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.

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.

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.

The 14-item short health anxiety inventory (SHAI-14) used as a screening tool: appropriate interpretation and diagnostic accuracy of the Swedish version.

BACKGROUND: The 14-item Short Health Anxiety Inventory (SHAI-14) is a common measure of health anxiety but its screening properties have not been studied. The aims of this study were to evaluate the SHAI-14 as a screening instrument, identify cut-offs for clinically significant health anxiety and investigate which scores correspond to different severity levels. METHOD: The study included 1729 psychiatric patients and 85 healthy controls. Participants completed the SHAI-14 and underwent a diagnostic interview. Cut-off scores were evaluated in three scenarios to approximate screening 1) in a psychiatric clinic, 2) in a low prevalence setting and, 3) of healthy volunteers (cut-off for remission). Receiver operating characteristics were used. Classification of severity was based on the distribution of SHAI-14 scores reported by patients with clinically significant health anxiety. RESULTS: The area under the curve (AUC) values were high in all scenarios (above 0.95). The optimal cut-off scores on the SHAI-14 were 22 in the psychiatric context, 29 in a setting with low prevalence of psychiatric disorders and 18 versus healthy controls. SHAI-14 scores of 0-27 represented no or mild health anxiety, 28-32 moderate health anxiety and 33-42 substantial health anxiety. CONCLUSION: Brief self-report measures used as screening instruments are a simple way of gathering information about the presence of specific symptoms and thus a way to detect the likelihood of a diagnosis. The SHAI-14 shows evidence of good diagnostic utility in both clinical and non-clinical settings. However, which cut-off score is to be used, depends on the intended purpose and the setting where the cut-off is used.

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.

Symptom Preoccupation in Fibromyalgia: Prevalence and Correlates of Somatic Symptom Disorder in a Self-Recruited Sample.

BACKGROUND: Somatic symptom disorder (SSD) is characterized by a persistent and distressing psychological reaction to somatic symptoms. In pain disorders, the preoccupation with physical symptoms is associated with poor long-term outcomes. SSD may therefore be of use to identify and help chronic pain patients with particular needs. OBJECTIVE: To test the hypothesis that in fibromyalgia, SSD is associated with higher anxiety sensitivity, health anxiety, and reactivity to pain, in addition to lower nonreactivity to inner experiences. In addition, to investigate if individuals with SSD report a larger impact of fibromyalgia core symptoms, more somatic symptoms, and higher psychiatric comorbidity. METHODS: Using data from a clinical trial involving self-referred individuals with fibromyalgia, we compared participants with SSD to participants without SSD using t-tests and logistic regression. RESULTS: Forty-nine out of 140 participants (35%) had SSD. Most findings corroborate that individuals with fibromyalgia who also meet criteria for SSD are worse off in terms of traits previously found to be predictive of a poor course in pain disorders. Post hoc analyses indicated that this could not be explained merely by a higher level of fibromyalgia core symptoms. CONCLUSION: SSD appears to be associated with a higher symptom burden in fibromyalgia, but further research is needed to draw firm conclusions regarding the reliability, acceptability, and utility of the SSD diagnosis in the clinic.

Cognitive behaviour therapy for depression in primary care: systematic review and meta-analysis.

Depression is common in primary care, and most patients prefer psychological treatment over pharmacotherapy. Cognitive behaviour therapy (CBT) is an effective treatment, but there are gaps in current knowledge about CBT in the primary care context, especially with regard to long-term effects and the efficacy of specific delivery formats. This is an obstacle to the integration of primary care and specialist psychiatry. We conducted a systematic review and meta-analysis of randomised controlled trials of CBT for primary care patients with depression to investigate the effect of CBT for patients with depression in primary care. A total of 34 studies, with 2543 patients in CBT and 2815 patients in control conditions, were included. CBT was more effective than the control conditions [g = 0.22 (95% confidence interval (CI) 0.15-0.30)], and the effect was sustained at follow-up [g = 0.17 (95% CI 0.10-0.24)]. CBT also led to a higher response rate [odds ratio (OR) = 2.47 (95% CI 1.60-3.80)] and remission rate [OR = 1.56 (95% CI 1.15-2.14)] than the control conditions. Heterogeneity was moderate. The controlled effect of CBT was significant regardless of whether patients met diagnostic criteria for depression, scored above a validated cut-off for depression, or merely had depressive symptoms. CBT also had a controlled effect regardless of whether the treatment was delivered as individual therapy, group therapy or therapist-guided self-help. We conclude that CBT appears to be effective for patients with depression in primary care, and recommend that patients with mild to moderate depression be offered CBT in primary care.

Cost-Effectiveness of Therapist-Guided Internet-Based Cognitive Behavioral Therapy for Stress-Related Disorders: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Stress-related disorders are associated with significant suffering, functional impairment, and high societal costs. Internet-based cognitive behavioral therapy (ICBT) is a promising treatment for stress-related disorders but has so far not been subjected to health economic evaluation. OBJECTIVE: The objective of this study was to evaluate the cost-effectiveness and cost-utility of ICBT for patients with stress-related disorders in the form of adjustment disorder (AD) or exhaustion disorder (ED). We hypothesized that ICBT, compared with a waitlist control (WLC) group, would generate improvements at low net costs, thereby making it cost-effective. METHODS: Health economic data were obtained in tandem with a randomized controlled trial of a 12-week ICBT in which patients (N=100) were randomized to an ICBT (n=50) or a WLC (n=50) group. Health outcomes and costs were surveyed pre- and posttreatment. We calculated incremental cost-effectiveness ratios (ICERs) based on remission rates and incremental cost-utility ratios (ICURs) based on health-related quality of life. Bootstrap sampling was used to assess the uncertainty of our results. RESULTS: The ICER indicated that the most likely scenario was that ICBT led to higher remission rates compared with the WLC and was associated with slightly larger reductions in costs from pre- to posttreatment. ICBT had a 60% probability of being cost-effective at a willingness to pay (WTP) of US $0 and a 96% probability of being cost-effective at a WTP of US $1000. The ICUR indicated that ICBT also led to improvements in quality of life at no net societal cost. Sensitivity analyses supported the robustness of our results. CONCLUSIONS: The results suggest that ICBT is a cost-effective treatment for patients suffering from AD or ED. Compared with no treatment, ICBT for these patients yields large effects at no or minimal societal net costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT02540317; https://clinicaltrials.gov/ct2/show/NCT02540317.

Internet-Based Cognitive Behavioral Therapy for Chronic Stress: A Randomized Controlled Trial.

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

Exposure-based cognitive-behavioural therapy via the internet and as bibliotherapy for somatic symptom disorder and illness anxiety disorder: randomised controlled trial.

BACKGROUND: In DSM-5 two new diagnoses, somatic symptom disorder (SSD) and illness anxiety disorder (IAD), have replaced DSM-IV hypochondriasis. There are no previous treatment studies for these disorders. Cognitive-behavioural therapy (CBT) delivered as therapist-guided or unguided internet treatment or as unguided bibliotherapy could be used to increase treatment accessibility. AIMS: To investigate the effect of CBT delivered as guided internet treatment (ICBT), unguided internet treatment (U-ICBT) and as unguided bibliotherapy. METHOD: A randomised controlled trial (RCT) where participants (n = 132) with a diagnosis of SSD or IAD were randomised to ICBT, U-ICBT, bibliotherapy or to a control condition on a waiting list (trial registration: Clinicaltrials.gov identifier NCT01966705). RESULTS: Compared with the control condition, all three treatment groups made large and significant improvements on the primary outcome Health Anxiety Inventory (between-group d at post-treatment was 0.80-1.27). CONCLUSIONS: ICBT, U-ICBT and bibliotherapy can be highly effective in the treatment of SSD and IAD. This is the first study showing that these new DSM-5 disorders can be effectively treated.

The health preoccupation diagnostic interview: inter-rater reliability of a structured interview for diagnostic assessment of DSM-5 somatic symptom disorder and illness anxiety disorder.

Somatic symptom disorder (SSD) and illness anxiety disorder (IAD) are two new diagnoses introduced in the DSM-5. There is a need for reliable instruments to facilitate the assessment of these disorders. We therefore developed a structured diagnostic interview, the Health Preoccupation Diagnostic Interview (HPDI), which we hypothesized would reliably differentiate between SSD, IAD, and no diagnosis. Persons with clinically significant health anxiety (n = 52) and healthy controls (n = 52) were interviewed using the HPDI. Diagnoses were then compared with those made by an independent assessor, who listened to audio recordings of the interviews. Ratings generally indicated moderate to almost perfect inter-rater agreement, as illustrated by an overall Cohen's κ of .85. Disagreements primarily concerned (a) the severity of somatic symptoms, (b) the differential diagnosis of panic disorder, and (c) SSD specifiers. We conclude that the HPDI can be used to reliably diagnose DSM-5 SSD and IAD.

Internet-delivered exposure-based cognitive-behavioural therapy and behavioural stress management for severe health anxiety: randomised controlled trial.

BACKGROUND: Exposure-based cognitive-behavioural therapy (CBT) delivered via the internet has been shown to be effective for severe health anxiety (hypochondriasis) but has not been compared with an active, effective and credible psychological treatment, such as behavioural stress management (BSM). AIMS: To investigate two internet-delivered treatments - exposure-based CBT v. BSM - for severe health anxiety in a randomised controlled trial (trial registration: NCT01673035). METHOD: Participants (n = 158) with a principal diagnosis of severe health anxiety were allocated to 12 weeks of exposure-based CBT (n = 79) or BSM (n = 79) delivered via the internet. The Health Anxiety Inventory (HAI) was the primary outcome. RESULTS: Internet-delivered exposure-based CBT led to a significantly greater improvement on the HAI compared with BSM. However, both treatment groups made large improvements on the HAI (pre-to-post-treatment Cohen's d: exposure-based CBT, 1.78; BSM, 1.22). CONCLUSIONS: Exposure-based CBT delivered via the internet is an efficacious treatment for severe health anxiety.

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.

Five-Year Follow-Up of Health-Related Quality of Life in Differentiated Thyroid Cancer Patients Treated with Total Thyroidectomy and Radioiodine in Sweden: A Nationwide Prospective Cohort Study.

Background: Despite a good prognosis, survivors of differentiated thyroid cancer (DTC) may have reduced health-related quality of life (HRQOL) many years after treatment, and it is unclear how suppression of thyroid-stimulating hormone (TSH) may contribute to HRQOL. This study investigated changes in HRQOL in the 5 years following DTC treatment, the association between HRQOL and TSH suppression, and how HRQOL compares to the general population. Methods: In this nationwide prospective cohort study, 487 patients with DTC were identified between 2012 and 2017 from all Swedish hospitals treating patients with DTC. Patients treated with total thyroidectomy and planned for radioiodine answered the Swedish version of the Short Form-36 Health Survey (SF-36) and a study specific questionnaire at treatment and after 1, 3, and 5 years. Summary measures for physical and mental QOL were derived from the SF-36, and TSH values were collected from patient records. To study changes in HRQOL over time, linear mixed models were fitted on multiply imputed data, with all patients and measurement points included in the model. Results: In total, 351 patients consented to participate in the study. In the 5 years following DTC treatment, physical QOL did not change significantly with time, while mental QOL improved by on average 0.61 (p < 0.001) per year. TSH levels were not predictive of either physical or mental QOL, or their change over time. At 5 years, there was a significant difference in physical and mental QOL compared with the Swedish general population, but effect sizes were small (Cohen's d = 0.29 and -0.21, respectively). The SF-36 domains general health, vitality, social functioning, and mental health were lower at 5 years compared with the general population (difference 8.7-13.3), and these differences were clinically significant. Conclusions: The mental component of HRQOL improves over time following DTC treatment. HRQOL in patients with DTC is not explained by TSH suppression. Although overall differences in physical and mental HRQOL compared with the general population were small 5 years after treatment, several specific psychosocial HRQOL domains were clinically meaningfully reduced. Psychosocial health issues should be screened for during DTC follow-up.

Psychometric evaluation of the Pain Vigilance and Awareness Questionnaire (PVAQ) in fibromyalgia: Confirmatory factor analysis and the development of a Swedish 8-item version.

BACKGROUND: Excessive attention to pain, or hypervigilance, is associated with negative outcomes in chronic pain conditions such as fibromyalgia. The Pain Vigilance and Awareness Questionnaire (PVAQ) is a self-report questionnaire to measure attention to pain. This study aimed to evaluate the psychometric properties of a Swedish version of the PVAQ. METHODS: Psychometric evaluation on cross-sectional data derived from a clinical trial for fibromyalgia (N = 274). We evaluated item characteristics, factor structure in a confirmatory factor analytic framework, internal consistency, and construct validity in terms of correlations with other clinical variables. RESULTS: Though confirmatory factor analysis did not result in a satisfactory solution for the full 16-item scale, acceptable two-factor solutions could be based on either nine or eight items (the PVAQ-9 and PVAQ-8). Internal consistency for both the PVAQ-9 and PVAQ-8 were good to excellent, and associations with pain catastrophizing, anxiety, depression, disability, and overall fibromyalgia impact were largely supportive of construct validity. An unexpected result was that, contrary to previous findings, no version of the PVAQ correlated consistently with pain intensity. CONCLUSIONS: The Swedish PVAQ-9 and PVAQ-8 appear to have acceptable psychometric properties when administered online to individuals with fibromyalgia. The PVAQ-8 may be preferable due to being shorter and including an equal number of items per factor. Replication is warranted. SIGNIFICANCE: This study evaluated the psychometric properties of a Swedish translation of the PVAQ in individuals with fibromyalgia. No convincing factor structure was found for the 16-item version. We could, however, confirm the factor structure of an established 9-item version (the PVAQ-9), and recommend further use of a new 8-item version (the PVAQ-8). In summary, the PVAQ exhibited more convincing psychometric properties when the number of items was roughly cut in half.

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.

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.

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.

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.