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

NCT02824562 | Completed Results

• 1 other identifier: X160328007
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Intervention Feasibility: Median Number of Study Intervention Sessions Attended by Participants

  Participants are expected to attend 6 one-on-one sessions and 6 group sessions. Maximum sessions if all attended per participant would be 12 sessions.

  From baseline throughout the entire 16 week intervention period

Secondary Outcomes (1)

• Outcome Assessment Feasibility: Number (Percentage) of Participants Who Complete Outcome Assessments Within One Month

  From the conclusion of the intervention through 30 days (Intervention Group). From the last group session through 30 days (Control Group).

Study Arms (2)

Intervention

OTHER

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.

Behavioral: Intervention

Control

OTHER

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.

Behavioral: Control

Interventions

Intervention 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.

Intervention

Control 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.

Control

Eligibility Criteria

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

You may qualify if:

• Enrolled in the Center for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort
• Age ≥ 18 years
• 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 times is 4 or greater)

You may not qualify if:

• Do not speak or understand English
• Are planning a new pain treatment like surgery
• Cannot attend the group sessions.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• 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.

  PMID: 28880698 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Jessica Merlin
• Organization: UAB

jmerlin@uabmc.edu

2059967894

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MBA

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 6, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: August 22, 2017
• Last Updated: October 10, 2018
• Results First Posted: October 10, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)