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SDR 15-196 – HSR&D Study

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SDR 15-196
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Jerome A Yesavage MD
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, CA
Funding Period: October 2017 - September 2021

BACKGROUND/RATIONALE:
Insomnia is a serious health problem in Gulf War Veterans that is often associated with extensive prescription of sleeping medications. Although safer, even the latest "sleeping pills" can lead to cognitive 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, namely Sleep Restriction (SR) and Cognitive Therapy (CT). 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 is efficacious, the optimal target populations for its major components have not yet been well-defined in Gulf War Veterans. We propose to address this gap and develop tools for clinicians to identify the best treatment for insomnia for individual Gulf War Veterans.


OBJECTIVE(S):
This study aims to address the insomnia problem in Gulf War Veterans by providing critical information for evidence-based personalization of CBT-I for Gulf War Veterans. It will achieve this by evaluating the efficacy and effectiveness of SR and CT in Gulf War Veterans with Insomnia.

METHODS:
Two treatments (SR and CT) will be compared in a randomized clinical trial with a parallel groups design. Efficacy and effectiveness data will be collected prior to the beginning of treatment, after six weeks of treatment, and at the end of a six-month follow-up. This four-year proposal will ultimately include a total of 100 expected subjects across three sites. The sites include, WRIISC California, located at VA Palo Alto, WRIISC New Jersey, located at VA New Jersey, and WRIISC Washington DC, at Washington DC VA. Subjects will be Gulf War Veterans who have a subjective complaint of Insomnia for at least three months. Data will include a sleep log, mediator and moderator measures, and quality of life measures on all subjects in each group. Efficacy and effectiveness data will be collected prior to the beginning of treatment, after 6 weeks of treatment, and at the end of a 6-month follow-up.

FINDINGS/RESULTS:
We hypothesize that the superiority of SR or CT will depend on an individual subject's baseline characteristics (in particular, "excessive time spent in bed" for SR; and cognitive arousal or pain for CT). In addition, we hypothesize that reductions in the amount of time spent in bed (TIB) with its associated increase in homeostatic pressure for sleep may account for some of the effects of SR and that reductions in measures of worry and perception of pain during treatment may explain some of the effects of CT. As of the October 1, 2018 submission, we are currently enrolling participants and have not yet analyzed the data.

IMPACT:
Although CBT-I has well documented efficacy and is recommended for use in Gulf War Veterans, the optimal target populations for the SR or CT components has not been well-defined for this cohort. Individual differences add substantial complexity when choosing a non-pharmacological intervention for insomnia. This may be the case in Veterans with and without PTSD or with combat-related pain syndromes relating to Gulf War service, a population quite distinct from the civilians in whom most studies have been conducted. We propose to address this gap with the research described here. Such knowledge, could lead to rational allocation of resources and not waste either patient or therapist time applying interventions that are not likely to be of benefit. There are no changes to the proposed impact, as of the October 1, 2018 submission.

PUBLICATIONS:

Journal Articles

  1. Yesavage JA, Fairchild JK, Mi Z, Biswas K, Davis-Karim A, Phibbs CS, Forman SD, Thase M, Williams LM, Etkin A, O'Hara R, Georgette G, Beale T, Huang GD, Noda A, George MS, VA Cooperative Studies Program Study Team. Effect of Repetitive Transcranial Magnetic Stimulation on Treatment-Resistant Major Depression in US Veterans: A Randomized Clinical Trial. JAMA psychiatry. 2018 Sep 1; 75(9):884-893.
  2. Tao Y, Peters ME, Drye LT, Devanand DP, Mintzer JE, Pollock BG, Porsteinsson AP, Rosenberg PB, Schneider LS, Shade DM, Weintraub D, Yesavage J, Lyketsos CG, Munro CA. Sex Differences in the Neuropsychiatric Symptoms of Patients With Alzheimer's Disease. American journal of Alzheimer's disease and other dementias. 2018 Nov 1; 33(7):450-457.
  3. McNerney MW, Sheng T, Nechvatal JM, Lee AG, Lyons DM, Soman S, Liao CP, O'Hara R, Hallmayer J, Taylor J, Ashford JW, Yesavage J, Adamson MM. Integration of neural and epigenetic contributions to posttraumatic stress symptoms: The role of hippocampal volume and glucocorticoid receptor gene methylation. PLoS ONE. 2018 Feb 7; 13(2):e0192222.


DRA: Military and Environmental Exposures, Other Conditions
DRE: TRL - Applied/Translational
Keywords: Gulf War Illness
MeSH Terms: none