N/A
N=85
Cognitive Behavioral Therapy for Insomnia for Gulf War Illness
Gulf War Illness · Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT02782780 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Gulf War Illness Symptom Severity Index — 67; 67; 61; 49 score on a scale — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behavioral Therapy for Insomnia (CBTi) (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gulf War Illness Symptom Severity Index |
67; 67; 61; 49; 54 | <0.01 sig |
| PRIMARY Insomnia Severity Index (ISI) |
19.0; 21.0; 19.0; 10.0; 13.0 | <0.001 sig |
| SECONDARY Fatigue Severity Scale (FSS) |
5.06; 5.56; 5.11; 3.44; 3.67 | <0.001 sig |
| SECONDARY Brief Pain Inventory (BPI) - Pain Interference |
4.29; 5.86; 4.57; 4.29; 4.29 | <0.05 sig |
| SECONDARY Brief Pain Inventory (BPI) - Pain Severity |
4.12; 5.00; 4.25; 5.25; 5.00 | =0.991 |
| SECONDARY Multiple Abilities Self-Report Questionnaire (MASQ) |
64; 61; 68; 55; 54 | <0.05 sig |
| SECONDARY Hospital Anxiety and Depression Scale (HADS), Anxiety |
10.5; 12.5; 11.0; 8.0; 9.0 | <0.01 sig |
| SECONDARY Hospital Anxiety and Depression Scale (HADS), Depression |
9.0; 9.5; 9.0; 4.0; 6.0 | <0.001 sig |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
12.0; 11.0; 11.0; 8.0; 7.0 | <0.001 sig |
| SECONDARY Sleep Efficiency (SE) |
82; 83; 78; 94; 91 | <0.001 sig |
| SECONDARY Minutes of Wake After Sleep Onset (WASO) |
25; 31; 33; 7; 20 | <0.001 sig |
| SECONDARY Sleep Latency (SL) |
22; 22; 24; 10; 12 | <0.001 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02782780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.