Online Acceptance-based Behavioural Treatment for Fibromyalgia
Primary Purpose
Fibromyalgia Syndrome
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Acceptance-based behavioural therapy
Will vary per participant
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia Syndrome focused on measuring Online treatment for Fibromyalgia Syndrome, Acceptance-based behavioural treatment
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.
Sites / Locations
- Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment-as-usual
Online ABBT treatment + TAU
Arm Description
Participants continue their pre-study treatment plan, based on their physician/other professional recommendations
Participants to complete a 6-unit online Acceptance-based behavioural treatment including training in pacing, mindfulness, acceptance, cognitive defusion, willingness, and exercise while also maintaining their pre-study treatment.
Outcomes
Primary Outcome Measures
Change from baseline in Fibromyalgia Impact Questionnaire-revised
Assesses overall impact of Fibromyalgia symptoms on daily functioning
Secondary Outcome Measures
Change from baseline in Center for Epidemiological Studies Depression Scale
Evaluation of depressive symptoms
Change from baseline in Chronic Pain Acceptance Questionnaire
Overall acceptance of chronic pain
Change from baseline in Cognitive Fusion Questionnaire
Evaluation of fusion with thoughts
Change from baseline in McGill Pain Questionnaire- short form
subjective measure of type and severity of pain
Change from baseline in Five Facet Mindfulness Questionnaire
Measure of mindfulness skills
Change from baseline in Pittsburgh Sleep Quality Index
Measure of sleep quality and quantity
Change from baseline in Tampa Scale of Kinesiophobia-11
Measure of fear of movement
Change from baseline in Valued Living Questionnaire
Measure of values, and how consistently one lives those values
Global Assessment Scale
unpublished scale evaluating the impact of treatment on symptoms, and how useful participants found the treatment protocol
Full Information
NCT ID
NCT01642810
First Posted
June 25, 2012
Last Updated
November 30, 2015
Sponsor
University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT01642810
Brief Title
Online Acceptance-based Behavioural Treatment for Fibromyalgia
Official Title
Online Acceptance-Based Behavioural Treatment for Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia Syndrome
Keywords
Online treatment for Fibromyalgia Syndrome, Acceptance-based behavioural treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment-as-usual
Arm Type
Active Comparator
Arm Description
Participants continue their pre-study treatment plan, based on their physician/other professional recommendations
Arm Title
Online ABBT treatment + TAU
Arm Type
Experimental
Arm Description
Participants to complete a 6-unit online Acceptance-based behavioural treatment including training in pacing, mindfulness, acceptance, cognitive defusion, willingness, and exercise while also maintaining their pre-study treatment.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance-based behavioural therapy
Intervention Description
Behavioral intervention focusing on acceptance, mindfulness and values-based living instead of focus on symptom control
Intervention Type
Other
Intervention Name(s)
Will vary per participant
Intervention Description
Participants will continue pre-study treatment under their current licensed practitioners. Intervention may include drug treatment, physical therapy, or other
Primary Outcome Measure Information:
Title
Change from baseline in Fibromyalgia Impact Questionnaire-revised
Description
Assesses overall impact of Fibromyalgia symptoms on daily functioning
Time Frame
baseline, 2 months, 5 months
Secondary Outcome Measure Information:
Title
Change from baseline in Center for Epidemiological Studies Depression Scale
Description
Evaluation of depressive symptoms
Time Frame
Baseline, 2 months, 5 months
Title
Change from baseline in Chronic Pain Acceptance Questionnaire
Description
Overall acceptance of chronic pain
Time Frame
Baseline, 2 months, 5 months
Title
Change from baseline in Cognitive Fusion Questionnaire
Description
Evaluation of fusion with thoughts
Time Frame
Baseline, 2 months, 5 months
Title
Change from baseline in McGill Pain Questionnaire- short form
Description
subjective measure of type and severity of pain
Time Frame
Baseline, 2 months, 5 months
Title
Change from baseline in Five Facet Mindfulness Questionnaire
Description
Measure of mindfulness skills
Time Frame
Baseline, 2 months, 5 months
Title
Change from baseline in Pittsburgh Sleep Quality Index
Description
Measure of sleep quality and quantity
Time Frame
Baseline, 2 months, 5 months
Title
Change from baseline in Tampa Scale of Kinesiophobia-11
Description
Measure of fear of movement
Time Frame
Baseline, 2 months, 5 months
Title
Change from baseline in Valued Living Questionnaire
Description
Measure of values, and how consistently one lives those values
Time Frame
Baseline, 2 months, 5 months
Title
Global Assessment Scale
Description
unpublished scale evaluating the impact of treatment on symptoms, and how useful participants found the treatment protocol
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Simister, MA
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
12. IPD Sharing Statement
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Online Acceptance-based Behavioural Treatment for Fibromyalgia
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