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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05058911
• Other study ID #: 2021-03302
• Status: Completed
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: November 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: May 30, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Internet-delivered exposure-based cognitive behavior therapy
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.
• Internet-delivered traditional cognitive behavior therapy
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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Solna
Sweden	Uppsala University	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression severity during screening, and suicidal ideation during treatment	Montgomery Asberg Depression Rating Scale - Self-rated, MADRS-S. Self-rated, range 0 to 60, a higher score indicates higher more depressive symptoms	Screening, item 9 weekly up to 9 weeks
Other	Alcohol use at screening	Alcohol Use Disorders Identification Test. Self-rated, range 0 to 40, a higher score indicates more problematic alcohol use	Screening
Other	Drug use at screening	Drug Use Disorders Identification Test. Self-rated, range: 0-44. A higher score indicates more problematic substance use	Screening
Other	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).	The Psychological Inflexibility in Pain Scale-avoidance subscale, PIPS-avoid. Self-rated, range 8-56. A higher score indicates more pain-related avoidance behaviors.	Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Other	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).	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.	Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Other	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).	Pain Catastrophizing Scale, PCS. Self-rated, range 0-52. A higher score indicates a higher degree of pain catastrophizing	Pre-treatment, weekly up to10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Other	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).	Pain Vigilance and Awareness Questionnaire, PVAQ. Self-rated, range 0-80. A higher score indicates more hypervigilance and awareness to pain.	Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Other	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).	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	Pre-treatment, weekly up to 10 weeks.
Other	Treatment credibility and expectancy of improvement at week 3 of main phase	Credibility/Expectancy scale (C/E-scale). Self-rated, range: 0-50. A higher score indicates higher credibility/expectancy	Week 3 of main phase
Other	Working alliance with therapist at 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.	Week 3 of main phase.
Other	Client satisfaction with treatment at primary endpoint assessment (10 weeks)	Client Satisfaction Questionnaire, CSQ-8. Self-rated, range: 8-32. A higher score indicates higher satisfaction with treatment.	10 weeks
Other	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	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	Pre-treatment, 10 weeks, 6- and 12-month follow-up.
Other	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.	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.	Pre-treatment, 10 weeks, 6- and 12-months follow-up
Other	Adverse events at primary endpoint assessment (10 weeks).	Adverse events measured using free-text items, primarily reported as the total number of reported events	10 weeks
Primary	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	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).	The Fibromyalgia Impact Questionnaire, FIQ-Pain subscale. Self-rated, range 0 to 10, a higher score indicates more pain.	Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Secondary	Change in pain over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)	Brief Pain Inventory-Short Form, BPI-Sf. Self-rated, range 0-10. A higher score indicates more pain.	Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-MFU assessments.
Secondary	Change in fatigue over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)	Fatigue Severity Scale, FSS. Self-rated, range 9-63. A higher score indicates greater fatigue severity	Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Secondary	Change in anxiety over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)	GAD-2. Self-rated, range: 0-6. A higher score indicates more general anxiety.	Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Secondary	Change in depression over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)	PHQ-2. Self-rated, range: 0-6. A higher score indicates more depressive symptoms.	Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Secondary	Change in functional impairment over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks).	12-item WHO Disability Assessment Schedule 2.0, WHODAS 2.0. Self-rated, range: 0-100. A higher score indicates more disability.	Pre-treatment, 10 weeks, Secondary analyses incorporate 6- and 12-months follow-up assessments.
Secondary	Change in quality of life over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks).	Brunnsviken Brief Quality of Life Inventory, BBQ. Self-rated, range 0 to 96, a higher score indicates better quality of life	Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Secondary	Global impression of perceived change at post-treatment	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	10 weeks