The PASSAGE Program: a structured multicomponent interdisciplinary group intervention for the self-management of fibromyalgia.
| ISRCTN | ISRCTN14526380 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14526380 |
| Protocol serial number | N/A |
| Sponsor | Centre de recherche du Centre hospitalier universitaire de Sherbrooke (Canada) |
| Funders | Community Alliances for Health Research and Knowledge Exchange in Pain of the Canadian Institutes of Health Research (CIHR) (Canada), AstraZeneca Canada Inc. (Grant # 86787) (Canada), Pfizer Canada Inc. (Canada) |
- Submission date
- 04/07/2014
- Registration date
- 23/07/2014
- Last edited
- 18/05/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Fibromyalgia syndrome (FMS) is a chronic condition that causes pain all over the body. Other symptoms include an increased sensitivity to pain, extreme tiredness, muscle stiffness, headaches, depression, difficulties sleeping and problems with memory and concentration. The aim of this study is to assess the performance of a new treatment (intervention) called the PASSAGE programme, which has been developed as a series of group therapy sessions to both alleviate symptoms and help patients to self-manage their symptoms.
Who can participate?
Patients who are 18 years or over, with a medical diagnosis of FMS and motivated to fully participate in the PASSAGE programme.
What does the study involve?
Participants are randomly allocated to one of two groups. The intervention group attend 8 group sessions (with 8 people in each group). Each session covers practical and emotional techniques for coping with FMS (psycho-education), cognitive behavioral therapy-related techniques and exercise activities. A follow up group session then takes place six months after the completion of the programme. The waitlist group continue with their usual treatment until the first group completes the PASSAGE programme, after which they also take part. A series of questionnaires completed by both groups are used to assess how well the intervention performs.
What are the possible benefits and risks of participating?
Possible benefits include better self-management of FMS and alleviation of symptoms. There is little risk in taking part in the study, the only inconvenience being giving up time and resources to participate in the research (e.g. traveling, completing questionnaires).
Where is the study run from?
The University of Sherbrooke (Canada)
When is the study starting and how long is it expected to run for?
September 2009 to March 2011
Who is funding the study?
1. Community Alliances for Health Research and Knowledge Exchange in Pain of the Canadian Institutes of Health Research (CIHR) (Canada)
2. AstraZeneca Canada Inc. (Canada)
3. Pfizer Canada Inc. (Canada)
Who is the main contact?
Dr Manon Choinière
manon.choiniere@umontreal.ca
Contact information
Scientific
Centre de recherche du Centre hospitalier de lUniversité de Montréal
Tour Saint-Antoine
850, rue Saint-Denis
Bureau S03-428
Montréal
H2X 0A9
Canada
| Phone | +1 (0) 514 890 8000, ext. 14082 |
|---|---|
| manon.choiniere@umontreal.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Mixed-methods multicenter open-label randomized wait-list controlled trial with both a quantitative and a qualitative aspect |
| Secondary study design | Randomised controlled trial |
| Scientific title | Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial |
| Study acronym | PASSAGE |
| Study objectives | The aim of the present study was thus to evaluate, quantitatively and qualitatively, the efficacy of the PASSAGE Program - a multicomponent interdisciplinary group intervention for the self-management of fibromyalgia syndrome (FMS) for improving the clinical condition of patients suffering from this type of disorder. |
| Ethics approval(s) | Ethics Committees of the University of Sherbrooke (Université de Sherbrooke), 15/05/2009, ref. 09-034 University of Québec in Abitibi-Témiscamingue (Université de Québec en Abitibi-Témiscamingue) 26/05/2009 |
| Health condition(s) or problem(s) studied | Fibromyalgia syndrome (FMS), chronic pain |
| Intervention | 1. Intervention group : The PASSAGE program is a structured multicomponent interdisciplinary group intervention aimed at reducing FMS symptoms and maintaining optimal function through the use of self-management strategies and patient education. The intervention consists of 8 group sessions with 8 participants lasting 2.5h each. Each session involved 3 major components 1.a. Psycho-educational tools 1.b. Cognitive behavioral therapy-related techniques 1.c. Patient-tailored exercise activities. A follow-up group session is schedule 6 months after the end of the intervention 2. Waitlist group : Participants randomized to the waitlist group were instructed to continue their treatment as usual until they could take part in the PASSAGE Program - i.e., 3 months after the intervention group had completed the program. |
| Intervention type | Other |
| Primary outcome measure(s) |
Pain intensity. Pain intensity was measured with a standardized numerical rating scale (NRS) |
| Key secondary outcome measure(s) |
1. Severity of FMS (Fibromyalgia Impact Questionnaire) |
| Completion date | 01/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 64 |
| Key inclusion criteria | 1. Aged 18 years or older 2. Had a medical diagnosis of FMS based on the American College of Rheumatology (ACR) classification criteria for at least 6 months 3. Reported pain of at least moderate intensity (at least 4/10) in the seven days prior to enrolment 4. Were motivated to attend all group sessions and to integrate the proposed self-management strategies 5. Agreed to not introduce new medications or treatments/therapies over the course of the PASSAGE program |
| Key exclusion criteria | 1. Subjects who presented pain-related symptoms commonly associated with FMS (e.g., irritable bowel syndrome, migraine) 2 Those who suffered from chronic pain syndromes other than FMS (e.g., painful diabetic neuropathy) 3. Physical/psychiatric disorders that could compromise their participation in the study |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 01/03/2011 |
Locations
Countries of recruitment
- Canada
Study participating centre
H2X 0A9
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/05/2015 | Yes | No |
