Trial Outcomes & Findings for Brief Behavioral Insomnia Treatment Study (NCT NCT02571452)
NCT ID: NCT02571452
Last Updated: 2020-02-07
Results Overview
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) \& Post-treatment (week 5).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate
Results posted on
2020-02-07
Participant Flow
Participants were recruited from 1/6/16 to 8/9/18 through local advertisements, referrals from other research studies or VA clinicians and direct mailings to veterans that had established care at the San Francisco VA (SFVA) or that lived within a 40-mile radius of the SFVA.
A total of 157 people provided consent for screening, 119 completed screening and 93 were eligible, enrolled and randomized to treatment. Of the 93, two were withdrawn during treatment or 6-month follow-up due to no longer meeting eligibility and two were pilot subjects that didn't meet inclusion criteria and weren't included in data analysis.
Participant milestones
| Measure |
Brief Behavioral Treatment for Insomnia
Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
Brief Behavioral Treatment for Insomnia: Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
|
Progressive Muscle Relaxation Training
Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
Progressive Muscle Relaxation: Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
|
|---|---|---|
|
Overall Study Treatment
STARTED
|
47
|
46
|
|
Overall Study Treatment
COMPLETED
|
47
|
45
|
|
Overall Study Treatment
NOT COMPLETED
|
0
|
1
|
|
Overall Study 6-Month Follow-up
STARTED
|
47
|
0
|
|
Overall Study 6-Month Follow-up
COMPLETED
|
42
|
0
|
|
Overall Study 6-Month Follow-up
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Brief Behavioral Treatment for Insomnia
Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
Brief Behavioral Treatment for Insomnia: Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
|
Progressive Muscle Relaxation Training
Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
Progressive Muscle Relaxation: Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
|
|---|---|---|
|
Overall Study Treatment
Protocol Violation
|
0
|
1
|
|
Overall Study 6-Month Follow-up
Lost to Follow-up
|
4
|
0
|
|
Overall Study 6-Month Follow-up
Protocol Violation
|
1
|
0
|
Baseline Characteristics
One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
Baseline characteristics by cohort
| Measure |
Brief Behavioral Treatment for Insomnia
n=47 Participants
Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
Brief Behavioral Treatment for Insomnia: Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
|
Progressive Muscle Relaxation Training
n=46 Participants
Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
Progressive Muscle Relaxation: Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.87 years
STANDARD_DEVIATION 15.66 • n=46 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
49.80 years
STANDARD_DEVIATION 15.46 • n=45 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
49.32 years
STANDARD_DEVIATION 15.48 • n=91 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
|
Sex: Female, Male
Female
|
9 Participants
n=46 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. These two individuals were not included in data analysis. Additionally, these categories exclude 1 transgender participant in the PMRT group, so the numbers below only reflects the individuals that identified as male or female.
|
8 Participants
n=44 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. These two individuals were not included in data analysis. Additionally, these categories exclude 1 transgender participant in the PMRT group, so the numbers below only reflects the individuals that identified as male or female.
|
17 Participants
n=90 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. These two individuals were not included in data analysis. Additionally, these categories exclude 1 transgender participant in the PMRT group, so the numbers below only reflects the individuals that identified as male or female.
|
|
Sex: Female, Male
Male
|
37 Participants
n=46 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. These two individuals were not included in data analysis. Additionally, these categories exclude 1 transgender participant in the PMRT group, so the numbers below only reflects the individuals that identified as male or female.
|
36 Participants
n=44 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. These two individuals were not included in data analysis. Additionally, these categories exclude 1 transgender participant in the PMRT group, so the numbers below only reflects the individuals that identified as male or female.
|
73 Participants
n=90 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. These two individuals were not included in data analysis. Additionally, these categories exclude 1 transgender participant in the PMRT group, so the numbers below only reflects the individuals that identified as male or female.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=46 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
5 Participants
n=45 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
11 Participants
n=91 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=46 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
38 Participants
n=45 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
77 Participants
n=91 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=46 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
2 Participants
n=45 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
3 Participants
n=91 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=46 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
0 Participants
n=45 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
0 Participants
n=91 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=46 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
7 Participants
n=45 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
17 Participants
n=91 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=46 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
2 Participants
n=45 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
3 Participants
n=91 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=46 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
4 Participants
n=45 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
12 Participants
n=91 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
|
Race (NIH/OMB)
White
|
22 Participants
n=46 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
24 Participants
n=45 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
46 Participants
n=91 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=46 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
5 Participants
n=45 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
8 Participants
n=91 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=46 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
3 Participants
n=45 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
5 Participants
n=91 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
|
Region of Enrollment
United States
|
46 participants
n=46 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
45 participants
n=45 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
91 participants
n=91 Participants • One participant in each group was a pilot participant that didn't meet all inclusion criteria. Therefore, these two individuals were not included in data analysis.
|
PRIMARY outcome
Timeframe: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariatePopulation: An intent-to-treat analysis was conducted on all participants that started treatment (91), not including the two pilot participants.
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) \& Post-treatment (week 5).
Outcome measures
| Measure |
Brief Behavioral Treatment for Insomnia
n=46 Participants
Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
Brief Behavioral Treatment for Insomnia: Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
|
Progressive Muscle Relaxation
n=45 Participants
Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
Progressive Muscle Relaxation: Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
|
|---|---|---|
|
Work and Social Adjustment Scale (WSAS)
Baseline
|
20.1 score on a scale
Standard Deviation 9.6
|
19.7 score on a scale
Standard Deviation 8.9
|
|
Work and Social Adjustment Scale (WSAS)
Mid-Treatment
|
14.1 score on a scale
Standard Deviation 9.1
|
15.8 score on a scale
Standard Deviation 9.5
|
|
Work and Social Adjustment Scale (WSAS)
Post-Treatment
|
10.8 score on a scale
Standard Deviation 9.3
|
14.1 score on a scale
Standard Deviation 10.0
|
PRIMARY outcome
Timeframe: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm onlyPopulation: An intent-to-treat analysis was conducted on the 46 participants that completed BBTI treatment. Participants in the PMRT group did not complete the 6-month follow-up assessment and were not included in the analysis.
The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The WSAS was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.
Outcome measures
| Measure |
Brief Behavioral Treatment for Insomnia
n=46 Participants
Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
Brief Behavioral Treatment for Insomnia: Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
|
Progressive Muscle Relaxation
Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
Progressive Muscle Relaxation: Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
|
|---|---|---|
|
Work and Social Adjustment Scale (WSAS)
Post-Treatment
|
10.8 score on a scale
Standard Deviation 9.3
|
—
|
|
Work and Social Adjustment Scale (WSAS)
6-month follow-up
|
11.2 score on a scale
Standard Deviation 10.3
|
—
|
SECONDARY outcome
Timeframe: Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariatePopulation: An intent-to-treat analysis was conducted on all participants that started treatment (91), not including the two pilot participants.
The ISI is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems. Scores range from 0-28, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) \& Post-treatment (week 5).
Outcome measures
| Measure |
Brief Behavioral Treatment for Insomnia
n=46 Participants
Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
Brief Behavioral Treatment for Insomnia: Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
|
Progressive Muscle Relaxation
n=45 Participants
Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
Progressive Muscle Relaxation: Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
|
|---|---|---|
|
Insomnia Severity (ISI)
Baseline
|
17.1 score on a scale
Standard Deviation 3.6
|
17.4 score on a scale
Standard Deviation 4.0
|
|
Insomnia Severity (ISI)
Mid-Treatment
|
10.4 score on a scale
Standard Deviation 4.6
|
14.2 score on a scale
Standard Deviation 4.3
|
|
Insomnia Severity (ISI)
Post-Treatment
|
8.1 score on a scale
Standard Deviation 5.4
|
12.4 score on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Change from Post-treatment to Follow-up (after 6 months)--for treatment arm onlyPopulation: An intent-to-treat analysis was conducted on the 46 participants that completed BBTI treatment. Participants in the PMRT group did not complete the 6-month follow-up assessment and were not included in the analysis.
Insomnia Severity Index (ISI) is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems. Scores range from 0-28, with higher scores meaning greater impairment. The ISI was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.
Outcome measures
| Measure |
Brief Behavioral Treatment for Insomnia
n=46 Participants
Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
Brief Behavioral Treatment for Insomnia: Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
|
Progressive Muscle Relaxation
Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
Progressive Muscle Relaxation: Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
|
|---|---|---|
|
Insomnia Severity (ISI)
Post-Treatment
|
8.1 score on a scale
Standard Deviation 5.4
|
—
|
|
Insomnia Severity (ISI)
6-month follow-up
|
7.5 score on a scale
Standard Deviation 5.7
|
—
|
Adverse Events
Brief Behavioral Treatment for Insomnia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Progressive Muscle Relaxation Training
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