CLINICAL TRIAL

Brief Behavioral Therapy for Insomnia (BBTI) for Alcohol Use, Unspecified

Recruiting · 18 - 65 · All Sexes · Seattle, WA

Research Evaluating Sleep & Trends for Universal Prevention

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About the trial for Alcohol Use, Unspecified

Eligible Conditions
Alcohol Use, Unspecified · Marijuana Abuse · Sleep Initiation and Maintenance Disorders · Marijuana Use · Alcohol Drinking · Insomnia

Treatment Groups

This trial involves 2 different treatments. Brief Behavioral Therapy For Insomnia (BBTI) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Brief Alcohol Screening and Intervention for College Students (BASICS)
BEHAVIORAL
Brief Behavioral Therapy for Insomnia (BBTI)
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Brief Alcohol Screening and Intervention for College Students (BASICS)
BEHAVIORAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brief Behavioral Therapy for Insomnia (BBTI)
2020
N/A
~50

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age 18-24, score on the ISI of 10 or higher, reporting at least one heavy drinking episode in the past two weeks, use of marijuana at least once in the past month
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: past 3 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: past 3 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Brief Behavioral Therapy for Insomnia (BBTI) will improve 5 primary outcomes and 2 secondary outcomes in patients with Alcohol Use, Unspecified. Measurement will happen over the course of past 7 days.

Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI)
PAST 7 DAYS
8-item measure assessing self-reported perceptions of impairment due to sleep problems. Response options range from 1=Not at all to 5=Very much. Responses are summed to create a raw score with higher scores indicating greater impairment.
Insomnia Severity Index (ISI)
PAST 2 WEEKS
7-item measure assessing insomnia severity with response options ranging from 0 to 4 where higher score indicate greater insomnia symptoms. Items are summed to create total scores where scores of 0-7=No clinically significant insomnia, 8-14=subthreshold insomnia, 15-21=clinical insomnia (moderate severity), and 22-28=clinical insomnia (severe).
Daily Drinking Questionnaire (DDQ)
PAST MONTH
Measures the typical number of standard drinks consumed on each day of a typical week over the previous month. Totals for each day are summed to create a total drinks per week score.
Daily Marijuana Questionnaire
PAST MONTH
Measures number of hours spent high on each day of a typical week over the previous month. Responses are summed to create a total score of hours spent high over a typical week in the previous months.
Quantity/Frequency/Peak Alcohol Use Index (QFP)
PAST 30 DAYS
Measures the typical frequency of drinking occasions per week over the previous 30 days. Response options range from 0=I do not drink at all to 7=Every day.
Marijuana-Related Consequences
PAST 3 MONTHS
25-item measure assessing consequences related to marijuana use. Response options range from 0=Never to 4=More than 10 times. Responses are recoded to create binary scores where 0=did not happen in the previous 3 months and 1=happened in the previous 3 months. Binary scores are summed to create a total score of number of problems experienced in the previous 3 months.
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Who is running the study

Principal Investigator
M. L.
Prof. Mary Larimer, Professor, School of Medicine
University of Washington

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get sleeplessness a year in the United States?

These data show that 30% of the adult population in the United States has [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea). In the United States, the sleep problem will worsen in one of eight respondents in every one hundred and twenty four. It implies a significant impact on a society's health.

Anonymous Patient Answer

Can sleeplessness be cured?

The data suggests that sleeplessness is a product of insomnia, or an individual's inherent tendency to engage the REM sleep system and the wakeful stages respectively.

Anonymous Patient Answer

What are the signs of sleeplessness?

In a cohort of US adults, we identified factors associated with sleep disturbances and identified potential factors for consideration when assessing sleep disturbance on the Brief International Classification of Sleep Disorders (BISD). These factors can be useful in the identification of individuals needing sleep intervention for sleep disorders and for optimizing sleep quality. Findings from a recent study suggest an association between the burden of chronic disease, obesity, medical conditions, and depression with increased symptom severity of sleep-based disordered breathing and nonrestorative sleep.

Anonymous Patient Answer

What causes sleeplessness?

There is a clear biological basis for sleeplessness as a symptom with many possible causes, but this does not account for the fact that one-quarter of adults report they never have a full night's sleep. More work is needed on biological explanations and the implications of this in order to investigate the ways this may be resolved to support sleep hygiene practices.

Anonymous Patient Answer

What is sleeplessness?

Sleeplessness is considered to be a symptom or consequence of mental illness in many, but not all, languages. Most languages have specific terminology for sleeplessness. However, in some languages, such as Arabic, there are very few terms for sleeplessness. For example, no single term is used for sleeplessness but there are two terms specifically related to sleeplessness, 'tire' and 'drear' (e.g., 'tirey' or 'dreary' refers to sleeplessness).

Anonymous Patient Answer

What are common treatments for sleeplessness?

Sleeping problems are treated with different techniques. Most often, no medications are prescribed. In the case of insomnia, medications are prescribed. The use of certain medications is not always adequate to treat sleep or insomnia symptomatology because the effect of a specific patient may not be predicted. These recommendations are based on data from a few trials about the management of sleep or insomnia. More data are needed to address the question of what is an adequate treatment.

Anonymous Patient Answer

Is brief behavioral therapy for insomnia (bbti) safe for people?

We report one case of suicide in a man with BBTI, suggesting that patients remain at risk for suicide even if they successfully complete treatment. Further research is warranted to evaluate the long-term outcomes and to examine risk factors for suicide in BBTI patients.

Anonymous Patient Answer

Who should consider clinical trials for sleeplessness?

According to these findings, patients may have a more severe response to treatment for sleep problems than to placebo. A higher percentage of patients with SES 2 (SQS 2) reported that their sleep quality improved more with nCPAP use than with placebo. Patients with SES 0 (SQS 0) reported that the use of nCPAP was not helpful for their sleep quality at either the nCPAP or the placebo group. NCPAP use was not helpful for patients with SES 1 (SQS 1) to sleep quality.

Anonymous Patient Answer

What are the common side effects of brief behavioral therapy for insomnia (bbti)?

In a recent study, findings point out the need for more research, to evaluate the long-term (6-months) efficacy of bbti, the most successful method presently used for the treatment in primary insomnia, among patients who are unwilling to accept medication therapy.

Anonymous Patient Answer

Have there been any new discoveries for treating sleeplessness?

The data suggest that sleep deprivation may have some adverse effects on cognitive abilities that depend on adequate neural systems related to the sleep system. Further studies are necessary to better evaluate the adverse effects of sleepiness.

Anonymous Patient Answer

What is brief behavioral therapy for insomnia (bbti)?

Results suggest that brief behavioral therapy for insomnia (bbti), specifically designed to treat insomnia, is a valuable intervention. A more thorough description of the BDT, as well as more rigorous controls for attrition within the BDT, is needed.

Anonymous Patient Answer

What does brief behavioral therapy for insomnia (bbti) usually treat?

The improvements seen in most of the participants were seen regardless of whether or not they had an active diagnosis of insomnia. Moreover, they were mostly short-lasting. Results from a recent clinical trial support the use of this brief intervention for sleep problems in primary care, but do not support the use of this technique as a treatment for insomnia.

Anonymous Patient Answer
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