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

Not Applicable

Completed

• Conditions: Chronic Pain

• Registration Number: NCT02824562
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2016-06-28
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-06
• Primary Completion: 2017-06-01
• Study Completion: 2017-08-22
• Results First Submitted: 2017-09-18
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-14
• Last Update Submitted: 2017-12-14
• Results First Posted: 2018-10-10
• Last Update Posted: 2018-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intervention Feasibility: Median Number of Study Intervention Sessions Attended by Participants	From baseline throughout the entire 16 week intervention period	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.

Secondary Outcome Measures

Name	Time	Method
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).	Outcome assessments are administered to participants by study staff.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States