Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-01-01 @ 6:34 AM
Study NCT ID:
NCT04229134
Status:
COMPLETED
Last Update Posted:
2025-07-04
First Post:
2020-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Piloting a Novel Peer Support Pain Self-Management Intervention (Project CONNECT)
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Targeting Barriers to Pain Self-Management in Women Veterans: Refinement and Feasibility of a Novel Peer Support Intervention (Project CONNECT) (CDA 18-005)
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONNECT
Brief Summary:
The proposed study will test the feasibility and acceptability of an 8-week home-based reciprocal peer support pain self-management intervention (CONNECT) for women Veterans with chronic musculoskeletal pain. The use of this format will improve the accessibility of treatment to women Veterans who experience logistical, healthcare delivery and psychosocial barriers to care. To address these barriers women Veterans who enroll in CONNECT will be paired and work together to learn/practice pain coping skills, set meaningful activity goals, and participate in a graduated walking program; they will exchange nightly text messages and engage in a weekly 20 minute phone call to reinforce each other and provide support for pain self-management efforts. This is a single-arm pilot project; all eligible and interested women with chronic musculoskeletal pain will receive CONNECT. The primary outcome will be post-treatment and long-term follow-up retention rates.
Detailed Description:
Objectives: The primary purpose of this pilot study is to evaluate the feasibility and acceptability of a reciprocal peer support pain self-management intervention (CONNECT) for women Veterans with chronic musculoskeletal pain. The primary hypothesis states that the post-treatment and long-term follow-up retention rates will not be less than 80% which is the lowest rate obtained in a behavioral pain trial and comparable to peer support interventions. Several secondary feasibility and acceptability hypotheses are proposed and include: a) rates of successful dyad connection will be greater than or equal to 80%, b) nightly assessment completion rates will meet or exceed the previously established 85% completion rate, c) reported rates of skill practice will meet or exceed 65% consistent with other behavioral pain trials, d) mean intervention satisfaction and credibility ratings will meet or exceed 80% d) 80% or more of participants will report favorable ratings of their peer. A responder analysis will also be completed to determine the percentage of participants who report clinically meaningful reductions in pain intensity and pain interference (as measured by the Brief Pain Inventory- Short Form) and depressive symptoms (as defined by a reduction of 5 or more points on the Patient Health Questionnaire-8). Additional qualitative objectives will solicit participant opinions of candidate control conditions for a future trial.
Research Design: A non-randomized pilot design will be employed. All eligible and interested participants will participate in a week-long behavioral run-in period. Those who successfully navigate it will receive CONNECT. Repeated assessments of key outcome domains will occur at baseline, and at 10 and 22 weeks after intervention start.
Methodology: Participants will be 45 women Veterans with chronic musculoskeletal pain receiving care at the VA Connecticut Healthcare System and VA Central Western Massachusetts. Interested and eligible Veterans will be verbally consented before participating in a brief telephone based qualitative interview and a 1-week behavioral run-in period designed to mimic demands of the intervention/study. Women who successfully navigate the run-in (estimate n=30) will participate in a telephone orientation with their peer and proceed through the 8-week CONNECT intervention. Together, pairs will learn one new pain coping skill each week, participate in a graduated walking program (using a study provided pedometer), and set meaningful activity goals. They will provide reinforcement and support for these activities via text messages and 1 weekly (15 minute call). Study staff will provide periodic feedback on their progress.
Research Design: A non-randomized pilot design will be employed. All eligible and interested participants will participate in a week-long behavioral run-in period. Those who successfully navigate it will receive CONNECT. Repeated assessments of key outcome domains will occur at baseline, and at 10 and 22 weeks after intervention start.
Methodology: Participants will be 45 women Veterans with chronic musculoskeletal pain receiving care at the VA Connecticut Healthcare System and VA Central Western Massachusetts. Interested and eligible Veterans will be verbally consented before participating in a brief telephone based qualitative interview and a 1-week behavioral run-in period designed to mimic demands of the intervention/study. Women who successfully navigate the run-in (estimate n=30) will participate in a telephone orientation with their peer and proceed through the 8-week CONNECT intervention. Together, pairs will learn one new pain coping skill each week, participate in a graduated walking program (using a study provided pedometer), and set meaningful activity goals. They will provide reinforcement and support for these activities via text messages and 1 weekly (15 minute call). Study staff will provide periodic feedback on their progress.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CDA 18-005 | OTHER_GRANT | VA HSRD | View |