Chronic Pain, HIV/AIDS
Conditions
Keywords
HIV, Chronic Pain, Acceptance and Commitment Therapy, Behavioral Intervention, Older Adults
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.
Interventions
BEHAVIORALAcceptance and Commitment Therapy (ACT)
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
Sponsors
National Institute on Aging (NIA)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Chronic Pain Acceptance Questionnaire (CPAQ) Week 0 to Week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Chronic Pain Acceptance Questionnaire Week 0 to Week 3 | 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. |
| Brief Pain Inventory Interference Subscale | 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. |
| Change in Pain Education Score | Week 0 to Week 6 | Difference from Week 0 to 6 in proportion of pain knowledge questions answered correctly. |
Countries
United States
Participant flow
Pre-assignment details
All participants were randomized to groups shortly after enrollment.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Acceptance and Commitment Therapy (ACT): Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility. | 7 |
| Education Control Consists of eight weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework.
Chronic Pain Education: Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life | 5 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Total | Acceptance and Commitment Therapy (ACT) | Education Control |
|---|---|---|---|
| Age, Continuous | 58 years | 58 years | 57 years |
| Baseline CPAQ-R Activity Engagement | 34 units on a scale | 42 units on a scale | 25.5 units on a scale |
| Baseline CPAQ-R Pain Willingness | 32 units on a scale | 32 units on a scale | 32 units on a scale |
| Baseline CPAQ-R (revised) Total Score | 66 units on a scale | 68 units on a scale | 56 units on a scale |
| Brief Pain Inventory: Pain interference | 5 units on a scale | 5 units on a scale | 5 units on a scale |
| Brief Pain Inventory: Pain Severity (average) | 8 units on a scale | 8 units on a scale | 4.5 units on a scale |
| Brief Pain Inventory: Pain Severity (worse) | 8 units on a scale | 8 units on a scale | 6 units on a scale |
| Current CD4 T cell count | 1051 cells/m3 | 716 cells/m3 | 1051 cells/m3 |
| Current HIV Viral Load | 46 HIV copies/mL | 0 HIV copies/mL | 46 HIV copies/mL |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Pain Knowledge Test % Correct | 80 % questions answered correctly | 80 % questions answered correctly | 75 % questions answered correctly |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 4 Participants | 4 Participants |
| Region of Enrollment United States | 12 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 3 Participants |
| Total # of opioid/opiates prescribed | 0.5 total # of opioid/opiates prescribed | 0 total # of opioid/opiates prescribed | 0.5 total # of opioid/opiates prescribed |
| Total # pain medications | 2 number of medications | 2 number of medications | 2 number of medications |
| Veterans Aging Cohort Study Index | 27 units on a scale | 33 units on a scale | 27 units on a scale |
| Years living with HIV | 24 years | 24 years | 29 years |
| Years on antiretroviral therapy | 23 years | 24 years | 23 years |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Change in Chronic Pain Acceptance Questionnaire (CPAQ) Week 0 to Week 6 | 5 score on a scale |
| Education Control | Change in Chronic Pain Acceptance Questionnaire (CPAQ) Week 0 to Week 6 | 13 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Brief Pain Inventory Interference Subscale | -1.71 score on a scale |
| Education Control | Brief Pain Inventory Interference Subscale | -0.14 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Change in Chronic Pain Acceptance Questionnaire Week 0 to Week 3 | 5.5 change in score from 0 to 6 weeks. |
| Education Control | Change in Chronic Pain Acceptance Questionnaire Week 0 to Week 3 | 13 change in score from 0 to 6 weeks. |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Change in Pain Education Score | 0.05 proportion of correct answers |
| Education Control | Change in Pain Education Score | 0.1 proportion of correct answers |