Insomnia Treatment and Problems (the iTAP Study)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03627832

Acronym

iTAP

Enrollment

Registered

2018-08-13

Start date

2018-08-29

Completion date

2019-09-27

Last updated

2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol; Harmful Use, Insomnia

Keywords

alcohol, drinking, sleep, insomnia, young adult

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.

Interventions

BEHAVIORALCognitive 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.

BEHAVIORALSleep 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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, 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.

Intervention model description

Participants will be assigned to receive either Cognitive Behavioral Therapy for Insomnia (CBT-I) or Sleep Hygiene.

Eligibility

Sex/Gender

ALL

Age

18 Years to 30 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Alcohol-related Consequences	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.
Insomnia Severity	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	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	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	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.

Secondary

Measure	Time frame	Description
Negative Affect	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	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	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.
Delay Discounting	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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	28
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.	28
Total	56

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	10	1

Baseline characteristics

Characteristic	Total	CBT-I	Sleep Hygiene
Age, Continuous	22.5 years STANDARD_DEVIATION 2.7	22.3 years STANDARD_DEVIATION 2.7	22.5 years STANDARD_DEVIATION 2.8
Alcohol Use Disorder	47 Participants	25 Participants	22 Participants
College Enrollment	41 Participants	21 Participants	20 Participants
Comorbid Mental Health Disorder	24 Participants	14 Participants	10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	2 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants	26 Participants	28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Insomnia Severity	16.04 units on a scale STANDARD_DEVIATION 4.01	16.43 units on a scale STANDARD_DEVIATION 4.06	15.93 units on a scale STANDARD_DEVIATION 2.92
Region of Enrollment United States	56 participants	28 participants	28 participants
Sex: Female, Male Female	42 Participants	22 Participants	20 Participants
Sex: Female, Male Male	14 Participants	6 Participants	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 28	0 / 28
other Total, other adverse events	0 / 28	0 / 28
serious Total, serious adverse events	0 / 28	0 / 28

Outcome results

Primary

Alcohol-related Consequences

Assessed using the Brief Young Adult Alcohol Consequences Questionnaire. Scores range from 0-24, with higher scores indicating more alcohol-related consequences.