Musculoskeletal PainCONNECTNCT04229134
Piloting a Novel Peer Support Pain Self-Management Intervention (Project CONNECT)
A study testing Project CONNECT in people with Musculoskeletal Pain, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Project CONNECT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2021to 30 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
About this study
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)
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.
Read the 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.
- Conditions
- Musculoskeletal Pain
- Being tested
- Project CONNECT
- Keywords
- Chronic pain
- Medical subject headings
- Musculoskeletal Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project CONNECTBehavioural
Home based pain self-management intervention using peer reinforcement to promote engagement and skill uptake
| Study group | Role | What they receive |
|---|---|---|
| Pilot Arm: Project CONNECT | Other | 8-week home based reciprocal peer support pain self-management program for chronic musculoskeletal pain Receives: Behavioral: Project CONNECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months post-baseline
Secondary outcomes (7)
Feasibility: Dyad Connection
Rates of successful dyad connection will be compared to 80% (comparable to other Reciprocal Peer Support interventions)
Measured: 3 months post baseline
Feasibility: Diary Completion Rates
Nightly assessment completion rates and their 95% confidence intervals will be compared to other Veteran behavioral pain trials demonstrating an 85% completion rate.
Measured: 3 months post baseline
Feasibility: Skill Practice Rates
Skill practice rates and their 95% confidence intervals will also be compared to 65% consistent with rates reported in similar pain trials.
Measured: 3 months post baseline
Acceptability: Satisfaction & Credibility
Mean intervention satisfaction and credibility ratings and their 95% confidence intervals will be compared to 80% which is the standard for behavioral pain trials
Measured: 3 months post baseline
Acceptability: Peer Matching
Favorable experience with peer ratings and their 95% confidence intervals will be compared with 80% which is comparable to other reciprocal peer support interventions
Measured: 3 months post baseline
Exploratory: Responder Analysis
A responder analysis will be completed to determine percent of subjects achieving a clinically meaningful reduction in pain intensity, pain interference and depression. For both the Brief Pain Inventory Pain Intensity and Pain Interference subscales, a 30% reduction is defined as clinically meaningful. For depressive symptoms, a reduction of 5 points on the Patient Health questionnaire-8 is considered clinically meaningful
Measured: 3 months post baseline
Exploratory: Long-term Responder Analysis
A responder analysis will be completed to determine percent of subjects achieving a clinically meaningful reduction in pain intensity, pain interference and depression. For both the Brief Pain Inventory Pain Intensity and Pain Interference subscales, a 30% reduction is defined as clinically meaningful. For depressive symptoms, a reduction of 5 points on the Patient Health questionnaire-8 is considered clinically meaningful
Measured: 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start5 May 2021
- Primary completion30 Apr 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Connecticut Healthcare System, Yale University
- Responsible party
- Sponsor
- Investigators
- Mary Driscoll, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229134
- Sponsor's protocol ID
- CDX 19-003
- Other IDs
- CDA 18-005
- Acronym
- CONNECT
- Status last verified
- Aug 2026
- First submitted
- 7 Jan 2020
- Last updated
- 2 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04229134
- Acronym / sponsor ID
- CONNECT / CDX 19-003
- Conditions
- Musculoskeletal Pain
- Keywords
- Chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Connecticut Healthcare System, Yale University
- Study start
- 5 May 2021 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 2 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot Arm: Project CONNECT | Other | Behavioral: Project CONNECT8-week home based reciprocal peer support pain self-management program for chronic musculoskeletal pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project CONNECTHome based pain self-management intervention using peer reinforcement to promote engagement and skill uptake | Behavioural | Pilot Arm: Project CONNECT |
Primary outcome
Feasibility: Retention
Time frame: 3 months post baseline
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
Feasibility: Long-term Retention
Time frame: 6 months post-baseline
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
7 secondary outcomes
Feasibility: Dyad Connection
Time frame: 3 months post baseline
Feasibility: Diary Completion Rates
Time frame: 3 months post baseline
Feasibility: Skill Practice Rates
Time frame: 3 months post baseline
Acceptability: Satisfaction & Credibility
Time frame: 3 months post baseline
Acceptability: Peer Matching
Time frame: 3 months post baseline
Exploratory: Responder Analysis
Time frame: 3 months post baseline
Exploratory: Long-term Responder Analysis
Time frame: 6 months post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Driscoll, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project CONNECT in people with Musculoskeletal Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Retention (time frame: 3 months post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.