Online Acceptance-based Behavioural Treatment for Fibromyalgia

Fibromyalgia Syndrome Clinical Trial

Official title:

Online Acceptance-Based Behavioural Treatment for Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642810
• Other study ID #: H2012:179
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2012
• Last updated: November 30, 2015
• Start date: September 2012
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Fibromyalgia Impact Questionnaire-revised	Assesses overall impact of Fibromyalgia symptoms on daily functioning	baseline, 2 months, 5 months	No
Secondary	Change from baseline in Center for Epidemiological Studies Depression Scale	Evaluation of depressive symptoms	Baseline, 2 months, 5 months	Yes
Secondary	Change from baseline in Chronic Pain Acceptance Questionnaire	Overall acceptance of chronic pain	Baseline, 2 months, 5 months	No
Secondary	Change from baseline in Cognitive Fusion Questionnaire	Evaluation of fusion with thoughts	Baseline, 2 months, 5 months	No
Secondary	Change from baseline in McGill Pain Questionnaire- short form	subjective measure of type and severity of pain	Baseline, 2 months, 5 months	No
Secondary	Change from baseline in Five Facet Mindfulness Questionnaire	Measure of mindfulness skills	Baseline, 2 months, 5 months	No
Secondary	Change from baseline in Pittsburgh Sleep Quality Index	Measure of sleep quality and quantity	Baseline, 2 months, 5 months	No
Secondary	Change from baseline in Tampa Scale of Kinesiophobia-11	Measure of fear of movement	Baseline, 2 months, 5 months	No
Secondary	Change from baseline in Valued Living Questionnaire	Measure of values, and how consistently one lives those values	Baseline, 2 months, 5 months	No
Secondary	Global Assessment Scale	unpublished scale evaluating the impact of treatment on symptoms, and how useful participants found the treatment protocol	2 months	No