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Predictors of Response to Insomnia Treatments for Gulf War Veterans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208049
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

The purpose of this study is to evaluate the efficacy and effectiveness of sleep restriction (SR) and cognitive therapy (CT) in Gulf War Veterans with insomnia.

The primary hypothesis is that the efficacy of these treatments will depend upon an individual subject's baseline characteristics. For SR we expect that baseline measures of "excessive time spent in bed" may predict response and for CT we expect that baseline measures of cognitive arousal and pain may predict response. Exploratory analyses using signal detection techniques will systematically compare and contrast the potential usefulness of a number of additional potential moderator measures.

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. 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 has not yet been well-defined for 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.


Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Sleep Restriction Therapy Behavioral: Cognitive Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Our hypotheses will be tested in a randomized parallel groups design. Randomization will be based on type of treatment assignment: either to Sleep Restriction (SR) or to Cognitive Therapy (CT). After screening and randomization in the 2-week baseline phase, subjects will receive SR or CT in the 6-week treatment phase. There will be no more treatment after this point. At the end of the 6-week treatment, subjects will return to repeat many of the psychological tests.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Predictors of Response to Insomnia Treatments for Gulf War Veterans
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Arm Intervention/treatment
Experimental: Sleep Restriction Therapy
Sleep Restriction Therapy (SR). The initial Time in Bed (TIB) prescription is calculated on the average total sleep time (TST) reported in the baseline sleep logs. After one week, depending on subject's daily sleep logs, the therapist suggests a new TIB prescription. Napping is neither prescribed nor proscribed. However, if subjects find themselves very sleepy (not just tired, but actually sleepy) they are advised to take a brief (15 to 30 minutes) nap to ensure their safety.
Behavioral: Sleep Restriction Therapy
Sleep Restriction Therapy will regulate the time you spend in bed on the basis of information collected about your sleep from sleep diaries during the evaluation and during treatment. Sleep restriction therapy is designed to improve your sleep quality by matching the opportunity you give yourself for sleep to the amount of average sleep ability you exhibit on your sleep diaries. Once the quality of your sleep has improved then then sleep quantity is gradually increased by slowly increasing your sleep opportunity. Sleep restriction therapy will also attempt to strengthen your bed sleep connection by focusing on what activities you engage in when you are awake in the middle of the night.

Experimental: Cognitive Therapy
Cognitive Therapy (CT). The CT treatment module is designed to meet three general goals: 1) identification of dysfunctional sleep cognitions, 2) challenging their validity, and 3) replacing them with more adaptive substitutes. Several specific techniques designed to meet these goals are discussed in materials distributed to subjects. Similar to SR, subjects in CT are given information about relevant elements of the science of sleep and healthy sleep practices.
Behavioral: Cognitive Therapy
Cognitive Therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. The treatment part of the study lasts six weeks. During the treatment, you will meet with the therapist for a total of six sessions: once per week for six consecutive weeks. Each session lasts approximately 60 minutes.




Primary Outcome Measures :
  1. Insomnia Severity Index [ Time Frame: 6 weeks ]
    The Veteran's subjective experience of severity of insomnia using the Insomnia Severity Index (ISI). The ISI has been shown to be a reliable subjective measure of insomnia severity as well as a sensitive measure of symptom change including Veteran insomnia treatment studies. Recently it has also been related to objective polysomnography measures. The scale ranges from 0 to 28, with a score of 0-7 indicating no clinically significant insomnia, scores 8-14 indicating sub threshold insomnia, 15-21 indicating moderate insomnia and 22-28 indicating severe insomnia.


Secondary Outcome Measures :
  1. wake after sleep onset [ Time Frame: 6 weeks ]
    Wake after sleep onset (WASO) will be measured by daily sleep logs. This is included as a secondary measure because difficulty in maintaining sleep is the most commonly reported insomnia complaint; i.e., they either experience unwanted wake time during the night and/or they wake earlier than they want in the morning.

  2. SF 36-Item Health Survey 1.0 (SF-36) [ Time Frame: 6 weeks ]
    The SF-36 measures Quality of Life (QOL), including both emotional and physical disabilities, is easy to understand, brief, widely used, and has been found to be useful as a measure of health status. It covers 8 domains of QOL: physical functioning, role functioning/physical, role functioning/emotional, energy/fatigue, emotional well-being, social functioning, pain, general health, and a single-item ninth component: reported health transition (health compared to 1 year ago). Each of the dimensions of the SF-36 yields a score (1-100). Large-sample means and standard deviations of the 8 dimensional scales have been published for various subject populations and disease groups. We will use the general health domain as our overall indicator of health-related QOL and perform additional analyses on the 8 individual scales.

  3. Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: 6 weeks ]
    The FOSQ is designed to be administered to individuals who have a sleep disorder, and is recommended for use in intervention studies as an outcome measure. The questionnaire is designed to measure functional status in situations that produce sleepiness. There are five subscales: vigilance, intimacy and sexual relationships, general productivity, activity level, and social outcome. Test-retest reliability for the scale has been found to be .91 when administered a week apart. The internal consistency of the components and the total score was above .85 (Cronbach's alpha).

  4. Multidimensional Fatigue Inventory (MFI) [ Time Frame: 6 weeks ]
    The FMI is designed to measure domains of fatigue including General Fatigue, Physical Fatigue, Mental Fatigue Reduced Motivation and Reduced Activity. CBT for insomnia has previously been associated with improvements in general fatigue levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female Gulf War Veterans of any racial or ethnic group
  • Independent Living (not in nursing home or VA Extended Care facility)
  • Subjective complaint of insomnia on the Insomnia Severity Index (ISI) greater than or equal to10
  • Subjects with PTSD will be included in this study as long as they do not meet criteria for depression described below
  • Stable (3 weeks) CNS active medications that could significantly impact sleep or alertness
  • Stable adult onset diabetes, controlled with insulin, oral medications or diet is

Exclusion Criteria:

Sleep-Related

  • Excessive caffeine consumption (4 cups of coffee per day) and unable to reduce to 3 cups before lunch a day for 3 weeks prior to treatment
  • Subjects will be initially screened by the Berlin Questionnaire (for sleep apnea)

    • those with responses suggestive of high risk for sleep apnea will be referred to Pulmonary Medicine for standard clinical screening including polysomnography
    • those in which apnea is primarily responsible for their sleep complaints should be excluded
  • Subjects working a rotating shift or an unconventional daytime shift (ending after 1830 h will be ineligible

Neuropsychiatric

  • Hamilton Depression Scale (HDRS 24) and classified as high risk on the Columbia Suicide Severity Scale (past month)
  • Individuals are considered high risk if they have endorsement of either of the following:

    • A positive endorsement, relative to the past 30 days, in the "Suicide Thoughts" section of item #4 (Have you had these thoughts and had some intention of acting on them) or item #5 (Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan?
    • A positive endorsement, relative to the past 90 days, in the "Suicide Behavior" section of item #6 (Have you ever done anything, started to do anything, or prepared to do anything to end your life?)
  • Current or lifetime history of a psychiatric disorder with primary psychotic features
  • Current or lifetime bipolar disorder; prominent suicidal or homicidal ideation
  • Current exposure to trauma, or exposure to trauma in the past 3 months
  • Current or within the past 30 days: drug abuse or dependence (except nicotine)
  • Current or expected cognitive behavior therapy for another condition, e.g.,:

    • depression
  • Excessive alcohol consumption

    • >14 drinks per week or > 4 drinks per occasion
  • Presence of any acute or unstable psychiatric condition(s) that requires referral for treatment
  • Montreal Cognitive Assessment (MOCA) < 20

Medical

  • Acute or unstable chronic illness, including but not limited to:

    • uncontrolled thyroid disease
    • kidney
    • prostate or bladder conditions causing excessively frequent urination (> 3 times per night)
    • medically unstable congestive heart failure
    • angina
    • other severe cardiac illness as defined by treatment regimen changes in the prior 3 months
    • stroke with serious sequelae
    • cancer if < 1 year since end of treatment
    • asthma
    • emphysema
    • or other severe respiratory diseases uncontrolled with medications
    • neurological disorders such as Alzheimer's disease, Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months
  • Unstable adult onset diabetes will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208049


Contacts
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Contact: Andrea Goldstein, PhD (650) 493-5000 ext 60584 Andrea.Goldstein2@va.gov
Contact: Jerome A Yesavage, MD (650) 493-5000 ext 65147 Jerome.Yesavage@va.gov

Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Stacy Moeder, MHA MBA    650-493-5000 ext 63316    Stacy.Moeder@va.gov   
Contact: Jerome A Yesavage, MD    (650) 493-5000 ext 65147    Jerome.Yesavage@va.gov   
Principal Investigator: Jerome A Yesavage, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jerome A Yesavage, MD VA Palo Alto Health Care System, Palo Alto, CA
Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03208049    
Other Study ID Numbers: SDR 15-196
1I01HX001839-01A2 ( U.S. NIH Grant/Contract )
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Insomnia
CBT
Gulf War Veterans
Sleep
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders