Predictors of Response to Insomnia Treatments for Gulf War Veterans

VA Office of Research and Development

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Cognitive Therapy (CT); Behavioral: Behavioral Therapy (BT)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03208049

1I01HX001839-01A2 (U.S. NIH Grant/Contract)

SDR 15-196

Details and patient eligibility

About

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).

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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) < 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Behavioral Therapy (BT)

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Therapy (BT)

Cognitive Therapy (CT)

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Therapy (CT)