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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

Brief Summary:
This project aims to evaluate the efficacy of insomnia treatment in improving insomnia symptoms and alcohol-related problems among heavy-drinking young adults.

Condition or disease Intervention/treatment Phase
Insomnia Alcohol; Harmful Use Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) Behavioral: Sleep Hygiene Not Applicable

Detailed Description:
Heavy alcohol use is prevalent among young adults and results in significant physical and psychological burden. Despite wide implementation of alcohol risk reduction efforts on college campuses, rates of heavy alcohol consumption remain high, with 35% of students reporting consumption of 5+ drinks on the same occasion in the past 2 weeks. Thus, additional strategies are needed to reduce the burden of heavy alcohol use among college students. More than half of heavy-drinking college students report symptoms of insomnia. In turn, insomnia symptoms have been associated with increased risk of alcohol-related problems. The proposed project aims to reduce the burden of heavy alcohol use on college campuses by examining the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) in reducing alcohol use and related problems among heavy-drinking college students. Twenty seven young adults who indicate risk for problem drinking and meet DSM-5 criteria for Insomnia Disorder will participate in a 5-week pilot trial. Participants will complete five individual sessions of CBT-I. Outcomes will be assessed at the end of the active intervention period (6 weeks) and 1 month post-intervention. Outcomes of interest include insomnia severity, total wake time, sleep quality, drinking quantity, and alcohol-related consequences. The proposed research aims to reduce the harms associated with heavy alcohol use among young adults by improving the availability of efficacious treatment. It will impact understanding of the benefits of CBT-I, and it is innovative because it evaluates improvement in insomnia as a mechanism for improvements in alcohol use disorder (AUD). This research is consistent with the National Institute on Alcohol Abuse and Alcoholism's initiative to evaluate and promote interventions that prevent the progression of AUD in diverse populations. It will enhance the stature of the university by improving our ability to compete successfully for federal funding to conduct high-quality research.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to receive either Cognitive Behavioral Therapy for Insomnia (CBT-I) or Sleep Hygiene.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: PI Miller will not be blinded to block size or participant assignment because she will inform study therapists of participant assignment to conditions. However, PI Miller and study therapists will be blinded to assessment outcomes, and the assessment RA will be blinded to participant condition. All participants will be told that they will be assigned to one of two insomnia treatment conditions in order to blind them to condition assignment.
Primary Purpose: Treatment
Official Title: Insomnia Treatment and Problems (the iTAP Study)
Actual Study Start Date : August 29, 2018
Actual Primary Completion Date : September 27, 2019
Actual Study Completion Date : September 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Sleep

Arm Intervention/treatment
Experimental: CBT-I
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for 6 weeks
Behavioral: 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. 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.

Behavioral: Sleep Hygiene
All participants will receive a one-page handout on sleep hygiene. 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.

Active Comparator: Sleep Hygiene
Sleep hygiene handout delivered once to all participants
Behavioral: Sleep Hygiene
All participants will receive a one-page handout on sleep hygiene. 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.




Primary Outcome Measures :
  1. Insomnia Severity [ Time Frame: 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.

  2. Sleep Efficiency [ Time Frame: 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).

  3. Sleep Quality [ Time Frame: 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.

  4. Drinking Quantity [ Time Frame: 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.

  5. Alcohol-related Consequences [ Time Frame: 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.


Secondary Outcome Measures :
  1. Delay Discounting [ Time Frame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) ]
    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).

  2. Negative Affect [ Time Frame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) ]
    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.

  3. Emotion Regulation [ Time Frame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) ]
    Assessed using the Difficulties with Emotion Regulation Scale. Scores range from 36-180, with higher scores indicating more difficulty with emotion regulation.

  4. Alcohol Craving [ Time Frame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) ]
    Assessed using the Penn Alcohol Craving Scale. Scores range from 0-30, with higher scores indicating greater alcohol craving.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-30 years
  • Heavy episodic drinking, defined as 1 heavy drinking episode (4/5+ drinks for women/men) in the past 30 days on the Timeline Followback
  • DSM-5 criteria for insomnia, with "daytime impairment" operationalized as ISI scores =>10

Exclusion Criteria:

  • Unable to provide informed consent
  • New sleep medication in the past 6 weeks
  • Contraindications for CBT-I (mania or seizure disorder)
  • Severe psychiatric disorder that requires clinical attention (PTSD, major depression)
  • Current treatment for insomnia or alcohol use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627832


Locations
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United States, Missouri
University of Missouri-Columbia
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Mary Beth Miller, PhD University of Missouri-Columbia
  Study Documents (Full-Text)

Documents provided by Mary E Miller, University of Missouri-Columbia:
Informed Consent Form  [PDF] May 22, 2019

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Responsible Party: Mary E Miller, Professor, Psychiatry, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03627832    
Other Study ID Numbers: 2010684
DXV15 ( Other Grant/Funding Number: University of Missouri Research Board )
First Posted: August 13, 2018    Key Record Dates
Results First Posted: June 4, 2020
Last Update Posted: June 16, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary E Miller, University of Missouri-Columbia:
alcohol
drinking
sleep
insomnia
young adult
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders