Clinical trial NCT02782780: Cognitive Behavioral Therapy for Insomnia for Gulf War Illness
Official title: Pilot Test of Telephone-Delivered Cognitive Behavioral Therapy for Insomnia for Veterans With Gulf War Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gulf War Illness
Insomnia
Keywords: insomnia
insomnia disorder
Gulf War Illness
Chronic Multisymptom Illness
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-05-25
Enrollment: 165
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Gulf War Illness Symptom Severity Index
timeFrame: At baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
measure: Insomnia Severity Index (ISI)
timeFrame: At baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Secondary outcomes:
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
measure: Brief Pain Inventory (BPI) - Pain Interference
timeFrame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
measure: Brief Pain Inventory (BPI) - Pain Severity
timeFrame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
measure: Multiple Abilities Self-Report Questionnaire (MASQ)
timeFrame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
measure: Hospital Anxiety and Depression Scale (HADS), Anxiety
timeFrame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
measure: Hospital Anxiety and Depression Scale (HADS), Depression
timeFrame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
measure: Sleep Efficiency (SE)
timeFrame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
measure: Minutes of Wake After Sleep Onset (WASO)
timeFrame: Baseline and after 8 weeks of study participation in all subjects; in subjects randomized to CBTi, 6 months after study participation
measure: Sleep Latency (SL)
timeFrame: Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Linda L. Chao, PhD
role: PRINCIPAL_INVESTIGATOR
References: