Online Acceptance-based Behavioural Treatment for Fibromyalgia

NCT01642810 | Completed Phase 3 DMC

• 1 other identifier: H2012:179
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

A recent study published by the Canadian Pain Society estimated the direct health care costs of chronic pain to be about 6 billion dollars. Over 1/3 of all Canadians reported that they either missed work or experienced reduced productivity due to chronic pain. Fibromyalgia Syndrome (FMS)is a condition that affects up to 10% of the Canadian population, many of whom are still in the prime of their lives. While pain and fatigue are prominent symptoms, FMS sufferers often experience sleep disturbance, gastrointestinal upset, chronic headache, memory and thinking problems, and depression. Standard treatments focus on medication and physical exercise but are not always successful. Acceptance-Based behavioural therapy (ABBT) is a relatively new approach that has been effective not only in treating mental health concerns such as anxiety and depression, but also other medical conditions such as diabetes and chronic pain. A novel ABBT for FMS was developed and pilot tested with a small group of participants. The results of this preliminary study were promising. Unfortunately, many people cannot adequately access available treatment due to long wait lists, prohibitive costs, or time/location constraints. Online treatments may offer improved access to care without reducing the effectiveness of treatment. Therefore, the ABBT for FMS used in the pilot study is being adapted to an online format and will be evaluated with a larger group of participants. A wait-list/control group will be employed to evaluate the effectiveness of the online treatment as compared with treatment-as-usual. If found effective, this treatment would offer patients easier access to care at a significantly reduced cost to the health care system.

Conditions

Fibromyalgia Syndrome

Keywords

Online treatment for Fibromyalgia Syndrome; Acceptance-based behavioural treatment

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Fibromyalgia Impact Questionnaire-revised

  Assesses overall impact of Fibromyalgia symptoms on daily functioning

  baseline, 2 months, 5 months

Secondary Outcomes (9)

• Change from baseline in Center for Epidemiological Studies Depression Scale

  Baseline, 2 months, 5 months

• Change from baseline in Chronic Pain Acceptance Questionnaire

  Baseline, 2 months, 5 months

• Change from baseline in Cognitive Fusion Questionnaire

  Baseline, 2 months, 5 months

• Change from baseline in McGill Pain Questionnaire- short form

  Baseline, 2 months, 5 months

• Change from baseline in Five Facet Mindfulness Questionnaire

  Baseline, 2 months, 5 months

Study Arms (2)

Treatment-as-usual

ACTIVE COMPARATOR

Participants continue their pre-study treatment plan, based on their physician/other professional recommendations

Other: Will vary per participant

Online ABBT treatment + TAU

EXPERIMENTAL

Participants to complete a 6-unit online Acceptance-based behavioural treatment including training in pacing, mindfulness, acceptance, cognitive defusion, willingness, and exercise while also maintaining their pre-study treatment.

Behavioral: Acceptance-based behavioural therapy; Other: Will vary per participant

Interventions

Acceptance-based behavioural therapy BEHAVIORAL

Behavioral intervention focusing on acceptance, mindfulness and values-based living instead of focus on symptom control

Online ABBT treatment + TAU

Will vary per participant OTHER

Participants will continue pre-study treatment under their current licensed practitioners. Intervention may include drug treatment, physical therapy, or other

Online ABBT treatment + TAU; Treatment-as-usual

Eligibility Criteria

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

You may qualify if:

• Participants of either sex aged 18 years and older with a formal diagnosis of FMS will be recruited.
• Individuals younger than 18 years of age will be excluded in order to ensure all participants have reached the age of majority and can provide consent.
• They will have a pain intensity rating of at least 4/10 based on self-report. Participants will also be screened using the Wolfe et al (2010) criteria during the in-person session to ensure they meet criteria for FMS.
• Must reside in and complete study from within Manitoba, Canada

You may not qualify if:

• People with co-morbidities such as rheumatologic conditions, other conditions affecting the immune system (e.g. chronic fatigue syndrome, multiple sclerosis, lupus), brain injury, cognitive impairment that would limit a participant's ability to complete informed consent, active psychosis, substance abuse, uncontrolled major depression or bipolar disorder, active suicidality, or those who have current active injury claims will be excluded.
• Given the use of a large amount of reading materials, participants will be asked if they have completed at least grade 9 in high school. Those who have only completed grade 8 or lower will be excluded.
• Further, participants will be asked to maintain their pre-study treatment regime and not making changes to their medications or beginning other treatments for the duration of the study.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Heather Simister, MA

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: July 17, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

CA (1)