# A Randomized Clinical Trial Comparing Brief and Standard Cognitive-Behavioral Therapies for Insomnia in Veterans

> **NIH VA I01** · VA SAN DIEGO HEALTHCARE SYSTEM · 2024 · —

## Abstract

Veterans seen in VA primary care and mental health clinics commonly present with complaints of sleep
disturbance, especially insomnia. For example, in a cross-sectional study examining sleep disorders among
Veterans seeking care through the Veterans Health Administration between 2000-2010, sleep apnea (47%) and
insomnia (26%) were the most commonly diagnosed conditions. In a study of 375 Operation Enduring
Freedom/Operation Iraqi Freedom Veterans, 45% reported extended time spent trying to fall asleep (> 30
minutes), 21% reported reduced total sleep times (< 4.5 hours), and 56% reported being awake in bed more
than 15% of the night. Similarly, in another observational study of 5,552 Veterans, 57.2% of the sample
population was found to have insomnia disorder. This sample also was at high-risk for a host of clinical disorders,
including PTSD, TBI, and pain; all of which showed higher rates of insomnia.
Cognitive Behavioral Therapy for Insomnia (CBT-I) is a multi-component intervention that features sleep
restriction, stimulus control, sleep hygiene education, cognitive therapy, and can include relaxation techniques.
CBT-I is recognized as the first-line treatment for chronic insomnia and is effective in Veterans, however,
limitations to use still remain. In recent years advances in treatment approaches have attempted to streamline
CBT-I by focusing on delivery of specific treatment components, reducing number of treatment sessions, and/or
use of technologies that provide for ease of dissemination and implementation. Brief Cognitive-Behavioral
Therapy for Insomnia (bCBT-I) represents one such empirically tested brief intervention which may decrease
patient burden through reduced sessions needed to achieve treatment goals and through use of hybrid treatment
administration (i.e., in-person and telemedicine).
To better inform both clinical practice and future research, this investigation proposes to assess the comparative
effectiveness of bCBT-I to VA standard CBT-, with several overarching goals: 1) in a randomized clinical trial
(RCT), evaluate the equivalence (non-inferiority) of bCBT-I to VA standard CBT-I; 2) evaluate the impact of these
treatment approaches on functional rehabilitation outcomes; 3) evaluate the impact of these treatment
approaches on psychiatric symptomatology; and 4) in an exploratory fashion, determine which patient factors
best predict success or failure with a given treatment as a means of developing insomnia phenotypes that might
be used diagnostically to match patient characteristics and type of treatment to help optimize clinical outcomes
(i.e., a “personalized medicine” approach to treatment).
The investigation timeline consists of four parts: 1) baseline assessment of sleep, functional, and psychiatric
outcome measures; 2) randomization and assignment to either CBT-I or bCBT-I; 3) post-treatment assessment;
and 4) 3-month follow-up assessment. Over 40 months of recruitment this study will enroll and randomize 180
Vetera...

## Key facts

- **NIH application ID:** 10820135
- **Project number:** 5I01RX003840-02
- **Recipient organization:** VA SAN DIEGO HEALTHCARE SYSTEM
- **Principal Investigator:** HENRY John ORFF
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2022-11-01 → 2026-10-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10820135

## Citation

> US National Institutes of Health, RePORTER application 10820135, A Randomized Clinical Trial Comparing Brief and Standard Cognitive-Behavioral Therapies for Insomnia in Veterans (5I01RX003840-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10820135. Licensed CC0.

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