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.

Using 360-degree videos for virtual reality exposure in CBT for panic disorder with agoraphobia: a feasibility study.

BACKGROUND: Cognitive behavioural therapy (CBT) is an effective treatment for panic disorder with agoraphobia (PDA). However, implementation of some of the procedures involved, particularly in vivo exposure, can be time consuming and taxing for routine health care services. CBT with exposure taking place in virtual reality (VR-CBT) is a more time-efficient option and has shown promising results in the treatment of PDA. However, VR-CBT requires expensive equipment and appropriate virtual environments, which historically has been costly and cumbersome to produce. Thus, access to VR-CBT has been sparse in regular care environments. AIMS: The aim of this study was to investigate whether VR-CBT using filmed virtual environments produced with a low-cost 360-degree film camera can be a feasible and acceptable treatment for PDA when implemented in a primary care context. METHOD: This was an open feasibility trial with a within-group design, with assessments conducted at pre-test, post-test, and 6-month follow-up. Participants (n = 12) received a 10-12 week treatment programme of VR-CBT and PDA-related symptoms were assessed by the primary outcome measure The Mobility Inventory for Agoraphobia (MIA) and the Panic-Disorder Severity Scale-Self Rated (PDSS-SR). RESULTS: The results showed that treatment satisfaction was high and participants were significantly improved on PDA-related measures at post-treatment and at 6-month follow-up with large effect sizes (Cohen's d range = 1.46-2.82). All 12 participants completed the treatment. CONCLUSIONS: These findings suggest that VR-CBT with 360-degree video virtual environments delivered to primary care patients with PDA is feasible, acceptable, and potentially efficacious.

Effect of Internet vs Face-to-Face Cognitive Behavior Therapy for Health Anxiety: A Randomized Noninferiority Clinical Trial.

Importance: Health anxiety is a common and often chronic mental health problem associated with distress, substantial costs, and frequent attendance throughout the health care system. Face-to-face cognitive behavior therapy (CBT) is the criterion standard treatment, but access is limited. Objective: To test the hypothesis that internet-delivered CBT, which requires relatively little resources, is noninferior to face-to-face CBT in the treatment of health anxiety. Design, Setting, and Participants: This randomized noninferiority clinical trial with health economic analysis was based at a primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care. Recruitment began in December 10, 2014, and the last treatment ended on July 23, 2017. Follow-up data were collected up to 12 months after treatment. Analysis began October 2017 and ended March 2020. Interventions: Patients were randomized (1:1) to 12 weeks of internet-delivered CBT or to individual face-to-face CBT. Main Outcomes and Measures: Change in health anxiety symptoms from baseline to week 12. Analyses were conducted from intention-to-treat and per-protocol (completers only) perspectives, using the noninferiority margin of 2.25 points on the Health Anxiety Inventory, which has a theoretical range of 0 to 54. Results: Overall, 204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period. Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50%) were randomized to face-to-face CBT. The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25). The between-group effect was not moderated by initial symptom level, recruitment path, or patient treatment preference. Therapists spent 10.0 minutes per patient per week in the online treatment vs 45.6 minutes for face-to-face CBT. The net societal cost was lower in the online treatment (treatment period point difference: $3854). There was no significant group difference in the number of adverse events, and no serious adverse event was reported. Conclusions and Relevance: In this trial, internet-delivered CBT appeared to be noninferior to face-to-face CBT for health anxiety, while incurring lower net societal costs. The online treatment format has potential to increase access to evidence-based treatment for health anxiety. Trial Registration: ClinicalTrials.gov Identifier: NCT02314065.

Internet-Delivered Exposure Therapy for Fibromyalgia: A Randomized Controlled Trial.

BACKGROUND: Fibromyalgia (FM) is a common and disabling chronic pain disorder, for which existing pharmacological and psychological treatments have yet yielded insufficient effects. Previous literature has shown that exposure therapy may be an effective treatment for chronic pain. This study constitutes the first randomized controlled trial evaluating exposure therapy for FM. METHODS: A total of 140 participants with diagnosed FM were randomized to a 10-week Internet-delivered exposure treatment (iExp; n=70) or a waitlist control condition (WLC; n=70). Primary outcome measure were FM symptoms and impact, and secondary outcome measures were fatigue, disability, quality of life, pain-related distress and avoidance behaviors, insomnia, depression, and anxiety. RESULTS: Data retention was high (100% data completion at posttreatment for primary outcome, 96% at 6-month follow-up and 94% at 12-month follow-up). Results showed that participants in the iExp group made large and superior improvements compared with WLC on FM symptoms and impact (B, -1.93; z, -10.14; P<0.001, between-group Cohen d=0.90), as well as all secondary outcomes (between-group Cohen d ranging from 0.44 to 1.38) with sustained results. CONCLUSIONS: We conclude that iExp seems to be an efficacious treatment for FM compared with no treatment, and the results also highlight the potential increase of accessibility by using the Internet format to deliver psychological treatments for these patients. Future trials with active control conditions are warranted.