Trial Outcomes & Findings for Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study (NCT NCT00515177)
NCT ID: NCT00515177
Last Updated: 2013-03-29
Results Overview
The PSQI is a 19-item self-reported sleep quality measure with scores that range from 0 to 21, where higher scores indicate worse sleep quality. Scores greater than 5 indicate poor sleep.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
30 participants
Primary outcome timeframe
8 weeks and 5 months
Results posted on
2013-03-29
Participant Flow
Participants were recruited through newspaper, radio advertisements and Internet.
Participant milestones
| Measure |
MBSR
A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness.
|
Pharmacotherapy Control Arm
A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.
eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of "as needed" use
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
|
Overall Study
COMPLETED
|
18
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study
Baseline characteristics by cohort
| Measure |
Randomized to MBSR
n=20 Participants
|
Randomized to PCT
n=10 Participants
|
Total
n=30 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
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age Continuous
|
47 years
n=5 Participants
|
53.5 years
n=7 Participants
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
10 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks and 5 monthsPopulation: In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.
The PSQI is a 19-item self-reported sleep quality measure with scores that range from 0 to 21, where higher scores indicate worse sleep quality. Scores greater than 5 indicate poor sleep.
Outcome measures
| Measure |
MBSR
n=18 Participants
A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness.
|
Pharmacotherapy Control Arm
n=9 Participants
A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.
eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of "as needed" use
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
8 weeks
|
7.7 units on a scale
Standard Deviation 3.6
|
9.2 units on a scale
Standard Deviation 2.0
|
|
Pittsburgh Sleep Quality Index (PSQI)
5 months
|
7.0 units on a scale
Standard Deviation 4.6
|
8.2 units on a scale
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: 8 weeks and 5 monthsPopulation: In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.
The Insomnia Severity Index is a 7-item scale that provides a total score indicating current (e.g., last 2 weeks) severity of insomnia symptoms with scores that can range from 0 to 28. Scores of 15 or higher indicate clinical insomnia.
Outcome measures
| Measure |
MBSR
n=18 Participants
A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness.
|
Pharmacotherapy Control Arm
n=9 Participants
A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.
eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of "as needed" use
|
|---|---|---|
|
Insomnia Severity Index
8 week
|
9.6 units on a scale
Standard Deviation 4.2
|
9.1 units on a scale
Standard Deviation 4.6
|
|
Insomnia Severity Index
5 months
|
8.1 units on a scale
Standard Deviation 5.5
|
7.8 units on a scale
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: In the PCT arm, one person who refused to take the drug and one who did not complete actigraphy were excluded. 10-2=8 In the MBSR arm, one person who did not attend MBSR, one person who attended fewer than 5 classes, and two who did not complete actigraphy were excluded. 20-4=16.
Total Sleep Time from Actigraphy
Outcome measures
| Measure |
MBSR
n=16 Participants
A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness.
|
Pharmacotherapy Control Arm
n=8 Participants
A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.
eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of "as needed" use
|
|---|---|---|
|
Actigraphy
|
6.2 hours
Standard Deviation 0.8
|
6.9 hours
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 8 weeks and 5 monthsPopulation: In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.
The STAI is a 20 item scale that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety. The norm for working adults is a score of 34.
Outcome measures
| Measure |
MBSR
n=18 Participants
A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness.
|
Pharmacotherapy Control Arm
n=9 Participants
A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.
eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of "as needed" use
|
|---|---|---|
|
State-Trait Anxiety Inventory (STAI)
8 week
|
32.9 units on a scale
Standard Deviation 12.0
|
31.3 units on a scale
Standard Deviation 14.9
|
|
State-Trait Anxiety Inventory (STAI)
5 months
|
30.1 units on a scale
Standard Deviation 11.8
|
28.3 units on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 8 weeks and 5 monthsPopulation: In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.
The CES-D is a 20-item self-report scale to measure symptoms of depression in the past week with scores having a range of 0 to 60 and a score of 16 or higher indicating clinically relevant symptoms.
Outcome measures
| Measure |
MBSR
n=18 Participants
A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness.
|
Pharmacotherapy Control Arm
n=9 Participants
A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.
eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of "as needed" use
|
|---|---|---|
|
Center for Epidemiological Studies Depression Scale (CES-D)
8 week
|
10.0 units on a scale
Standard Deviation 8.5
|
10.1 units on a scale
Standard Deviation 12.1
|
|
Center for Epidemiological Studies Depression Scale (CES-D)
5 months
|
8.4 units on a scale
Standard Deviation 7.6
|
7.0 units on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 8 weeks and 5 monthsPopulation: In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.
Mental component summary score (MCS) of the SF-12 is a self-reported measure of mental health-related quality of life. Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired mental health quality or function.
Outcome measures
| Measure |
MBSR
n=18 Participants
A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness.
|
Pharmacotherapy Control Arm
n=9 Participants
A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.
eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of "as needed" use
|
|---|---|---|
|
Medical Outcome Study Short Form (SF-12)
8 week
|
48.8 units on a scale
Standard Deviation 8.5
|
48.3 units on a scale
Standard Deviation 12.7
|
|
Medical Outcome Study Short Form (SF-12)
5 months
|
49.7 units on a scale
Standard Deviation 10.1
|
50.1 units on a scale
Standard Deviation 6.7
|
Adverse Events
Pharmacotherapy (Eszopiclone, 3mg)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
MBSR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pharmacotherapy (Eszopiclone, 3mg)
n=10 participants at risk
The PCT control treatment consisted of 3mg eszopiclone nightly for 8 weeks, followed by use as needed for 3 months.
|
MBSR
n=20 participants at risk
Mindfulness-Based Stress Reduction (MBSR) is an 8 week program of yoga and mindfulness training taught by a trained instructor in a group format.
|
|---|---|---|
|
Nervous system disorders
Excessive sleepiness
|
30.0%
3/10 • Number of events 9 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
0.00%
0/20 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
|
General disorders
Headache
|
20.0%
2/10 • Number of events 7 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
0.00%
0/20 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
|
General disorders
Taste disturbance
|
40.0%
4/10 • Number of events 12 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
0.00%
0/20 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • Number of events 3 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
0.00%
0/20 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
|
Gastrointestinal disorders
Reflux
|
10.0%
1/10 • Number of events 2 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
0.00%
0/20 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
0.00%
0/20 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
|
Renal and urinary disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
0.00%
0/20 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
|
Nervous system disorders
Strange dreams
|
10.0%
1/10 • Number of events 1 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
0.00%
0/20 • Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).
Participants in the PCT (pharmacotherapy) arm received scheduled phone calls and were asked if they had experienced common known side-effects of their medication (e.g. headache, nausea/vomiting, excessive sleepiness, taste disturbance) or health problem since the last call. MBSR participants were also called weekly \& asked how there health was.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place