iBIT: Implementation of Brief Insomnia Treatments - Clinical Trial

• Sponsor: VA Pittsburgh Healthcare System (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02724800
• Collaborator: VA Office of Research and Development (U.S. Fed)
• Enrollment: 92
• Location: 1
• Arms: 2
• Actual Duration (Months): 47
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The purpose of this study is to directly compare the effectiveness of two interventions for insomnia: Brief Behavioral Treatment for Insomnia (BBTI) vs. Cognitive Behavioral Therapy for Insomnia (CBTI).

Condition or Disease	Intervention/Treatment	Phase
Chronic Insomnia	Behavioral: CBTI; Behavioral: BBTI	N/A

Detailed Description

Cognitive Behavioral Therapy for Insomnia (CBTI) is the evidence-based first line treatment for chronic insomnia. Randomized controlled trials and meta-analyses have established that CBTI is efficacious and effective. Despite the strong evidence for CBTI, chronic insomnia remains under-treated among Veterans because of several barriers that limit access to behavioral treatments. In recent years, the VA has taken substantial measures to train more clinicians to provide insomnia treatment; however, a deficit in treatment availability remains. In 2011, the VA began to train clinicians in CBTI as part of the VA's Evidence Based Psychotherapy (EBP) training program, with a goal to train 1000 clinicians. Even with 1000 VA clinicians trained in CBTI, a shortage of clinicians will likely remain due to the high prevalence of insomnia. High prevalence and a shortage of clinicians prevent the VA from meeting the care demand of Veterans with insomnia. While the CBTI roll-out is a significant investment from the VA, additional mechanisms, such as dissemination and implementation of other evidence-based treatments for insomnia with fewer implementation barriers, must be considered to address the high prevalence of insomnia.

The in-person delivery and length of treatment for CBTI may be one of barriers to accessing care. Briefer protocols that use multiple delivery modalities have recently been developed and may help to increase session attendance and treatment completion. These shorter insomnia treatments are often referred to as Brief Behavioral Treatment for Insomnia (BBTI) and consist of ≤4 sessions. Besides fewer and briefer sessions, and utilizing both in-person and phone delivery of treatment, BBTI also emphasizes the behavioral components of CBTI (i.e., stimulus control and sleep restriction) rather than a combined approach focusing on both behavioral and cognitive components. BBTI is efficacious in adults-studies with older adults and Veterans found BBTI resulted in a significant decrease in insomnia severity with Cohen's d effect sizes in the moderate to large range. Like CBTI, BBTI significantly improves insomnia severity and may also help to improve secondary outcomes like depression and anxiety.

Integration of newer insomnia treatments, like BBTI, will first depend on establishing its evidence directly compared to CBTI. Effectiveness trials of BBTI, especially those conducted with military Veterans in typical VA settings, have yet to be conducted. Before BBTI can be broadly implemented and integrated into the VA, it needs to be established as a clinically effective treatment for insomnia among Veterans and a statistically non-inferior treatment (not necessarily better or worse) for Veterans compared to CBTI.

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Mar 1, 2019
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CBTI CBTI consists of five in-person sessions within an eight week period. Topics covered include: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene.	Behavioral: CBTI; 28 Veterans with chronic insomnia will be randomized to CBTI. The intervention will be delivered in 5 face-to-face session within an 8 week time period. The intervention will be delivered at the VA Pittsburgh Healthcare System. Treatment visits will last approximately 45 minutes.; Other Names: Cognitive Behavioral Therapy for Insomnia
Active Comparator: BBTI BBTI consists of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered include: sleep education, stimulus control, and sleep restriction.	Behavioral: BBTI; 28 Veterans with chronic insomnia will be randomized to BBTI. The intervention will be delivered over 4 consecutive weeks, which include individual face-to-face visits on Weeks 1 and 3 (option for telephone), and telephone appointments on Weeks 2 and 4. Interventions will be delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit is approximately 45-minutes, and the follow-up visit on Week 3 will last no more than 30 minutes. Brief (<20 minutes) telephone sessions will be conducted on Weeks 2 and 4.; Other Names: Brief Behavioral Treatment for Insomnia

Outcome Measures

Primary Outcome Measures

1. Insomnia Severity Index (ISI) [post-treatment (BBTI: week 5; CBTI: week 6-9)]

   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

Secondary Outcome Measures

1. Patient Health Questionnaire (PHQ-9) [post-treatment (BBTI: week 5; CBTI: week 6-9)]

   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

2. Generalized Anxiety Disorder (GAD-7) [post-treatment (BBTI: week 5; CBTI: week 6-9)]

   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

3. PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) [post-treatment (BBTI: week 5; CBTI: week 6-9)]

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

4. Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale [post-treatment (BBTI: week 5; CBTI: week 6-9)]

   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.

5. Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health [post-treatment (BBTI: week 5; CBTI: week 6-9)]

   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.

6. Work and Social Adjustment Scale (WSAS) [post-treatment (BBTI: week 5; CBTI: week 6-9)]

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

7. Pittsburgh Sleep Quality Index (PSQI) [post-treatment (BBTI: week 5; CBTI: week 6-9)]

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

8. Epworth Sleepiness Scale (ESS) [post-treatment (BBTI: week 5; CBTI: week 6-9)]

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

9. Dysfunctional Beliefs and Attitudes About Sleep (DBAS) [post-treatment (BBTI: week 5; CBTI: week 6-9)]

   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

10. Patient Global Impression of Change (PGIC) [post-treatment (BBTI: week 5; CBTI: week 6-9)]

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

11. Sleep Diary [post-treatment (BBTI: week 5; CBTI: week 6-9)]

    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

12. Sleep Diary - Sleep Efficiency [post-treatment (BBTI: week 5; CBTI: week 6-9)]

    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

13. Sleep Diary - Sleep Quality [post-treatment (BBTI: week 5; CBTI: week 6-9)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age 18 years old and older

2. Military Veteran

3. Insomnia Severity Index (ISI) ≥15 & Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for insomnia disorder

4. If using sleep medications, medication and dosage have not been changed in the past month, and will remain unchanged for the duration of the treatment phase of the study (i.e., 4-8 weeks)

5. If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the treatment phase of the study (i.e., 4-8 weeks)

Exclusion Criteria:

1. Untreated, current, and severe PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID)

2. Untreated, current, and severe Major Depressive Disorder as determined by the SCID

3. Current/Past Psychotic or Bipolar disorder

4. Current substance or alcohol use disorder as determined by the SCID

5. Current unstable medical condition

6. Hospitalization in the previous 1 month for a medical condition or surgery for which recovery overlaps with the study onset and duration

7. Seizure disorder, open skull brain injury, or moderate to severe traumatic brain injury (TBI)

8. Current, untreated, sleep disorders such as nightmare disorder, restless legs syndrome, circadian rhythm disorder (or shift work), or a suspected sleep disorder requiring polysomnographic assessment, such as obstructive sleep apnea or periodic leg movements as determined by the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR) Clinical Interview for DSM-5 Sleep-Wake Disorders and/or the STOP-BANG questionnaire

9. Moderate to severe cognitive impairment (St. Louis University Mental Status [SLUMS] exam ≤20) and/or diagnosis in medical record indicative of moderate to severe cognitive impairment

10. Unstable environment that is not in one's control (e.g., homeless, temporary group home, care taking duties at night)

11. Pregnancy and/or breast-feeding

STOP-BANG is not a true acronym but indicates the symptoms each item assess:

• S-snores T-tired/sleepy O-observed apneas P-high blood pressure

• B-body mass index A-age N-neck circumference G-gender

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania	United States	15240

Sponsors and Collaborators

• VA Pittsburgh Healthcare System
• VA Office of Research and Development

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - Jul 31, 2018
• Study Protocol and Statistical Analysis Plan - Jul 29, 2019

More Information

Publications

None provided.

• Responsible Party: Adam Bramoweth, Research Health Scientist, VA Pittsburgh Healthcare System
• ClinicalTrials.gov Identifier: NCT02724800
• Other Study ID Numbers: Pro00001553; 1IK2HX001548-01A2
• First Posted: Mar 31, 2016
• Last Update Posted: Aug 11, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Adam Bramoweth, Research Health Scientist, VA Pittsburgh Healthcare System: Insomnia; Veterans; Cognitive Behavioral Therapy for Insomnia; Brief Behavioral Treatment for Insomnia; Comparative Effectiveness Research
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Cognitive Behavioral Therapy for Insomnia (CBTI)	Brief Behavioral Treatment for Insomnia (BBTI)
Arm/Group Description	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) 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.
Period Title: Overall Study
STARTED	32	31
COMPLETED	15	22
NOT COMPLETED	17	9

Baseline Characteristics

Arm/Group Title	Cognitive Behavioral Therapy for Insomnia (CBTI)	Brief Behavioral Treatment for Insomnia (BBTI)	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	32	31	63
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.4 (15.2)	56.8 (13.7)	55.1 (14.4)
Sex: Female, Male (Count of Participants)
Female	4 12.5%	2 6.5%	6 9.5%
Male	28 87.5%	29 93.5%	57 90.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 3.2%	1 1.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 15.6%	6 19.4%	11 17.5%
White	26 81.3%	24 77.4%	50 79.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 3.1%	0 0%	1 1.6%
Region of Enrollment (participants) [Number]
United States	32 100%	31 100%	63 100%
Insomnia Severity Index (ISI) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	20.6 (3.7)	19.8 (3.5)	20.22 (3.59)
Pittsburgh Sleep Quality Index (PSQI) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	12.9 (3.5)	12.3 (4.0)	12.6 (3.7)
Patient Global Impression of Change (PGIC) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	1.9 (1.3)	1.7 (1.1)	1.8 (1.2)

Outcome Measures

1. Primary Outcome

Title	Insomnia Severity Index (ISI)
Description	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
Time Frame	post-treatment (BBTI: week 5; CBTI: week 6-9)

Outcome Measure Data

Analysis Population Description

Participants who completed post-treatment ISI

Arm/Group Title	CBTI	BBTI
Arm/Group Description	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 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.
Measure Participants	17	22
Mean (Standard Deviation) [score on a scale]	9.6 (4.9)	11.0 (6.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CBTI, BBTI
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	non-inferiority margin = 3.43
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	a priori
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.2
	Confidence Interval	(2-Sided) 95%; -0.9 to 5.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Patient Health Questionnaire (PHQ-9)
Description	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
Time Frame	post-treatment (BBTI: week 5; CBTI: week 6-9)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CBTI	BBTI
Arm/Group Description	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 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.
Measure Participants	17	22
Mean (Standard Deviation) [score on a scale]	5.1 (4.3)	5.1 (4.9)

3. Secondary Outcome

Title	Generalized Anxiety Disorder (GAD-7)
Description	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
Time Frame	post-treatment (BBTI: week 5; CBTI: week 6-9)

Outcome Measure Data

Analysis Population Description

Participants who completed post-treatment GAD-7

Arm/Group Title	CBTI	BBTI
Arm/Group Description	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 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.
Measure Participants	17	22
Mean (Standard Deviation) [score on a scale]	5.2 (3.5)	5.0 (4.7)

4. Secondary Outcome

Title	PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
Description	PTSD Checklist for DSM-5 (PCL-5) 0-76 (sleep item removed), higher scores indicate greater PTSD severity >33, likely PTSD diagnosis
Time Frame	post-treatment (BBTI: week 5; CBTI: week 6-9)

Outcome Measure Data

Analysis Population Description

Participants who completed post-treatment PCL-5

Arm/Group Title	CBTI	BBTI
Arm/Group Description	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 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.
Measure Participants	17	22
Mean (Standard Deviation) [score on a scale]	14.2 (14.1)	14.8 (13.4)

5. Secondary Outcome

Title	Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
Description	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.
Time Frame	post-treatment (BBTI: week 5; CBTI: week 6-9)

Outcome Measure Data

Analysis Population Description

Participants who completed post-treatment PROMIS Fatigue

Arm/Group Title	CBTI	BBTI
Arm/Group Description	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 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.
Measure Participants	17	22
Mean (Standard Deviation) [T-score]	53.4 (9.3)	54.2 (11.4)

6. Secondary Outcome

Title	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Description	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.
Time Frame	post-treatment (BBTI: week 5; CBTI: week 6-9)

Outcome Measure Data

Analysis Population Description

Participants who completed post-treatment PROMIS Global Health

Arm/Group Title	CBTI	BBTI
Arm/Group Description	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 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.
Measure Participants	17	22
Physical Health (post-tx)	41.8 (8.3)	41.4 (8.1)
Mental Health (post-tx)	45.6 (8.6)	45.8 (9.2)

7. Secondary Outcome

Title	Work and Social Adjustment Scale (WSAS)
Description	Work and Social Adjustment Scale (WSAS) 0-40 higher scores indicate worse functioning
Time Frame	post-treatment (BBTI: week 5; CBTI: week 6-9)

Outcome Measure Data

Analysis Population Description

Participants who completed post-treatment WSAS

Arm/Group Title	CBTI	BBTI
Arm/Group Description	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 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.
Measure Participants	17	22
Mean (Standard Deviation) [score on a scale]	10.8 (9.1)	12.5 (10.1)

8. Secondary Outcome

Title	Pittsburgh Sleep Quality Index (PSQI)
Description	Pittsburgh Sleep Quality Index (PSQI) 0-21 higher score indicates worse sleep quality, >5 indicates poor quality sleep
Time Frame	post-treatment (BBTI: week 5; CBTI: week 6-9)

Outcome Measure Data

Analysis Population Description

Participants that completed post-treatment PSQI assessment

Arm/Group Title	CBTI	BBTI
Arm/Group Description	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 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.
Measure Participants	17	22
Mean (Standard Deviation) [score on a scale]	6.8 (3.5)	8.4 (4.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CBTI, BBTI
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.3
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Epworth Sleepiness Scale (ESS)
Description	Epworth Sleepiness Scale (ESS) 0-24 higher score indicates greater sleepiness, >10 indicates excessive daytime sleepiness
Time Frame	post-treatment (BBTI: week 5; CBTI: week 6-9)

Outcome Measure Data

Analysis Population Description

Participants who completed post-treatment ESS

Arm/Group Title	CBTI	BBTI
Arm/Group Description	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 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.
Measure Participants	17	22
Mean (Standard Deviation) [score on a scale]	9.2 (4.7)	9.4 (5.0)

10. Secondary Outcome

Title	Dysfunctional Beliefs and Attitudes About Sleep (DBAS)
Description	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
Time Frame	post-treatment (BBTI: week 5; CBTI: week 6-9)

Outcome Measure Data

Analysis Population Description

Participants who completed post-treatment DBAS

Arm/Group Title	CBTI	BBTI
Arm/Group Description	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 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.
Measure Participants	17	22
Mean (Standard Deviation) [score on a scale]	4.6 (1.9)	4.4 (1.6)

11. Secondary Outcome

Title	Patient Global Impression of Change (PGIC)
Description	Patient Global Impression of Change (PGIC) 1-7 higher score indicative of greater subjective improvement
Time Frame	post-treatment (BBTI: week 5; CBTI: week 6-9)

Outcome Measure Data

Analysis Population Description

Participants that completed post-treatment PGIC

Arm/Group Title	CBTI	BBTI
Arm/Group Description	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 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.
Measure Participants	17	22
Mean (Standard Deviation) [score on a scale]	5.0 (1.6)	4.7 (1.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CBTI, BBTI
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.3
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Sleep Diary
Description	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
Time Frame	post-treatment (BBTI: week 5; CBTI: week 6-9)

Outcome Measure Data

Analysis Population Description

Participants who completed post-treatment Sleep Diaries

Arm/Group Title	CBTI	BBTI
Arm/Group Description	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 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.
Measure Participants	12	9
Sleep Onset Latency (SOL)	23.5 (22.0)	20.8 (10.9)
Wake After Sleep Onset (WASO)	27.4 (33.0)	18.5 (15.9)
Early Morning Awakenings (EMA)	10.7 (14.7)	12.8 (20.2)
Total Wake Time (TWT)	78.9 (35.2)	67.5 (29.9)
Total Sleep Time (TST)	410.3 (67.6)	381.6 (60.0)
Time in Bed (TIB)	489.3 (77.7)	449.0 (37.6)

13. Secondary Outcome

Title	Sleep Diary - Sleep Efficiency
Description	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
Time Frame	post-treatment (BBTI: week 5; CBTI: week 6-9)

Outcome Measure Data

Analysis Population Description

Participants who completed post-treatment Sleep Diaries

Arm/Group Title	CBTI	BBTI
Arm/Group Description	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 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.
Measure Participants	12	9
Mean (Standard Deviation) [percentage of TST / TIB]	83.9 (6.1)	84.6 (7.8)

14. Secondary Outcome

Title	Sleep Diary - Sleep Quality
Description	The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors Sleep Quality (SQ) 1-5 higher is better
Time Frame	post-treatment (BBTI: week 5; CBTI: week 6-9)

Outcome Measure Data

Analysis Population Description

Participants who completed post-treatment Sleep Diaries

Arm/Group Title	CBTI	BBTI
Arm/Group Description	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 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.
Measure Participants	12	9
Mean (Standard Deviation) [score on a scale]	3.4 (0.7)	2.8 (0.5)

Adverse Events

Time Frame	baseline to 12-month follow-up (approximately 57-60 weeks)
Arm/Group Title	CBTI		BBTI
Arm/Group Description	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 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.
All Cause Mortality
	CBTI		BBTI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/31 (0%)
Serious Adverse Events
	CBTI		BBTI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	CBTI		BBTI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/31 (0%)

Limitations/Caveats

In general, higher than expected dropout leading to smaller number of participants analyzed. For sleep diaries, higher than expected dropout and poor completion at post-treatment resulted in small number analyzed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.