Co-construction of CALM-Pain, a mindfulness-based chronic pain management program for Veterans to improve quality of life
| ISRCTN | ISRCTN10637979 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10637979 |
- Submission date
- 28/10/2025
- Registration date
- 28/10/2025
- Last edited
- 28/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Chronic pain (a pain that lasts longer than 3 months) is 2-3 times more prevalent, but also more severe in Veterans than in the general population. It has numerous physical, psychological, and social consequences that adversely impact one’s well-being. Chronic pain in Veterans transitioning to civilian life is associated with poor quality of life. Symptoms of anxiety, depression and post-traumatic stress can exacerbate pain, which in turn can worsen psychological states. In this context, interventions that have the potential to impact both chronic pain and psychological distress are desired. Over 50% of Veterans use complementary/alternative approaches to manage chronic pain, anxiety and depression; a third have been exposed to mindfulness. Mindfulness typically helps individuals refocus on the present moment and increase awareness of their surroundings, internal sensations and cognitions, which allow for stepping back and reframing experiences. In military personnel/Veterans, mindfulness programs showed promising preliminary results to reduce psychological distress and improve QoL. These studies are limited however, since they either did not tailor the program to the needs of military personnel/Veterans or did not use a trauma-informed approach essential to this population.
The three study objectives are to: (1) co-construct with Veterans and clinicians CALM-Pain (Cultivating Awareness and Living Mindfully for Veterans – Pain), a mindfulness-based chronic pain management program for Veterans living with chronic pain (CP); (2) analyze the feasibility and acceptability of CALM-Pain using the ORBIT framework; and (3) co-refine the intervention.
Who can participate?
To be eligible to participate in the intervention, individuals must be adult Veterans from the Canadian Armed Forces (18 years old or above), living in the province of Quebec or Ontario (Canada), experiencing pain for over 3 months, speaking English or French, and having access to the Internet. Individuals are not eligible if they have already completed a mindfulness program for chronic pain, have active suicidal ideations or severe psychiatric diagnoses.
What does the study involve?
Participation in the intervention will involve:
1. Consultation with one of the clinicians that will lead the program, in order to verify eligibility criteria and that participation in the program is optimal for participants. This will include questions about pain, physical and mental health, and prior experience with mindfulness.
2. Complete baseline questionnaires about 2 weeks before the start of the intervention, to document pain interference, resilience, posttraumatic stress, psychological distress, pain beliefs, self-efficacy and quality of life
3. Take part in a 12-session online mindfulness-based program for chronic pain adapted to the needs of Veterans. Each session will last 2h30. Some exercises will be assigned to practice in between sessions.
4. Half-way through the program, at the end of the program, and six months later, complete follow-up questionnaires to measure program satisfaction, pain, physical and mental health, and prior experience with mindfulness.
5. For a subset of participants, take part in an online semi-structured interview
What are the possible benefits and risks of participating?
Participation in the intervention will require 30 hours for the program itself, in addition to completing questionnaires for approximately 2 hours and for some participants, taking part in an online interview of 90 minutes. This might cause some inconvenient. Participation in the program could also bring on some discomfort (e.g., increased pain, unpleasant emotions).
Where is the study run from?
This is an Internet-based study carried out in Canada.
When is the study starting and how long it is expected to run for?
October 2024 to December 2027
Who is funding the study?
This study is funded by a research grant from the Chronic Pain Centre of Excellence for Canadian Veterans
Who is the main contact?
Prof. Gabrielle Pagé, gabrielle.page@umontreal.ca
Contact information
Public, Scientific, Principal investigator
850 St Denis
Office S03-910
Montreal
H2X0A9
Canada
 ORCID ID |
0000-0002-7742-2717 |
|---|---|
| Phone | +1 (0)514 890 8000 x 31601 |
| gabrielle.page@umontreal.ca |
Study information
| Study design | Multi-center longitudinal multi-methods single-arm interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Co-construction of CALM-Pain, a trauma-informed mindfulness-based chronic pain management program for Veterans to improve quality of life: A pilot mixed methods study |
| Study acronym | CALM-PAIN |
| Study objectives | The three study objectives are to: 1. Co-construct with Veterans and clinicians CALM-Pain (Cultivating Awareness and Living Mindfully for Veterans – Pain), a mindfulness-based chronic pain management program for Veterans living with chronic pain (CP) 2. Analyze the feasibility and acceptability of CALM-Pain using the ORBIT framework 3. Co-refine the intervention. |
| Ethics approval(s) |
Approved 10/06/2025, Research Ethics Board of the Centre hospitalier de l'Université de Montréal (900 St-Denis, Montreal, H2X0A9, Canada; +1 (0)514 890 8000; ethique.recherche.chum@ssss.gouv.qc.ca), ref: 2025-12587 |
| Health condition(s) or problem(s) studied | Improvement of quality of life among veterans living with chronic pain |
| Intervention | Trauma-informed and trauma-sensitive mindfulness-based program for chronic pain in Veterans. This is a single-arm study in order to develop and refine the program so that it meets the needs of Veterans living with chronic pain. Phase 1 will include individual interviews and focus groups with Veterans with and without experience with mindfulness interventions, to gather their feedback on the current intervention format and content. Rapid data analysis will be carried out to improve the program. Phase 2 will involve the delivery of the program four times to Veterans living with chronic pain. Quantitative and qualitative data will be collected before, during and at the end of the intervention to document acceptability, feasibility, satisfaction, and preliminary effectiveness. Phase 3 will use data collected in Phase 2 to finalize the intervention format and content. |
| Intervention type | Behavioural |
| Primary outcome measure | Health-related quality of life assessed using the Short-Form Health Survey V2 (SF-12v2) at baseline (within the 2 weeks prior to start of the intervention), T1 (session 6 of the intervention), T2 (within 2 weeks of intervention completion) T3 (6 months after intervention completion) |
| Secondary outcome measures | 1. Pain self-efficacy measured using the Pain Self-Efficacy Questionnaire at baseline (within the 2 weeks prior to start of the intervention), T1 (mid-way through intervention sessions), T2 (within 2 weeks of intervention completion) and T3 (6 months after intervention completion) 2. Pain catastrophizing measured using the Pain Catastrophizing Scale at baseline (within the 2 weeks prior to start of the intervention), T1 (mid-way through intervention sessions), T2 (within 2 weeks of intervention completion) and T3 (6 months after intervention completion). 3. Pain intensity measured using an 11-point Numeric Rating Scale at baseline (within the 2 weeks prior to start of the intervention), T1 (mid-way through intervention sessions), T2 (within 2 weeks of intervention completion) and T3 (6 months after intervention completion) 4. Psychological distress assessed using the Patient Health Questionnaire-4 at baseline (within the 2 weeks prior to start of the intervention), T1 (mid-way through intervention sessions), T2 (within 2 weeks of intervention completion) and T3 (6 months after intervention completion). 5. Pain resilience measured using the Pain Resilience Scale at Baseline (within the 2 weeks prior to start of the intervention), T1 (mid-way through intervention sessions), T2 (within 2 weeks of intervention completion) and T3 (6 months after intervention completion) 6. Pain interference measured using the Brief Pain Inventory at Baseline (within the 2 weeks prior to start of the intervention), T1 (mid-way through intervention sessions), T2 (within 2 weeks of intervention completion), and T3 (6 months after intervention completion). 7. Posttraumatic stress symptoms measured using the PTSD checklist for DSM-5 (PCL-5) at Baseline (within the 2 weeks prior to start of the intervention), T1 (mid-way through intervention sessions), T2 (within 2 weeks of intervention completion) and T3 (6 months after intervention completion). 8. Recruitment rates: The number and proportion of eligible patients recruited, reasons for ineligibility, and refusals. Provides feasibility data according to CONSORT recommendations for pilot studies. Time Frame: During active recruitment period for the study (up to 12 months) 9. Attendance: Number of sessions attended by participants. Time Frame: Each session for a total of 12 sessions (up to 3 months) 10. Adverse events: The number and nature of adverse events reported during the study. Time Frame: Each session for a total of 12 sessions (up to 3 months) 11. Acceptability measured using a modified version of the Pain Program Satisfaction Questionnaire . Acceptable level defined as >50% of participants rating moderate-high (>=3/4) satisfaction items. Time Frame: T2 (within 2 weeks of intervention completion) 12. Retention rates: The number and proportion of eligible patients who complete the program and who drop-out. Provides feasibility data according to CONSORT recommendations for pilot studies. Time Frame: (T2) End of intervention (assessed up to 4 weeks) |
| Overall study start date | 10/10/2024 |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Living with pain for more than 3 months 2. Able to communicate in French or English 3. Residing in Canada (Quebec or Ontario for Phase 2) 4. Having access to the Internet |
| Key exclusion criteria | 1. Having prior experience with a structured mindfulness program for chronic pain (Phase 2 only) 2. Active suicidal ideations or severe psychiatric diagnosis that prevents participation |
| Date of first enrolment | 01/12/2025 |
| Date of final enrolment | 01/09/2026 |
Locations
Countries of recruitment
- Canada
Study participating centre
Montreal
H2X0A9
Canada
Sponsor information
Hospital/treatment centre
900 St-Denis
Montreal
H2X 0A9
Canada
| Phone | +1 (0)514 890 8000 |
|---|---|
| soutien.rc.chum@ssss.gouv.qc.ca | |
| Website | http://www.chumontreal.qc.ca/ |
"ROR" |
https://ror.org/0410a8y51 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Expected outputs: 1. A final version of CALM-Pain to be tested for effectiveness 2. Recruitment and delivery modalities adapted to the needs of Veterans, and capacity building to train Veteran co-facilitators 3. Consolidation of collaborations between researchers, clinicians, stakeholders and Veterans Target populations will include the scientific community, decision makers, Veterans, the general public and clinicians. KT dissemination strategies will use various modalities (e.g., scientific presentations/publications, workshops, media outreach, newsletters and webinars for Veterans, infographics published on various media, mentoring of curriculum facilitators). Key messages: Scientific community: Message will highlight CALM-Pain as a new intervention focused on the needs of Veterans that has significant potential as a stand-alone approach or in combination with other CP management approaches. We also highlight our innovative and interactive methodology that can inspire other implementation teams. Decision makers: Document potential target of interventions to improve the lives of Veterans living with CP. Health care professionals: Document the feasibility of deploying a new intervention that can be integrated with existing care protocols. Veterans and the general public: Large-scale deployment of this intervention has the potential to improve the QoL of Veterans with CP. |
| IPD sharing plan | Following recommendations for open access science, denominated data might be made available to other researchers if an official request is sent, pending approbation by the ethics committee. |
Editorial Notes
28/10/2025: Study's existence confirmed by the Research Ethics Board of the Centre hospitalier de l'Université de Montréal.
