Acceptance and Commitment Therapy for Aging People Living With HIV in Chronic Pain

October 31, 2023 updated by: Maile Young Karris, University of California, San Diego

Acceptance and Commitment Therapy to Address the Psychosocial Co-Morbidities of Chronic Pain in Aging People Living With HIV

Chronic pain impacts a large proportion of aging people living with HIV (aPLWH) and involves factors directly related to HIV (neurotoxicity) and psychosocial co-morbidities common in aPLWH (i.e. social isolation and loneliness). The investigators hypothesize that novel interventions that acknowledge these psychosocial co-morbidities may improve the efficacy of chronic pain management and minimize the use of potentially dangerous medications. This grant proposes to adapt and pilot a pain psychotherapy approach using group acceptance and commitment therapy (ACT) in aPLWH with chronic pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic pain affects a very high proportion of aging people living with HIV (aPLWH) and is thought to be related to both direct toxicity of HIV and antiretroviral therapy (ART) and by psychosocial factors that negatively affect pain (i.e. loneliness, HIV stigma). PLWH are also at increased risk for prescription opiate misuse. However as PLWH age, non-opiate medications used for pain can contribute to other negative outcomes such as falls, altered mental status and gastrointestinal bleeding. Thus there is a critical need for the development of novel interventions in the management of chronic pain in aPLWH that consider the psychological co-morbidities of aging with HIV and that can minimize the need for prescription medications. Acceptance and commitment therapy (ACT) has previously been evaluated in older persons with chronic pain and has demonstrated higher levels of satisfaction and efficacy when compared to cognitive behavioral therapy (CBT). ACT has never been evaluated in aPLWH for chronic pain, but has theoretical advantages over CBT for this population. Specifically several negatively modifying factors of CBT efficacy such as cognitive deficits are common in aPLWH.

The overarching objective of this study is to determine the acceptability and feasibility of an ACT intervention for the management of chronic pain adapted to aPLWH. To accomplish this objective the investigators will 1) train lay personnel to perform ACT to determine feasibility of this approach for future implementation, 2) conduct uncontrolled group ACT in aPLWH to generate participant feedback and questionnaire data to inform ACT adaption with the assistance of a steering commitee, and 3) conduct a pilot randomized controlled trial (RCT) evaluating the acceptability of adapted ACT compared to pain education. At completion of this grant the investigators expect to have successfully trained lay personnel to perform group ACT, adapted ACT from quantitative and qualitative data collected from an uncontrolled study of group ACT, and determined whether ACT is acceptable and feasible as an intervention in aPLWH. These expected outcomes may benefit other aging populations with chronic pain that are enriched for psychosocial co-morbidities such as persons who inject drugs, the socioeconomically disadvantaged, and racial or gender minorities. This proposal is aligned with the Office of AIDS Research High Priorities to better understand "HIV-associated comorbidities" which includes pain and to "Reduce Health Disparities in treatment outcomes of those living with HIV/AIDS" and with the National Pain Strategy to "expand investment ... in the development of safe and effective pain treatments."

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103-8208
        • AntiViral Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • HIV seropositive
  • Diagnosis of chronic non cancer pain
  • English speaking
  • Deemed appropriate for study by primary care provider
  • Consents to participation

Exclusion Criteria:

  • Cancer associated pain
  • Unwillingness to participate in audio recorded sessions
  • Enrollment in hospice
  • Moderate to severe neurocognitive deficits (MOCA < 16)
  • Currently undergoing other psychotherapy for chronic pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acceptance and Commitment Therapy (ACT)
The intervention will consists of eight weekly two hour group ACT sessions led by trained lay personnel and followed by homework. ACT is a behavioral therapy.
Behavioral: Acceptance and Commitment Therapy (ACT)
Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.
Experimental: Education Control
Consists of eight weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework.
Other: Chronic Pain Education
Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Chronic Pain Acceptance Questionnaire (CPAQ) Week 0 to Week 6
Time Frame: 6 weeks
Change in Chronic Pain Acceptance Questionnaire or CPAQ from study entry to end of intervention. This scale measures acceptance of chronic pain and measures two factors: activity engagement (pursuit of life activities regardless of pain) and pain willingness (recognition that avoidance and control are often unworkable methods of adapting to chronic pain). A total of 20 items represents these two factors and the items are rated on a 7-point scale from 0 (never true) to 6 (always true). Scoring the CPAQ requires adding the summed items for activity engagement and pain willingness for a total score. Thus the range of scores is from 0 (no acceptance) to 120 (full acceptance). Change in scale will be represented by the difference in CPAQ total score from baseline to week 6.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Chronic Pain Acceptance Questionnaire Week 0 to Week 3
Time Frame: 3 weeks
Change in Chronic Pain Acceptance Questionnaire or CPAQ from study entry to end of intervention. This scale measures acceptance of chronic pain and measures two factors: activity engagement (pursuit of life activities regardless of pain) and pain willingness (recognition that avoidance and control are often unworkable methods of adapting to chronic pain). A total of 20 items represents these two factors and the items are rated on a 7-point scale from 0 (never true) to 6 (always true). Scoring the CPAQ requires adding the summed items for activity engagement and pain willingness for a total score. Thus the range of scores is from 0 (no acceptance) to 120 (full acceptance). Change in scale will be represented by the difference in CPAQ total score from baseline to week 3.
3 weeks
Brief Pain Inventory Interference Subscale
Time Frame: 6 weeks
Change in the Brief Pain Inventory (BPI) Interference subscale from week 0 to 6. The BPI allows persons to rate the severity of their pain (pain severity subscale) and the degree to which their pain interferes with feeling and function (interference subscale). The severity scale assess pain at its "worst, least, average and now". These 4 items are ranked from 0 (no pain) to 10 (pain as bad as you can imagine). Most commonly single items of "worst" and "average" are used to represent severity. A composite of the four items (mean severity score) is often also presented. Pain interference has 7 items "general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life" and is scored from 0 (does not interfere) to 10 (completely interferes). Pain interference subscale is scored as the mean of the seven interference items. Change in BPI interference subscale will be represented by the difference in mean interference from baseline to week 6.
6 weeks
Change in Pain Education Score
Time Frame: Week 0 to Week 6
Difference from Week 0 to 6 in proportion of pain knowledge questions answered correctly.
Week 0 to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180837
  • 1R03AG060183-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data including quantitative (questionnaires, baseline data) and qualitative (focus group) data will be stored in our secure database and made available to researchers upon request.

IPD Sharing Time Frame

Data will be available twelve months after study has ended and for five years.

IPD Sharing Access Criteria

Contact PI and submission of brief proposal to minimize duplication of effort and ensure research questions are answerable using IPD available.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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