Trial Outcomes & Findings for Insomnia Treatment and Problems (the iTAP Study) (NCT NCT03627832)
NCT ID: NCT03627832
Last Updated: 2020-06-16
Results Overview
Assessed using the Insomnia Severity Index. Scores range from 0 to 28, with higher scores indicating higher insomnia severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Results posted on
2020-06-16
Participant Flow
Participant milestones
| Measure |
CBT-I
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.
Participants will attend 1-hour individual sessions of CBT-I once a week for five weeks. 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.
Participants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
Sleep Hygiene
Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
18
|
27
|
|
Overall Study
NOT COMPLETED
|
10
|
1
|
Reasons for withdrawal
| Measure |
CBT-I
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.
Participants will attend 1-hour individual sessions of CBT-I once a week for five weeks. 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.
Participants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
Sleep Hygiene
Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
1
|
Baseline Characteristics
Insomnia Treatment and Problems (the iTAP Study)
Baseline characteristics by cohort
| Measure |
CBT-I
n=28 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.
Participants will attend 1-hour individual sessions of CBT-I once a week for five weeks. 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.
Participants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
Sleep Hygiene
n=28 Participants
Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.3 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
22.5 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
22.5 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 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
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Alcohol Use Disorder
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
College Enrollment
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Comorbid Mental Health Disorder
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Insomnia Severity
|
16.43 units on a scale
STANDARD_DEVIATION 4.06 • n=5 Participants
|
15.93 units on a scale
STANDARD_DEVIATION 2.92 • n=7 Participants
|
16.04 units on a scale
STANDARD_DEVIATION 4.01 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)Assessed using the Insomnia Severity Index. Scores range from 0 to 28, with higher scores indicating higher insomnia severity.
Outcome measures
| Measure |
CBT-I
n=28 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.
Participants will attend 1-hour individual sessions of CBT-I once a week for five weeks. 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.
Participants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
Sleep Hygiene
n=28 Participants
Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
|---|---|---|
|
Insomnia Severity
Post Treatment
|
6.86 units on scale, Insomnia Severity Index
Standard Deviation 3.66
|
10.84 units on scale, Insomnia Severity Index
Standard Deviation 3.5
|
|
Insomnia Severity
1-Month Follow-Up
|
6.58 units on scale, Insomnia Severity Index
Standard Deviation 3.41
|
9.32 units on scale, Insomnia Severity Index
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)Assessed using daily sleep diaries and actigraphy -- sleep efficiency is the proportion of time spent in bed (from lights out until out of bed in the morning) that is actually spent sleeping (subtracting how long it took to fall asleep and how much time was spent awake in the middle of the night).
Outcome measures
| Measure |
CBT-I
n=28 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.
Participants will attend 1-hour individual sessions of CBT-I once a week for five weeks. 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.
Participants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
Sleep Hygiene
n=28 Participants
Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
|---|---|---|
|
Sleep Efficiency
Post Treatment
|
79.27 % of time spent in bed actually asleep
Standard Deviation 7.95
|
76.48 % of time spent in bed actually asleep
Standard Deviation 7.09
|
|
Sleep Efficiency
1-Month Follow-Up
|
76.22 % of time spent in bed actually asleep
Standard Deviation 9.8
|
76.54 % of time spent in bed actually asleep
Standard Deviation 7.94
|
PRIMARY outcome
Timeframe: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)Assessed using a single question on the daily sleep diary. Sleep quality score ranges from 0-4, where 0=very poor sleep quality and 4=very good sleep quality.
Outcome measures
| Measure |
CBT-I
n=28 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.
Participants will attend 1-hour individual sessions of CBT-I once a week for five weeks. 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.
Participants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
Sleep Hygiene
n=28 Participants
Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
|---|---|---|
|
Sleep Quality
Post Treatment
|
2.25 units on a scale
Standard Deviation .66
|
2.32 units on a scale
Standard Deviation .62
|
|
Sleep Quality
1-Month Follow-Up
|
2.49 units on a scale
Standard Deviation .62
|
2.29 units on a scale
Standard Deviation .55
|
PRIMARY outcome
Timeframe: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)Assessed using the Daily Drinking Questionnaire. Participants estimate how many alcoholic drinks they typically consume on each day of the week, averaged over the past 3 months.Responses for drinking quantity range from 0 to infinity, where higher numbers indicate more standard drinks consumed per day. Reports from each day are summed to create a "Drinks Per Week" score. Participants also report the amount of time they typically spend drinking during each day of the week. Responses range from 0-24 hours per day, where higher numbers indicate more hours drinking.
Outcome measures
| Measure |
CBT-I
n=28 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.
Participants will attend 1-hour individual sessions of CBT-I once a week for five weeks. 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.
Participants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
Sleep Hygiene
n=28 Participants
Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
|---|---|---|
|
Drinking Quantity
Post Treatment
|
11.45 Drinks per Week
Standard Deviation 8.25
|
11.80 Drinks per Week
Standard Deviation 9.20
|
|
Drinking Quantity
1-Month Follow-Up
|
8.7 Drinks per Week
Standard Deviation 7.70
|
9.33 Drinks per Week
Standard Deviation 8.77
|
PRIMARY outcome
Timeframe: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)Assessed using the Brief Young Adult Alcohol Consequences Questionnaire. Scores range from 0-24, with higher scores indicating more alcohol-related consequences.
Outcome measures
| Measure |
CBT-I
n=28 Participants
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week.
Participants will attend 1-hour individual sessions of CBT-I once a week for five weeks. 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.
Participants will also receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
Sleep Hygiene
n=28 Participants
Participants will receive a one-page handout on sleep hygiene that is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
|
|---|---|---|
|
Alcohol-related Consequences
Post Treatment
|
4.18 units on a scale - BYAAC
Standard Deviation 5.53
|
5.01 units on a scale - BYAAC
Standard Deviation 4.18
|
|
Alcohol-related Consequences
1-Month Follow-Up
|
5.04 units on a scale - BYAAC
Standard Deviation 5.15
|
3.47 units on a scale - BYAAC
Standard Deviation 3.17
|
SECONDARY outcome
Timeframe: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)Population: Secondary data have not been analyzed yet.
Assessed using the Monetary Choice Questionnaire. Responses will be used to calculate discount rate (k), consistency of the discount rate (the inferred k), and the proportion of immediate reward choices (immediate choice ratios).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)Population: Secondary data have not been analyzed yet.
Assessed using the Positive and Negative Affect Schedule. Participants respond to words that describe negative feelings/emotions and report the extent (1-5) that they feel each emotion presently or during the past week. Higher scores indicate higher negative affect.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)Population: Secondary data not analyzed yet.
Assessed using the Difficulties with Emotion Regulation Scale. Scores range from 36-180, with higher scores indicating more difficulty with emotion regulation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)Population: Secondary data not analyzed yet.
Assessed using the Penn Alcohol Craving Scale. Scores range from 0-30, with higher scores indicating greater alcohol craving.
Outcome measures
Outcome data not reported
Adverse Events
CBT-I
Serious events: 0 serious events
Other events: 0 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
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place