Cognitive Behavioral Therapy for Insomnia for Gulf War Illness

NCT02782780 | Completed Results DMC

• 2 other identifiers: SPLD-12-15FI21CX001428
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Gulf War Illness; Insomnia

Keywords

insomnia; insomnia disorder; Gulf War Illness; Chronic Multisymptom Illness

Outcome Measures

Primary Outcomes (2)

• Gulf War Illness Symptom Severity Index

  Due to its novelty, complexity, and variability, no single measure of severity addresses all possible presentations of Gulf War Illness (GWI). Therefore, we used the symptom portion of the Kansas Gulf War Military History and Health Questionnaire to query about fatigue/sleep problems, somatic pain, skin abnormalities, gastrointestinal, respiratory, and neurologic/cognitive/mood symptoms, based on the Kansas GWI and CDC CMI case definition. To assess current GWI symptoms, participants will be asked about the absence (0), presence, and severity (1=mild; 2=moderate; 3=severe) of the symptoms over the past 2 weeks instead of over the past 6-months. Score range: 0-87; higher scores = more symptoms and/or more severe symptoms.

  At baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation

• Insomnia Severity Index (ISI)

  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. Higher scores indicate more severe insomnia. This outcome will be measured at 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.

  At baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation

Secondary Outcomes (10)

• Fatigue Severity Scale (FSS)

  Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation

• Brief Pain Inventory (BPI) - Pain Interference

  Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation

• Brief Pain Inventory (BPI) - Pain Severity

  Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation

• Multiple Abilities Self-Report Questionnaire (MASQ)

  Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation

• Hospital Anxiety and Depression Scale (HADS), Anxiety

  Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation

Study Arms (2)

CBTi

EXPERIMENTAL

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)

Monitor Only

NO INTERVENTION

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.

Interventions

Cognitive Behavioral Therapy for Insomnia (CBTi) BEHAVIORAL

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.

Also known as: CBTi

CBTi

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Linda Chao
• Organization: San Francisco VA Health Care System

linda.chao@va.gov

415-221-4810

Study Officials

• Linda L. Chao, PhD

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 25, 2016
• Study Start: October 24, 2016
• Primary Completion: January 31, 2020
• Study Completion: June 1, 2020
• Last Updated: February 2, 2021
• Results First Posted: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)