NCT04229134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 5, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

January 7, 2020

Last Update Submit

July 1, 2025

Conditions

Musculoskeletal Pain

Keywords

Chronic pain

Outcome Measures

Primary Outcomes (2)

  • Feasibility: Retention

    Post-treatment follow-up retention rates and their 95% confidence intervals. These will be compared to 80%, which is the lowest rate obtained in a behavioral pain trial and comparable to peer support interventions

    3 months post baseline

  • Feasibility: Long-term Retention

    Long-term follow-up retention rates and their 95% confidence intervals. These will be compared to 80%, which is the lowest rate obtained in a behavioral pain trial and comparable to peer support interventions

    6 months post-baseline

Secondary Outcomes (7)

  • Feasibility: Dyad Connection

    3 months post baseline

  • Feasibility: Diary Completion Rates

    3 months post baseline

  • Feasibility: Skill Practice Rates

    3 months post baseline

  • Acceptability: Satisfaction & Credibility

    3 months post baseline

  • Acceptability: Peer Matching

    3 months post baseline

  • +2 more secondary outcomes

Study Arms (1)

Pilot Arm: Project CONNECT

OTHER

8-week home based reciprocal peer support pain self-management program for chronic musculoskeletal pain

Behavioral: Project CONNECT

Interventions

Project CONNECTBEHAVIORAL

Home based pain self-management intervention using peer reinforcement to promote engagement and skill uptake

Pilot Arm: Project CONNECT

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

MeSH Terms

Conditions

Musculoskeletal PainChronic Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mary Driscoll, PhD

    VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 18, 2020

Study Start

May 5, 2021

Primary Completion

April 30, 2025

Study Completion

May 30, 2025

Last Updated

July 4, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)