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N/A N=50 Randomized Treatment

Predictors of Response to Insomnia Treatments for Gulf War Veterans

Insomnia

Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Insomnia Severity Index (ISI) — 17.0; 18.9; 7.3; 10.9 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Behavioral Therapy (BT) (Behavioral); Cognitive Therapy (CT) (Behavioral)
Age
Adult, Older Adult · 20+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Oct 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Insomnia Severity Index (ISI)
17.0; 18.9; 7.3; 10.9; 7.9; 9.8
SECONDARY
Beck Depression Index (BDI)
11.2; 12.6; 6.1; 10.4; 7.7; 8.7
SECONDARY
Beck Anxiety Index (BAI)
10.2; 8.5; 5.4; 7.6; 7.8; 12.8
SECONDARY
SF 36-Item Health Survey 1.0 (SF-36)
62.4; 62.1; 71.4; 62.3; 52.2; 56.5
SECONDARY
Functional Outcomes of Sleep Questionnaire (FOSQ)
15.3; 14.0; 17.3; 14.8; 16.9; 15.4
SECONDARY
Multidimensional Fatigue Inventory (MFI)
61.8; 63.7; 64.8; 64.8; 64.6; 61.5
SECONDARY
Wake After Sleep Onset (WASO)
34.8; 41.5; 6.5; 40.4; 18.7; 8.5

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).

Eligibility 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 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.

Exclusion Criteria

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)
  • 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) 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03208049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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