Clinical trial NCT01642810: Online Acceptance-based Behavioural Treatment for Fibromyalgia
Official title: Online Acceptance-Based Behavioural Treatment for Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia Syndrome
Keywords: Online treatment for Fibromyalgia Syndrome
Acceptance-based behavioural treatment
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in Fibromyalgia Impact Questionnaire-revised
timeFrame: baseline, 2 months, 5 months
Secondary outcomes:
measure: Change from baseline in Center for Epidemiological Studies Depression Scale
timeFrame: Baseline, 2 months, 5 months
measure: Change from baseline in Chronic Pain Acceptance Questionnaire
timeFrame: Baseline, 2 months, 5 months
measure: Change from baseline in Cognitive Fusion Questionnaire
timeFrame: Baseline, 2 months, 5 months
measure: Change from baseline in McGill Pain Questionnaire- short form
timeFrame: Baseline, 2 months, 5 months
measure: Change from baseline in Five Facet Mindfulness Questionnaire
timeFrame: Baseline, 2 months, 5 months
measure: Change from baseline in Pittsburgh Sleep Quality Index
timeFrame: Baseline, 2 months, 5 months
measure: Change from baseline in Tampa Scale of Kinesiophobia-11
timeFrame: Baseline, 2 months, 5 months
measure: Change from baseline in Valued Living Questionnaire
timeFrame: Baseline, 2 months, 5 months
measure: Global Assessment Scale
timeFrame: 2 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Heather Simister, MA
role: PRINCIPAL_INVESTIGATOR
References: