Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
NCT Number: NCT01642810
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Winnipeg, Manitoba, R3A 1R9, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Behavioral intervention focusing on acceptance, mindfulness and values-based living instead of focus on symptom control
Participants will continue pre-study treatment under their current licensed practitioners. Intervention may include drug treatment, physical therapy, or other
Time frame: baseline, 2 months, 5 months
Assesses overall impact of Fibromyalgia symptoms on daily functioning
Time frame: Baseline, 2 months, 5 months
Evaluation of depressive symptoms
Time frame: Baseline, 2 months, 5 months
Overall acceptance of chronic pain
Time frame: Baseline, 2 months, 5 months
Evaluation of fusion with thoughts
Time frame: Baseline, 2 months, 5 months
subjective measure of type and severity of pain
Time frame: Baseline, 2 months, 5 months
Measure of mindfulness skills
Time frame: Baseline, 2 months, 5 months
Measure of sleep quality and quantity
Time frame: Baseline, 2 months, 5 months
Measure of fear of movement
Time frame: Baseline, 2 months, 5 months
Measure of values, and how consistently one lives those values
Time frame: 2 months
unpublished scale evaluating the impact of treatment on symptoms, and how useful participants found the treatment protocol
University of Manitoba
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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