Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2020 by Maile Young Karris, University of California, San Diego

Sponsor
University of California, San Diego

Collaborator
National Institute on Aging (NIA)

Information provided by (Responsible Party)
Maile Young Karris, University of California, San Diego

ClinicalTrials.gov Identifier
NCT03699020

First received: July 12, 2018
Last updated: May 4, 2020
Last Verified: May 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV/AIDS
Chronic Pain

Behavioral : Acceptance and Commitment Therapy (ACT)
Other : Chronic Pain Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acceptance and Commitment Therapy to Address the Psychosocial Co-Morbidities of Chronic Pain in Aging People Living With HIV

Further study details as provided by Maile Young Karris, University of California, San Diego:

Primary Outcome Measures

  • Chronic Pain Acceptance Questionnaire (CPAQ) [ 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 8.
Secondary Outcome Measures:
  • Chronic Pain Acceptance Questionnaire [ 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 4.
  • Brief Pain Inventory Interference subscale [ Time Frame: 6 weeks ]
    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.

Estimated Enrollment: 50
Study Start Date: January 7, 2019
Estimated Study Completion Date: September 1, 2020
Estimated Primary Completion Date: September 1, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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."

Eligibility

Eligibility

Ages Eligible for Study: 50 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03699020

Contacts

Contact:   Maile Y Karris, MD 619-543-5039 m1young@ucsd.edu

Locations

United States, California
AntiViral Research Center Recruiting
San Diego, California, United States, 92103-8208
Contact: Maile A Karris, MD    619-543-5039    m1young@ucsd.edu

Sponsors and Collaborators

University of California, San Diego
National Institute on Aging (NIA)
More Information

More Information


Responsible Party: Maile Young Karris, Associate Professor, University of California, San Diego  
ClinicalTrials.gov Identifier: NCT03699020   History of Changes  
Other Study ID Numbers: 180837  
  1R03AG060183-01  
Study First Received: July 12, 2018  
Last Updated: May 4, 2020  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Maile Young Karris, University of California, San Diego:

HIV
Chronic Pain
Acceptance and Commitment Therapy
Behavioral Intervention
Older Adults

Additional relevant MeSH terms:
Chronic Pain

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.