Trial Outcomes & Findings for The iTAP Study for Veterans (NCT NCT03804788)
NCT ID: NCT03804788
Last Updated: 2025-01-15
Results Overview
Number of eligible participants who enrolled in the study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
Assessed at baseline
Results posted on
2025-01-15
Participant Flow
Heavy-drinking Veterans were recruited via online digital marketing between April 2019 and August 2023.
Participant milestones
| Measure |
CBT-I
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for six (6) weeks.
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. A sixth week of treatment will be included - and scheduled for the same date as the post-treatment assessment - if the participant and research team agree that it would be beneficial (e.g., if a participant has difficulty grasping cognitive therapy concepts). Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
Sleep Hygiene
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
33
|
|
Overall Study
COMPLETED
|
38
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The iTAP Study for Veterans
Baseline characteristics by cohort
| Measure |
CBT-I
n=38 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for six (6) weeks.
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. A sixth week of treatment will be included - and scheduled for the same date as the post-treatment assessment - if the participant and research team agree that it would be beneficial (e.g., if a participant has difficulty grasping cognitive therapy concepts). Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
Sleep Hygiene
n=33 Participants
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
Total
n=71 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
37.7 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
33 participants
n=7 Participants
|
71 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at baselineNumber of eligible participants who enrolled in the study
Outcome measures
| Measure |
Eligible Participants
n=92 Participants
Individuals who met all inclusion/exclusion criteria and were invited to participate in the study
|
Sleep Hygiene
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
|---|---|---|
|
Recruitment
|
71 Participants
|
—
|
PRIMARY outcome
Timeframe: Assessed at post-treatment (week 6)Number of participants who complete all treatment sessions
Outcome measures
| Measure |
Eligible Participants
n=38 Participants
Individuals who met all inclusion/exclusion criteria and were invited to participate in the study
|
Sleep Hygiene
n=33 Participants
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
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|---|---|---|
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Retention
|
33 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.Population: Some participants lost to follow-up.
Assessed using Daily Drinking Questionnaire. Participants report the number of standard drinks consumed on each day of a typical week in the past month (on Monday, Tuesday, Wednesday, etc). Responses for each day are then summed to calculate a total "drinks per week" variable, where higher scores indicate more standard drinks.
Outcome measures
| Measure |
Eligible Participants
n=38 Participants
Individuals who met all inclusion/exclusion criteria and were invited to participate in the study
|
Sleep Hygiene
n=33 Participants
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
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|---|---|---|
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Drinking Quantity
Baseline
|
18.63 drinks per week
Standard Deviation 15.76
|
17.94 drinks per week
Standard Deviation 15.26
|
|
Drinking Quantity
Post (week 6)
|
15.29 drinks per week
Standard Deviation 14.73
|
12.00 drinks per week
Standard Deviation 9.84
|
|
Drinking Quantity
Follow-up (week 20)
|
15.12 drinks per week
Standard Deviation 21.96
|
15.73 drinks per week
Standard Deviation 15.89
|
PRIMARY outcome
Timeframe: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.Population: Some participants lost to follow-up.
Assessed using the Brief Young Adult Alcohol Consequences Questionnaire, which asks participants to indicate (yes/no) which of 24 consequences they have experienced in the past month. Responses range from 0 to 24, with greater scores indicating more consequences.
Outcome measures
| Measure |
Eligible Participants
n=38 Participants
Individuals who met all inclusion/exclusion criteria and were invited to participate in the study
|
Sleep Hygiene
n=33 Participants
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
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|---|---|---|
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Alcohol-related Consequences
Baseline
|
7.92 number of alcohol-related consequences
Standard Deviation 5.34
|
8.45 number of alcohol-related consequences
Standard Deviation 6.49
|
|
Alcohol-related Consequences
Post (week 6)
|
2.45 number of alcohol-related consequences
Standard Deviation 3.25
|
4.46 number of alcohol-related consequences
Standard Deviation 4.76
|
|
Alcohol-related Consequences
Follow-up (week 20)
|
3.31 number of alcohol-related consequences
Standard Deviation 4.20
|
5.28 number of alcohol-related consequences
Standard Deviation 4.35
|
PRIMARY outcome
Timeframe: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.Population: Some participants lost to follow-up.
Assessed using Insomnia Severity Index (ISI). ISI scores from 0 to 28, with higher scores indicating more severe insomnia.
Outcome measures
| Measure |
Eligible Participants
n=38 Participants
Individuals who met all inclusion/exclusion criteria and were invited to participate in the study
|
Sleep Hygiene
n=33 Participants
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
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|---|---|---|
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Insomnia Symptoms
Baseline
|
17.29 score on a scale
Standard Deviation 4.39
|
16.88 score on a scale
Standard Deviation 4.15
|
|
Insomnia Symptoms
Post (week 6)
|
7.24 score on a scale
Standard Deviation 4.83
|
12.27 score on a scale
Standard Deviation 4.57
|
|
Insomnia Symptoms
Follow-up (week 20)
|
6.97 score on a scale
Standard Deviation 5.84
|
12.30 score on a scale
Standard Deviation 5.14
|
PRIMARY outcome
Timeframe: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.Population: Some participants lost to follow-up.
On daily sleep diaries, participants reported sleep quality on a scale from 0 (very poor) to 4 (very good). Higher scores indicate better sleep quality.
Outcome measures
| Measure |
Eligible Participants
n=38 Participants
Individuals who met all inclusion/exclusion criteria and were invited to participate in the study
|
Sleep Hygiene
n=33 Participants
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
|---|---|---|
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Sleep Quality
Baseline
|
1.92 score on a scale
Standard Deviation 0.60
|
1.73 score on a scale
Standard Deviation 0.65
|
|
Sleep Quality
Post (week 6)
|
2.49 score on a scale
Standard Deviation 0.52
|
2.13 score on a scale
Standard Deviation 0.87
|
|
Sleep Quality
Follow-up (week 20)
|
2.53 score on a scale
Standard Deviation 0.63
|
2.14 score on a scale
Standard Deviation 0.93
|
PRIMARY outcome
Timeframe: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.Population: Some participants lost to follow-up.
Daily sleep diaries were used to calculate the amount of time that participants spent sleeping out of all the time they spent in bed. Values from 0 to 100, with higher scores indicating better sleep efficiency. The treatment goal is 85%.
Outcome measures
| Measure |
Eligible Participants
n=38 Participants
Individuals who met all inclusion/exclusion criteria and were invited to participate in the study
|
Sleep Hygiene
n=33 Participants
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
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|---|---|---|
|
Sleep Efficiency
Baselin
|
71.94 percentage of time asleep
Standard Deviation 11.84
|
68.82 percentage of time asleep
Standard Deviation 12.07
|
|
Sleep Efficiency
Post (week 6)
|
87.89 percentage of time asleep
Standard Deviation 6.39
|
77.89 percentage of time asleep
Standard Deviation 8.84
|
|
Sleep Efficiency
Follow-up (week 20)
|
87.10 percentage of time asleep
Standard Deviation 9.57
|
79.90 percentage of time asleep
Standard Deviation 10.57
|
PRIMARY outcome
Timeframe: Mean score at post-treatment (week 6).Assessed using the 8-item Client Satisfaction Questionnaire. Participants rate their satisfaction with insomnia treatment on a scale from 1 (poor) to 4 (excellent). Scores were summed and then divided by the number of items to create a meaningful standardized score. Higher scores indicate greater satisfaction.
Outcome measures
| Measure |
Eligible Participants
n=29 Participants
Individuals who met all inclusion/exclusion criteria and were invited to participate in the study
|
Sleep Hygiene
n=27 Participants
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
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|---|---|---|
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Client Satisfaction
|
3.59 score on a scale
Standard Deviation 0.40
|
2.72 score on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.Population: Some participants were lost to follow-up.
Assessed using the Monetary Choice Questionnaire (MCQ). Participants indicate if they would rather receive a smaller amount of money now or a greater amount of money in a specified amount of time (e.g., 100 days, 2 days). The MCQ is scored using a logarithmic subject-specific discount rate (k variable). K values typically fall between 0.0 and 0.5, with higher values indicating a preference for smaller, immediate rewards over larger, delayed reward ("delay discounting").
Outcome measures
| Measure |
Eligible Participants
n=36 Participants
Individuals who met all inclusion/exclusion criteria and were invited to participate in the study
|
Sleep Hygiene
n=33 Participants
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
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|---|---|---|
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Delay Discounting
Baseline
|
.028 log (k)
Standard Deviation .062
|
.022 log (k)
Standard Deviation .046
|
|
Delay Discounting
Post (week 6)
|
.037 log (k)
Standard Deviation .062
|
.009 log (k)
Standard Deviation .009
|
|
Delay Discounting
Follow-up (week 20)
|
.033 log (k)
Standard Deviation .062
|
.011 log (k)
Standard Deviation .014
|
SECONDARY outcome
Timeframe: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.Population: Some participants lost to follow-up.
Assessed using the Positive and Negative Affect Schedule. Participants indicate using a 1 (not at all) - 5 (extremely) scale to indicate to what extent they feel negative emotions. The final score is the sum of the ten negative emotions/feelings. Higher scores indicate more negative affect.
Outcome measures
| Measure |
Eligible Participants
n=38 Participants
Individuals who met all inclusion/exclusion criteria and were invited to participate in the study
|
Sleep Hygiene
n=33 Participants
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
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|---|---|---|
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Negative Affect
Baseline
|
16.82 score on a scale
Standard Deviation 7.06
|
16.39 score on a scale
Standard Deviation 6.82
|
|
Negative Affect
Post (week 6)
|
14.18 score on a scale
Standard Deviation 5.19
|
18.29 score on a scale
Standard Deviation 8.48
|
|
Negative Affect
Follow-up (week 20)
|
15.77 score on a scale
Standard Deviation 7.55
|
16.48 score on a scale
Standard Deviation 5.67
|
SECONDARY outcome
Timeframe: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.Population: Some participants lost to follow-up.
Assessed using the Difficulties in Emotion Regulation Scale (DERS-16). Scores range from 0 to 64, with higher scores indicating more difficulties with emotion regulation.
Outcome measures
| Measure |
Eligible Participants
n=38 Participants
Individuals who met all inclusion/exclusion criteria and were invited to participate in the study
|
Sleep Hygiene
n=33 Participants
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
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|---|---|---|
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Emotion Regulation
Baseline
|
34.53 score on a scale
Standard Deviation 13.22
|
32.85 score on a scale
Standard Deviation 12.17
|
|
Emotion Regulation
Post (week 6)
|
27.14 score on a scale
Standard Deviation 7.07
|
35.79 score on a scale
Standard Deviation 12.54
|
|
Emotion Regulation
Follow-up (week 20)
|
30.00 score on a scale
Standard Deviation 11.49
|
34.88 score on a scale
Standard Deviation 11.79
|
SECONDARY outcome
Timeframe: Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.Population: Some participants lost to follow-up.
Assessed using the Penn Alcohol Craving Scale (PACS). Scores range from 0 to 30, with higher scores indicating more craving.
Outcome measures
| Measure |
Eligible Participants
n=38 Participants
Individuals who met all inclusion/exclusion criteria and were invited to participate in the study
|
Sleep Hygiene
n=33 Participants
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
|---|---|---|
|
Alcohol Craving
Baseline
|
9.29 score on a scale
Standard Deviation 5.63
|
9.70 score on a scale
Standard Deviation 6.82
|
|
Alcohol Craving
Post (week 6)
|
6.46 score on a scale
Standard Deviation 5.91
|
7.62 score on a scale
Standard Deviation 6.74
|
|
Alcohol Craving
Follow-up (week 20)
|
7.30 score on a scale
Standard Deviation 7.18
|
7.04 score on a scale
Standard Deviation 5.96
|
SECONDARY outcome
Timeframe: Primary analyses will measure between-group change at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.Population: Some participants lost to follow-up.
Participants completed 2 weeks of sleep diaries assessing use of alcohol to help with sleep. Number of days reporting use of alcohol as a sleep aid was divided by the number of diaries completed to indicate the percentage of diary days they used alcohol as a sleep aid. Higher scores indicate more frequent use of alcohol as a sleep aid.
Outcome measures
| Measure |
Eligible Participants
n=38 Participants
Individuals who met all inclusion/exclusion criteria and were invited to participate in the study
|
Sleep Hygiene
n=33 Participants
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
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|---|---|---|
|
Percentage of Days Using Alcohol to Help With Sleep
Baseline
|
16.71 % of diary days using alcohol for sleep
Standard Deviation 27.86
|
6.73 % of diary days using alcohol for sleep
Standard Deviation 16.56
|
|
Percentage of Days Using Alcohol to Help With Sleep
Post (week 6)
|
3.22 % of diary days using alcohol for sleep
Standard Deviation 8.60
|
6.89 % of diary days using alcohol for sleep
Standard Deviation 22.94
|
|
Percentage of Days Using Alcohol to Help With Sleep
Follow-up (week 20)
|
2.24 % of diary days using alcohol for sleep
Standard Deviation 4.88
|
9.12 % of diary days using alcohol for sleep
Standard Deviation 26.17
|
SECONDARY outcome
Timeframe: Primary analyses will measure between-group change at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.Population: Some participants lost to follow-up.
Participants completed 2 weeks of sleep diaries assessing use of sleep medication. Number of days reporting use of sleep medication was divided by the number of diaries completed to indicate the percentage of diary days they used a sleep medication. Higher scores indicate more frequent use of sleep medication.
Outcome measures
| Measure |
Eligible Participants
n=38 Participants
Individuals who met all inclusion/exclusion criteria and were invited to participate in the study
|
Sleep Hygiene
n=33 Participants
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
|---|---|---|
|
Percentage of Days Using Sleep Medication
Baseline
|
30.92 % of diary days using a sleep medication
Standard Deviation 36.23
|
23.15 % of diary days using a sleep medication
Standard Deviation 35.49
|
|
Percentage of Days Using Sleep Medication
Post (week 6)
|
14.04 % of diary days using a sleep medication
Standard Deviation 30.71
|
28.44 % of diary days using a sleep medication
Standard Deviation 41.56
|
|
Percentage of Days Using Sleep Medication
Follow-up (week 20)
|
11.55 % of diary days using a sleep medication
Standard Deviation 28.18
|
20.36 % of diary days using a sleep medication
Standard Deviation 38.35
|
Adverse Events
CBT-I
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sleep Hygiene
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CBT-I
n=38 participants at risk
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for six (6) weeks.
Cognitive Behavioral Therapy for Insomnia: Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. A sixth week of treatment will be included - and scheduled for the same date as the post-treatment assessment - if the participant and research team agree that it would be beneficial (e.g., if a participant has difficulty grasping cognitive therapy concepts). Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
Sleep Hygiene
n=33 participants at risk
Sleep hygiene handout delivered once to all participants.
Sleep Hygeine: All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
|---|---|---|
|
Psychiatric disorders
Unanticipated Problem Involving Risk
|
2.6%
1/38 • Number of events 1 • Adverse event data were collected through study completion, up to 22 weeks.
|
0.00%
0/33 • Adverse event data were collected through study completion, up to 22 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place