Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DXV15 | Other Grant/Funding Number | University of Missouri Research Board |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This project aims to evaluate the efficacy of insomnia treatment in improving insomnia symptoms and alcohol-related problems among heavy-drinking young adults.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I | Experimental | Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for 6 weeks |
|
| Sleep Hygiene | Active Comparator | Sleep hygiene handout delivered once to all participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity | Assessed using the Insomnia Severity Index. Scores range from 0 to 28, with higher scores indicating higher insomnia severity. | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
| Sleep Efficiency | 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). | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
| Sleep Quality | 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. | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
| Drinking Quantity | 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. | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Delay Discounting | 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). | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mary Beth Miller, PhD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri-Columbia | Columbia | Missouri | 65212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34870584 | Derived | Miller MB, Carpenter RW, Freeman LK, Curtis AF, Yurasek AM, McCrae CS. Cannabis use as a moderator of cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2022 Apr 1;18(4):1047-1054. doi: 10.5664/jcsm.9796. | |
| 34605392 | Derived | Miller MB, Curtis AF, Hall NA, Freeman LK, Everson AT, Martinez LD, Park CJ, McCrae CS. Daily associations between modifiable sleep behaviors and nighttime sleep among young adult drinkers with insomnia. J Clin Sleep Med. 2022 Mar 1;18(3):703-712. doi: 10.5664/jcsm.9706. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insomnia Severity | Assessed using the Insomnia Severity Index. Scores range from 0 to 28, with higher scores indicating higher insomnia severity. | Posted | Mean | Standard Deviation | units on scale, Insomnia Severity Index | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
|
11 Weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary Beth Miller | University of Missouri | 573-882-1813 | millmary@health.missouri.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 22, 2019 | Mar 23, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2019 | May 8, 2020 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Participants will be assigned to receive either Cognitive Behavioral Therapy for Insomnia (CBT-I) or Sleep Hygiene.
Not provided
Not provided
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.
|
| Sleep Hygiene | Behavioral | 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. |
|
| Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
| Negative Affect |
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. |
| Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
| Emotion Regulation | Assessed using the Difficulties with Emotion Regulation Scale. Scores range from 36-180, with higher scores indicating more difficulty with emotion regulation. | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
| Alcohol Craving | Assessed using the Penn Alcohol Craving Scale. Scores range from 0-30, with higher scores indicating greater alcohol craving. | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
| 33773200 | Derived | Miller MB, Freeman LK, Deroche CB, Park CJ, Hall NA, McCrae CS. Sleep and alcohol use among young adult drinkers with Insomnia: A daily process model. Addict Behav. 2021 Aug;119:106911. doi: 10.1016/j.addbeh.2021.106911. Epub 2021 Mar 15. |
| 32886778 | Derived | Miller MB, Deroche CB, Freeman LK, Park CJ, Hall NA, Sahota PK, McCrae CS. Cognitive behavioral therapy for insomnia among young adults who are actively drinking: a randomized pilot trial. Sleep. 2021 Feb 12;44(2):zsaa171. doi: 10.1093/sleep/zsaa171. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Alcohol Use Disorder | Count of Participants | Participants |
|
| College Enrollment | Count of Participants | Participants |
|
| Comorbid Mental Health Disorder | Count of Participants | Participants |
|
| Insomnia Severity | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
| Primary | Sleep Efficiency | 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). | Posted | Mean | Standard Deviation | % of time spent in bed actually asleep | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
|
|
|
| Primary | Sleep Quality | 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. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
|
|
|
| Primary | Drinking Quantity | 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. | Posted | Mean | Standard Deviation | Drinks per Week | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale - BYAAC | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
|
|
|
| Secondary | Delay Discounting | 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). | Secondary data have not been analyzed yet. | Posted | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
|
|
| Secondary | Negative Affect | 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. | Secondary data have not been analyzed yet. | Posted | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
|
|
| Secondary | Emotion Regulation | Assessed using the Difficulties with Emotion Regulation Scale. Scores range from 36-180, with higher scores indicating more difficulty with emotion regulation. | Secondary data not analyzed yet. | Posted | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
|
|
| Secondary | Alcohol Craving | Assessed using the Penn Alcohol Craving Scale. Scores range from 0-30, with higher scores indicating greater alcohol craving. | Secondary data not analyzed yet. | Posted | Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12) |
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | 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. | 0 | 28 | 0 | 28 | 0 | 28 |
Not provided
Not provided
Not provided
| D001523 |
| Mental Disorders |