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

NCT05058911 | Completed

• 1 other identifier: 2021-03302
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

cognitive behavior therapy; randomized controlled trial; internet-delivered treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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).

  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)

  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)

  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)

  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)

  Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.

Other Outcomes (14)

• Depression severity during screening, and suicidal ideation during treatment

  Screening, item 9 weekly up to 9 weeks

• Alcohol use at screening

  Screening

• Drug use at screening

  Screening

Study Arms (2)

Internet-delivered exposure-based cognitive behavior therapy (Exp-CBT)

EXPERIMENTAL

10-week self-help treatment delivered via a secure online platform, with regular therapist support.

Behavioral: Internet-delivered exposure-based cognitive behavior therapy

Internet-delivered traditional cognitive behavior therapy (T-CBT)

ACTIVE COMPARATOR

10-week self-help treatment delivered via a secure online platform, with regular therapist support.

Behavioral: Internet-delivered traditional cognitive behavior therapy

Interventions

Internet-delivered exposure-based cognitive behavior therapy BEHAVIORAL

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

Internet-delivered exposure-based cognitive behavior therapy (Exp-CBT)

Internet-delivered traditional cognitive behavior therapy BEHAVIORAL

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

Internet-delivered traditional cognitive behavior therapy (T-CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Uppsala University: collaborator

Study Sites (2)

Karolinska Institutet

Solna, 17177, Sweden

Location

Uppsala University

Uppsala, 75105, Sweden

Location

Related Publications (1)

• Hedman-Lagerlof M, Gasslander N, Ahnlund Hoffmann A, Bragesjo M, Etzell A, Ezra S, Frostell E, Hedman-Lagerlof E, Ivert C, Liliequist B, Ljotsson B, Hoppe JM, Palmgren J, Spansk E, Sundstrom F, Sarnholm J, Tzavara G, Buhrman M, Axelsson E. Effect of exposure-based vs traditional cognitive behavior therapy for fibromyalgia: a two-site single-blind randomized controlled trial. Pain. 2024 Jun 1;165(6):1278-1288. doi: 10.1097/j.pain.0000000000003128. Epub 2023 Dec 15.

  PMID: 38131181 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Maria Hedman-Lagerlöf, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized controlled trial with repeated measurments and two conditions: the experimental group (Exp-CBT) and an active control group (T-CBT).

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 28, 2021
• Study Start: September 22, 2021
• Primary Completion: June 1, 2022
• Study Completion: May 30, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)