Predictors of Response to Insomnia Treatments for Gulf War Veterans
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|ClinicalTrials.gov Identifier: NCT03208049|
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : July 10, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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)|
|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|
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.
- 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.
- 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.
- 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.
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208049
|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|
|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|
|Principal Investigator:||Jerome A Yesavage, MD||VA Palo Alto Health Care System, Palo Alto, CA|