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

NCT03699020 | Completed Results DMC

• 2 other identifiers: 1808371R03AG060183-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS; Chronic Pain

Keywords

HIV; Chronic Pain; Acceptance and Commitment Therapy; Behavioral Intervention; Older Adults

Outcome Measures

Primary Outcomes (1)

• Change in Chronic Pain Acceptance Questionnaire (CPAQ) Week 0 to Week 6

  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 Outcomes (3)

• Change in Chronic Pain Acceptance Questionnaire Week 0 to Week 3

  3 weeks

• Brief Pain Inventory Interference Subscale

  6 weeks

• Change in Pain Education Score

  Week 0 to Week 6

Study Arms (2)

Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

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)

Education Control

EXPERIMENTAL

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

Other: Chronic Pain Education

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.

Acceptance and Commitment Therapy (ACT)

Chronic Pain Education OTHER

Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life

Education Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

AntiViral Research Center

San Diego, California, 92103-8208, United States

Location

Related Publications (26)

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• By the American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2015 Nov;63(11):2227-46. doi: 10.1111/jgs.13702. Epub 2015 Oct 8.

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MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Chronic Pain

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

We hypothesize our ability to recruit and engage participants was impaired by the COVID-19 pandemic. Barriers included halting of non-covid studies, IRB approval for remote delivery of the intervention, disinterest in research participation in the context of COVID, lack of access to reliable internet connectivity and unfamiliarity with video visits.

Results Point of Contact

• Title: Maile Young Karris
• Organization: University of California San Diego

m1young@health.ucsd.edu

1-619-543-5039

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: October 9, 2018
• Study Start: January 7, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available twelve months after study has ended and for five years.
• Access Criteria: Contact PI and submission of brief proposal to minimize duplication of effort and ensure research questions are answerable using IPD available.

Locations

US (1)