Trial Outcomes & Findings for Treatment of Insomnia Secondary to Chronic Pain (NCT NCT00127790)
NCT ID: NCT00127790
Last Updated: 2012-10-17
Results Overview
Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Pre to Post Treatment Change (Over an average of approximately 10 weeks)
Results posted on
2012-10-17
Participant Flow
Men and women aged 35-75 experiencing chronic pain and insomnia were recruited from the community through newspaper advertisements and from local pain clinics via recruitment flyers.
Participants completed intake interview, physical exam, clinical chemistries and toxicology screens; completed daily pain-sleep diaries for two weeks; and then underwent polysomnography. Seven subjects were excluded prior to randomization (4 due to sleep apnea, 1 did not meet pain severity criteria, and 2 subsequently declined to participate).
Participant milestones
| Measure |
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
|
Cognitive-Behavioral Therapy for Pain (CBT-P)
Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
|
Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)
Cognitive-Behavioral Therapy for Insomnia \& Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
|
Wait-List Control (WL)
Waitlist Control condition (WL) with no contact during the intervention period.
|
|---|---|---|---|---|
|
Pre-Treatment
STARTED
|
6
|
5
|
6
|
4
|
|
Pre-Treatment
COMPLETED
|
6
|
5
|
6
|
4
|
|
Pre-Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Post-Treatment
STARTED
|
6
|
5
|
6
|
4
|
|
Post-Treatment
COMPLETED
|
6
|
5
|
6
|
4
|
|
Post-Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Insomnia Secondary to Chronic Pain
Baseline characteristics by cohort
| Measure |
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
n=6 Participants
Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
|
Cognitive-Behavioral Therapy for Pain (CBT-P)
n=5 Participants
Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
|
Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)
n=6 Participants
Cognitive-Behavioral Therapy for Insomnia \& Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
|
Wait-List Control (WL)
n=4 Participants
Waitlist Control condition (WL) with no contact during the intervention period.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age Continuous
|
45.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
50.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 1.0 • n=4 Participants
|
50.7 years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
4 participants
n=4 Participants
|
21 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre to Post Treatment Change (Over an average of approximately 10 weeks)Population: completed the intervention and self report instruments
Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
n=6 Participants
Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
|
Cognitive-Behavioral Therapy for Pain (CBT-P)
n=5 Participants
Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
|
Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)
n=6 Participants
Cognitive-Behavioral Therapy for Insomnia \& Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
|
Wait-List Control (WL)
n=4 Participants
Waitlist Control condition (WL) with no contact during the intervention period.
|
|---|---|---|---|---|
|
Insomnia Severity
|
6.0 units on a scale
Standard Error 1.9
|
12.8 units on a scale
Standard Error 1.1
|
4.4 units on a scale
Standard Error 1.0
|
13.0 units on a scale
Standard Error 1.7
|
PRIMARY outcome
Timeframe: Pre to Post Treatment Change (Over an average of approximately 10 weeks)Multidimensional Pain Inventory - Pain Severity SubScale score. The subscale consists of 3 items with a total subscale score ranging from 0-18 with higher values indicating greater pain severity.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
n=6 Participants
Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
|
Cognitive-Behavioral Therapy for Pain (CBT-P)
n=5 Participants
Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
|
Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)
n=6 Participants
Cognitive-Behavioral Therapy for Insomnia \& Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
|
Wait-List Control (WL)
n=4 Participants
Waitlist Control condition (WL) with no contact during the intervention period.
|
|---|---|---|---|---|
|
Pain Severity
|
11.0 units on a scale
Standard Error 2.3
|
6.2 units on a scale
Standard Error 1.7
|
8.8 units on a scale
Standard Error 1.9
|
7.5 units on a scale
Standard Error 1.0
|
PRIMARY outcome
Timeframe: Pre to Post Treatment Change (Over an average of approximately 10 weeks)Population: Subjects completing blood draws to obtain plasma. One subject in the CBT-I\&P condition did not complete blood draws.
Circulating levels of Interleukin-6 (IL-6)from plasma drawn in the morning. Values are presented as picograms per milliliter (pg/mL) and can range from 0 to 500, though tend to be in the range of 0-10. Higher values indicate higher amounts of circulating levels of IL-6, a marker of increased inflammatory processes.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
n=6 Participants
Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
|
Cognitive-Behavioral Therapy for Pain (CBT-P)
n=5 Participants
Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
|
Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)
n=5 Participants
Cognitive-Behavioral Therapy for Insomnia \& Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
|
Wait-List Control (WL)
n=4 Participants
Waitlist Control condition (WL) with no contact during the intervention period.
|
|---|---|---|---|---|
|
IL-6
|
0.7 pg/mL
Standard Error 0.2
|
1.6 pg/mL
Standard Error 1.0
|
1.2 pg/mL
Standard Error 0.2
|
1.2 pg/mL
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)Population: participants who completed intervention and pre and post treatment assessments
Total score from the 20-item Center for Epidemiologic Studies Depression Scale-revised where the total score ranges from 0-60 and higher scores indicate greater depression severity.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
n=6 Participants
Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
|
Cognitive-Behavioral Therapy for Pain (CBT-P)
n=5 Participants
Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
|
Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)
n=5 Participants
Cognitive-Behavioral Therapy for Insomnia \& Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
|
Wait-List Control (WL)
n=4 Participants
Waitlist Control condition (WL) with no contact during the intervention period.
|
|---|---|---|---|---|
|
Depression Severity
|
2.3 units on a scale
Standard Error 1.9
|
10.2 units on a scale
Standard Error 2.9
|
4.4 units on a scale
Standard Error 1.8
|
17.6 units on a scale
Standard Error 1.2
|
Adverse Events
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive-Behavioral Therapy for Pain (CBT-P)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait-List Control (WL)
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