Trial Outcomes & Findings for Telephone Cognitive Behavior Therapy for OEF Veterans With Pain (NCT NCT01236196)
NCT ID: NCT01236196
Last Updated: 2014-12-23
Results Overview
Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Baseline, 46 weeks
Results posted on
2014-12-23
Participant Flow
41 veterans were enrolled, but 2 dropped out before being randomized to treatment condition and did not receive either treatment.
Participant milestones
| Measure |
Arm 1 - Telephone CBT
Telephone cognitive behavior therapy for pain management
Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period).
|
Arm 2 - Telephone Education
Telephone pain education
Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period).
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
21
|
|
Overall Study
COMPLETED
|
17
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telephone Cognitive Behavior Therapy for OEF Veterans With Pain
Baseline characteristics by cohort
| Measure |
Arm 1 - Telephone CBT
n=18 Participants
Telephone cognitive behavior therapy for pain management
Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period).
|
Arm 2 - Telephone Education
n=21 Participants
Telephone pain education
Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period).
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 11 • n=5 Participants
|
34 years
STANDARD_DEVIATION 10 • n=7 Participants
|
35 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
21 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Marital status
Married
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Marital status
Not married
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Education
|
15 years
STANDARD_DEVIATION 2 • n=5 Participants
|
15 years
STANDARD_DEVIATION 2 • n=7 Participants
|
15 years
STANDARD_DEVIATION 2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 46 weeksPopulation: OEF/OIF/OND military veterans with chronic pain
Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning
Outcome measures
| Measure |
Arm 1 - Telephone CBT
n=18 Participants
Telephone cognitive behavior therapy for pain management
Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period).
|
Arm 2 - Telephone Education
n=21 Participants
Telephone pain education
Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period).
|
|---|---|---|
|
Level of Functioning
46 weeks
|
47 units on a scale
Standard Deviation 11
|
37 units on a scale
Standard Deviation 12
|
|
Level of Functioning
Baseline
|
41 units on a scale
Standard Deviation 12
|
36 units on a scale
Standard Deviation 9
|
PRIMARY outcome
Timeframe: Baseline, 46 weeksPopulation: OEF/OIF/OND military veterans with chronic pain
Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63)
Outcome measures
| Measure |
Arm 1 - Telephone CBT
n=18 Participants
Telephone cognitive behavior therapy for pain management
Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period).
|
Arm 2 - Telephone Education
n=21 Participants
Telephone pain education
Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period).
|
|---|---|---|
|
Depressive Symptoms
46 weeks
|
12 units on a scale
Standard Deviation 11
|
12 units on a scale
Standard Deviation 10
|
|
Depressive Symptoms
Baseline
|
13 units on a scale
Standard Deviation 8
|
18 units on a scale
Standard Deviation 13
|
PRIMARY outcome
Timeframe: Baseline, 46 weeksPopulation: OEF/OIF/OND military veterans with chronic pain
Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior
Outcome measures
| Measure |
Arm 1 - Telephone CBT
n=18 Participants
Telephone cognitive behavior therapy for pain management
Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period).
|
Arm 2 - Telephone Education
n=21 Participants
Telephone pain education
Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period).
|
|---|---|---|
|
Pain Behavior
46 weeks
|
1.0 units on a scale
Standard Deviation 1.0
|
2.1 units on a scale
Standard Deviation 1.4
|
|
Pain Behavior
Baseline
|
1.2 units on a scale
Standard Deviation 1
|
2.4 units on a scale
Standard Deviation 1
|
PRIMARY outcome
Timeframe: Baseline, 46 weeksPopulation: OEF/OIF/OND military veterans with chronic pain
Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity
Outcome measures
| Measure |
Arm 1 - Telephone CBT
n=18 Participants
Telephone cognitive behavior therapy for pain management
Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period).
|
Arm 2 - Telephone Education
n=21 Participants
Telephone pain education
Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period).
|
|---|---|---|
|
Pain Intensity
46 weeks
|
3.1 units on a scale
Standard Deviation 2.2
|
4.8 units on a scale
Standard Deviation 2.6
|
|
Pain Intensity
Baseline
|
3.2 units on a scale
Standard Deviation 1.9
|
5.6 units on a scale
Standard Deviation 2.3
|
Adverse Events
Arm 1 - Telephone CBT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2 - Telephone Education
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