Sleep as a Mechanism of Change in Alcohol Use
NCT06286774, Not applicable, Recruiting, University of Missouri-Columbia
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Sleep as a Mechanism of Change in Alcohol Use | ClinicalTrials.gov |
| NCT number | NCT06286774 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 256 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Missouri-Columbia | ClinicalTrials.gov |
| Conditions | Insomnia, Alcohol; Harmful Use | ClinicalTrials.gov |
| Interventions | Cognitive Behavioral Therapy for Insomnia | ClinicalTrials.gov |
| First posted | 2024-02-29 | ClinicalTrials.gov |
| Last updated | 2026-09-14 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Insomnia Symptoms | Change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups | Assessed using Insomnia Severity Index (ISI). Response options range from 0 (not at all worried) to 4 (very much worried), with total scores ranging from 0 to 28 and higher scores indicating more severe insomnia. | ClinicalTrials.gov |
| Primary | Drinking quantity | Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups | Assessed using Timeline Followback and Daily Drinking Questionnaire. Typical weekly drinking quantity estimates will be summed to create a "drinks per week" total score, which will be used as our outcome variable. | ClinicalTrials.gov |
| Primary | Alcohol-related consequences | Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups | Assessed using the Drinker Inventory of Consequences (DrINC). Scores range from 0 to 120, with higher scores indicating more consequences. The common consequence subscale scores range from 0 to 18. | ClinicalTrials.gov |
| Secondary | Treatment willingness (alcohol) | Change from baseline to post-treatment (week 6) | Assessed using a modified Treatment Willingness Scale. Participants rate their agreement with the statement that they would seek treatment for 5 medical and 5 mental health conditions if they experienced problems related to them. Willingness to seek alcohol or drug treatment is assessed on a 0-5 scale, with higher scores indicating greater willingness. | ClinicalTrials.gov |
| Secondary | Alcohol craving | Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups | Assessed using the Penn Alcohol Craving Scale (PACS). PACS evaluates thoughts about drinking by assessing the duration, frequency, and intensity of such thoughts. Scores range 0-30, with higher scores indicating more severe craving. | ClinicalTrials.gov |
| Secondary | Negative emotionality | Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups | Negative emotionality will be assessed as a latent construct of mood, anxiety, depression, PTSD symptoms, and difficulties with emotion regulation. Changes in individual symptoms will be reported for descriptive purposes. | ClinicalTrials.gov |
| Secondary | Response inhibition | Change from baseline to post (week 6) to 3-month follow-up | Assessed using the Stroop Task. Average reaction time (RT; measured from color word/color rectangle stimuli onset until a response is made) on correct trials for each trial type (control trials, congruent trials, incongruent trials) were computed as the outcomes of interest. Higher RTs indicate worse performance. | ClinicalTrials.gov |
| Secondary | Working memory | Change from baseline to post (week 6) to 3-month follow-up | Assessed using the N-Back Task. The dependent measure is the proportion of correct responses (yes and no) across all four blocks. Omissions are counted as errors. | ClinicalTrials.gov |
| Secondary | Delay discounting | Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups | Assessed using the Monetary Choice Questionnaire (MCQ). Participants indicate if they would rather receive a smaller amount of money now or a greater amount of money in a specified amount of time (e.g., 100 days, 2 days). The MCQ is scored using a logarithmic subject-specific discount rate (k variable). Higher k values indicate a greater preference for smaller, immediate rewards over larger, delayed reward. | ClinicalTrials.gov |
| Secondary | Alcohol to help with sleep | Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups | Assessed using daily sleep diaries. The outcome will be percentage of days using alcohol to help with sleep. | ClinicalTrials.gov |
| Secondary | Heartrate variability | Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups | Assessed using Fitbit Charge 6. Heart-rate variability (HRV) is an indicator of activity in the autonomic nervous system that quantifies changes in intervals between heart beats. In general, HRV increases with increasing parasympathetic activity, then plateaus and decreases with increasing sympathetic activity. | ClinicalTrials.gov |
| Secondary | Dysfunctional Beliefs and Attitudes about Sleep Scale | Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups | Assessed using the revised Dysfunctional Beliefs and Attitudes about Sleep Scale. Responses range from 0 to 70, with higher scores indicating more dysfunctional beliefs. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Delay Discounting | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)