20 and older, any sex, with 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.
Insomnia Severity Index (ISI)Primary· Week 1, Week 8, and Week 32
Measure Description: This seven-item questionnaire asks respondents to rate the nature and symptoms of their sleep problems using a Likert scale. Questions relate to subjective qualities of sleep, including the severity of symptoms, the satisfaction with sleep patterns, the degree to which insomnia interferes with daily functioning, how noticeable the respondent feels his or her insomnia is to others, and the overall level of distress created by the sleep problem. Responses can range from zero to 4, where higher scores indicate more acute symptoms of insomnia; thus, the total score range is ze
Week 1
Group
Value
95% CI
Behavioral Therapy (BT)
17.0
± 4.4
Cognitive Therapy (CT)
18.9
± 3.7
Week 8
Group
Value
95% CI
Behavioral Therapy (BT)
7.3
± 4.9
Cognitive Therapy (CT)
10.9
± 7.7
Week 32
Group
Value
95% CI
Behavioral Therapy (BT)
7.9
± 7.1
Cognitive Therapy (CT)
9.8
± 6.4
Beck Depression Index (BDI)Secondary· Week 1, Week 8, and Week 32
The Beck Depression Index (BDI) is a formative assessment and rating scale of depression. This self-report inventory, or 21-item questionnaire uses a Likert scale that measures the scale quality of magnitude of depression. Responses can range from zero to 3, where higher scores indicate more acute symptoms of depression; thus, the total score range is zero to 63.
Week 1
Group
Value
95% CI
Behavioral Therapy (BT)
11.2
± 8.1
Cognitive Therapy (CT)
12.6
± 9.4
Week 8
Group
Value
95% CI
Behavioral Therapy (BT)
6.1
± 8.3
Cognitive Therapy (CT)
10.4
± 13.9
Week 32
Group
Value
95% CI
Behavioral Therapy (BT)
7.7
± 9.0
Cognitive Therapy (CT)
8.7
± 7.5
Beck Anxiety Index (BAI)Secondary· Week 1, Week 8, and Week 32
The Beck Anxiety Index (BAI) is a formative assessment and rating scale of anxiety. This self-report inventory, or 21-item questionnaire uses a Likert scale that measures the scale quality of magnitude of anxiety. Responses can range from zero to 3, where higher scores indicate more acute symptoms of depression; thus, the total score range is zero to 63.
Week 1
Group
Value
95% CI
Behavioral Therapy (BT)
10.2
± 10.1
Cognitive Therapy (CT)
8.5
± 8.0
Week 8
Group
Value
95% CI
Behavioral Therapy (BT)
5.4
± 6.6
Cognitive Therapy (CT)
7.6
± 9.2
Week 32
Group
Value
95% CI
Behavioral Therapy (BT)
7.8
± 9.3
Cognitive Therapy (CT)
12.8
± 13.4
SF 36-Item Health Survey 1.0 (SF-36)Secondary· Week 1, Week 8, and Week 32
The 36-Item Short-Form Health Survey (SF-36) is a self-reported patient survey that measures health status and quality of life (QoL). It is used in a variety of settings, including clinical practice, research, and health policy evaluations. To score the SF-36, scales are standardized to obtain a score ranging from 0 to 100. Higher scores indicate better health status,
Week 1
Group
Value
95% CI
Behavioral Therapy (BT)
62.4
± 18.8
Cognitive Therapy (CT)
62.1
± 18.5
Week 8
Group
Value
95% CI
Behavioral Therapy (BT)
71.4
± 14.9
Cognitive Therapy (CT)
62.3
± 23.9
Week 32
Group
Value
95% CI
Behavioral Therapy (BT)
52.2
± 15.9
Cognitive Therapy (CT)
56.5
± 24.2
Functional Outcomes of Sleep Questionnaire (FOSQ)Secondary· Week 1, Week 8, and Week 32
The Functional Outcomes of Sleep Questionnaire (FOSQ) is a self-report tool that assesses how sleepiness affects a person's ability to perform daily activities. The score range is 5 to 20, with higher scores indicating better functioning.
The Multidimensional Fatigue Inventory (MFI), scores each item on a 5-point Likert scale. The total score for each of the five fatigue dimensions (general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue) is calculated by summing the relevant items, resulting in a range of 20 to 100, where a higher score signifies more severe fatigue.
Week 1
Group
Value
95% CI
Behavioral Therapy (BT)
61.8
± 6.4
Cognitive Therapy (CT)
63.7
± 4.9
Week 8
Group
Value
95% CI
Behavioral Therapy (BT)
64.8
± 8.4
Cognitive Therapy (CT)
64.8
± 7.7
Week 32
Group
Value
95% CI
Behavioral Therapy (BT)
64.6
± 5.1
Cognitive Therapy (CT)
61.5
± 6.6
Wake After Sleep Onset (WASO)Secondary· Week 1, Week 8, and Week 32
WASO refers to the total amount of time a person spends awake after initially falling asleep and before finally waking up in the morning, essentially measuring the duration of wakefulness periods that occur once sleep has begun; a high WASO indicates fragmented sleep and can be a sign of a sleep disorder like insomnia. WASO will be reported in minutes.
Week 1
Group
Value
95% CI
Behavioral Therapy (BT)
34.8
± 47.8
Cognitive Therapy (CT)
41.5
± 28.9
Week 8
Group
Value
95% CI
Behavioral Therapy (BT)
6.5
± 7.1
Cognitive Therapy (CT)
40.4
± 20.8
Week 32
Group
Value
95% CI
Behavioral Therapy (BT)
18.7
± 9.6
Cognitive Therapy (CT)
8.5
± 6.3
Sponsor's own description
The purpose of this study is to evaluate the efficacy and effectiveness of Behavioral Therapy (BT) and Cognitive Therapy (CT) in Gulf War Veterans with insomnia. The Primary Outcome measure is the Insomnia Severity Index (ISI).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 26 January 2026
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/NCT03208049.