Internet-delivered transdiagnostic psychological treatments for individuals with depression, anxiety or both: a systematic review with meta-analysis of randomised controlled trials.

OBJECTIVE: Depression and anxiety are major public health problems. This study evaluated the effects of internet-delivered transdiagnostic psychological treatments for individuals with depression, anxiety, or both. DESIGN: Systematic review with meta-analysis. DATA SOURCES: Medline (Ovid), Cochrane Library (Wiley), the Web of Science Core Collection (Clarivate), and PsycInfo (EBSCO) were searched on 24 May 2021, with an update on 6 February 2023. ELIGIBILITY CRITERIA: Randomised controlled trials of internet-delivered transdiagnostic psychological treatments, open to both participants with primary depression and participants with primary anxiety. This review concerned all treatment frameworks, both guided and unguided formats and all age groups. DATA EXTRACTION AND SYNTHESIS: In random-effects meta-analysis, we estimated pooled effects on depression symptoms and anxiety in terms of Hedges' g with 95% CIs. Absolute and relative heterogeneity was quantified as the τ2 and I 2. RESULTS: We included 57 trials with 21 795 participants. Nine trials (16%) recruited exclusively from routine care, and three (5%) delivered treatment via video. For adults, large within-group reductions were seen in depression (g=0.90; 95% CI 0.81 to 0.99) and anxiety (g=0.87; 95% CI 0.78 to 0.96). Compared with rudimentary passive controls, the added effects were moderate (depression: g=0.52; 95% CI 0.42 to 0.63; anxiety: g=0.45; 95% CI 0.34 to 0.56) and larger in trials that required all participants to meet full diagnostic criteria for depression or an anxiety disorder. Compared with attention/engagement controls, the added effects were small (depression: g=0.30; 95% CI 0.07 to 0.53; anxiety: g=0.21; 95% CI 0.01 to 0.42). Heterogeneity was substantial, and the certainty of the evidence was very low. Two trials concerned adolescents and reported mixed results. One trial concerned older adults and reported promising results. CONCLUSION: Internet-delivered transdiagnostic treatments for depression and anxiety show small-to-moderate added effects, varying by control condition. Research is needed regarding routine care, the video format, children and adolescents and older adults. PROSPERO REGISTRATION NUMBER: CRD42021243172.

Shared and distinct effect mediators in exposure-based and traditional cognitive behavior therapy for fibromyalgia: Secondary analysis of a randomized controlled trial.

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.

Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental or Injection Phobia: Randomized Controlled Trial.

BACKGROUND: Dental phobia (DP) and injection phobia (IP) are common in children and adolescents and are considered some of the biggest obstacles to successful treatment in pediatric dentistry. Cognitive behavioral therapy (CBT) is an evidence-based treatment for anxiety and phobias. As the availability of CBT in dentistry is low, internet-based CBT (ICBT) was developed. Open trials have shown that ICBT is a promising intervention, but randomized trials are lacking. OBJECTIVE: This randomized controlled trial tests whether therapist-guided ICBT supported by a parent could reduce fear, allowing children and adolescents with DP or IP to receive dental treatment. METHODS: We enrolled 33 participants (mean age 11.2, SD 1.9 y) whom a clinical psychologist had diagnosed with DP, IP, or both. After inclusion, participants were randomized to either ICBT (17/33, 52%) or a control group of children on a waitlist (16/33, 48%). ICBT was based on exposure therapy and comprised a 12-week at-home program combined with visits to their regular dental clinic. Participants corresponded weekly with their therapist after completing each module, and 1 parent was designated as a coach to support the child in the assignments during treatment. All participants completed measurements of the outcome variables before treatment start and after 12 weeks (at treatment completion). The measurements included a structured diagnostic interview with a clinical psychologist. Our primary outcome measure was the Picture-Guided Behavioral Avoidance Test (PG-BAT), which assesses the ability to approach 17 dental clinical procedures, and a positive clinical diagnosis. Secondary outcome measures included self-report questionnaires that measured self-efficacy and levels of dental and injection anxiety. The children and their parents completed the questionnaires. RESULTS: All participants underwent the 12-week follow-up. After treatment, 41% (7/17) of the participants in the ICBT group no longer met the diagnostic criteria for DP or IP, whereas all participants in the control group did (P=.004). Repeated-measure ANOVAs showed that ICBT led to greater improvements on the PG-BAT compared with the control group; between-group effect sizes for the Cohen d were 1.6 (P<.001) for the child-rated PG-BAT and 1.0 (P=.009) for the parent-rated PG-BAT. Reductions in our secondary outcomes-dental fear and anxiety (P<.001), negative cognitions (P=.001), and injection fear (P=.011)-as well as improvements in self-efficacy (P<.001), were all significantly greater among children in the ICBT group than in the controls. No participants reported adverse events. CONCLUSIONS: ICBT seems to be an effective treatment for DP and IP in children and adolescents. It reduced fear and anxiety and enabled participants to willingly receive dental treatment. ICBT should be seriously considered in clinical practice to increase accessibility; this therapy may reduce the need for sedation and restraint and lead to better dental health in children and adolescents. TRIAL REGISTRATION: ClinicalTrials.gov NCT02588079; https://clinicaltrials.gov/study/NCT02588079.

All-Cause and Cause-Specific Mortality Among Individuals With Hypochondriasis.

Importance: Hypochondriasis, also known as health anxiety disorder, is a prevalent, yet underdiagnosed psychiatric disorder characterized by persistent preoccupation about having serious and progressive physical disorders. The risk of mortality among individuals with hypochondriasis is unknown. Objective: To investigate all-cause and cause-specific mortality among a large cohort of individuals with hypochondriasis. Design, Setting, and Participants: This Swedish nationwide matched-cohort study included 4129 individuals with a validated International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) diagnosis of hypochondriasis assigned between January 1, 1997, and December 31, 2020, and 41 290 demographically matched individuals without hypochondriasis. Individuals with diagnoses of dysmorphophobia (body dysmorphic disorder) assigned during the same period were excluded from the cohort. Statistical analyses were conducted between May 5 and September 27, 2023. Exposure: Validated ICD-10 diagnoses of hypochondriasis in the National Patient Register. Main Outcome and Measures: All-cause and cause-specific mortality in the Cause of Death Register. Covariates included birth year, sex, county of residence, country of birth (Sweden vs abroad), latest recorded education, civil status, family income, and lifetime psychiatric comorbidities. Stratified Cox proportional hazards regression models were used to estimate the hazard ratios (HRs) and 95% CIs of all-cause and cause-specific mortality. Results: Of the 4129 individuals with hypochondriasis (2342 women [56.7%]; median age at first diagnosis, 34.5 years [IQR, 26.3-46.1 years]) and 41 290 demographically matched individuals without hypochondriasis (23 420 women [56.7%]; median age at matching, 34.5 years [IQR, 26.4-46.2 years]) in the study, 268 individuals with hypochondriasis and 1761 individuals without hypochondriasis died during the study period, corresponding to crude mortality rates of 8.5 and 5.5 per 1000 person-years, respectively. In models adjusted for sociodemographic variables, an increased rate of all-cause mortality was observed among individuals with hypochondriasis compared with individuals without hypochondriasis (HR, 1.69; 95% CI, 1.47-1.93). An increased rate was observed for both natural (HR, 1.60; 95% CI, 1.38-1.85) and unnatural (HR, 2.43; 95% CI, 1.61-3.68) causes of death. Most deaths from unnatural causes were attributed to suicide (HR, 4.14; 95% CI, 2.44-7.03). The results were generally robust to additional adjustment for lifetime psychiatric disorders. Conclusions and Relevance: This cohort study suggests that individuals with hypochondriasis have an increased risk of death from both natural and unnatural causes, particularly suicide, compared with individuals from the general population without hypochondriasis. Improved detection and access to evidence-based care should be prioritized.

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.

Effect of exposure-based vs traditional cognitive behavior therapy for fibromyalgia: a two-site single-blind randomized controlled trial.

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

Brief digital self-care intervention for health anxiety in a Swedish Medical University Clinic: a prospective single-group feasibility study.

OBJECTIVES: In routine psychiatric care in Stockholm, Sweden, a comprehensive therapist-guided intervention for clinically significant health anxiety is implemented. However, there is a need for more easily accessible self-care interventions to improve treatment dissemination. This study aimed to transform an existing therapist-guided digital intervention into a self-care intervention, reducing patient burden and used clinical resources while maintaining quality and safety. DESIGN: An uncontrolled feasibility study. SETTING: Conducted at Karolinska Institutet, a medical university in Sweden, with nationwide recruitment trough online advertisements. PARTICIPANTS: Twenty-five adults used the self-care intervention and underwent telephone assessments, along with completing self-rated questionnaires. INTERVENTION: The newly developed 8-week self-care intervention was designed to be user-friendly without therapist guidance, and to facilitate high levels of behavioural engagement. PRIMARY AND SECONDARY OUTCOME MEASURES: Indicators of quality and safety, including changes in health anxiety severity (primary), clinician time, participant adherence, perceived credibility/satisfaction with the intervention and adverse events, were benchmarked against a previous study of the more comprehensive intervention it was based on. RESULTS: Compared with the original guided intervention, the self-care intervention was condensed in terms of text (up to 70% less reading), duration (8 weeks instead of 12) and number of exercises. Quality indicators were similar to the original version. Most participants worked actively with core components in the self-care intervention. Within-group effects on health anxiety from pretreatment to the 3-month follow-up were large (g=1.37; 95% CI 0.74 to 2.00). No serious adverse events were reported. CONCLUSIONS: This brief digital self-care intervention shows potential for increasing access to treatment for individuals with health anxiety while reducing the burden on patients and clinical resources. Future studies should investigate the optimal type of intervention and support for different individuals, and if non-inferiority can be established. TRIAL REGISTRATION NUMBER: NCT05446766.

Psychometric and structural properties of the Karolinska Exhaustion Disorder Scale: a 1,072-patient study.

OBJECTIVE: Exhaustion disorder is a stress-related diagnosis that was introduced in 2005 to the Swedish version of the International Statistical Classification of Diseases and Related Health Problems, 10th edition (ICD-10). The Karolinska Exhaustion Disorder Scale (KEDS) was developed to assess exhaustion disorder symptomatology. While the KEDS is intended to reflect a single construct and be used based on its total score, the instrument's characteristics have received limited attention. This study investigated the KEDS's psychometric and structural properties in a large clinical sample. METHODS: The study relied on data from 1,072 patients diagnosed with exhaustion disorder that were included in two clinical trials in Sweden. We investigated the dimensionality, homogeneity, and reliability of the KEDS using advanced statistical techniques, including exploratory structural equation modeling (ESEM) bifactor analysis. RESULTS: A one-factor confirmatory analytic model exhibited a poor fit, suggesting at least a degree of multidimensionality. The ESEM bifactor analysis found the general factor to explain about 72% of the common variance extracted, with an omega hierarchical coefficient of 0.680. Thus, the ESEM bifactor analysis did not clearly support the scale's essential unidimensionality. A homogeneity analysis revealed a scale-level H of only 0.296, suggesting that KEDS's total scores do not accurately rank individuals on the latent continuum assumed to underlie the measure. The KEDS's reliability was modest, signaling considerable measurement error. CONCLUSION: Findings reveal important limitations to the KEDS with possible implications for the status of exhaustion disorder as a nosological category. TRIAL REGISTRATION: This study was pre-registered on Open Science Framework (osf.io) on April 24, 2022 ( https://osf.io/p34sq/ ).

Healthy lifestyle promotion via digital self-help for mental health patients in primary care: a pilot study including an embedded randomized recruitment trial.

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

Joint factor analysis and approximate equipercentile linking of common trait health anxiety measures: a cross-sectional study of the 14-, 18- and 64-item health anxiety inventory, the illness attitude scale, and the 14-item Whiteley Index.

BACKGROUND: Research on health anxiety has bloomed in recent years, but summaries of the literature are complicated by the use of dissimilar self-report questionnaires. Furthermore, these instruments have rarely been administered in parallel, and especially not in clinical samples. In this study, we aimed to investigate the relationship between five widespread health anxiety measures, and to draft guidelines for the conversion of different sum scores. METHODS: Clinical trial participants with principal pathological health anxiety (n = 335) and a sample of healthy volunteers (n = 88) completed the 14-item Whiteley Index (WI-14), the Illness Attitude Scale (IAS), and the 14-, 18-, and 64-item Health Anxiety Inventory (the HAI-64, HAI-18, and HAI-14). Cross-sectional data from all participants were pooled (N = 423) and we conducted a joint factor analysis and approximate equipercentile linking of the WI-14, IAS, HAI-64, HAI-18, and HAI-14. RESULTS: Inter-scale correlations were high (rs ≥ 0.90 and ≥ 0.88 in adjusted analyses), and the scree plot of the joint factor analysis spoke for a unifactorial solution where 89/105 items (85%) had loadings ≥ 0.40. Most items at the core of this broad trait health anxiety factor pertained to the worry about health, the fear of having or developing a serious disease, and to some extent bodily preoccupation. We present a cross-walk table of observed equipercentile linked sum scores. CONCLUSIONS: This study speaks clearly in favor of the WI-14, IAS, HAI-64, HAI-18, and HAI-14 all tapping into the same trait health anxiety construct, the core of which appears to concern the worry about health, the fear of having or developing a serious disease, and to some extent bodily preoccupation. Based on recently reported cut-offs for the HAI-14, a reasonable cutoff for pathological health anxiety in a psychiatric setting probably lies around 7-8 on the WI-14, 52-53 on the IAS, 82-83 on the HAI-64, and 26-27 on the HAI-18. TRIAL REGISTRATION: ClinicalTrials.gov NCT01966705, NCT02314065.

A Digital Self-help Intervention for Atopic Dermatitis: Analysis of Secondary Outcomes From a Feasibility Study.

BACKGROUND: Atopic dermatitis (AD) is a common inflammatory skin disease characterized by dry skin, eczematous lesions, and an often severe pruritus. The disease may have a negative effect on quality of life and is also associated with symptoms of anxiety and depression. Few individuals with AD receive any form of behavioral intervention. Behavioral interventions for AD are potentially efficacious but need to be constructed so that they are safe, credible, and user-friendly. We have previously reported on a feasibility study that demonstrated that a self-management version of a digital intervention based on cognitive behavioral therapy (CBT) for AD can potentially be effective in reducing AD symptoms. The aim of this secondary report was to further examine treatment feasibility and preliminary effects on dermatological quality of life, itching sensations, depressive symptoms, and perceived stress. OBJECTIVE: This is a secondary report on intervention credibility, usability, adverse events, and preliminary effects on secondary measures of a self-management digital intervention for atopic dermatitis. METHODS: In total, 21 adults with AD, recruited nationwide in Sweden, were assessed by telephone, and used the digital intervention for 8 weeks. Participants were also assessed directly afterward and 3 months after the end of the intervention. There was no therapist guidance. Feasibility indicators included intervention credibility, usability, and possible adverse effects. Other measures included preliminary effects on dermatological quality of life, itching sensations, depressive symptoms, and perceived stress. RESULTS: The intervention was regarded as credible and no serious adverse events were reported. System usability was, however, found to be below the predetermined cutoff for acceptable usability. Preliminary effects at 3-month follow-up were in the moderate to large range for dermatological quality of life (Cohen d=0.89, 95% CI 0.18-1.56), itching sensations (Cohen d=0.85, 95% CI 0.15-1.52), depressive symptoms (Cohen d=0.78, 95% CI 0.1-1.45), and perceived stress (Cohen d=0.75, 95% CI 0.01-1.36). CONCLUSIONS: This 8-week self-management digital CBT-based intervention was, together with telephone calls before and after, a feasible intervention for participants with AD. Preliminary effects were promising and should be explored further in a randomized controlled trial. Intervention usability was, however, rated below cutoff scores. Efforts should be made to improve written material to increase usability.

Unwanted outcomes in cognitive behavior therapy for pathological health anxiety: a systematic review and a secondary original study of two randomized controlled trials.

INTRODUCTION: Cognitive behavior therapy (CBT) is effective for pathological health anxiety, but little is known about unwanted outcomes. AREAS COVERED: We investigated unwanted outcomes in the form of adverse events, overall symptom deterioration, and dropouts in CBT for pathological health anxiety based on a systematic review of 19 randomized controlled trials (PubMed, PsycInfo, and OATD; last updated 2 June 2023; pooled N = 2188), and then a secondary original study of two randomized controlled trials (pooled N = 336). In the systematic review, 10% of participants in CBT reported at least one adverse event and 17% dropped out. Heterogeneity was substantial. In the original investigation, 17% reported at least one adverse event, 0-10% met criteria for overall symptom deterioration, and 10-19% dropped out. In guided Internet-delivered CBT, dropouts were more common with lower education and lower credibility/expectancy ratings. Higher adherence was associated with a larger reduction in health anxiety. EXPERT OPINION: Unwanted effects are routinely seen in CBT for pathological health anxiety, but, under typical circumstances, appear to be acceptable in light of the treatment's efficacy. There is a need for more consistent methods to improve our understanding adverse events, dropouts, and overall symptom deterioration, and how these outcomes can be prevented.

People who worry excessively about having or developing a serious disease are commonly offered cognitive behavior therapy (CBT). Little is known about unwanted outcomes in CBT for this patient group. This study had two parts. First, we conducted a systematic search of the existing literature where we found that about 10% of patients in CBT experience an event that they perceive as unwanted or negative. About 17% of patients drop out of treatment prematurely. Results differed substantially between studies. Second, we analyzed the outcome of two original studies and found that about 17% of patients in CBT experience an event that they perceive as unwanted or negative. Patients who experienced such an event reported, on average, a smaller reduction in health anxiety if CBT was delivered face-to-face, but not if it was delivered via the Internet. About 0­10% rated their health anxiety as having become worse after CBT, and 10­19% dropped out prematurely. In CBT delivered via the Internet, patients were more likely to drop out if their level of education was lower, and if they rated the treatment as less credible and expectancy-evoking during week 2. We conclude that unwanted effects are relatively common but typically mild and acceptable.

Objective cognitive functioning in patients with stress-related disorders: a cross-sectional study using remote digital cognitive testing.

BACKGROUND: Patients with stress-related mental disorders often report cognitive impairment, but studies investigating objective cognitive impairment in patients with stress-related disorders have produced inconsistent findings. AIM: The primary aim of this study was to investigate objective cognitive functioning in patients diagnosed with the stress-related disorders adjustment disorder or exhaustion disorder, compared to a healthy normative group. Secondary aims were to conduct subgroup analyses of cognitive functioning between the diagnostic groups and explore associations between self-reported symptoms and cognitive functioning. METHODS: Cognitive test results on a digitally self-administered cognitive test battery from 266 patients (adjustment disorder, n = 131; exhaustion disorder, n = 135) were cross-sectionally compared with results from a healthy normative group (N = 184 to 692) using one-tailed t-tests. ANOVAs were conducted for subgroup analyses, and regression analyses for associations between self-reported symptoms and cognitive functioning. Effect sizes were calculated. RESULTS: Patients performed significantly worse than the normative group on all measures with small to moderate effect sizes ranging from d = -.13 to -.57. Those diagnosed with exhaustion disorder performed worse than norms on more measures than did patients with adjustment disorder, but no significant differences between diagnostic groups were found on any measure. Self-reported memory impairment was weakly associated with one of two memory measures. No clear associations between self-reported burnout symptoms and objective cognitive functioning were found. CONCLUSIONS: This study adds to the literature indicative of small to moderate objective cognitive impairments in patients diagnosed with stress-related mental disorders. Further exploration into mechanisms of cognitive functioning in different populations is needed for development of theoretical models that may explain the weak correlation between self-reported symptoms and objective measures. TRIAL REGISTRATION: ClinicalTrial.gov: NCT04797273. Trial registration date 15 March 2021. This study was also pre-registered on Open Science Framework (osf.io) with https://doi.org/10.17605/OSF.IO/TQXZV .

Effect of Internet-Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial.

Importance: Nonsuicidal self-injury is prevalent in adolescence and associated with adverse clinical outcomes. Effective interventions that are brief, transportable, and scalable are lacking. Objective: To test the hypotheses that an internet-delivered emotion regulation individual therapy for adolescents delivered adjunctive to treatment as usual is superior to treatment as usual only in reducing nonsuicidal self-injury and that improvements in emotion regulation mediate these treatment effects. Design, Setting, and Participants: This 3-site, single-masked, randomized superiority trial enrolled participants from November 20, 2017, to April 9, 2020. Eligible participants were aged between 13 and 17 years and met diagnostic criteria for nonsuicidal self-injury disorder; they were enrolled as a mixed cohort of consecutive patients and volunteers. Parents participated in parallel to their children. The primary end point was at 1 month after treatment. Participants were followed up at 3 months posttreatment. Data collection ended in January 2021. Interventions: Twelve weeks of therapist-guided, internet-delivered emotion regulation individual therapy delivered adjunctive to treatment as usual vs treatment as usual only. Main Outcomes and Measures: Primary outcome was the youth version of the Deliberate Self-harm Inventory, both self-reported by participants prior to treatment, once every week during treatment, and for 4 weeks posttreatment, and clinician-rated by masked assessors prior to treatment and at 1 and 3 months posttreatment. Results: A total of 166 adolescents (mean [SD] age, 15.0 [1.2] years; 154 [92.8%] female) were randomized to internet-delivered emotion regulation therapy plus treatment as usual (84 participants) or treatment as usual only (82 participants). The experimental intervention was superior to the control condition in reducing clinician-rated nonsuicidal self-injury (82% vs 47% reduction; incidence rate ratio, 0.34; 95% CI, 0.20-0.57) from pretreatment to 1-month posttreatment. These results were maintained at 3-month posttreatment. Improvements in emotion dysregulation mediated improvements in self-injury during treatment. Conclusions and Relevance: In this randomized clinical trial, a 12-week, therapist-guided, internet-delivered emotion regulation therapy delivered adjunctive to treatment as usual was efficacious in reducing self-injury, and mediation analysis supported the theorized role of emotion regulation as the mechanism of change in this treatment. This treatment may increase availability of evidence-based psychological treatments for adolescents with nonsuicidal self-injury. Trial Registration: ClinicalTrials.gov Identifier: NCT03353961.

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.

Therapist-supported Internet-based cognitive behaviour therapy yields similar effects as face-to-face therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis.

Providing therapist-guided cognitive behaviour therapy via the Internet (ICBT) has advantages, but a central research question is to what extent similar clinical effects can be obtained as with gold-standard face-to-face cognitive behaviour therapy (CBT). In a previous meta-analysis published in this journal, which was updated in 2018, we found evidence that the pooled effects for the two formats were equivalent in the treatment of psychiatric and somatic disorders, but the number of published randomized trials was relatively low (n=20). As this is a field that moves rapidly, the aim of the current study was to conduct an update of our systematic review and meta-analysis of the clinical effects of ICBT vs. face-to-face CBT for psychiatric and somatic disorders in adults. We searched the PubMed database for relevant studies published from 2016 to 2022. The main inclusion criteria were that studies had to compare ICBT to face-to-face CBT using a randomized controlled design and targeting adult populations. Quality assessment was made using the Cochrane risk of bias criteria (Version 1), and the main outcome estimate was the pooled standardized effect size (Hedges' g) using a random effects model. We screened 5,601 records and included 11 new randomized trials, adding them to the 20 previously identified ones (total n=31). Sixteen different clinical conditions were targeted in the included studies. Half of the trials were in the fields of depression/depressive symptoms or some form of anxiety disorder. The pooled effect size across all disorders was g=0.02 (95% CI: -0.09 to 0.14) and the quality of the included studies was acceptable. This meta-analysis further supports the notion that therapist-supported ICBT yields similar effects as face-to-face CBT.

Brief self-guided digital intervention versus a comprehensive therapist-guided online cognitive behavioural therapy for atopic dermatitis: a trial protocol for a randomised non-inferiority trial.

INTRODUCTION: Our aim is to investigate whether a shortened digital self-care intervention is non-inferior to, and cost-effective compared with, a comprehensive and therapist-guided cognitive behavioural therapy treatment for atopic dermatitis (AD). METHODS AND ANALYSIS: This is a single-blind, randomised clinical non-inferiority trial at Karolinska Institutet, a medical university in Stockholm, Sweden. We will recruit 174 adult participants with AD through self-referral. Participants will be randomised 1:1 to the two experimental conditions. Participants randomised to guided care will receive internet-delivered cognitive behavioural therapy for 12 weeks. Participants randomised to digital self-care will have access to this self-guided intervention for 12 weeks. At post-treatment (primary endpoint), non-inferiority will be tested and resource use will be compared between the two treatment groups. Cost-effectiveness will be explored at 1-year follow-up. Potential mediators will be investigated. Data will be analysed intention to treat. We define non-inferiority as a three-point difference on the primary outcome measure (Patient-oriented Eczema Measure). Recruitment started in November 2022. ETHICS AND DISSEMINATION: This study is approved by the Swedish ethics authority (reg. no 2021-06704-01) and is preregistered at ClinicalTrials.gov. The study will be reported according to the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. The results of the study will be published in peer-reviewed scientific journals and disseminated to patient organisations and media. TRIAL REGISTRATION NUMBER: NCT05517850.

The efficacy of an internet-based cognitive behavioral program added to treatment-as-usual for alcohol-dependent patients in primary care: a randomized controlled trial.

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

Validity and clinical utility of distinguishing between DSM-5 somatic symptom disorder and illness anxiety disorder in pathological health anxiety: Should we close the chapter?

OBJECTIVE: To investigate the validity and clinical utility of distinguishing between DSM-5 somatic symptom disorder (SSD) and illness anxiety disorder (IAD) in pathological health anxiety: the excessive and recurrent fear of, or preoccupation with, having or developing a serious health condition. METHODS: We compared SSD to IAD in pathological health anxiety (N = 334) with regard to concurrent, antecedent, and predictive validators. This was primarily a cross-sectional study, though we studied the effect of CBT longitudinally. Because we were interested in the discriminatory value of SSD and IAD over and above trait health anxiety, we used trait health anxiety as a covariate. RESULTS: SSD (68%; 228/334) vs. IAD (32%; 106/334) differences were mostly non-significant and small in sociodemographics, core clinical characteristics, apparent course, etiological attribution, and physician visits (gs = -0.18-0.20; RRs = 0.84-1.09; IRRs = 0.87-0.99). However, SSD was associated with a significantly higher somatic symptom burden (gs = 0.20-0.72), more psychologist visits (IRR = 2.02, 95% CI: 1.24-3.28), and slightly higher disability (g = 0.22, 95% CI: 0.03-0.42). There was no significant difference in symptom reduction during CBT (g = -0.16, 95% CI: -0.37-0.05). CONCLUSION: Although not all differences between SSD and IAD in pathological health anxiety seem to be explained by the level of trait health anxiety, the SSD vs. IAD distinction appears to convey little useful information in pathological health anxiety. Tentatively, considering the well-documented clinical characteristics and effective clinical interventions, it is probably most helpful to regard pathological health anxiety as a de facto anxiety or perhaps obsessive-compulsive spectrum disorder, regardless of the DSM-5 diagnosis of SSD or IAD.