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Online Acceptance-based Behavioural Treatment for Fibromyalgia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Heather Simister, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01642810
First received: June 25, 2012
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Fibromyalgia Syndrome
Behavioral: Acceptance-based behavioural therapy
Other: Will vary per participant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Online Acceptance-Based Behavioural Treatment for Fibromyalgia

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Change from baseline in Fibromyalgia Impact Questionnaire-revised [ Time Frame: baseline, 2 months, 5 months ] [ Designated as safety issue: No ]
    Assesses overall impact of Fibromyalgia symptoms on daily functioning


Secondary Outcome Measures:
  • Change from baseline in Center for Epidemiological Studies Depression Scale [ Time Frame: Baseline, 2 months, 5 months ] [ Designated as safety issue: Yes ]
    Evaluation of depressive symptoms

  • Change from baseline in Chronic Pain Acceptance Questionnaire [ Time Frame: Baseline, 2 months, 5 months ] [ Designated as safety issue: No ]
    Overall acceptance of chronic pain

  • Change from baseline in Cognitive Fusion Questionnaire [ Time Frame: Baseline, 2 months, 5 months ] [ Designated as safety issue: No ]
    Evaluation of fusion with thoughts

  • Change from baseline in McGill Pain Questionnaire- short form [ Time Frame: Baseline, 2 months, 5 months ] [ Designated as safety issue: No ]
    subjective measure of type and severity of pain

  • Change from baseline in Five Facet Mindfulness Questionnaire [ Time Frame: Baseline, 2 months, 5 months ] [ Designated as safety issue: No ]
    Measure of mindfulness skills

  • Change from baseline in Pittsburgh Sleep Quality Index [ Time Frame: Baseline, 2 months, 5 months ] [ Designated as safety issue: No ]
    Measure of sleep quality and quantity

  • Change from baseline in Tampa Scale of Kinesiophobia-11 [ Time Frame: Baseline, 2 months, 5 months ] [ Designated as safety issue: No ]
    Measure of fear of movement

  • Change from baseline in Valued Living Questionnaire [ Time Frame: Baseline, 2 months, 5 months ] [ Designated as safety issue: No ]
    Measure of values, and how consistently one lives those values

  • Global Assessment Scale [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    unpublished scale evaluating the impact of treatment on symptoms, and how useful participants found the treatment protocol


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment-as-usual 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 ABBT treatment 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642810

Locations
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Heather Simister, MA University of Manitoba
  More Information

No publications provided

Responsible Party: Heather Simister, PhD Candidate, University of Manitoba
ClinicalTrials.gov Identifier: NCT01642810     History of Changes
Other Study ID Numbers: H2012:179
Study First Received: June 25, 2012
Last Updated: April 17, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Online treatment for Fibromyalgia Syndrome
Acceptance-based behavioural treatment

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Syndrome
Disease
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2014