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Cognitive Behavioral Therapy for Insomnia for Gulf War Illness (CBTi GWI)

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ClinicalTrials.gov Identifier: NCT02782780
Recruitment Status : Recruiting
First Posted : May 25, 2016
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Sleep disturbance is a common complaint of Veterans with Gulf War Illness (GWI). Because there is clinical evidence that sleep quality influences pain, fatigue, mood, cognition, and daily functioning, this study will investigate whether a type of behavioral sleep treatment called Cognitive Behavioral Therapy for Insomnia (CBTi) can help Gulf War Veterans with GWI. CBTi is a multicomponent treatment where patients learn about sleep and factors affecting sleep as well as how to alter habits that may impair or even prevent sleep. The investigators hypothesize that helping Gulf War Veterans learn how to achieve better sleep with CBTi may also help to alleviate their other non-sleep symptoms of GWI.

Condition or disease Intervention/treatment Phase
Gulf War Illness Insomnia Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi) Phase 2

Detailed Description:

Insomnia is common among Veterans with Gulf War Illness (GWI). Moreover, untreated insomnia is associated with significant medical and psychiatric morbidity. Cognitive Behavioral Therapy for Insomnia (CBTi) is a multicomponent treatment that seeks not only to teach patients about sleep and factors affecting sleep (e.g., circadian rhythm, age, social and work schedule) but the therapist will also to work with the patient toward minimizing unwanted arousal at bedtime and altering sleep habits to increase sleep propensity and regularity.

Because many Veterans with GWI suffer from a profound loss of physical and functional status that may prevent them from participating in treatments that require regular clinic visits, the proposed study will deliver CBTi by telephone to extend this effective form of behavioral sleep medicine to Veterans who have chronic illnesses and disabilities and/or who live in rural areas with limited access to trained CBTi providers. Recent studies suggest that telephone-delivered CBTi is as effective as CBTi delivered in-person.

The proposed trial will examine the efficacy of telephone-delivered CBTi for alleviating sleep and non-sleep GWI symptoms in a two-arm randomized controlled trial. Veterans who have GWI and persistent insomnia disorder will be randomized to a group that will receive CBTi right away or to a group that will receive treatment-as-usual (i.e., the control group). Veterans randomized to the control group will have the option of receiving telephone-delivered CBTi upon completion of post-treatment assessments. The primary outcomes will be effect sizes base on within-group comparisons of pre-to-post-treatment change and maintenance of treatment effects at 6 months in the CBTi group.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Pilot Test of Telephone-Delivered Cognitive Behavioral Therapy for Insomnia for Veterans With Gulf War Illness
Actual Study Start Date : October 24, 2016
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : May 30, 2020

Arm Intervention/treatment
Experimental: CBTi
CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep as well as to work with the patient toward altering sleep habits to increase sleep propensity and regularity. Specifically, participants will receive 8 weekly individual sessions of CBTi according to the VA CBTi protocol. The investigators will follow the semi-structured approach to treatment described in the VA CBTi protocol, which allows the case conceptualization to drive the order in which treatment components are introduced.
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi)
CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep (e.g., homeostatic regulation, circadian rhythm, age, social and work schedule) and to work with the patients toward minimizing unwanted arousal at bedtime and altering sleep habits to increase sleep propensity and regularity. The intervention is 8-weeks long.
Other Name: CBTi

No Intervention: Monitor Only
Study participants who are randomized to the Monitor Only (MO) control group will be followed for 8 weeks of usual care (i.e., they will be advised to continue doing whatever they were doing to manage their GWI and insomnia symptoms without change dosage or frequency of treatment). Participants randomized to the Monitor Only condition will have the option of receiving CBTi delivered by telephone, at no cost to them, upon completion of post-study procedures.



Primary Outcome Measures :
  1. Insomnia Severity Index (ISI) [ Time Frame: after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation ]
    The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The internal consistency of the ISI was found to be excellent (Cronbach's = 0.74) and has been validated with both sleep diary and polysomnography. This outcome will be measured at 6 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.

  2. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation ]
    The PSQI is a self-report measure that provides a subjective assessment of sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sedative-hypnotics, and daytime energy. This index is widely used and has been validated by polysomnography. This outcome will be measured at 6 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.

  3. Gulf War Illness Symptoms [ Time Frame: after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation ]
    Due to its novelty, complexity, and variability, no single measure of severity addresses all possible presentations of Gulf War Illness (GWI). Therefore, we will use the symptom portion of the Kansas Gulf War Military History and Health Questionnaire, which includes 32 questions about fatigue/sleep problems, somatic pain, skin abnormalities, gastrointestinal symptoms, respiratory symptoms, and neurologic/cognitive/mood symptoms, based on the Kansas GWI and CDC CMI case definition. The investigators will make the following modifications for the proposed study: (1) the 2 questions about sleep difficulties will be excluded. Thus, the investigators will query GWI symptoms with 30 questions. (2) To assess current GWI symptoms, we ask participants about the absence, presence, and severity of the symptoms over the past 2 weeks instead of over the past 6-months. This outcome will be measured at 6 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.

  4. Sleep Latency (SL) [ Time Frame: after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation ]
    In a self-report sleep diary, participants will be asked to report the length of time it takes from lying down for the night until sleep onset. This outcome will be measured at 6 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.

  5. Minutes of Wake After Sleep Onset (WASO) [ Time Frame: after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation ]
    WASO is the sum of wake time during sleep as recorded in a self-report sleep diary. This outcome will be measured at 6 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.

  6. Sleep Efficiency (SE) [ Time Frame: after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation ]
    SE, as determined by self-reported sleep diary, is the total sleep time (TST) divided by the time in bed, multiplied by 100. This outcome will be measured at 6 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.


Secondary Outcome Measures :
  1. Fatigue Severity Scale (FSS) [ Time Frame: after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation ]
    The FSS is a 9-item questionnaire reflecting the consequences of fatigue. It gives a single score (range 0-7, high scores represent high levels of fatigue). A score of 4 has been described as the cutoff for clinical fatigue. This outcome will be measured at 6 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.

  2. Brief Pain Inventory (BPI) [ Time Frame: after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation ]
    The BPI is a 17-item self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain. The BPI includes items that address components of sensory pain including severity, location (identified with a body map as a measure of pain distribution), chronicity, degree of relief due to therapy, and reactive pain (e.g., depression, suffering, and perceived availability of relief). This outcome will be measured at 6 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.

  3. Multiple Abilities Self-Report Questionnaire (MASQ) [ Time Frame: after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation ]
    The MASQ is a 38-item self-report measure of cognitive function compared to same age peers across 5 domains (i.e., verbal memory, attention, language, visual memory, visuo-perceptual ability). This outcome will be measured at 6 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.

  4. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation ]
    The HADS will be used to assess anxiety and depressive symptoms. The HADS is widely used in community settings and in primary care and not just in "hospitals." This outcome will be measured at 6 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.


Other Outcome Measures:
  1. PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation ]
    The PCL-5 a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. This outcome will only be assessed in participants who have PTSD at baseline. In participants with PTSD randomized to CBTi, it will be assessed after 6 weeks and 6 months after study participation. In participants with PTSD randomized to monitor-only, it will be assessed after 6 weeks of study participation.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Deployed to the Gulf Theater of operations, as defined by 38 CFR 3.317 in the years 1990-1991, in accordance with the inclusion/exclusion criteria set forth in the federal definition of Gulf War Illness as used for the Gulf War Registry.

    • This will be confirmed through VA records or by asking veterans to provide a copy of their DD214.
  • Have Gulf War Illness (GWI) according to the Kansas case definition.

    • GWI symptom will be assessed with the Kansas Gulf War Military History and Health Questionnaire.
  • Have an Insomnia Severity Index score greater than or equal to 14.

Exclusion Criteria:

  • Have conditions or substances that may be associated with comorbid insomnia independent of GWI status, including:

    • a lifetime history of any psychiatric disorder with psychotic features
    • bipolar disorder
    • panic disorder
    • obsessive-compulsive disorder
    • alcohol or substance dependence
    • a history of alcohol or substance abuse within the past year
  • Currently exposed to recurrent trauma or have been exposed to a traumatic event within the past 3 months.
  • Pregnancy (because insomnia will worsen after 8 weeks).
  • Prominent suicidal or homicidal ideation.
  • History of sleep restriction therapy or cognitive restructuring therapies of beliefs related to sleep.
  • Subjects concurrently enrolled in another clinical trial.
  • Veterans who work night shifts or have extreme morning or evening tendencies as described below will be excluded in order to avoid the impact of circadian factors on evaluating insomnia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782780


Contacts
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Contact: Kara Dolar, BA (415) 221-4810 ext 24386 kara.dolar@va.gov
Contact: Shirley Yan, BA (415) 221-4810 ext 22562

Locations
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United States, California
San Francisco VA Medical Center, San Francisco, CA Recruiting
San Francisco, California, United States, 94121
Contact: Linda L Chao, PhD BS       Linda.Chao@va.gov   
Principal Investigator: Linda L. Chao, PhD BS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Linda L. Chao, PhD BS San Francisco VA Medical Center, San Francisco, CA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02782780     History of Changes
Other Study ID Numbers: SPLD-12-15F
I21CX001428 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
insomnia
insomnia disorder
Gulf War Illness
Chronic Multisymptom Illness
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders