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InsomniaNCT03208049

Predictors of Response to Insomnia Treatments for Gulf War Veterans

A study testing Behavioral Therapy (BT) and Cognitive Therapy (CT) in people with Insomnia, run by VA Office of Research and Development at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and effectiveness of Behavioral Therapy (BT) and Cognitive Therapy (CT) in Gulf War Veterans with insomnia. The Primary Outcome measure is the Insomnia Severity Index (ISI). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Insomnia
What is being tested?
Behavioral Therapy (BT) and Cognitive Therapy (CT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesUnited States
Study dates
1 Aug 2017to 21 May 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 to 10
  • 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 acceptable
  • Access to a device with video capabilities and ability to have the video on during study visits.

Who cannot join

  • Sleep-Related
  • Excessive caffeine consumption (4 or more cups of coffee per day) and unable to reduce to 3 cups or less a day 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 where apnea is primarily responsible for their sleep complaints will be excluded
  • Subjects working a rotating shift or an unconventional daytime shift (ending after 1830h) will be ineligible
Show all 34Show fewer
  • Neuropsychiatric
  • Hamilton Depression Scale (HDRS 24) and classified as high risk on the Columbia Suicide Severity Rating Scale (C-SSRS) in the past month
  • Individuals are considered high risk if they have endorsement of either of the following on the C-SSRS:
  • 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 of >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 or Montreal Cognitive Assessment Blind (MOCA-Blind) < 15
  • Medical
  • Acute or unstable chronic illness, including but not limited to:
  • Uncontrolled thyroid disease
  • Kidney disease
  • 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
  • Other severe respiratory diseases uncontrolled with medications
  • Neurological disorders such as Alzheimer's disease, Parkinson's disease, and/or unstable epilepsy as defined by treatment regimen changes in the prior 3 months
  • Unstable adult-onset diabetes will be excluded

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

    East Orange, New Jersey, 07018

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1207

  • Washington DC VA Medical Center, Washington, DC

    Washington D.C., District of Columbia, 20422

Other trials in United States

About this study

The purpose of this study is to evaluate the efficacy and effectiveness of Behavioral Therapy (BT) and Cognitive Therapy (CT) in Gulf War Veterans with insomnia. The Primary Outcome measure is the Insomnia Severity Index (ISI).

Read the detailed description

The investigators' hypotheses will be tested in a randomized parallel groups design. Randomization will be based on type of treatment assignment: either to BT or CT. After screening and randomization in the 2-week baseline phase, subjects will receive BT or CT in the 8-week treatment phase. There will be no more treatment after this point.

All subjects will receive education about basic sleep hygiene as well as information about the science of sleep including sleep stages and sleep regulation.

Behavioral Therapy (BT). The subject is prescribed a time in bed. After one week, depending on subject's daily sleep logs and adherence to treatment, the therapist suggests a new time in bed prescription. Napping is neither prescribed nor proscribed. However, if subjects find themselves having difficulty staying awake during the day, they are advised to take a brief (15 to 30 minutes) nap to ensure their safety. Subjects in BT are also provided with information about relevant elements of the science of sleep and healthy sleep practices.

Cognitive Therapy (CT). CT is designed to meet three general goals: 1) identify dysfunctional sleep cognitions, 2) challenge the validity of these thoughts, and 3) replace them with more adaptive substitutes. Several specific techniques designed to meet these goals are discussed in materials distributed to subjects.

The investigators will continue to monitor progress post-treatment during the follow-up period. The complete package of outcome measures will be repeated at the follow-up session. The investigators will tell subjects the expected benefits of treatment is to continue and/or improve with time and the investigators will also encourage subjects to continue practicing the treatment instructions to maintain their progress after active treatment ends.

Subjects will be screened for eligibility via a phone interview and an in-person evaluation.

At the in-person evaluation, informed consent will be received and documented. The evaluation will consist of measures of cognitive impairment and depression, sleep disturbance, and medical and psychiatric history.

The following measures will be completed at weeks 1, 8, and 32: Insomnia Severity Index (ISI), Beck Depression Inventory (BDI); Beck Anxiety Inventory (BAI), 36-Item Short-Form Health Survey (SF-36), Functional Outcomes of Sleep Questionnaire (FOSQ), Multidimensional Fatigue Inventory (MFI), and Wake After Sleep Onset (WASO).

Conditions
Insomnia
Being tested
Behavioral Therapy (BT), Cognitive Therapy (CT)
Keywords
Insomnia, Behavioral Therapy, Cognitive Therapy, Sleep, Gulf War Veterans
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral Therapy (BT)Behavioural

    Behavioral Therapy will regulate time spent in bed based on information collected from sleep diaries during evaluation and treatment. Behavioral therapy is designed to improve sleep quality by matching opportunity for sleep to the amount of average total sleep calculated from sleep diaries. Once the quality of sleep has improved, sleep quantity is gradually increased by slowly increasing sleep opportunity. Stimulus control will strengthen the bed/sleep association by eliminating non-sleep activities from the bedroom.

  • Cognitive Therapy (CT)Behavioural

    Cognitive Therapy is designed to identify maladaptive beliefs about sleep, challenge their validity, and replace them with more adaptive thinking patterns. This therapy aims to reduce sleep-related worry, anxiety, and fear. The treatment phase of the study lasts six weeks. During treatment, you will meet with a study therapist for a total of six sessions: once per week for six consecutive weeks. Each session lasts approximately 60 minutes.

Study groups in NCT03208049
Study groupRoleWhat they receive
Behavioral Therapy (BT)ExperimentalBehavioral Therapy (BT). The subject is prescribed a time in bed. After one week, depending on subject's daily sleep logs and adherence to treatment, the therapist suggests a new time in bed prescription. Napping is neither prescribed nor proscribed. However, if subjects find themselves having difficulty staying awake during the day, they are advised to take a brief (15 to 30 minutes) nap to ensure their safety. Subjects in BT are also provided with information about relevant elements of the science of sleep and healthy sleep practices.
Receives: Behavioral: Behavioral Therapy (BT)
Cognitive Therapy (CT)ExperimentalCognitive Therapy (CT). The CT treatment module is designed to meet three general goals: 1) identify dysfunctional sleep cognitions, 2) challenge their validity, and 3) replace them with more adaptive substitutes. Several specific techniques designed to meet these goals are discussed in materials distributed to subjects. Similar to BT, subjects in CT are provided with information about relevant elements of the science of sleep and healthy sleep practices.
Receives: Behavioral: Cognitive Therapy (CT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insomnia Severity Index (ISI)

    Measure Description: This seven-item questionnaire asks respondents to rate the nature and symptoms of their sleep problems using a Likert scale. Questions relate to subjective qualities of sleep, including the severity of symptoms, the satisfaction with sleep patterns, the degree to which insomnia interferes with daily functioning, how noticeable the respondent feels his or her insomnia is to others, and the overall level of distress created by the sleep problem. Responses can range from zero to 4, where higher scores indicate more acute symptoms of insomnia; thus, the total score range is zero to 28.

    Measured: Week 1, Week 8, and Week 32

Secondary outcomes (6)

  1. Beck Depression Index (BDI)

    The Beck Depression Index (BDI) is a formative assessment and rating scale of depression. This self-report inventory, or 21-item questionnaire uses a Likert scale that measures the scale quality of magnitude of depression. Responses can range from zero to 3, where higher scores indicate more acute symptoms of depression; thus, the total score range is zero to 63.

    Measured: Week 1, Week 8, and Week 32

  2. Beck Anxiety Index (BAI)

    The Beck Anxiety Index (BAI) is a formative assessment and rating scale of anxiety. This self-report inventory, or 21-item questionnaire uses a Likert scale that measures the scale quality of magnitude of anxiety. Responses can range from zero to 3, where higher scores indicate more acute symptoms of depression; thus, the total score range is zero to 63.

    Measured: Week 1, Week 8, and Week 32

  3. SF 36-Item Health Survey 1.0 (SF-36)

    The 36-Item Short-Form Health Survey (SF-36) is a self-reported patient survey that measures health status and quality of life (QoL). It is used in a variety of settings, including clinical practice, research, and health policy evaluations. To score the SF-36, scales are standardized to obtain a score ranging from 0 to 100. Higher scores indicate better health status,

    Measured: Week 1, Week 8, and Week 32

  4. Functional Outcomes of Sleep Questionnaire (FOSQ)

    The Functional Outcomes of Sleep Questionnaire (FOSQ) is a self-report tool that assesses how sleepiness affects a person's ability to perform daily activities. The score range is 5 to 20, with higher scores indicating better functioning.

    Measured: Week 1, Week 8, and Week 32

  5. Multidimensional Fatigue Inventory (MFI)

    The Multidimensional Fatigue Inventory (MFI), scores each item on a 5-point Likert scale. The total score for each of the five fatigue dimensions (general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue) is calculated by summing the relevant items, resulting in a range of 20 to 100, where a higher score signifies more severe fatigue.

    Measured: Week 1, Week 8, and Week 32

  6. Wake After Sleep Onset (WASO)

    WASO refers to the total amount of time a person spends awake after initially falling asleep and before finally waking up in the morning, essentially measuring the duration of wakefulness periods that occur once sleep has begun; a high WASO indicates fragmented sleep and can be a sign of a sleep disorder like insomnia. WASO will be reported in minutes.

    Measured: Week 1, Week 8, and Week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2017
  2. Study start1 Aug 2017
  3. Primary completion21 Oct 2022
  4. Study completion21 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The investigators' hypotheses will be tested in a randomized parallel groups design. Randomization will be based on type of treatment assignment: either to Behavioral Therapy (BT) or to Cognitive Therapy (CT). After screening and randomization in the 2-week baseline phase, subjects will receive BT 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 the tests.
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03208049
Sponsor's protocol ID
SDR 15-196
Other IDs
1I01HX001839-01A2
Status last verified
Jan 2026
First submitted
30 Jun 2017
Last updated
26 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. Am J Alzheimers Dis Other Demen. 2018 Nov;33(7):450-457. doi: 10.1177/1533317518783278. Epub 2018 Jul 3.

    PubMed 29969907

  • 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. doi: 10.1001/jamapsychiatry.2018.1483.

    PubMed 29955803

  • 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. doi: 10.1371/journal.pone.0192222. eCollection 2018.

    PubMed 29415058

  • Hantke N, Adamson MM, Noda A, Lazzeroni LC, Beaudreau SA, Yutsis M, Fairchild JK, Kinoshita LM, Kong J, Sheng T, Waltzman D, Ashford JW, Yesavage JA. Posttraumatic Stress Disorder-Associated Cognitive Deficits on the Repeatable Battery for the Assessment of Neuropsychological Status in a Veteran Population. Fed Pract. 2021 Jan;38(1):28-34. doi: 10.12788/fp.0083.

    PubMed 33574646

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Therapy (BT) and Cognitive Therapy (CT) in people with Insomnia, run by VA Office of Research and Development at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insomnia Severity Index (ISI) (time frame: Week 1, Week 8, and Week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03208049, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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