An interventional study of Internet-delivered exposure-based cognitive behavior therapy and Internet-delivered traditional cognitive behavior therapy in Fibromyalgia, sponsored by Karolinska Institutet. Completed at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
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.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's enrollment of 274 is above the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
10-week self-help treatment delivered via a secure online platform, with regular therapist support.
Behavioral: Internet-delivered exposure-based cognitive behavior therapy
10-week self-help treatment delivered via a secure online platform, with regular therapist support.
Behavioral: Internet-delivered traditional cognitive behavior therapy
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.
Also known as: Exp-CBT
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.
Also known as: T-CBT
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.
Time frame: 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 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 10 weeks
Depression severity during screening, and suicidal ideation during treatment
Montgomery Asberg Depression Rating Scale - Self-rated, MADRS-S. Self-rated, range 0 to 60, a higher score indicates higher more depressive symptoms
Time frame: Screening, item 9 weekly up to 9 weeks
Alcohol use at screening
Alcohol Use Disorders Identification Test. Self-rated, range 0 to 40, a higher score indicates more problematic alcohol use
Time frame: Screening
Drug use at screening
Drug Use Disorders Identification Test. Self-rated, range: 0-44. A higher score indicates more problematic substance use
Time frame: Screening
Change in pain-related avoidance behavior over the main phase, as modelled using data from all 11 assessments from pre-treatment assessment, weekly to the primary endpoint (10 weeks).
The Psychological Inflexibility in Pain Scale-avoidance subscale, PIPS-avoid. Self-rated, range 8-56. A higher score indicates more pain-related avoidance behaviors.
Time frame: Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Change in pacing and overdoing behavior over the main phase, as modelled using data from all 11 assessments from pre-treatment assessment, weekly to the primary endpoint (10 weeks).
Patterns of Activity Measure - Pain, Short form: pacing and overdoing subscales, POAM-P-sf, p/o. Self-rated, range 0-40. A higher score indicates higher degree of pacing and overdoing.
Time frame: Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Change in catastrophizing over the main phase, as modelled using data from all 11 assessments from the pre-treatment assessment, weekly to the primary endpoint (10 weeks).
Pain Catastrophizing Scale, PCS. Self-rated, range 0-52. A higher score indicates a higher degree of pain catastrophizing
Time frame: Pre-treatment, weekly up to10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Change in hypervigilance over the main phase, as modelled using data from all 11 assessments from pre-treatment assessment, weekly to the primary endpoint (10 weeks).
Pain Vigilance and Awareness Questionnaire, PVAQ. Self-rated, range 0-80. A higher score indicates more hypervigilance and awareness to pain.
Time frame: Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Change in physical activity 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 Godin-Shephard leisure-time physical activity questionnaire, GSLTPAQ. Self-rated, range 0-99. A higher score indicates more blocks of at least 15 minutes of physical activity
Time frame: Pre-treatment, weekly up to 10 weeks.
Treatment credibility and expectancy of improvement at week 3 of main phase
Credibility/Expectancy scale (C/E-scale). Self-rated, range: 0-50. A higher score indicates higher credibility/expectancy
Time frame: Week 3 of main phase
Working alliance with therapist at week 3 of main phase
Working alliance inventory-Short, Internet version, WAI-S-Internet. Self-rated, range: 7-144. A higher score indicates better relationship with the therapist.
Time frame: Week 3 of main phase.
Client satisfaction with treatment at primary endpoint assessment (10 weeks)
Client Satisfaction Questionnaire, CSQ-8. Self-rated, range: 8-32. A higher score indicates higher satisfaction with treatment.
Time frame: 10 weeks
Change in health-related quality of life over the main phase. Data from pre-treatment assessment, the primary endpoint (10 weeks), and the 6- and 12-month follow-up are used for health economic analysis focusing on the main phase
EuroQol 5D, EQ-5D. Self-rated, range: 0-1, i.e., scored as utility for the purpose of calculating quality-adjusted life years for health economic analysis. A higher utility score indicates a higher health-related quality of life
Time frame: Pre-treatment, 10 weeks, 6- and 12-month follow-up.
Change in resource use and medications over the main phase. Data from pre-treatment assessment, the primary endpoint, and the 6- and 12-month follow-up are used for health economic analysis focusing on the main phase.
Trimbos Institute and Institute of Medical Technology Questionnaire for Costs Associated with Psychiatric Illness, TIC-P. This instrument is scored in terms of resource use for the purpose of calculating societal costs for health economic analysis.
Time frame: Pre-treatment, 10 weeks, 6- and 12-months follow-up
Adverse events at primary endpoint assessment (10 weeks).
Adverse events measured using free-text items, primarily reported as the total number of reported events
Time frame: 10 weeks
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