Clinical trial NCT05058911: Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia
Official title: Randomized Controlled Trial of Internet-delivered Exposure-based Cognitive Behavior Therapy vs. Internet-delivered Traditional Cognitive Behavior Therapy for Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: cognitive behavior therapy
randomized controlled trial
internet-delivered treatment
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2021-09-28
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with repeated measurments and two conditions: the experimental group (Exp-CBT) and an active control group (T-CBT).
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Secondary outcomes:
measure: 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).
timeFrame: Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
measure: Change in pain over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
timeFrame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-MFU assessments.
measure: Change in fatigue over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
timeFrame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
measure: Change in anxiety over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
timeFrame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
measure: Change in depression over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
timeFrame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
measure: Change in functional impairment over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks).
timeFrame: Pre-treatment, 10 weeks, Secondary analyses incorporate 6- and 12-months follow-up assessments.
measure: Change in quality of life over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks).
timeFrame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
measure: Global impression of perceived change at post-treatment
timeFrame: 10 weeks
Other outcomes:
measure: Depression severity during screening, and suicidal ideation during treatment
timeFrame: Screening, item 9 weekly up to 9 weeks
measure: Alcohol use at screening
timeFrame: Screening
measure: Drug use at screening
timeFrame: Screening
measure: 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).
timeFrame: Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
measure: 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).
timeFrame: Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
measure: 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).
timeFrame: Pre-treatment, weekly up to10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
measure: 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).
timeFrame: Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
measure: 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).
timeFrame: Pre-treatment, weekly up to 10 weeks.
measure: Treatment credibility and expectancy of improvement at week 3 of main phase
timeFrame: Week 3 of main phase
measure: Working alliance with therapist at week 3 of main phase
timeFrame: Week 3 of main phase.
measure: Client satisfaction with treatment at primary endpoint assessment (10 weeks)
timeFrame: 10 weeks
measure: 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
timeFrame: Pre-treatment, 10 weeks, 6- and 12-month follow-up.
measure: 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.
timeFrame: Pre-treatment, 10 weeks, 6- and 12-months follow-up
measure: Adverse events at primary endpoint assessment (10 weeks).
timeFrame: 10 weeks
Locations:
city: Solna
country: Sweden
facility: Karolinska Institutet
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Karolinska Institutet
name: Maria Hedman-Lagerlöf, PhD
role: PRINCIPAL_INVESTIGATOR
References: