Pilot Testing of a Behavioral Intervention for Chronic Pain in Individuals With HIV

NCT ID: NCT02824562

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-08-22

Brief Summary

Due to its specific pathophysiology and impact on health outcomes, the Institute of Medicine has described chronic pain as a complex chronic disease and a "national public health crisis." The unique neurobiological basis and psychosocial context of chronic pain in HIV-infected patients underscores the importance of developing and testing a behavioral intervention specifically tailored to this population. This study will pilot test a newly-developed behavioral intervention for chronic pain tailored to individuals with HIV.

Detailed Description

Chronic pain is a chronic condition with a unique neurobiologic basis, which has a substantial impact on physical and emotional function. Chronic pain in HIV-infected patients is common, and associated with serious health consequences, including up to 10 times greater odds of impaired physical function. Many pharmacologic therapies, including opioids, often do not lead to improved pain and function, and carry significant risk. Evidence-based behavioral interventions are among the most effective and safe non-pharmacologic chronic pain treatments investigated in the general medical population. Therefore, behavioral interventions to improve pain, physical, and emotional function in HIV-infected patients are needed. There is much to be learned from existing interventions. However, the success of a behavioral intervention is heavily influenced by how well it is tailored to the target population's biological, psychological, and social environment. Therefore, in this study investigators will conduct a two-arm pilot randomized controlled trial of a recently-developed behavioral intervention compared to routine HIV and pain care, to determine feasibility, acceptability, and preliminary impact.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention

The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain. The participants will complete an outcome assessment within 30 days of the last group session.

Group Type: OTHER

Intervention

Intervention Type: BEHAVIORAL

The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain.

Control

The control group will receive "treatment as usual". The "treatment as usual" or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group. The participants will complete an outcome assessment within 30 days of the last group session.

Group Type: OTHER

Control

Intervention Type: BEHAVIORAL

The control group will receive "treatment as usual". The "treatment as usual" or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group.

Interventions

Intervention

The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain.

Intervention Type: BEHAVIORAL

Control

The control group will receive "treatment as usual". The "treatment as usual" or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Enrolled in the Center for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort

2. Age ≥ 18 years

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

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

Exclusion Criteria

1. Do not speak or understand English

2. Are planning a new pain treatment like surgery

3. Cannot attend the group sessions.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Jessica Merlin

MD, MBA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

Merlin JS, Westfall AO, Johnson MO, Kerns RD, Bair MJ, Kertesz S, Turan JM, Clay OJ, Starrels JL, Kilgore M. Cost-effectiveness of a chronic pain intervention for people living with HIV (PLWH). J Med Econ. 2018 Feb;21(2):122-126. doi: 10.1080/13696998.2017.1377719. Epub 2017 Sep 18.

Reference Type: DERIVED

PMID: 28880698 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

X160328007

Identifier Type: -

Identifier Source: org_study_id