Trial Outcomes & Findings for Implementation of Brief Insomnia Treatments - Clinical Trial (NCT NCT02724800)

NCT ID: NCT02724800

Last Updated: 2020-08-11

Results Overview

Insomnia Severity Index (ISI) 0-28; 0-7 (no symptoms), 8-14 (sub-threshold symptoms), 15-21 (moderately severe), 22-28 (severe) high scores indicate worse outcome/greater severity

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 92 participants
• Primary outcome timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)
• Results posted on: 2020-08-11

Participant Flow

92 participants met initial eligibility criteria and signed informed consent to participate in the study. However, only 63 participants met full criteria to participate and were randomized to a treatment arm.

Participant milestones

Measure	Cognitive Behavioral Therapy for Insomnia (CBTI) Cognitive Behavioral Therapy for Insomnia (CBTI) consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	Brief Behavioral Treatment for Insomnia (BBTI) Brief Behavioral Treatment for Insomnia (BBTI) consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
Overall Study STARTED	32	31
Overall Study COMPLETED	15	22
Overall Study NOT COMPLETED	17	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Implementation of Brief Insomnia Treatments - Clinical Trial

Baseline characteristics by cohort

Measure	Cognitive Behavioral Therapy for Insomnia (CBTI) n=32 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	Brief Behavioral Treatment for Insomnia (BBTI) n=31 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.	Total n=63 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 15.2 • n=5 Participants	56.8 years STANDARD_DEVIATION 13.7 • n=7 Participants	55.1 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	29 Participants n=7 Participants	57 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	1 Participants n=7 Participants	1 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	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	24 Participants n=7 Participants	50 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	31 participants n=7 Participants	63 participants n=5 Participants
Insomnia Severity Index (ISI)	20.6 score on a scale STANDARD_DEVIATION 3.7 • n=5 Participants	19.8 score on a scale STANDARD_DEVIATION 3.5 • n=7 Participants	20.22 score on a scale STANDARD_DEVIATION 3.59 • n=5 Participants
Pittsburgh Sleep Quality Index (PSQI)	12.9 score on a scale STANDARD_DEVIATION 3.5 • n=5 Participants	12.3 score on a scale STANDARD_DEVIATION 4.0 • n=7 Participants	12.6 score on a scale STANDARD_DEVIATION 3.7 • n=5 Participants
Patient Global Impression of Change (PGIC)	1.9 score on a scale STANDARD_DEVIATION 1.3 • n=5 Participants	1.7 score on a scale STANDARD_DEVIATION 1.1 • n=7 Participants	1.8 score on a scale STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)

Population: Participants who completed post-treatment ISI

Insomnia Severity Index (ISI) 0-28; 0-7 (no symptoms), 8-14 (sub-threshold symptoms), 15-21 (moderately severe), 22-28 (severe) high scores indicate worse outcome/greater severity

Outcome measures

Measure	CBTI n=17 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	BBTI n=22 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
Insomnia Severity Index (ISI)	9.6 score on a scale Standard Deviation 4.9	11.0 score on a scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)

Population: Participants who completed post-treatment PHQ-9 (no sleep item)

Patient Health Questionnaire (PHQ-9) 0-27; 0-5 (minimal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate-severe), 21-27 (severe) high scores indicate worse outcome/greater severity

Outcome measures

Measure	CBTI n=17 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	BBTI n=22 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
Patient Health Questionnaire (PHQ-9)	5.1 score on a scale Standard Deviation 4.3	5.1 score on a scale Standard Deviation 4.9

SECONDARY outcome

Timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)

Population: Participants who completed post-treatment GAD-7

Generalized Anxiety Disorder (GAD-7) 0-21; 0-5 (minimal), 6-10 (mild), 11-15 (moderate), 16-21 (severe) high scores indicate worse outcome/greater severity

Outcome measures

Measure	CBTI n=17 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	BBTI n=22 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
Generalized Anxiety Disorder (GAD-7)	5.2 score on a scale Standard Deviation 3.5	5.0 score on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)

Population: Participants who completed post-treatment PCL-5

PTSD Checklist for DSM-5 (PCL-5) 0-76 (sleep item removed), higher scores indicate greater PTSD severity >33, likely PTSD diagnosis

Outcome measures

Measure	CBTI n=17 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	BBTI n=22 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)	14.2 score on a scale Standard Deviation 14.1	14.8 score on a scale Standard Deviation 13.4

SECONDARY outcome

Timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)

Population: Participants who completed post-treatment PROMIS Fatigue

PROMIS Fatigue Scale 33.4 - 76.8 (T-score) The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a participant with a T-score of 50 is equal to the mean and a T-score of 40 is one SD below the mean. Scores less than 50 indicate less fatigue symptoms than an age and gender matched healthy population and scores greater than 50 indicate greater fatigue symptoms than an age and gender matched healthy population.

Outcome measures

Measure	CBTI n=17 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	BBTI n=22 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale	53.4 T-score Standard Deviation 9.3	54.2 T-score Standard Deviation 11.4

SECONDARY outcome

Timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)

Population: Participants who completed post-treatment PROMIS Global Health

PROMIS Global Health Physical Health: 16.2 - 67.7 (T-score) Mental Health: 21.2 - 67.6 (T-score) The T-score re-scales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a participant with a T-score of 50 is equal to the mean and a T-score of 40 is one SD below the mean. Scores less than 50 indicate worse quality of life than an age and gender matched healthy population and scores greater than 50 indicate better quality of life than an age and gender matched healthy population.

Outcome measures

Measure	CBTI n=17 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	BBTI n=22 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Physical Health (post-tx)	41.8 T-score Standard Deviation 8.3	41.4 T-score Standard Deviation 8.1
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Mental Health (post-tx)	45.6 T-score Standard Deviation 8.6	45.8 T-score Standard Deviation 9.2

SECONDARY outcome

Timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)

Population: Participants who completed post-treatment WSAS

Work and Social Adjustment Scale (WSAS) 0-40 higher scores indicate worse functioning

Outcome measures

Measure	CBTI n=17 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	BBTI n=22 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
Work and Social Adjustment Scale (WSAS)	10.8 score on a scale Standard Deviation 9.1	12.5 score on a scale Standard Deviation 10.1

SECONDARY outcome

Timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)

Population: Participants that completed post-treatment PSQI assessment

Pittsburgh Sleep Quality Index (PSQI) 0-21 higher score indicates worse sleep quality, >5 indicates poor quality sleep

Outcome measures

Measure	CBTI n=17 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	BBTI n=22 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
Pittsburgh Sleep Quality Index (PSQI)	6.8 score on a scale Standard Deviation 3.5	8.4 score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)

Population: Participants who completed post-treatment ESS

Epworth Sleepiness Scale (ESS) 0-24 higher score indicates greater sleepiness, >10 indicates excessive daytime sleepiness

Outcome measures

Measure	CBTI n=17 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	BBTI n=22 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
Epworth Sleepiness Scale (ESS)	9.2 score on a scale Standard Deviation 4.7	9.4 score on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)

Population: Participants who completed post-treatment DBAS

Dysfunctional Beliefs and Attitudes About Sleep (DBAS) 0-160 reported as mean score (sum of items answered / 10 for a range 0-16) higher scores indicate greater dysfunctional beliefs and attitudes

Outcome measures

Measure	CBTI n=17 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	BBTI n=22 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
Dysfunctional Beliefs and Attitudes About Sleep (DBAS)	4.6 score on a scale Standard Deviation 1.9	4.4 score on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)

Population: Participants that completed post-treatment PGIC

Patient Global Impression of Change (PGIC) 1-7 higher score indicative of greater subjective improvement

Outcome measures

Measure	CBTI n=17 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	BBTI n=22 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
Patient Global Impression of Change (PGIC)	5.0 score on a scale Standard Deviation 1.6	4.7 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)

Population: Participants who completed post-treatment Sleep Diaries

The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors Sleep Onset Latency (SOL) - lower is better Wake After Sleep Onset (WASO) - lower is better Early Morning Awakenings (EMA) - lower is better Total Wake Time (TWT) - lower is better Total Sleep Time (TST) - higher is better Time in Bed (TIB) - value depends on TWT and TST

Outcome measures

Measure	CBTI n=12 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	BBTI n=9 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
Sleep Diary Sleep Onset Latency (SOL)	23.5 minutes Standard Deviation 22.0	20.8 minutes Standard Deviation 10.9
Sleep Diary Wake After Sleep Onset (WASO)	27.4 minutes Standard Deviation 33.0	18.5 minutes Standard Deviation 15.9
Sleep Diary Early Morning Awakenings (EMA)	10.7 minutes Standard Deviation 14.7	12.8 minutes Standard Deviation 20.2
Sleep Diary Total Wake Time (TWT)	78.9 minutes Standard Deviation 35.2	67.5 minutes Standard Deviation 29.9
Sleep Diary Total Sleep Time (TST)	410.3 minutes Standard Deviation 67.6	381.6 minutes Standard Deviation 60.0
Sleep Diary Time in Bed (TIB)	489.3 minutes Standard Deviation 77.7	449.0 minutes Standard Deviation 37.6

SECONDARY outcome

Timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)

Population: Participants who completed post-treatment Sleep Diaries

The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors Sleep Efficiency (total sleep time [TST] / time in bed [TIB]) x 100 - higher is better

Outcome measures

Measure	CBTI n=12 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	BBTI n=9 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
Sleep Diary - Sleep Efficiency	83.9 percentage of TST / TIB Standard Deviation 6.1	84.6 percentage of TST / TIB Standard Deviation 7.8

SECONDARY outcome

Timeframe: post-treatment (BBTI: week 5; CBTI: week 6-9)

Population: Participants who completed post-treatment Sleep Diaries

The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors Sleep Quality (SQ) 1-5 higher is better

Outcome measures

Measure	CBTI n=12 Participants CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes.	BBTI n=9 Participants BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4.
Sleep Diary - Sleep Quality	3.4 score on a scale Standard Deviation 0.7	2.8 score on a scale Standard Deviation 0.5

Adverse Events

CBTI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BBTI

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

Adam Bramoweth, PhD

VA Pittsburgh Healthcare System

Phone: 412-360-2806

Email: Adam.Bramoweth@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place