Trial Outcomes & Findings for Acceptance and Commitment Therapy for Aging People Living With HIV in Chronic Pain (NCT NCT03699020)

Last Updated: 2023-11-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

6 weeks

Results posted on

2023-11-18

Participant Flow

All participants were randomized to groups shortly after enrollment.

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	7	5
Overall Study Intervention Attendance Completion	4	3
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acceptance and Commitment Therapy (ACT) n=7 Participants 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.	Education Control n=5 Participants 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	Total n=12 Participants Total of all reporting groups
Age, Continuous	58 years n=5 Participants	57 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Years living with HIV	24 years n=5 Participants	29 years n=7 Participants	24 years n=5 Participants
Years on antiretroviral therapy	24 years n=5 Participants	23 years n=7 Participants	23 years n=5 Participants
Current HIV Viral Load	0 HIV copies/mL n=5 Participants	46 HIV copies/mL n=7 Participants	46 HIV copies/mL n=5 Participants
Current CD4 T cell count	716 cells/m3 n=5 Participants	1051 cells/m3 n=7 Participants	1051 cells/m3 n=5 Participants
Veterans Aging Cohort Study Index	33 units on a scale n=5 Participants	27 units on a scale n=7 Participants	27 units on a scale n=5 Participants
Total # pain medications	2 number of medications n=5 Participants	2 number of medications n=7 Participants	2 number of medications n=5 Participants
Total # of opioid/opiates prescribed	0 total # of opioid/opiates prescribed n=5 Participants	0.5 total # of opioid/opiates prescribed n=7 Participants	0.5 total # of opioid/opiates prescribed n=5 Participants
Baseline CPAQ-R Activity Engagement	42 units on a scale n=5 Participants	25.5 units on a scale n=7 Participants	34 units on a scale n=5 Participants
Baseline CPAQ-R Pain Willingness	32 units on a scale n=5 Participants	32 units on a scale n=7 Participants	32 units on a scale n=5 Participants
Baseline CPAQ-R (revised) Total Score	68 units on a scale n=5 Participants	56 units on a scale n=7 Participants	66 units on a scale n=5 Participants
Brief Pain Inventory: Pain Severity (worse)	8 units on a scale n=5 Participants	6 units on a scale n=7 Participants	8 units on a scale n=5 Participants
Brief Pain Inventory: Pain Severity (average)	8 units on a scale n=5 Participants	4.5 units on a scale n=7 Participants	8 units on a scale n=5 Participants
Brief Pain Inventory: Pain interference	5 units on a scale n=5 Participants	5 units on a scale n=7 Participants	5 units on a scale n=5 Participants
Pain Knowledge Test % Correct	80 % questions answered correctly n=5 Participants	75 % questions answered correctly n=7 Participants	80 % questions answered correctly n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Acceptance and Commitment Therapy (ACT) n=4 Participants The intervention will consists of six 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.	Education Control n=3 Participants Consists of six 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
Change in Chronic Pain Acceptance Questionnaire (CPAQ) Week 0 to Week 6	5 score on a scale Interval 2.5 to 7.0	13 score on a scale Interval 6.0 to 29.0

SECONDARY outcome

Timeframe: 3 weeks

Outcome measures

Outcome measures
Measure	Acceptance and Commitment Therapy (ACT) n=4 Participants The intervention will consists of six 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.	Education Control n=3 Participants Consists of six 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
Change in Chronic Pain Acceptance Questionnaire Week 0 to Week 3	5.5 change in score from 0 to 6 weeks. Interval 4.75 to 6.25	13 change in score from 0 to 6 weeks. Interval 5.0 to 21.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Acceptance and Commitment Therapy (ACT) n=4 Participants The intervention will consists of six 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.	Education Control n=3 Participants Consists of six 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
Brief Pain Inventory Interference Subscale	-1.71 score on a scale Interval -2.57 to -0.86	-0.14 score on a scale Interval -1.21 to 0.21

SECONDARY outcome

Timeframe: Week 0 to Week 6

Difference from Week 0 to 6 in proportion of pain knowledge questions answered correctly.

Outcome measures

Outcome measures
Measure	Acceptance and Commitment Therapy (ACT) n=4 Participants The intervention will consists of six 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.	Education Control n=3 Participants Consists of six 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
Change in Pain Education Score	0.05 proportion of correct answers Interval -0.075 to 0.175	0.1 proportion of correct answers Interval 0.1 to 0.2

Adverse Events

Acceptance and Commitment Therapy (ACT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Education Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maile Young Karris

University of California San Diego

Phone: 1-619-543-5039

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place