NCT01642810

Online Acceptance-based Behavioural Treatment for Fibromyalgia

Online Acceptance-Based Behavioural Treatment for Fibromyalgia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Fibromyalgia Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-08-01
• Completion: 2015-08-01
• First posted: 2012-07-17
• Last updated: 2015-12-02

Locations

1 site across 1 country: Canada