Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV

NCT03692611 | Completed Results DMC

• 2 other identifiers: STUDY190500511R01MH115754-01A1
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Pain

Keywords

Chronic pain; HIV; Opioid prescribing; Behavioral clinical trial

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI) Total Score

  The Brief Pain Inventory (BPI) is a validated tool measuring pain severity and its impact on daily functioning. It includes 11 items assessing pain severity (worst, least, average, current) and pain interference with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life. Each item is rated from 0 (no pain/no interference) to 10 (worst pain imaginable/complete interference). The Pain Severity Subscore (0-10) is the average of four severity items, the Functional Interference Subscore (0-10) is the average of seven interference items, and the Total Score (0-10) is the average of all 11 items. Higher scores indicate worse pain severity and greater pain interference.

  Immediately postintervention and 3-month follow-up (postintervention)

Secondary Outcomes (6)

• Brief Pain Inventory (BPI) Functional Interference Subscore

  Immediately postintervention and 3-month follow-up (postintervention)

• Brief Pain Inventory (BPI) Pain Severity Subscore

  Immediately postintervention and 3-month follow-up (postintervention)

• The Pain, Enjoyment and General Activity (PEG) Scale

  Immediately postintervention and 3-month follow-up (postintervention)

• The Pain Self-Efficacy Questionnaire (PSEQ)

  Immediately postintervention and 3-month follow-up (postintervention)

• The Patient Health Questionnaire-8 (PHQ-8)

  Immediately postintervention and 3-month follow-up (postintervention)

Study Arms (2)

Skills to Manage Pain (STOMP)

EXPERIMENTAL

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.

Behavioral: Skills TO Manage Pain (STOMP)

comparison group

ACTIVE COMPARATOR

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.

Behavioral: Comparison group

Interventions

Skills TO Manage Pain (STOMP) BEHAVIORAL

12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.

Skills to Manage Pain (STOMP)

Comparison group BEHAVIORAL

Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.

Also known as: active comparator

comparison group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled in CNICS
• Age ≥ 18 years
• English-speaking
• Chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least moderate pain for at least 3 months)
• Moderately severe and impairing chronic pain (PEG pain questionnaire = average of all three items is 4 or greater)
• Ability and willingness to attend the group sessions at the date/time specified
• No plans for major surgery during the study period that would interfere with study procedures.

You may not qualify if:

• Do not speak or understand English
• Are planning a new pain treatment like surgery
• Cannot attend the group sessions
• Had previously participated in the pilot study (STOMP)
• Unwilling to provide informed consent

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Alabama at Birmingham: collaborator
• National Institute of Mental Health (NIMH): collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (2)

University of Alabama

Birmingham, Alabama, 352940, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

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MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations include a specific population (people with HIV and chronic pain), limiting generalizability to other groups. Short follow-up (3 months) restricts insight into long-term effects. Women were slightly underrepresented, reducing applicability to chronic pain populations where women are more common. Participants were not blinded, possibly introducing bias, though staff and investigators remained blinded. Addressing these in future trials can improve applicability and robustness.

Results Point of Contact

• Title: Dr. Jessica Merlin
• Organization: University of Pittsburgh

merlinjs@upmc.edu

(412) 383-0617

Study Officials

• Jessica Merlin, MD PhD MBA

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Associate Professor

Model Details: This is a randomized controlled trial to discover whether STOMP is an efficacious Pain Self-Management (PSM) intervention, mediated by the hypothesized Social Cognitive Theory (SCT) constructs.

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: October 2, 2018
• Study Start: August 14, 2019
• Primary Completion: January 14, 2024
• Study Completion: January 6, 2025
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)