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.

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.

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.

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.

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.

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.

Cognitive Behavioral Therapy Improves Quality of Life in Patients With Symptomatic Paroxysmal Atrial Fibrillation.

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

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.

Feasibility of a video-delivered mental health course for primary care patients: a single-group prospective cohort study.

BACKGROUND: In many health care systems, primary care is tasked with offering psychological treatment for common mental disorders. Resources are often limited, which complicates widespread dissemination of traditional psychological treatments. Stepped care models where the less resource-intensive interventions are delivered first, can be employed, but often do not eliminate the need for a thorough diagnostic assessment, which can be time-consuming, has the potential to bottleneck patient intake, and can add to waiting times. Novel low-threshold formats are needed to improve access to mental health care in the primary care setting. METHODS: This was a single-group prospective cohort study (N = 91). We assessed the feasibility of a video-delivered course as a first-line intervention for patients seeking help for mental health problems at a primary care center. The course had a transdiagnostic approach, suitable for both depression and anxiety disorders, and was based on cognitive behavioral techniques. Patients in need of psychosocial assessment, which usually entailed a four- to six-week wait, were referred by physicians or triage nurses. Study participants could start within a week, without the need for conventional diagnostic assessment, and were informed that they would be offered assessment after the course if needed. Key feasibility outcomes included participant satisfaction, attendance rates, the proportion of participants in need of additional clinical intervention after the course, and the rate of clinically significant improvement in anxiety and depression symptoms. RESULTS: Participants scored a mean of 21.8 (SD = 4.0, 9-32, n = 86) on the Client Satisfaction Questionnaire-8; just below our target of 22. The mean attendance rate was 5.0/6 lectures (SD = 1.6, range: 0-6, n = 91). Forty-six percent (37/81) reported experiencing no need of further clinical intervention after the course. The rate of clinically significant improvement was 59% (27/46) for anxiety and 48% (22/46) for depression. No serious adverse event was reported. CONCLUSIONS: Delivering a low-threshold online video-delivered mental health course in primary care appears to be feasible. Adjustments to further improve patient satisfaction are warranted, such as offering the choice of participating online or face-to-face. TRIAL REGISTRATION: (ClinicalTrials.gov NCT04522713) August 21, 2020.

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.

Effect moderators in Internet-based exposure therapy for fibromyalgia: The role of pain intensity.

BACKGROUND: A recent randomized controlled trial (N = 140) was indicative of large and sustained average improvements of Internet-based exposure for fibromyalgia, as compared to a waitlist. However, little is known about who benefits the most from this treatment. OBJECTIVES: To test for potential moderating effects of age, educational attainment, the duration of fibromyalgia, baseline overall fibromyalgia severity, pain intensity, fibromyalgia-related avoidance behaviour and symptom preoccupation on the waitlist-controlled effect of 10 weeks of Internet-based exposure for fibromyalgia. METHODS: Secondary analysis of a randomized controlled trial (ClinicalTrials.gov NCT02638636). We used linear mixed effects models to determine whether the waitlist-controlled effect of exposure therapy on overall fibromyalgia severity (Fibromyalgia Impact Questionnaire) differed as a function of the potential moderators. RESULTS: Only pain intensity (0-10) was found to be a significant moderator, where a higher baseline pain intensity predicted a more limited waitlist-controlled effect of Internet-based exposure (B = 3.48, 95% CI: 0.84-6.13). Standardized point estimates of effects were small for the sociodemographic variables, and in the moderate range for some clinical variables that did not reach statistical significance such as behavioural avoidance and time with the fibromyalgia diagnosis. CONCLUSIONS: Results suggest that Internet-based exposure treatment was more useful for participants with lower baseline levels of pain, and less so for participants with higher baseline levels of pain. The treatment had relatively similar effects across the other tested moderators. SIGNIFICANCE: This study evaluated potential effect moderators in exposure-based treatment for fibromyalgia. Results indicated that a higher level of pain intensity at baseline was predictive of a less favourable outcome. It may be extra important to monitor progression for these patients and to provide additional therapeutic support when needed.

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.

A unified Internet-delivered exposure treatment for undifferentiated somatic symptom disorder: single-group prospective feasibility trial.

BACKGROUND: Exposure-based psychological treatment appears to have beneficial effects for several patient groups that commonly report distress related to persistent somatic symptoms. Yet exposure-based treatment is rarely offered in routine care. This may be because existing treatment protocols have been developed for specific symptom clusters or specific unwanted responses to somatic symptoms, and many clinics do not have the resources to offer all these specialised treatments in parallel. In preparation for a randomised controlled trial, we investigated the feasibility of a new and unified Internet-delivered exposure treatment (OSF.io: cnbwj) for somatic symptom disorder regardless of somatic symptom domain (e.g. cardiopulmonary, fatigue, gastrointestinal, pain), combination of unwanted emotions (e.g. anger, anxiety, fear, shame) and whether somatic symptoms are medically explained or not. We hypothesised that a wide spectrum of subgroups would show interest, that the treatment would be rated as credible, that adherence would be adequate, that the measurement strategy would be acceptable and that there would be no serious adverse events. METHODS: Single-group prospective cohort study where 33 self-referred adults with undifferentiated DSM-5 somatic symptom disorder took part in 8 weeks of unified Internet-delivered exposure treatment delivered via a web platform hosted by a medical university. Self-report questionnaires were administered online before treatment, each week during treatment, post treatment and 3 months after treatment. RESULTS: Participants reported a broad spectrum of symptoms. The Credibility/Expectancy mean score was 34.5 (SD = 7.0, range: 18-47). Participants completed 91% (150/165) of all modules and 97% of the participants (32/33) completed at least two exposure exercises. The average participant rated the adequacy of the rationale as 8.4 (SD = 1.5) on a scale from 0 to 10. The post-treatment assessment was completed by 97% (32/33), and 84% (27/32) rated the measurement strategy as acceptable. The Client Satisfaction Questionnaire mean score was 25.3 (SD = 4.7, range: 17-32) and no serious adverse events were reported. Reductions in subjective somatic symptom burden (the Patient Health Questionnaire 15; d = 0.90) and symptom preoccupation (the somatic symptom disorder 12; d = 1.17) were large and sustained. CONCLUSIONS: Delivering a unified Internet-delivered exposure-based treatment protocol for individuals with undifferentiated somatic symptom disorder appears to be feasible. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04511286 . Registered on August 13, 2020.

Psychometric properties of the emotional processing scale in individuals with psychiatric symptoms and the development of a brief 15-item version.

The 25-item Emotional Processing Scale (EPS) can be used with clinical populations, but there is little research on its psychometric properties (factor structure, test-retest reliability, and validity) in individuals with psychiatric symptoms. We administered the EPS-25 to a large sample of people (N = 512) with elevated psychiatric symptoms. We used confirmatory factor analysis to evaluate three a priori models from previous research and then evaluated discriminant and convergent validity against measures of alexithymia (Toronto Alexithymia Scale-20), depressive symptoms (Patient Health Questionaire-9), and anxiety symptoms (Generalized Anxiety Disorder-7). None of the a priori models achieved acceptable fit, and subsequent exploratory factor analysis did not yield a clear factor solution for the 25 items. A 5-factor model did, however, achieve acceptable fit when we retained only 15 items, and this solution was replicated in a validation sample. Convergent and discriminant validity for this revised version, the EPS-15, was r = - 0.19 to 0.46 vs. TAS-20, r = 0.07- 0.25 vs. PHQ-9, and r = 0.29- 0.57 vs. GAD-7. Test-retest reliability was acceptable (ICC = 0.73). This study strengthens the case for the reliability and validity of the 5-factor structure of the EPS but suggest that only 15 items should be retained. Future studies should further examine the reliability and validity of the EPS-15.

Health Anxiety and Its Relationship to Thyroid-Hormone-Suppression Therapy in Patients with Differentiated Thyroid Cancer.

Differentiated thyroid cancer (DTC) has a good prognosis; however, patients often need lifelong follow up, and they face potential side effects. The aim of this study was to investigate health anxiety among DTC patients and its relationship to TSH suppression. In 2020, patients from a previous cohort who were from Stockholm completed the 14-item Short Health Anxiety Inventory (SHAI-14; 0−42; 18 being the threshold for clinical significance) and a study-specific questionnaire. Clinical information was also retrieved from medical records. Linear regression was used to investigate the relationship between the TSH levels and the SHAI-14, while adjusting for potential confounders. In total, 146 (73%) patients were included. A total of 24 respondents (16%) scored 18 or more on the SHAI-14, and the mean score was 11.3. Patients with TSH levels of 0.1−0.5 (mE/L) scored, on average, 3.28 points more (p-value 0.01) on the SHAI-14 compared to patients with TSH levels > 0.5. There was no statistically significant difference between patients with TSH levels < 0.1 and TSH levels > 0.5. Thus, we found no linear relationship between the TSH values and health anxiety. Clinically significant levels of health anxiety are slightly higher than those in the general population, but do not appear to be a major psychiatric comorbidity among patients with DTC.