- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05058911
Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia
Randomized Controlled Trial of Internet-delivered Exposure-based Cognitive Behavior Therapy vs. Internet-delivered Traditional Cognitive Behavior Therapy for Patients With Fibromyalgia
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Solna, Sweden, 17177
- Karolinska Institutet
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Uppsala, Sweden, 75105
- Uppsala University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Internet-delivered exposure-based cognitive behavior therapy (Exp-CBT)
10-week self-help treatment delivered via a secure online platform, with regular therapist support.
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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.
Other Names:
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Active Comparator: Internet-delivered traditional cognitive behavior therapy (T-CBT)
10-week self-help treatment delivered via a secure online platform, with regular therapist support.
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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.
Other Names:
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What is the study measuring?
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).
Time Frame: Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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The Fibromyalgia Impact Questionnaire, FIQ.
Self-rated, range 0-100.
Higher score indicate higher FM severity.
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Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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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).
Time Frame: Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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The Fibromyalgia Impact Questionnaire, FIQ-Pain subscale.
Self-rated, range 0 to 10, a higher score indicates more pain.
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Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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Change in pain over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
Time Frame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-MFU assessments.
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Brief Pain Inventory-Short Form, BPI-Sf.
Self-rated, range 0-10.
A higher score indicates more pain.
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Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-MFU assessments.
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Change in fatigue over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
Time Frame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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Fatigue Severity Scale, FSS.
Self-rated, range 9-63.
A higher score indicates greater fatigue severity
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Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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Change in anxiety over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
Time Frame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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GAD-2.
Self-rated, range: 0-6.
A higher score indicates more general anxiety.
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Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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Change in depression over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
Time Frame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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PHQ-2.
Self-rated, range: 0-6.
A higher score indicates more depressive symptoms.
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Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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Change in functional impairment over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks).
Time Frame: Pre-treatment, 10 weeks, Secondary analyses incorporate 6- and 12-months follow-up assessments.
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12-item WHO Disability Assessment Schedule 2.0, WHODAS 2.0.
Self-rated, range: 0-100.
A higher score indicates more disability.
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Pre-treatment, 10 weeks, Secondary analyses incorporate 6- and 12-months follow-up assessments.
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Change in quality of life over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks).
Time Frame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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Brunnsviken Brief Quality of Life Inventory, BBQ.
Self-rated, range 0 to 96, a higher score indicates better quality of life
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Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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Global impression of perceived change at post-treatment
Time Frame: 10 weeks
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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
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10 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression severity during screening, and suicidal ideation during treatment
Time Frame: Screening, item 9 weekly up to 9 weeks
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Montgomery Asberg Depression Rating Scale - Self-rated, MADRS-S.
Self-rated, range 0 to 60, a higher score indicates higher more depressive symptoms
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Screening, item 9 weekly up to 9 weeks
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Alcohol use at screening
Time Frame: Screening
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Alcohol Use Disorders Identification Test.
Self-rated, range 0 to 40, a higher score indicates more problematic alcohol use
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Screening
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Drug use at screening
Time Frame: Screening
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Drug Use Disorders Identification Test.
Self-rated, range: 0-44.
A higher score indicates more problematic substance use
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Screening
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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).
Time Frame: Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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The Psychological Inflexibility in Pain Scale-avoidance subscale, PIPS-avoid.
Self-rated, range 8-56.
A higher score indicates more pain-related avoidance behaviors.
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Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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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).
Time Frame: Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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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.
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Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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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).
Time Frame: Pre-treatment, weekly up to10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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Pain Catastrophizing Scale, PCS.
Self-rated, range 0-52.
A higher score indicates a higher degree of pain catastrophizing
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Pre-treatment, weekly up to10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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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).
Time Frame: Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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Pain Vigilance and Awareness Questionnaire, PVAQ.
Self-rated, range 0-80.
A higher score indicates more hypervigilance and awareness to pain.
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Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
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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).
Time Frame: Pre-treatment, weekly up to 10 weeks.
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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
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Pre-treatment, weekly up to 10 weeks.
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Treatment credibility and expectancy of improvement at week 3 of main phase
Time Frame: Week 3 of main phase
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Credibility/Expectancy scale (C/E-scale).
Self-rated, range: 0-50.
A higher score indicates higher credibility/expectancy
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Week 3 of main phase
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Working alliance with therapist at week 3 of main phase
Time Frame: Week 3 of main phase.
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Working alliance inventory-Short, Internet version, WAI-S-Internet.
Self-rated, range: 7-144.
A higher score indicates better relationship with the therapist.
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Week 3 of main phase.
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Client satisfaction with treatment at primary endpoint assessment (10 weeks)
Time Frame: 10 weeks
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Client Satisfaction Questionnaire, CSQ-8.
Self-rated, range: 8-32.
A higher score indicates higher satisfaction with treatment.
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10 weeks
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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
Time Frame: Pre-treatment, 10 weeks, 6- and 12-month follow-up.
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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
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Pre-treatment, 10 weeks, 6- and 12-month follow-up.
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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.
Time Frame: Pre-treatment, 10 weeks, 6- and 12-months follow-up
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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.
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Pre-treatment, 10 weeks, 6- and 12-months follow-up
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Adverse events at primary endpoint assessment (10 weeks).
Time Frame: 10 weeks
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Adverse events measured using free-text items, primarily reported as the total number of reported events
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10 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maria Hedman-Lagerlöf, PhD, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-03302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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