Eligibility, any sex, with Gulf War Illness or Insomnia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Gulf War Illness Symptom Severity IndexPrimary· At baseline, 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 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
Baseline
Group
Value
95% CI
Monitor Only
67
53 – 78
CBTi
67
58 – 82
Post-treatment
Group
Value
95% CI
Monitor Only
61
50 – 78
CBTi
49
44 – 62
6-month follow-up
Group
Value
95% CI
CBTi
54
49 – 66
Insomnia Severity Index (ISI)Primary· At baseline, 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. Higher scores indicate more severe insomnia. This o
Baseline
Group
Value
95% CI
Monitor Only
19.0
16.0 – 24.0
CBTi
21.0
18.0 – 24.0
post-treatment
Group
Value
95% CI
Monitor Only
19.0
13.5 – 22.0
CBTi
10.0
6.0 – 15.0
6-month follow-up
Group
Value
95% CI
CBTi
13.0
7.0 – 18.0
Fatigue Severity Scale (FSS)Secondary· Baseline, 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 baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Baseline
Group
Value
95% CI
Monitor Only
5.06
3.47 – 5.78
CBTi
5.56
4.67 – 6.28
Post-treatment
Group
Value
95% CI
Monitor Only
5.11
3.22 – 5.83
CBTi
3.44
2.89 – 5.03
6-month follow-up
Group
Value
95% CI
CBTi
3.67
2.78 – 5.44
Brief Pain Inventory (BPI) - Pain InterferenceSecondary· Baseline, 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 measures two domains: pain intensity (severity) and the impact of pain on functioning (interference). The score range for BPI-Severity is 0-10, higher score = more severe/intense pain. The range for BPI-interference is 0-10, higher score = greater impact of pain on function.
This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Baseline
Group
Value
95% CI
Monitor Only
4.29
2.46 – 6.68
CBTi
5.86
3.79 – 7.29
Post-treatment
Group
Value
95% CI
Monitor Only
4.57
2.07 – 6.86
CBTi
4.29
1.57 – 5.57
6-month follow-up
Group
Value
95% CI
CBTi
4.29
1.64 – 6.64
Brief Pain Inventory (BPI) - Pain SeveritySecondary· Baseline, 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 measures two domains: pain intensity (severity) and the impact of pain on functioning (interference). The score range for BPI-Severity is 0-10, higher score = more severe/intense pain. The range for BPI-interference is 0-10, higher score = greater impact of pain on function. This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Baseline
Group
Value
95% CI
Monitor Only
4.12
2.88 – 6.75
CBTi
5.00
3.38 – 6.50
Post-treatment
Group
Value
95% CI
Monitor Only
4.25
2.88 – 5.75
CBTi
5.25
3.00 – 5.75
6-month follow-up
Group
Value
95% CI
CBTi
5.00
3.00 – 6.00
Multiple Abilities Self-Report Questionnaire (MASQ)Secondary· Baseline, 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). Score range: 38-190. Higher scores = greater cognitive dysfunction.
This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Baseline
Group
Value
95% CI
Monitor Only
64
39 – 77
CBTi
61
44 – 76
Post-treatment
Group
Value
95% CI
Monitor Only
68
42 – 89
CBTi
55
37 – 69
6-month followup
Group
Value
95% CI
CBTi
54
44 – 77
Hospital Anxiety and Depression Scale (HADS), AnxietySecondary· Baseline, 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." The range for HADS-anxiety measure is 0-21. Higher scores = more anxiety.
This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Baseline
Group
Value
95% CI
Monitor Only
10.5
6.2 – 13.8
CBTi
12.5
9.2 – 14.0
Post-treatment
Group
Value
95% CI
Monitor Only
11.0
7.0 – 15.5
CBTi
8.0
5.0 – 11.0
6-month follow-up
Group
Value
95% CI
CBTi
9.0
6.5 – 11.0
Hospital Anxiety and Depression Scale (HADS), DepressionSecondary· Baseline, 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." The range for HADS-depression measure is 0-21. Higher scores = more anxiety.
This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Baseline
Group
Value
95% CI
Monitor Only
9.0
5.2 – 11.8
CBTi
9.5
7.0 – 12.0
Post-treatment
Group
Value
95% CI
Monitor Only
9.0
5.5 – 11.0
CBTi
4.0
2.0 – 8.0
6-month follow-up
Group
Value
95% CI
CBTi
6.0
3.0 – 9.0
Pittsburgh Sleep Quality Index (PSQI)Secondary· Baseline, 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. The score range for the PSQI is 0 to 21, with the higher scores indicating worse sleep quality.This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Baseline
Group
Value
95% CI
Monitor Only
12.0
9.2 – 14.8
CBTi
11.0
9.0 – 15.0
Post-treatment
Group
Value
95% CI
Monitor Only
11.0
8.5 – 13.0
CBTi
8.0
3.0 – 9.0
6-month follow-up
Group
Value
95% CI
CBTi
7.0
5.0 – 10.5
Sleep Efficiency (SE)Secondary· Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Sleep Efficiency, as determined by self-reported sleep diary, is the total sleep time (TST) divided by the time in bed, multiplied by 100. Good sleepers have high sleep efficiency because they are asleep the majority of time they spend in bed. Insomniacs tend to have low sleep efficiency because they spend a lot of time awake while they are in bed (tossing and turning).
This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Baseline
Group
Value
95% CI
Monitor Only
82
74 – 89
CBTi
83
74 – 88
Post-treatment
Group
Value
95% CI
Monitor Only
78
73 – 89
CBTi
94
90 – 95
6-month follow-up
Group
Value
95% CI
CBTi
91
89 – 94
Minutes of Wake After Sleep Onset (WASO)Secondary· Baseline and after 8 weeks of study participation in all subjects; in subjects randomized to CBTi, 6 months after study participation
Wake After Sleep Onset is the amount of time that a person is awake time during the night, as recorded in a self-report sleep diary. Insomniacs tend to have greater WASO than good sleepers because they wake up a lot in the middle of the might.
This outcome will be measured at baseline, post-treatment in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Baseline
Group
Value
95% CI
Monitor Only
25
11 – 43
CBTi
31
19 – 53
Post-treatment
Group
Value
95% CI
Monitor Only
33
18 – 57
CBTi
7
4 – 22
6-month follow-up
Group
Value
95% CI
CBTi
20
11 – 27
Sleep Latency (SL)Secondary· Baseline, after 8 weeks of study participation in all subjects, in subjects randomized to CBTi, 6 months after study participation
Sleep latency (SL) is the amount of time that it takes someone to fall asleep. Participants will be asked to estimate this time in their sleep diaries. Good sleepers tend to have low sleep latencies because they can fall asleep quickly. Insomniacs tend to have longer sleep latencies because it takes them a long time to fall asleep.
This outcome will be measured at baseline, after 8 weeks in both the CBTi and monitor-only groups and at 6 months in subjects randomized to CBTi.
Baseline
Group
Value
95% CI
Monitor Only
22
15 – 44
CBTi
22
13 – 34
Post-treatment
Group
Value
95% CI
Monitor Only
24
14 – 46
CBTi
10
7 – 12
6-month follow-up
Group
Value
95% CI
CBTi
12
7 – 16
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05972291 — Mechanisms of Gulf War Illness
· NA
· recruiting
NCT05375812 — NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)
· recruiting
NCT05675878 — Confirmation of Diet as a Treatment for Gulf War Illness
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 2 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02782780.