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STOMP for Chronic Pain (STOMP Trial)

N/A

Waitlist Available

Led By Jessica Merlin, MD PhD MBA

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderately severe and impairing chronic pain (PEG pain questionnaire = average of all three items is 4 or greater)

Chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least moderate pain for at least 3 months)

Must not have

Do not speak or understand English

Cannot attend the group sessions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up bpi will be conducted at baseline and immediately after the intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial seeks to improve chronic pain treatment for people living with HIV, in accordance with the Department of Health and Human Services National Pain Strategy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since STOMP focuses on self-management skills rather than medication or invasive treatments, side effects are minimal but may include discomfort from discussing personal experiences or emotional fatigue related to participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience chronic pain that significantly affects my daily life.

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I have been in moderate pain for at least 3 months.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot speak or understand English.

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I am unable to attend group sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ bpi will be conducted at baseline and immediately after the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~bpi will be conducted at baseline and immediately after the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and bpi will be conducted at baseline and immediately after the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brief Pain Inventory (BPI) score immediately post intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Skills to Manage Pain (STOMP)Experimental Treatment1 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 groupActive Control1 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.

0 / 5Eligibility criteria met