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Insomnia Treatment and Problems (the iTAP Study) (iTAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627832
Recruitment Status : Completed
First Posted : August 13, 2018
Results First Posted : June 4, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Mary E Miller, University of Missouri-Columbia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Insomnia
Alcohol; Harmful Use
Interventions Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Behavioral: Sleep Hygiene
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CBT-I Sleep Hygiene
Hide Arm/Group Description

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.

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.
Period Title: Overall Study
Started 28 28
Completed 18 27
Not Completed 10 1
Reason Not Completed
Withdrawal by Subject             10             1
Arm/Group Title CBT-I Sleep Hygiene Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 28 28 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 28 participants 56 participants
22.3  (2.7) 22.5  (2.8) 22.5  (2.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
Female
22
  78.6%
20
  71.4%
42
  75.0%
Male
6
  21.4%
8
  28.6%
14
  25.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
Hispanic or Latino
2
   7.1%
0
   0.0%
2
   3.6%
Not Hispanic or Latino
26
  92.9%
28
 100.0%
54
  96.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 28 participants 56 participants
28 28 56
Alcohol Use Disorder  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
25
  89.3%
22
  78.6%
47
  83.9%
College Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
21
  75.0%
20
  71.4%
41
  73.2%
Comorbid Mental Health Disorder  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
14
  50.0%
10
  35.7%
24
  42.9%
Insomnia Severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 28 participants 28 participants 56 participants
16.43  (4.06) 15.93  (2.92) 16.04  (4.01)
[1]
Measure Description: Insomnia Severity measured using the Insomnia Severity Index. Participants rate how severe their concerns are to seven sleep-related questions on a scale of 0-4, where higher scores indicate worse insomnia. Total scores range from 0-28.
1.Primary Outcome
Title Insomnia Severity
Hide Description Assessed using the Insomnia Severity Index. Scores range from 0 to 28, with higher scores indicating higher insomnia severity.
Time Frame Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CBT-I Sleep Hygiene
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: units on scale, Insomnia Severity Index
Post Treatment 6.86  (3.66) 10.84  (3.5)
1-Month Follow-Up 6.58  (3.41) 9.32  (4.8)
2.Primary Outcome
Title Sleep Efficiency
Hide Description 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).
Time Frame Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CBT-I Sleep Hygiene
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: % of time spent in bed actually asleep
Post Treatment 79.27  (7.95) 76.48  (7.09)
1-Month Follow-Up 76.22  (9.8) 76.54  (7.94)
3.Primary Outcome
Title Sleep Quality
Hide Description 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.
Time Frame Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CBT-I Sleep Hygiene
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Post Treatment 2.25  (.66) 2.32  (.62)
1-Month Follow-Up 2.49  (.62) 2.29  (.55)
4.Primary Outcome
Title Drinking Quantity
Hide Description 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.
Time Frame Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CBT-I Sleep Hygiene
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: Drinks per Week
Post Treatment 11.45  (8.25) 11.80  (9.20)
1-Month Follow-Up 8.7  (7.70) 9.33  (8.77)
5.Primary Outcome
Title Alcohol-related Consequences
Hide Description Assessed using the Brief Young Adult Alcohol Consequences Questionnaire. Scores range from 0-24, with higher scores indicating more alcohol-related consequences.
Time Frame Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CBT-I Sleep Hygiene
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: units on a scale - BYAAC
Post Treatment 4.18  (5.53) 5.01  (4.18)
1-Month Follow-Up 5.04  (5.15) 3.47  (3.17)
6.Secondary Outcome
Title Delay Discounting
Hide Description 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).
Time Frame Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary data have not been analyzed yet.
Arm/Group Title CBT-I Sleep Hygiene
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Negative Affect
Hide Description 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.
Time Frame Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary data have not been analyzed yet.
Arm/Group Title CBT-I Sleep Hygiene
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Emotion Regulation
Hide Description Assessed using the Difficulties with Emotion Regulation Scale. Scores range from 36-180, with higher scores indicating more difficulty with emotion regulation.
Time Frame Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary data not analyzed yet.
Arm/Group Title CBT-I Sleep Hygiene
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Alcohol Craving
Hide Description Assessed using the Penn Alcohol Craving Scale. Scores range from 0-30, with higher scores indicating greater alcohol craving.
Time Frame Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary data not analyzed yet.
Arm/Group Title CBT-I Sleep Hygiene
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 11 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CBT-I Sleep Hygiene
Hide Arm/Group Description

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.

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.
All-Cause Mortality
CBT-I Sleep Hygiene
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Hide Serious Adverse Events
CBT-I Sleep Hygiene
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CBT-I Sleep Hygiene
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mary Beth Miller
Organization: University of Missouri
Phone: 573-882-1813
EMail: millmary@health.missouri.edu
Layout table for additonal information
Responsible Party: Mary E Miller, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03627832    
Other Study ID Numbers: 2010684
DXV15 ( Other Grant/Funding Number: University of Missouri Research Board )
First Submitted: July 23, 2018
First Posted: August 13, 2018
Results First Submitted: April 27, 2020
Results First Posted: June 4, 2020
Last Update Posted: June 16, 2020