Trial Outcomes & Findings for Acceptance and Commitment Therapy for Aging People Living With HIV in Chronic Pain (NCT NCT03699020)
NCT ID: 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.
COMPLETED
NA
13 participants
6 weeks
2023-11-18
Participant Flow
All participants were randomized to groups shortly after enrollment.
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
| 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
| 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=99 Participants
|
57 years
n=107 Participants
|
58 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Years living with HIV
|
24 years
n=99 Participants
|
29 years
n=107 Participants
|
24 years
n=206 Participants
|
|
Years on antiretroviral therapy
|
24 years
n=99 Participants
|
23 years
n=107 Participants
|
23 years
n=206 Participants
|
|
Current HIV Viral Load
|
0 HIV copies/mL
n=99 Participants
|
46 HIV copies/mL
n=107 Participants
|
46 HIV copies/mL
n=206 Participants
|
|
Current CD4 T cell count
|
716 cells/m3
n=99 Participants
|
1051 cells/m3
n=107 Participants
|
1051 cells/m3
n=206 Participants
|
|
Veterans Aging Cohort Study Index
|
33 units on a scale
n=99 Participants
|
27 units on a scale
n=107 Participants
|
27 units on a scale
n=206 Participants
|
|
Total # pain medications
|
2 number of medications
n=99 Participants
|
2 number of medications
n=107 Participants
|
2 number of medications
n=206 Participants
|
|
Total # of opioid/opiates prescribed
|
0 total # of opioid/opiates prescribed
n=99 Participants
|
0.5 total # of opioid/opiates prescribed
n=107 Participants
|
0.5 total # of opioid/opiates prescribed
n=206 Participants
|
|
Baseline CPAQ-R Activity Engagement
|
42 units on a scale
n=99 Participants
|
25.5 units on a scale
n=107 Participants
|
34 units on a scale
n=206 Participants
|
|
Baseline CPAQ-R Pain Willingness
|
32 units on a scale
n=99 Participants
|
32 units on a scale
n=107 Participants
|
32 units on a scale
n=206 Participants
|
|
Baseline CPAQ-R (revised) Total Score
|
68 units on a scale
n=99 Participants
|
56 units on a scale
n=107 Participants
|
66 units on a scale
n=206 Participants
|
|
Brief Pain Inventory: Pain Severity (worse)
|
8 units on a scale
n=99 Participants
|
6 units on a scale
n=107 Participants
|
8 units on a scale
n=206 Participants
|
|
Brief Pain Inventory: Pain Severity (average)
|
8 units on a scale
n=99 Participants
|
4.5 units on a scale
n=107 Participants
|
8 units on a scale
n=206 Participants
|
|
Brief Pain Inventory: Pain interference
|
5 units on a scale
n=99 Participants
|
5 units on a scale
n=107 Participants
|
5 units on a scale
n=206 Participants
|
|
Pain Knowledge Test % Correct
|
80 % questions answered correctly
n=99 Participants
|
75 % questions answered correctly
n=107 Participants
|
80 % questions answered correctly
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeksChange 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.
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 weeksChange 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.
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 weeksChange 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
| 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 6Difference from Week 0 to 6 in proportion of pain knowledge questions answered correctly.
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)
Education Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place