This application is a joint submission of the War Related Illness and Injury Study Center (WRIISC), The Polytrauma Network Site (PNS) and the VISN 21 Mental Illness Research, Educational and Clinical Center (MIRECC) at the VA Palo Alto Health Care System. One of the major post-deployment health concerns that the WRIISC & PNS are focusing on is Traumatic Brain Injury (TBI). The VISN 21 MIRECC has a long research history addressing sleep disorders in Veterans including several research projects on insomnia in Veterans. In recent years over 650 VA mental health clinicians have been trained in CBT-I by the VISN 21 MIRECC. The proposed collaboration between WRIISC, PNS and MIRECC will evaluate the efficacy of Cognitive Behavior Therapy for Insomnia (CBT-I) in TBI Veterans with chronic insomnia in a randomized controlled trial. CBT-I has been suggested to be a good alternative to pharmacological approaches in the treatment of TBI patients with insomnia but evidence to support this claim is lacking. This trial will compare CBT-I with a previously used manualized active control condition called ?Credible Control Therapy for Insomnia? (CCT-I) in mild TBI (mTBI) patients suffering from insomnia. Like many previous control conditions in randomized controlled trials CCT-I includes a sleep hygiene component. Our hypotheses will be tested in a randomized controlled clinical trial. The randomization will be stratified by potential comorbidity of current Post-Traumatic Stress Disorder (PTSD) and use of sleep medications. After screening and randomization in the 2-week baseline phase, subjects will receive either CBT-I or CCT-I in the 6-week treatment phase. This 4-year proposal will include 120 mTBI patients (2 groups of n=60 each) with relevant measures collected at baseline, week 8 after treatment and week 32 for follow-up. The primary outcome will be the Insomnia Severity Index. The secondary outcome will be the SF 36-Item Health Survey.

Public Health Relevance

Insomnia is a serious health problem in Veterans suffering from chronic Traumatic Brain Injury (TBI) and often associated with extensive prescription of sleeping medications. Although safer, even the latest ?sleeping pills? can lead to daytime impairment and risk of abuse. Thus non-pharmacological treatments for insomnia have been pursued as alternatives to medications. Cognitive Behavior Therapy for Insomnia (CBT-I) is the term widely used to describe therapies that combine behavioral and cognitive therapies for insomnia. The combined CBT-I approach has well-documented efficacy. Between 2012 and 2014 over 650 VA mental health clinicians have received extensive training in CBT-I. Although CBT-I has been suggested to be a good treatment alternative to pharmacological approaches its efficacy has not yet been sufficiently demonstrated in TBI associated insomnia. We propose to address this gap in our knowledge with a carefully designed clinical trial comparing the benefits of CBT-I with an active control/placebo condition in Veterans with TBI.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Non-HHS Research Projects (I01)
Project #
1I01RX002319-01A2
Application #
9395122
Study Section
Brain Injury: TBI & Stroke (RRD1)
Project Start
2018-02-01
Project End
2022-01-31
Budget Start
2018-02-01
Budget End
2019-01-31
Support Year
1
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Veterans Admin Palo Alto Health Care Sys
Department
Type
DUNS #
046017455
City
Palo Alto
State
CA
Country
United States
Zip Code
94304