The PASSAGE Program: a structured multicomponent interdisciplinary group intervention for the self-management of fibromyalgia.

ISRCTN ISRCTN14526380
DOI https://doi.org/10.1186/ISRCTN14526380
Secondary identifying numbers N/A
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Manon Choinière
Scientific

Centre de recherche du Centre hospitalier de l’Université de Montréal
Tour Saint-Antoine
850, rue Saint-Denis
Bureau S03-428
Montréal
H2X 0A9
Canada

Phone +1 (0) 514 890 8000, ext. 14082
Email manon.choiniere@umontreal.ca

Study information

Study designMixed-methods multicenter open-label randomized wait-list controlled trial with both a quantitative and a qualitative aspect
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleMulticomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial
Study acronymPASSAGE
Study objectivesThe 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) studiedFibromyalgia syndrome (FMS), chronic pain
Intervention1. 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 typeOther
Primary outcome measurePain intensity. Pain intensity was measured with a standardized numerical rating scale (NRS)
Secondary outcome measures1. Severity of FMS (Fibromyalgia Impact Questionnaire)
2. Pain interference (Brief Pain Inventory)
3. Impact of pain on sleep quality (Chronic Pain Sleep Inventory)
4. Pain coping strategies and (Coping Strategy Questionnaire)
5. Tendency to catastrophize (Pain Catastrophizing Scale)
6. Depressive symptoms (The Beck Depression Inventory)
7. Health-related quality of life (SF-12v2)
8. Patient global impression of change (PGIC)
9. Perceived pain relief (0 to 100% Pain Relief Scale)

Quantitative data were collected in both study groups at baseline (T0), after the intervention group completed the 8 sessions of the PASSAGE Program (T1), and 3 months later (T2). In order to document and further capture the intervention group patients’ experiences, face-to-face open ended group narrative qualitative interviews were conducted 6 to 9 months after completion of the PASSAGE Program.
Overall study start date01/09/2009
Completion date01/03/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants64 (32 per study site)
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2009
Date of final enrolment01/03/2011

Locations

Countries of recruitment

  • Canada

Study participating centre

Centre de recherche du Centre hospitalier de l'Université de Montréal
Montréal
H2X 0A9
Canada

Sponsor information

Centre de recherche du Centre hospitalier universitaire de Sherbrooke (Canada)
Hospital/treatment centre

c/o Dr Patricia Bourgault
Centre de recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS)
3001, 12e Avenue Nord
Sherbrooke
J1H 5N4
Canada

Phone +1 (0) 819 346 1110, ext. 12885
Email patricia.bourgault@usherbrooke.ca
Website http://cr.chus.qc.ca/en/axes/sante-population/chercheurs/patricia-bourgault-ph-d/
ROR logo "ROR" https://ror.org/020r51985

Funders

Funder type

Other

Community Alliances for Health Research and Knowledge Exchange in Pain of the Canadian Institutes of Health Research (CIHR) (Canada)

No information available

AstraZeneca Canada Inc. (Grant # 86787) (Canada)

No information available

Pfizer Canada Inc. (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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