Trial Outcomes & Findings for Behavioral Treatments for Chronic Pain (NCT NCT00371865)
NCT ID: NCT00371865
Last Updated: 2015-04-10
Results Overview
This questionnaire measures pain severity and interference. Scores range from 0-10, with higher scores indicating more pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
12 weeks (post treatment)
Results posted on
2015-04-10
Participant Flow
Participant milestones
| Measure |
Cognitive Behavioral Therapy
8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving
|
Acceptance-Based Therapy
8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
|
Overall Study
COMPLETED
|
42
|
43
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
Reasons for withdrawal
| Measure |
Cognitive Behavioral Therapy
8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving
|
Acceptance-Based Therapy
8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
12
|
10
|
Baseline Characteristics
Behavioral Treatments for Chronic Pain
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy
n=57 Participants
8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving
|
Acceptance-Based Therapy
n=57 Participants
8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 12.5 • n=93 Participants
|
54.9 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
54.9 years
STANDARD_DEVIATION 12.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
NonHispanic white
|
38 participants
n=93 Participants
|
39 participants
n=4 Participants
|
77 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
19 participants
n=93 Participants
|
18 participants
n=4 Participants
|
37 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=93 Participants
|
57 participants
n=4 Participants
|
114 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (post treatment)This questionnaire measures pain severity and interference. Scores range from 0-10, with higher scores indicating more pain.
Outcome measures
| Measure |
Arm 1
n=57 Participants
8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving
|
Arm 2
n=57 Participants
8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action
|
|---|---|---|
|
Brief Pain Inventory
|
4.5 units on a scale
Standard Deviation 2.7
|
5.1 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 12 weeks (post treatment)This questionnaire measures levels of activity that can be affected by pain. Full measure has a range of 0-6, with higher scores indicating higher levels of activity.
Outcome measures
| Measure |
Arm 1
n=57 Participants
8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving
|
Arm 2
n=57 Participants
8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action
|
|---|---|---|
|
West Haven-Yale Multidimensional Pain Inventory - Activity Subscales
|
2.3 units on a scale
Standard Deviation 0.8
|
2.0 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 12 weeks (post treatment)This questionnaire measures quality of life. Scores range from 0 to 100, with higher scores indicating better quality of life.
Outcome measures
| Measure |
Arm 1
n=57 Participants
8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving
|
Arm 2
n=57 Participants
8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action
|
|---|---|---|
|
SF-12
|
44.9 units on a scale
Standard Deviation 12.1
|
41.0 units on a scale
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: 12 weeks (post treatment)This questionnaire measures depressive symptoms. Scores range from 0 to 63, with higher scores indicating higher levels of depressive symptoms.
Outcome measures
| Measure |
Arm 1
n=57 Participants
8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving
|
Arm 2
n=57 Participants
8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action
|
|---|---|---|
|
Beck Depression Inventory
|
13.2 units on a scale
Standard Deviation 11.1
|
17.8 units on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 12 weeks (post treatment)This questionnaire measures pain-related anxiety. Scores range from 0 to 100, with higher scores indicating higher levels of anxiety.
Outcome measures
| Measure |
Arm 1
n=57 Participants
8 group-administered sessions of Cognitive-Behavioral Therapy
Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving
|
Arm 2
n=57 Participants
8 group-administered sessions of Acceptance-based therapy
Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action
|
|---|---|---|
|
Pain Anxiety Symptom Scale - 20
|
37.9 units on a scale
Standard Deviation 20.7
|
41.5 units on a scale
Standard Deviation 23.4
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place