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NCT Number: NCT05058911

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

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet, Solna, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

Other names: T-CBT

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).

    Time frame: Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.

    The Fibromyalgia Impact Questionnaire, FIQ. Self-rated, range 0-100. Higher score indicate higher FM severity.

Secondary outcomes

  1. 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.

    The Fibromyalgia Impact Questionnaire, FIQ-Pain subscale. Self-rated, range 0 to 10, a higher score indicates more pain.

  2. 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.

    Brief Pain Inventory-Short Form, BPI-Sf. Self-rated, range 0-10. A higher score indicates more pain.

  3. 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.

    Fatigue Severity Scale, FSS. Self-rated, range 9-63. A higher score indicates greater fatigue severity

  4. 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.

    GAD-2. Self-rated, range: 0-6. A higher score indicates more general anxiety.

  5. 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.

    PHQ-2. Self-rated, range: 0-6. A higher score indicates more depressive symptoms.

  6. 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.

    12-item WHO Disability Assessment Schedule 2.0, WHODAS 2.0. Self-rated, range: 0-100. A higher score indicates more disability.

  7. 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.

    Brunnsviken Brief Quality of Life Inventory, BBQ. Self-rated, range 0 to 96, a higher score indicates better quality of life

  8. Global impression of perceived change at post-treatment

    Time frame: 10 weeks

    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

Other outcomes

  1. Depression severity during screening, and suicidal ideation during treatment

    Time frame: Screening, item 9 weekly up to 9 weeks

    Montgomery Asberg Depression Rating Scale - Self-rated, MADRS-S. Self-rated, range 0 to 60, a higher score indicates higher more depressive symptoms

  2. Alcohol use at screening

    Time frame: Screening

    Alcohol Use Disorders Identification Test. Self-rated, range 0 to 40, a higher score indicates more problematic alcohol use

  3. Drug use at screening

    Time frame: Screening

    Drug Use Disorders Identification Test. Self-rated, range: 0-44. A higher score indicates more problematic substance use

  4. 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.

    The Psychological Inflexibility in Pain Scale-avoidance subscale, PIPS-avoid. Self-rated, range 8-56. A higher score indicates more pain-related avoidance behaviors.

  5. 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.

    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.

  6. 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.

    Pain Catastrophizing Scale, PCS. Self-rated, range 0-52. A higher score indicates a higher degree of pain catastrophizing

  7. 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.

    Pain Vigilance and Awareness Questionnaire, PVAQ. Self-rated, range 0-80. A higher score indicates more hypervigilance and awareness to pain.

  8. 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.

    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

  9. Treatment credibility and expectancy of improvement at week 3 of main phase

    Time frame: Week 3 of main phase

    Credibility/Expectancy scale (C/E-scale). Self-rated, range: 0-50. A higher score indicates higher credibility/expectancy

  10. Working alliance with therapist at week 3 of main phase

    Time frame: 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.

  11. Client satisfaction with treatment at primary endpoint assessment (10 weeks)

    Time frame: 10 weeks

    Client Satisfaction Questionnaire, CSQ-8. Self-rated, range: 8-32. A higher score indicates higher satisfaction with treatment.

  12. 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.

    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

  13. 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

    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.

  14. Adverse events at primary endpoint assessment (10 weeks).

    Time frame: 10 weeks

    Adverse events measured using free-text items, primarily reported as the total number of reported events

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Uppsala University

Registry information

Official study title

Randomized Controlled Trial of Internet-delivered Exposure-based Cognitive Behavior Therapy vs. Internet-delivered Traditional Cognitive Behavior Therapy for Patients With Fibromyalgia

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 28, 2021
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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