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

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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

Tracking Information
First Submitted Date  ICMJE July 23, 2018
First Posted Date  ICMJE August 13, 2018
Results First Submitted Date  ICMJE April 27, 2020
Results First Posted Date  ICMJE June 4, 2020
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE August 29, 2018
Actual Primary Completion Date September 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • 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.
  • Total wake time [ 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 Quality [ Time Frame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) ]
    Assessed using daily sleep diaries
  • Drinking Quantity [ Time Frame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) ]
    Assessed using the Timeline Followback
  • 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.
  • Frequency of heavy-episodic drinking [ Time Frame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) ]
    Assessed using the Timeline Followback
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2020)
  • 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).
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • 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).
  • 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
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Insomnia Treatment and Problems (the iTAP Study)
Official Title  ICMJE Insomnia Treatment and Problems (the iTAP Study)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Insomnia
  • Alcohol; Harmful Use
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: CBT-I
    Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for 6 weeks
    Interventions:
    • Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
    • Behavioral: Sleep Hygiene
  • Active Comparator: Sleep Hygiene
    Sleep hygiene handout delivered once to all participants
    Intervention: Behavioral: Sleep Hygiene
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2019)
56
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2018)
52
Actual Study Completion Date  ICMJE September 27, 2019
Actual Primary Completion Date September 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03627832
Other Study ID Numbers  ICMJE 2010684
DXV15 ( Other Grant/Funding Number: University of Missouri Research Board )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mary E Miller, University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary Beth Miller, PhD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP