STOMP for Chronic Pain

(STOMP Trial)

Recruiting at 1 trial location

Overseen By Michael Mugavero, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Non-English speakers, Surgery plans, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12-16 weeks

278 Participants Needed

Trial Summary

What is the purpose of this trial?

Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance with the approach recommended by the Department of Health and Human Services National Pain Strategy: to develop and test Pain Self-Management interventions tailored to the needs of vulnerable populations, particularly people living with HIV (PLWH). Chronic pain is an important and understudied comorbidity among PLWH; therefore, this proposal is responsive to the NIH's HIV Research Priorities, which identify comorbidities as a high priority research topic.

Research Team

Jessica Merlin, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for English-speaking adults over 18 with chronic pain, specifically those living with HIV who experience moderate to severe pain lasting at least 3 months. Participants must be able to attend group sessions and not have major surgery planned that could interfere with the study.

Inclusion Criteria

I experience chronic pain that significantly affects my daily life.

I can and will attend all group sessions as scheduled.

Enrolled in CNICS

Exclusion Criteria

Unwilling to provide informed consent

I cannot speak or understand English.

I am planning to undergo surgery for pain management.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the STOMP behavioral intervention consisting of 12 sessions over 12-16 weeks

12-16 weeks

6 group sessions, 6 individual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• comparison group
• Skills TO Manage Pain (STOMP)

Trial Overview The STOMP intervention, a program designed to help manage chronic pain tailored for people living with HIV, is being tested against a comparison group. The goal is to see if STOMP can improve quality of life and health outcomes in this vulnerable population.

Participant Groups

Group I: Skills to Manage Pain (STOMP) Experimental Treatment 1 Intervention

The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.

Group II: comparison group Active Control 1 Intervention

The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+