NCT05058911

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

Completed NA Last updated 7 November 2023

What this trial tests

NA trial testing Internet-delivered exposure-based cognitive behavior therapy in Fibromyalgia in 274 participants. Completed in 30 May 2023.

Timeline

22 September 2021

Primary endpoint
1 June 2022

30 May 2023

Quick facts

Lead sponsor	Karolinska Institutet
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	274
Start date	22 September 2021
Primary completion	1 June 2022
Estimated completion	30 May 2023
Sites	2 locations across Sweden

Drugs / interventions tested

• Internet-delivered exposure-based cognitive behavior therapy
• Internet-delivered traditional cognitive behavior therapy

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Karolinska Institutet

Who can join

18 and older, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of exposure-based vs traditional cognitive behavior therapy for fibromyalgia: a two-site single-blind randomized controlled trial.
   Hedman-Lagerlöf M, Gasslander N, Ahnlund Hoffmann A, Bragesjö M, et al · · 2024 · cited 11× · PMID 38131181 · DOI 10.1097/j.pain.0000000000003128