Clinical trial NCT04229134: Piloting a Novel Peer Support Pain Self-Management Intervention (Project CONNECT)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Musculoskeletal Pain
Keywords: Chronic pain
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Connecticut Healthcare System
name: Yale University
First posted: 2020-01-18
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Women Veteran receiving care at the VA Connecticut Healthcare System or VA Central Western Massachusetts
* Possession of a cell phone with no limits on utilization and willingness to engage in regular phone/text interactions with a peer partner
* Moderate-Severe musculoskeletal pain
* Pain on at least half of the days of the prior six months
* Primary care provider or mental health provider clearance

Exclusion Criteria:

* Life threatening conditions that could impede participation
* Sensory deficits that would impair participation in telephone calls
* Current or pending surgical interventions
* Presence of any mental health condition that would impair ability to engage in treatment or serve as a suitable peer as defined by:

  * diagnosis
  * screening measures

Primary outcomes:
measure: Feasibility: Retention
timeFrame: 3 months post baseline
measure: Feasibility: Long-term Retention
timeFrame: 6 months post-baseline
Secondary outcomes:
measure: Feasibility: Dyad Connection
timeFrame: 3 months post baseline
measure: Feasibility: Diary Completion Rates
timeFrame: 3 months post baseline
measure: Feasibility: Skill Practice Rates
timeFrame: 3 months post baseline
measure: Acceptability: Satisfaction & Credibility
timeFrame: 3 months post baseline
measure: Acceptability: Peer Matching
timeFrame: 3 months post baseline
measure: Exploratory: Responder Analysis
timeFrame: 3 months post baseline
measure: Exploratory: Long-term Responder Analysis
timeFrame: 6 months post baseline
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Mary Driscoll, PhD
role: PRINCIPAL_INVESTIGATOR
References: