with increased respiratory morbidity and mortality. Repeated inhalation of cold and dry air is considered the cause of the high prevalence of asthma among winter endurance athletes. This study assessed whether a heat- and moisture-exchanging breathing device (HME) attenuates airway responses to high-intensity exercise in sub-zero temperatures among healthy subjects. METHODS: Using a randomized cross-over design, 23 healthy trained participants performed a 30-min warm-up followed by a 4-min maximal, self-paced running time trial in - 15 °C, with and without HME. Lung function was assessed pre- and immediately post-trials. Club cell protein (CC-16), 8-isoprostane, and cytokine concentrations were measured in plasma and urine pre- and 60 min post trials. Symptoms were assessed prior to, during, and immediately after each trial in the chamber. RESULTS: HME use attenuated the decrease in forced expiratory volume in 1 s (FEV1) post trials (∆FEV1: mean (SD) HME - 0.5 (1.9) % vs. no-HME - 2.7 (2.7) %, p = 0.002). HME also substantially attenuated the median relative increase in plasma-CC16 concentrations (with HME + 27% (interquartile range 9-38) vs no-HME + 121% (55-162), p < 0.001) and reduced airway and general symptom intensity, compared to the trial without HME. No significant changes between trials were detected in urine CC16, 8-isoprostane, or cytokine concentrations. CONCLUSION: The HME attenuated acute airway responses induced by moderate-to-maximal-intensity exercise in - 15 °C in healthy subjects. Further studies are needed to examine whether this HMEs could constitute primary prevention against asthma in winter endurance athletes.

Hit-and-run: a Swedish nationwide cohort study of serious transport accidents and convictions due to traffic offenses in obsessive-compulsive disorder.

PURPOSE: Individuals with obsessive-compulsive disorder (OCD) often report driving-related obsessions, such as fears of causing accidents, but the risk of transport accidents in OCD is unknown. We investigated whether individuals with OCD have an increased risk of serious transport accidents and convictions due to traffic offenses and explored the role of psychiatric comorbidities. METHODS: We included all individuals ≥ 18 years living in Sweden between 1997 and 2013 (N = 5,760,734). A total of 23,126 individuals had a diagnosis of OCD in the National Patient Register. We also identified 16,607 families with full siblings discordant for OCD. Cox proportional hazards regression models estimated hazard ratios (HRs) with 95% confidence intervals (CIs) for the risk of three outcomes in individuals with OCD, compared to unexposed individuals and their unexposed full siblings: injuries or deaths due to transport accidents, injuries or deaths due to motor vehicle accidents, and convictions related to traffic offenses. Psychiatric comorbidities were systematically adjusted for. RESULTS: Women, but not men, with OCD had a marginally increased risk of serious transport accidents (adjusted HR = 1.20 [95% CI 1.13-1.28]) and motor vehicle accidents (adjusted HR = 1.20 [95% CI 1.09-1.31]), compared to unaffected individuals. Neither women nor men with OCD had a significantly increased risk of convictions. The sibling comparisons showed no significant associations. When psychiatric comorbidities were adjusted for, several observed associations became non-significant or inversed (HRs and 95% CIs below one). CONCLUSION: The risks of serious transport accidents and driving-related criminal convictions in OCD are negligible and heavily influenced by psychiatric comorbidity.

Implementing therapist-guided internet-delivered cognitive behaviour therapy for obsessive-compulsive disorder in the UK's IAPT programme: A pilot trial.

OBJECTIVES: Digital therapies such as internet-delivered cognitive behaviour therapy (ICBT) can improve treatment access for patients with common mental disorders, but are rarely used in the Improving Access to Psychological Therapies (IAPT) programme in the United Kingdom. The objective of this study was to evaluate an evidence-based ICBT intervention for obsessive-compulsive disorder (OCD-NET) in three IAPT services in an open trial. METHODS: Consecutively referred patients with a primary diagnosis of OCD (n = 474) were offered OCD-NET. Symptoms of OCD, depression, anxiety, and level of functioning were measured weekly throughout treatment. RESULTS: In the full intention to treat sample (n = 474), the intervention was associated with large reductions in self-reported OCD symptoms (d = 1.77), anxiety (d = 1.55) and depression (d = 0.8), as well as improvements in functional impairment (d = 0.51 to 0.72). Further, 35% of participants were in recovery at their last assessment, 25% achieved reliable improvement and 15% met criteria for both recovery and improvement. Among participants completing at least 4 modules (n = 261), corresponding to an adequate 'dose' of treatment, the rates of recovery (44%), reliable improvement (34%) and reliable recovery (21%) were higher. A majority of participants were satisfied with the online treatment and found the online materials helpful. CONCLUSIONS: OCD-NET is an effective treatment when delivered in regular care within the IAPT system. Challenges associated with implementing ICBT in regular health care are discussed.

Initial evaluation of a therapist-supported online cognitive therapy self-help for patients with taboo obsessions.

OBJECTIVES: The current study evaluated the feasibility of an internet-delivered cognitive therapy (I-CT) in a self-help format with minimal therapist support for patients with obsessive-compulsive disorder (OCD) with primary taboo obsessions. Specifically, the aims were to investigate (1) whether participants were able to grasp and apply the internet-delivered cognitive framework to their own situation; (2) whether they had clinically meaningful reductions of OCD symptom severity; and (3) whether reduced negative appraisals (hypothesized mechanism of change in CT) preceded reductions in OCD symptom severity. METHOD: Nineteen OCD patients with primary taboo obsessions, recruited from an OCD clinic or self-referrals, received the I-CT intervention for 10 weeks. I-CT did not contain any systematic exposure or response prevention. RESULTS: Adherence and engagement with the intervention was high. Most participants (n = 13, 68%) understood and successfully applied the cognitive model to their own situation. Within-group analyses showed large reductions in OCD symptom severity at post-treatment (bootstrapped within group d = 1.67 [95% CI; 0.67 to 2.66]) measured with the Yale-Brown Obsessive-Compulsive Scale. The gains were maintained at the 6-month follow-up. Post-hoc analyses revealed that the large reductions in OCD symptom severity were driven by the participants who understood the cognitive model. Reductions in negative appraisals predicted subsequent reductions in OCD symptom severity during treatment. CONCLUSION: It is possible to adapt a purely cognitive intervention to a digital guided self-help format and to achieve both cognitive change and meaningful symptom reduction. The results require confirmation in a randomized clinical trial.

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.

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).