Trial Outcomes & Findings for Predictors of Response to Insomnia Treatments for Gulf War Veterans (NCT NCT03208049)
NCT ID: NCT03208049
Last Updated: 2026-01-26
Results Overview
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 zero to 28.
COMPLETED
NA
50 participants
Week 1, Week 8, and Week 32
2026-01-26
Participant Flow
Participant milestones
| Measure |
Behavioral Therapy (BT)
Behavioral Therapy (BT). The subject is prescribed a time in bed. After one week, depending on subject's daily sleep logs and adherence to treatment, the therapist suggests a new time in bed prescription. Napping is neither prescribed nor proscribed. However, if subjects find themselves having difficulty staying awake during the day, they are advised to take a brief (15 to 30 minutes) nap to ensure their safety. Subjects in BT are also provided with information about relevant elements of the science of sleep and healthy sleep practices
|
Cognitive Therapy (CT)
Cognitive Therapy (CT). The CT treatment module is designed to meet three general goals: 1) identify dysfunctional sleep cognitions, 2) challenge their validity, and 3) replace them with more adaptive substitutes. Several specific techniques designed to meet these goals are discussed in materials distributed to subjects. Similar to BT, subjects in CT are provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Baseline characteristics by cohort
| Measure |
Behavioral Therapy (BT)
n=26 Participants
Behavioral Therapy (BT). The subject is prescribed a time in bed. After one week, depending on subject's daily sleep logs and adherence to treatment, the therapist suggests a new time in bed prescription. Napping is neither prescribed nor proscribed. However, if subjects find themselves having difficulty staying awake during the day, they are advised to take a brief (15 to 30 minutes) nap to ensure their safety. Subjects in BT are also provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
Cognitive Therapy (CT)
n=24 Participants
Cognitive Therapy (CT). The CT treatment module is designed to meet three general goals: 1) identify dysfunctional sleep cognitions, 2) challenge their validity, and 3) replace them with more adaptive substitutes. Several specific techniques designed to meet these goals are discussed in materials distributed to subjects. Similar to BT, subjects in CT are provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 9.3 • n=25 Participants
|
54.8 years
STANDARD_DEVIATION 6.0 • n=25 Participants
|
56.5 years
STANDARD_DEVIATION 8.0 • n=50 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
10 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=25 Participants
|
19 Participants
n=25 Participants
|
40 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=25 Participants
|
3 Participants
n=25 Participants
|
4 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=25 Participants
|
21 Participants
n=25 Participants
|
46 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=25 Participants
|
13 Participants
n=25 Participants
|
24 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=25 Participants
|
7 Participants
n=25 Participants
|
19 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=25 Participants
|
4 Participants
n=25 Participants
|
6 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=25 Participants
|
24 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Insomnia Severity Index (ISI)
|
17.0 units on a scale
STANDARD_DEVIATION 4.4 • n=25 Participants
|
18.9 units on a scale
STANDARD_DEVIATION 3.7 • n=25 Participants
|
17.9 units on a scale
STANDARD_DEVIATION 4.2 • n=50 Participants
|
PRIMARY outcome
Timeframe: Week 1, Week 8, and Week 32Population: Number analyzed decreased due to dropouts and missing data.
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 zero to 28.
Outcome measures
| Measure |
Behavioral Therapy (BT)
n=26 Participants
Behavioral Therapy (BT). The subject is prescribed a time in bed. After one week, depending on subject's daily sleep logs and adherence to treatment, the therapist suggests a new time in bed prescription. Napping is neither prescribed nor proscribed. However, if subjects find themselves having difficulty staying awake during the day, they are advised to take a brief (15 to 30 minutes) nap to ensure their safety. Subjects in BT are also provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
Cognitive Therapy (CT)
n=24 Participants
Cognitive Therapy (CT). The CT treatment module is designed to meet three general goals: 1) identify dysfunctional sleep cognitions, 2) challenge their validity, and 3) replace them with more adaptive substitutes. Several specific techniques designed to meet these goals are discussed in materials distributed to subjects. Similar to BT, subjects in CT are provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
|---|---|---|
|
Insomnia Severity Index (ISI)
Week 1
|
17.0 score on a scale
Standard Deviation 4.4
|
18.9 score on a scale
Standard Deviation 3.7
|
|
Insomnia Severity Index (ISI)
Week 8
|
7.3 score on a scale
Standard Deviation 4.9
|
10.9 score on a scale
Standard Deviation 7.7
|
|
Insomnia Severity Index (ISI)
Week 32
|
7.9 score on a scale
Standard Deviation 7.1
|
9.8 score on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Week 1, Week 8, and Week 32Population: Number analyzed decreased due to dropouts and missing data.
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.
Outcome measures
| Measure |
Behavioral Therapy (BT)
n=25 Participants
Behavioral Therapy (BT). The subject is prescribed a time in bed. After one week, depending on subject's daily sleep logs and adherence to treatment, the therapist suggests a new time in bed prescription. Napping is neither prescribed nor proscribed. However, if subjects find themselves having difficulty staying awake during the day, they are advised to take a brief (15 to 30 minutes) nap to ensure their safety. Subjects in BT are also provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
Cognitive Therapy (CT)
n=23 Participants
Cognitive Therapy (CT). The CT treatment module is designed to meet three general goals: 1) identify dysfunctional sleep cognitions, 2) challenge their validity, and 3) replace them with more adaptive substitutes. Several specific techniques designed to meet these goals are discussed in materials distributed to subjects. Similar to BT, subjects in CT are provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
|---|---|---|
|
Beck Depression Index (BDI)
Week 1
|
11.2 units on a scale
Standard Deviation 8.1
|
12.6 units on a scale
Standard Deviation 9.4
|
|
Beck Depression Index (BDI)
Week 8
|
6.1 units on a scale
Standard Deviation 8.3
|
10.4 units on a scale
Standard Deviation 13.9
|
|
Beck Depression Index (BDI)
Week 32
|
7.7 units on a scale
Standard Deviation 9.0
|
8.7 units on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Week 1, Week 8, and Week 32Population: Number analyzed decreased due to dropouts and missing data.
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.
Outcome measures
| Measure |
Behavioral Therapy (BT)
n=26 Participants
Behavioral Therapy (BT). The subject is prescribed a time in bed. After one week, depending on subject's daily sleep logs and adherence to treatment, the therapist suggests a new time in bed prescription. Napping is neither prescribed nor proscribed. However, if subjects find themselves having difficulty staying awake during the day, they are advised to take a brief (15 to 30 minutes) nap to ensure their safety. Subjects in BT are also provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
Cognitive Therapy (CT)
n=24 Participants
Cognitive Therapy (CT). The CT treatment module is designed to meet three general goals: 1) identify dysfunctional sleep cognitions, 2) challenge their validity, and 3) replace them with more adaptive substitutes. Several specific techniques designed to meet these goals are discussed in materials distributed to subjects. Similar to BT, subjects in CT are provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
|---|---|---|
|
Beck Anxiety Index (BAI)
Week 32
|
7.8 units on a scale
Standard Deviation 9.3
|
12.8 units on a scale
Standard Deviation 13.4
|
|
Beck Anxiety Index (BAI)
Week 1
|
10.2 units on a scale
Standard Deviation 10.1
|
8.5 units on a scale
Standard Deviation 8.0
|
|
Beck Anxiety Index (BAI)
Week 8
|
5.4 units on a scale
Standard Deviation 6.6
|
7.6 units on a scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Week 1, Week 8, and Week 32Population: Number analyzed decreased due to dropouts and missing data.
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,
Outcome measures
| Measure |
Behavioral Therapy (BT)
n=14 Participants
Behavioral Therapy (BT). The subject is prescribed a time in bed. After one week, depending on subject's daily sleep logs and adherence to treatment, the therapist suggests a new time in bed prescription. Napping is neither prescribed nor proscribed. However, if subjects find themselves having difficulty staying awake during the day, they are advised to take a brief (15 to 30 minutes) nap to ensure their safety. Subjects in BT are also provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
Cognitive Therapy (CT)
n=11 Participants
Cognitive Therapy (CT). The CT treatment module is designed to meet three general goals: 1) identify dysfunctional sleep cognitions, 2) challenge their validity, and 3) replace them with more adaptive substitutes. Several specific techniques designed to meet these goals are discussed in materials distributed to subjects. Similar to BT, subjects in CT are provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
|---|---|---|
|
SF 36-Item Health Survey 1.0 (SF-36)
Week 1
|
62.4 units on a scale
Standard Deviation 18.8
|
62.1 units on a scale
Standard Deviation 18.5
|
|
SF 36-Item Health Survey 1.0 (SF-36)
Week 8
|
71.4 units on a scale
Standard Deviation 14.9
|
62.3 units on a scale
Standard Deviation 23.9
|
|
SF 36-Item Health Survey 1.0 (SF-36)
Week 32
|
52.2 units on a scale
Standard Deviation 15.9
|
56.5 units on a scale
Standard Deviation 24.2
|
SECONDARY outcome
Timeframe: Week 1, Week 8, and Week 32Population: Number analyzed decreased due to dropouts and missing data.
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.
Outcome measures
| Measure |
Behavioral Therapy (BT)
n=25 Participants
Behavioral Therapy (BT). The subject is prescribed a time in bed. After one week, depending on subject's daily sleep logs and adherence to treatment, the therapist suggests a new time in bed prescription. Napping is neither prescribed nor proscribed. However, if subjects find themselves having difficulty staying awake during the day, they are advised to take a brief (15 to 30 minutes) nap to ensure their safety. Subjects in BT are also provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
Cognitive Therapy (CT)
n=22 Participants
Cognitive Therapy (CT). The CT treatment module is designed to meet three general goals: 1) identify dysfunctional sleep cognitions, 2) challenge their validity, and 3) replace them with more adaptive substitutes. Several specific techniques designed to meet these goals are discussed in materials distributed to subjects. Similar to BT, subjects in CT are provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
|---|---|---|
|
Functional Outcomes of Sleep Questionnaire (FOSQ)
Week 32
|
16.9 units on a scale
Standard Deviation 4.0
|
15.4 units on a scale
Standard Deviation 4.4
|
|
Functional Outcomes of Sleep Questionnaire (FOSQ)
Week 1
|
15.3 units on a scale
Standard Deviation 4.1
|
14.0 units on a scale
Standard Deviation 3.3
|
|
Functional Outcomes of Sleep Questionnaire (FOSQ)
Week 8
|
17.3 units on a scale
Standard Deviation 3.7
|
14.8 units on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Week 1, Week 8, and Week 32Population: Number analyzed decreased due to dropouts and missing data.
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.
Outcome measures
| Measure |
Behavioral Therapy (BT)
n=25 Participants
Behavioral Therapy (BT). The subject is prescribed a time in bed. After one week, depending on subject's daily sleep logs and adherence to treatment, the therapist suggests a new time in bed prescription. Napping is neither prescribed nor proscribed. However, if subjects find themselves having difficulty staying awake during the day, they are advised to take a brief (15 to 30 minutes) nap to ensure their safety. Subjects in BT are also provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
Cognitive Therapy (CT)
n=22 Participants
Cognitive Therapy (CT). The CT treatment module is designed to meet three general goals: 1) identify dysfunctional sleep cognitions, 2) challenge their validity, and 3) replace them with more adaptive substitutes. Several specific techniques designed to meet these goals are discussed in materials distributed to subjects. Similar to BT, subjects in CT are provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
|---|---|---|
|
Multidimensional Fatigue Inventory (MFI)
Week 1
|
61.8 units on a scale
Standard Deviation 6.4
|
63.7 units on a scale
Standard Deviation 4.9
|
|
Multidimensional Fatigue Inventory (MFI)
Week 8
|
64.8 units on a scale
Standard Deviation 8.4
|
64.8 units on a scale
Standard Deviation 7.7
|
|
Multidimensional Fatigue Inventory (MFI)
Week 32
|
64.6 units on a scale
Standard Deviation 5.1
|
61.5 units on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Week 1, Week 8, and Week 32Population: Number analyzed decreased due to dropouts and missing data.
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.
Outcome measures
| Measure |
Behavioral Therapy (BT)
n=19 Participants
Behavioral Therapy (BT). The subject is prescribed a time in bed. After one week, depending on subject's daily sleep logs and adherence to treatment, the therapist suggests a new time in bed prescription. Napping is neither prescribed nor proscribed. However, if subjects find themselves having difficulty staying awake during the day, they are advised to take a brief (15 to 30 minutes) nap to ensure their safety. Subjects in BT are also provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
Cognitive Therapy (CT)
n=23 Participants
Cognitive Therapy (CT). The CT treatment module is designed to meet three general goals: 1) identify dysfunctional sleep cognitions, 2) challenge their validity, and 3) replace them with more adaptive substitutes. Several specific techniques designed to meet these goals are discussed in materials distributed to subjects. Similar to BT, subjects in CT are provided with information about relevant elements of the science of sleep and healthy sleep practices.
|
|---|---|---|
|
Wake After Sleep Onset (WASO)
Week 32
|
18.7 Minutes
Standard Deviation 9.6
|
8.5 Minutes
Standard Deviation 6.3
|
|
Wake After Sleep Onset (WASO)
Week 1
|
34.8 Minutes
Standard Deviation 47.8
|
41.5 Minutes
Standard Deviation 28.9
|
|
Wake After Sleep Onset (WASO)
Week 8
|
6.5 Minutes
Standard Deviation 7.1
|
40.4 Minutes
Standard Deviation 20.8
|
Adverse Events
Behavioral Therapy (BT)
Cognitive Therapy (CT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Andrea Goldstein-Piekarski
VA Palo Alto Health Care System, Palo Alto, CA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place