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Online Acceptance-based Behavioural Treatment for Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01642810
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):
Heather Simister, University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Syndrome Behavioral: Acceptance-based behavioural therapy Other: Will vary per participant Phase 3

Detailed Description:
The current study extended a pilot study (Shay, Tkachuk, Simister, Bailly, & Skrabek, 2011), modifying the previous treatment to a 6 unit program that could be delivered online. Sixty-one participants completed the study, being randomly assigned to an online ABBT plus treatment-as-usual (online ABBT + TAU) group or a treatment-as-usual alone (TAU) group. All participants completed a series of self-report measures at baseline, at post-treatment, and at a 3-month follow-up. Linear mixed modelling supported significant differences between the groups in favour of the ABBT + TAU treatment group on the primary outcome measure (Fibromyalgia Impact Questionnaire-Revised (FIQ-R); F (2, 52.82) = 20.10, p < .0001) following treatment. The online ABBT + TAU group also had significantly greater improvements in depression, pain, acceptance, perceived helplessness, and kinesiophobia. Increased acceptance mediated the effects of treatment on improvements in FMS quality of life and FMS impact, while reduced helplessness mediated the effects of treatment on improvements in level of reported pain. Comments and subjective ratings of improvement were consistent with the quantitative results. Participants rated mindfulness (contact with present moment experience) as the most useful treatment unit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Online Acceptance-Based Behavioural Treatment for Fibromyalgia
Study Start Date : September 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Active Comparator: Treatment-as-usual
Participants continue their pre-study treatment plan, based on their physician/other professional recommendations
Other: Will vary per participant
Participants will continue pre-study treatment under their current licensed practitioners. Intervention may include drug treatment, physical therapy, or other

Experimental: Online ABBT treatment + TAU
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
Behavioral intervention focusing on acceptance, mindfulness and values-based living instead of focus on symptom control

Other: Will vary per participant
Participants will continue pre-study treatment under their current licensed practitioners. Intervention may include drug treatment, physical therapy, or other

Primary Outcome Measures :
  1. Change from baseline in Fibromyalgia Impact Questionnaire-revised [ Time Frame: baseline, 2 months, 5 months ]
    Assesses overall impact of Fibromyalgia symptoms on daily functioning

Secondary Outcome Measures :
  1. Change from baseline in Center for Epidemiological Studies Depression Scale [ Time Frame: Baseline, 2 months, 5 months ]
    Evaluation of depressive symptoms

  2. Change from baseline in Chronic Pain Acceptance Questionnaire [ Time Frame: Baseline, 2 months, 5 months ]
    Overall acceptance of chronic pain

  3. Change from baseline in Cognitive Fusion Questionnaire [ Time Frame: Baseline, 2 months, 5 months ]
    Evaluation of fusion with thoughts

  4. Change from baseline in McGill Pain Questionnaire- short form [ Time Frame: Baseline, 2 months, 5 months ]
    subjective measure of type and severity of pain

  5. Change from baseline in Five Facet Mindfulness Questionnaire [ Time Frame: Baseline, 2 months, 5 months ]
    Measure of mindfulness skills

  6. Change from baseline in Pittsburgh Sleep Quality Index [ Time Frame: Baseline, 2 months, 5 months ]
    Measure of sleep quality and quantity

  7. Change from baseline in Tampa Scale of Kinesiophobia-11 [ Time Frame: Baseline, 2 months, 5 months ]
    Measure of fear of movement

  8. Change from baseline in Valued Living Questionnaire [ Time Frame: Baseline, 2 months, 5 months ]
    Measure of values, and how consistently one lives those values

  9. Global Assessment Scale [ Time Frame: 2 months ]
    unpublished scale evaluating the impact of treatment on symptoms, and how useful participants found the treatment protocol

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01642810

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Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
University of Manitoba
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Principal Investigator: Heather Simister, MA University of Manitoba
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Responsible Party: Heather Simister, PhD Candidate, University of Manitoba Identifier: NCT01642810    
Other Study ID Numbers: H2012:179
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Heather Simister, University of Manitoba:
Online treatment for Fibromyalgia Syndrome
Acceptance-based behavioural treatment
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases