Predictors of Response to Insomnia Treatments for Gulf War Veterans

NCT03208049 | Completed Results

• 2 other identifiers: SDR 15-1961I01HX001839-01A2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Insomnia

Keywords

Insomnia; Behavioral Therapy; Cognitive Therapy; Sleep; Gulf War Veterans

Outcome Measures

Primary Outcomes (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.

  Week 1, Week 8, and Week 32

Secondary Outcomes (6)

• Beck Depression Index (BDI)

  Week 1, Week 8, and Week 32

• Beck Anxiety Index (BAI)

  Week 1, Week 8, and Week 32

• SF 36-Item Health Survey 1.0 (SF-36)

  Week 1, Week 8, and Week 32

• Functional Outcomes of Sleep Questionnaire (FOSQ)

  Week 1, Week 8, and Week 32

• Multidimensional Fatigue Inventory (MFI)

  Week 1, Week 8, and Week 32

Study Arms (2)

Behavioral Therapy (BT)

EXPERIMENTAL

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.

Behavioral: Behavioral Therapy (BT)

Cognitive Therapy (CT)

EXPERIMENTAL

Cognitive 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.

Behavioral: Cognitive Therapy (CT)

Interventions

Behavioral Therapy (BT) BEHAVIORAL

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.

Behavioral Therapy (BT)

Cognitive Therapy (CT) BEHAVIORAL

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.

Cognitive Therapy (CT)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

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

East Orange, New Jersey, 07018, United States

Location

Related Publications (4)

• 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.

  PMID: 29969907 RESULT

• 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.

  PMID: 29955803 RESULT

• 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.

  PMID: 29415058 RESULT

• 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.

  PMID: 33574646 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Behavior Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

The COVID pandemic limited subject recruitment and follow-up.

Results Point of Contact

• Title: Dr. Andrea Goldstein-Piekarski
• Organization: VA Palo Alto Health Care System, Palo Alto, CA

Andrea.Goldstein2@va.gov

(650) 493-5000

Study Officials

• Jerome A Yesavage, MD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 5, 2017
• Study Start: August 1, 2017
• Primary Completion: October 21, 2022
• Study Completion: May 21, 2023
• Last Updated: January 26, 2026
• Results First Posted: January 23, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)