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Completed

NCT Number: NCT02824562

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Intervention Feasibility: Median Number of Study Intervention Sessions Attended by Participants

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Development of a Behavioral Intervention for Chronic Pain in Individuals With HIV

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 6, 2016
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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