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

Primary Purpose

HIV/AIDS, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy (ACT)
Chronic Pain Education
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring HIV, Chronic Pain, Acceptance and Commitment Therapy, Behavioral Intervention, Older Adults

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • AntiViral Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acceptance and Commitment Therapy (ACT)

Education Control

Arm Description

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.

Consists of eight weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework.

Outcomes

Primary Outcome Measures

Chronic Pain Acceptance Questionnaire (CPAQ)
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 8.

Secondary Outcome Measures

Chronic Pain Acceptance Questionnaire
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 4.
Brief Pain Inventory Interference subscale
Change in the Brief Pain Inventory (BPI) Interference subscale from week 0 to 8. 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 8.

Full Information

First Posted
July 12, 2018
Last Updated
February 17, 2023
Sponsor
University of California, San Diego
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03699020
Brief Title
Acceptance and Commitment Therapy for Aging People Living With HIV in Chronic Pain
Official Title
Acceptance and Commitment Therapy to Address the Psychosocial Co-Morbidities of Chronic Pain in Aging People Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Chronic Pain
Keywords
HIV, Chronic Pain, Acceptance and Commitment Therapy, Behavioral Intervention, Older Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and Commitment Therapy (ACT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Education Control
Arm Type
Experimental
Arm Description
Consists of eight weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy (ACT)
Intervention Description
Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.
Intervention Type
Other
Intervention Name(s)
Chronic Pain Education
Intervention Description
Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life
Primary Outcome Measure Information:
Title
Chronic Pain Acceptance Questionnaire (CPAQ)
Description
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 8.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Chronic Pain Acceptance Questionnaire
Description
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 4.
Time Frame
3 weeks
Title
Brief Pain Inventory Interference subscale
Description
Change in the Brief Pain Inventory (BPI) Interference subscale from week 0 to 8. 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 8.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
AntiViral Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
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Acceptance and Commitment Therapy for Aging People Living With HIV in Chronic Pain

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