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

June 25, 2012
April 17, 2014
September 2012
July 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01642810 on ClinicalTrials.gov Archive Site
  • 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    unpublished scale evaluating the impact of treatment on symptoms, and how useful participants found the treatment protocol
Same as current
Not Provided
Not Provided
 
Online Acceptance-based Behavioural Treatment for Fibromyalgia
Online Acceptance-Based Behavioural Treatment for Fibromyalgia

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fibromyalgia Syndrome
  • 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
  • Active Comparator: Treatment-as-usual
    Intervention: Other: Will vary per participant
  • Experimental: Online ABBT treatment + TAU
    Participants to complete a 6-unit online ABBT treatment while also maintaining their pre-study treatment
    Interventions:
    • Behavioral: Acceptance-based behavioural therapy
    • Other: Will vary per participant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2014
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01642810
H2012:179
Yes
Heather Simister, University of Manitoba
University of Manitoba
Not Provided
Principal Investigator: Heather Simister, MA University of Manitoba
University of Manitoba
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP