An interventional study of Acceptance and Commitment Therapy (ACT) and Chronic Pain Education in HIV/AIDS and Chronic Pain, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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.
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."
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 13 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
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Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Exclusion Criteria:
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)
Consists of eight weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework.
Other: Chronic Pain Education
Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.
Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life
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.
Time frame: 6 weeks
Change in Chronic Pain Acceptance Questionnaire Week 0 to Week 3
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.
Time frame: 3 weeks
Brief Pain Inventory Interference Subscale
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.
Time frame: 6 weeks
Change in Pain Education Score
Difference from Week 0 to 6 in proportion of pain knowledge questions answered correctly.
Time frame: Week 0 to Week 6
| Milestone | Acceptance and Commitment Therapy (ACT) | Education Control |
|---|---|---|
| Started | 7 | 5 |
| Intervention attendance completion | 4 | 3 |
| Completed | 4 | 3 |
| Not completed | 3 | 2 |
| Withdrew: Withdrawal by subject | 3 | 2 |
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.
| score on a scale | Acceptance and Commitment Therapy (ACT) | Education Control |
|---|---|---|
| Change in Chronic Pain Acceptance Questionnaire (CPAQ) Week 0 to Week 6 | 5 (2.5 to 7) | 13 (6 to 29) |
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.
| change in score from 0 to 6 weeks. | Acceptance and Commitment Therapy (ACT) | Education Control |
|---|---|---|
| Change in Chronic Pain Acceptance Questionnaire Week 0 to Week 3 | 5.5 (4.75 to 6.25) | 13 (5 to 21) |
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.
| score on a scale | Acceptance and Commitment Therapy (ACT) | Education Control |
|---|---|---|
| Brief Pain Inventory Interference Subscale | -1.71 (-2.57 to -0.86) | -0.14 (-1.21 to 0.21) |
Difference from Week 0 to 6 in proportion of pain knowledge questions answered correctly.
| proportion of correct answers | Acceptance and Commitment Therapy (ACT) | Education Control |
|---|---|---|
| Change in Pain Education Score | 0.05 (-0.075 to 0.175) | 0.1 (0.1 to 0.2) |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acceptance and Commitment Therapy (ACT) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Education Control | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
These participants were randomized, however once the intervention or control started several participants opted to no longer continue
| Age, Continuous(years) | Acceptance and Commitment Therapy (ACT) | Education Control | Total |
|---|---|---|---|
| Median | 58 (57.5 to 66.5) | 57 (57 to 62) | 58 (57 to 62.25) |
| Sex: Female, Male(Participants) | Acceptance and Commitment Therapy (ACT) | Education Control | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 4 | 3 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Acceptance and Commitment Therapy (ACT) | Education Control | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 6 | 3 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Acceptance and Commitment Therapy (ACT) | Education Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 4 | 4 | 8 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Acceptance and Commitment Therapy (ACT) | Education Control | Total |
|---|---|---|---|
| United States | 7 | 5 | 12 |
| Years living with HIV(years) | Acceptance and Commitment Therapy (ACT) | Education Control | Total |
|---|---|---|---|
| Median | 24 (22.5 to 24) | 29 (27 to 33) | 24 (23 to 27.5) |
| Years on antiretroviral therapy(years) | Acceptance and Commitment Therapy (ACT) | Education Control | Total |
|---|---|---|---|
| Median | 24 (22.5 to 24) | 23 (14 to 24) | 23 (19.3 to 24.5) |
| Current HIV Viral Load(HIV copies/mL) | Acceptance and Commitment Therapy (ACT) | Education Control | Total |
|---|---|---|---|
| Median | 0 (0 to 0) | 46 (46 to 184) | 46 (46 to 88) |
11 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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University of California, San Diego