Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.

NCT02638636 | Completed

• 1 other identifier: EPN 2015/1528-31/1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing Fibromyalgia symptoms and impact amongst patients with Fibromyalgia.

Conditions

Fibromyalgia

Keywords

Cognitive behavior therapy; Randomized controlled trial; Exposure therapy; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change in the Fibromyalgia Impact Questionnaire (FIQ)

  Change in Fibromyalgia symptoms and impact from baseline to Week 10, and at 6- and 12 months after treatment has ended.

  Week 0, week 10, Long term follow-up at 6- and 12-months after treatment has ended]

Secondary Outcomes (11)

• Insomnia Severity Index (ISI)

  Week 0, week 10, follow-up at 6- and 12-months after treatment has ended

• Fatigue Severity Scale (FSS)

  Week 0, week 10, follow-up at 6- and 12-months after treatment has ended

• WHO Disability Assessment Schedule 2.0 (WHODAS 2)

  Week 0, week 10, follow-up at 6- and 12-months after treatment has ended

• Brunnsviken Brief Quality of Life Inventory (BBQ)

  Week 0, week 10, follow-up at 6- and 12-months after treatment has ended

• The Psychological Inflexibility in Pain Scale (PIPS)

  Week 0, week 10, follow-up at 6- and 12-months after treatment has ended

Other Outcomes (1)

• Item 9 from Montgomery Asberg Depression Rating Scale (MADRS-S)

  Week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8, week 9

Study Arms (2)

Internet-based exposure therapy

EXPERIMENTAL

The experimental group will go through active internet-based treatment which is delivered on a safe internet platform. Treatment is divided into eight modules, each containing homework assignments. Participants in experimental group will be assigned a therapist that they can contact through a message system in the platform and expect answer within 48 hours.

Behavioral: Internet-based exposure therapy

Waitlist

NO INTERVENTION

Waitlist control, i.e. no active active intervention during waiting list period. Will be offered treatment when the first group has finished (i.e. week 10).

Interventions

Internet-based exposure therapy BEHAVIORAL

The treatment is a 10 week long cognitive behavior therapy. It is based mainly on the principles of exposure; i.e. the participant is instructed to approach situations they have avoided in order to reduce or avoid pain or other aversive experiences until they feel less discomfort and extended behavior repertoire in presence of pain and aversive inner experiences Other interventions include psychoeducation, mindfulness and acceptance strategies and are employed in order to facilitate exposure.

Internet-based exposure therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fibromyalgia diagnosis
• Swedish resident
• Internet connection before, under and after treatment
• Willing to refrain from other concurrent psychological treatment during the study
• Agreement to keep psychotrophic medication constant during the study

You may not qualify if:

• Severe depression (≥30 points on Montgomery Åsberg Depression Rating Scale - Self Rated (MADRS-S) or risk of suicide (≥4 points on the suicide item on MADRS-S)
• Ongoing alcohol or substance abuse
• Psychosis
• Other severe illness that require immediate treatment and/or was considered the participants primary concern other than FM, or bodily condition that makes treatment unfeasible (such as late pregnancy; \>29 weeks gestation
• Illiteracy or poor skills in Swedish language
• Insufficient computer or language skills to manage a text-based treatment.
• Other concurrent psychological treatment
• Recent changes in psychotrophic medication (\<6 weeks prior to randomization)

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Solna, Stockholm County, 17177, Sweden

Location

Related Publications (1)

• Hedman-Lagerlof M, Andersson E, Ljotsson B, Engelbrektsson J, Lundback K, Bjorkander D, Hedman-Lagerlof E, Flink I, Axelsson E. Effect moderators in Internet-based exposure therapy for fibromyalgia: The role of pain intensity. Eur J Pain. 2023 Apr;27(4):507-517. doi: 10.1002/ejp.2074. Epub 2023 Jan 10.

  PMID: 36585933 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Med Dr.

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 23, 2015
• Study Start: December 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 14, 2016

Record last verified: 2016-12

Locations

SE (1)