Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia

Study Overview
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Brief Summary
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Fibromyalgia (FM) is a common medical condition characterized by chronic generalized musculoskeletal pain, fatigue, and a series of additional somatic and psychiatric problems that give rise to distress, functional impairment, and substantial societal costs. The most extensively evaluated treatment for FM is traditional cognitive behavior therapy (T-CBT) which typically appears to have small to moderate effects when compared to waitlist, attention control, treatment as usual or other active nonpharmacological therapies. Internet-delivered exposure-based cognitive behavior therapy (Exp-CBT) where the patient willingly and systematically engages with stimuli associated with pain and pain-related distress has shown promising controlled effects versus a waiting-list but has never been compared to T-CBT in a randomized controlled trial. In this randomized controlled trial, self-recruited adults with FM (N=260) are randomly assigned (1:1) to 10 weeks of internet-delivered Exp-CBT or internet-delivered T-CBT and complete self-report questionnaires to measure symptoms and therapeutic processes up to 12 months after treatment. Primary outcome is the relative effect of Exp-CBT and T-CBT on FM severity as modelled using linear mixed models fitted on weekly Fibromyalgia Impact Questionnaire sum scores over the treatment period, testing the hypothesis of Exp-CBT superiority based on the coefficient for the time × group interaction. The investigators will also calculate the number of treatment completers in each treatment condition, defined as having commenced module five out of eight treatment modules. Cost-effectiveness and mediational processes are investigated in secondary analyses. The investigators expect this trial to be of notable clinical significance as it will provide valuable information about the value of Exp-CBT in helping patients with FM as compared to using other interventions.

Detailed Description
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FM is a common problem with substantial negative consequences. The most widely evaluated psychological treatment for FM is T-CBT which usually has small to moderate controlled effects on pain, mood and functional impairment. Based on one pilot study and one wailist-controlled RCT, Exp-CBT appears to have promising effects on FM but this treatment has not yet been compared to an active control condition. The present study aims to compare internet-delivered Exp-CBT to internet-delivered T-CBT in a randomized controlled trial. Participants in Exp-CBT and T-CBT are encouraged to work with self-help texts and complete regular homework exercises via a secure treatment platform. Both treatments are 10 weeks long, equally exhaustive, and involve approximately the same level of therapist support. Primary outcome is the relative effect of Exp-CBT and T-CBT on FM severity as modelled using linear mixed models fitted on weekly Fibromyalgia Impact Questionnaire sum scores over the treatment period, testing the hypothesis of Exp-CBT superiority based on the coefficient for the time × group interaction. The investigators will also calculate the number of treatment completers in each treatment condition, defined as having commenced module five out of eight treatment modules. Detailed information regarding analysis of clinical efficacy is provided in the supplementary file. In addition to clinical efficacy, the investigators will also investigate cost-effectiveness and mediational processes. The primary hypothesis is that Exp-CBT is significantly more efficacious than T-CBT in reducing FM severity, i.e., the Fibromyalgia Impact Questionnaire (FIQ) composite score indicative of symptoms and functional status, from the baseline assessment to the 10-week assessment.

Official Title
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Randomized Controlled Trial of Internet-delivered Exposure-based Cognitive Behavior Therapy vs. Internet-delivered Traditional Cognitive Behavior Therapy for Patients With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: Internet-delivered exposure-based cognitive behavior therapy
* Behavioral: Internet-delivered traditional cognitive behavior therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Living in Sweden Access to the internet Completed pre-treatment assessment If on psychotropic medication, dose kept stable for at least 4 weeks before randomization and the participant agrees to keep it constant during treatment Exclusion Criteria: Severe depression (≥ 30 on the Montgomery Åsberg Depression Rating Scale-Self Rated [MADRS-S] at screening) Suicidal ideation (≥ 4 on the suicide item of the MADRS-S at screening), Psychosis Alcohol or substance use disorder as primary diagnosis or likely to severely interfere with treatment Ongoing psychological treatment Pregnancy (>29 wk gestation) Another somatic condition that requires immediate treatment and/or is deemed to be the primary condition Insufficient knowledge of the Swedish language or insufficient computer skills to benefit from the text-based online treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with repeated measurments and two conditions: the experimental group (Exp-CBT) and an active control group (T-CBT).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-delivered exposure-based cognitive behavior therapy (Exp-CBT)<br>10-week self-help treatment delivered via a secure online platform, with regular therapist support. | Behavioral: Internet-delivered exposure-based cognitive behavior therapy<br>* The primary treatment component is exposure to stimuli (situations and activities) that give rise to pain, distress, and unwanted emotional responses. The treatment proceeds in accordance with functional analysis. Exercises are tailored for the patient so that, for example, individuals whose main coping strategy is to be overly active (i.e., persistence behavior) are encouraged to sit down and observe pain and other aversive bodily sensations as they arise. The protocol also includes regular exercises where the participant is encouraged to observe and name physical sensations without acting on them.<br>* Other names: Exp-CBT;|
| Active Comparator: Internet-delivered traditional cognitive behavior therapy (T-CBT)<br>10-week self-help treatment delivered via a secure online platform, with regular therapist support. | Behavioral: Internet-delivered traditional cognitive behavior therapy<br>* This treatment is based on components typical of T-CBT for FM, such as relaxation, activity planning or pacing, cognitive restructuring techniques and stress management strategies.<br>* Other names: T-CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FM severity over the main phase, as modelled using data from all 11 assessments from the pre-treatment assessment, weekly to the primary endpoint (10 weeks). | The Fibromyalgia Impact Questionnaire, FIQ. Self-rated, range 0-100. Higher score indicate higher FM severity. | Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain over the main phase, as modelled using data from all 11 assessments from the pre-treatment assessment, weekly to the primary endpoint (10 weeks). | The Fibromyalgia Impact Questionnaire, FIQ-Pain subscale. Self-rated, range 0 to 10, a higher score indicates more pain. | Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments. | 
| Change in pain over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks) | Brief Pain Inventory-Short Form, BPI-Sf. Self-rated, range 0-10. A higher score indicates more pain. | Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-MFU assessments. | 
| Change in fatigue over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks) | Fatigue Severity Scale, FSS. Self-rated, range 9-63. A higher score indicates greater fatigue severity | Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments. | 
| Change in anxiety over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks) | GAD-2. Self-rated, range: 0-6. A higher score indicates more general anxiety. | Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments. | 
| Change in depression over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks) | PHQ-2. Self-rated, range: 0-6. A higher score indicates more depressive symptoms. | Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments. | 
| Change in functional impairment over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks). | 12-item WHO Disability Assessment Schedule 2.0, WHODAS 2.0. Self-rated, range: 0-100. A higher score indicates more disability. | Pre-treatment, 10 weeks, Secondary analyses incorporate 6- and 12-months follow-up assessments. | 
| Change in quality of life over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks). | Brunnsviken Brief Quality of Life Inventory, BBQ. Self-rated, range 0 to 96, a higher score indicates better quality of life | Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments. | 
| Global impression of perceived change at post-treatment | Patient Global Impression of Change, PGIC. Self-rated, range no change [or condition has got worse] to a great deal better, and a considerable improvement that has made all the difference | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive behavior therapy, randomized controlled trial, internet-delivered treatment