Sleep as a Mechanism of Change in Alcohol Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-49
SponsorUniversity of Missouri-Columbia
About this trial
This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
report heavy drinking in a typical week in the past month
meet DSM-5 criteria for Alcohol Use Disorder
meet DSM-5 and research diagnostic criteria for Insomnia Disorder
Disqualifiers
≥50 years
unable to provide informed consent
report contraindications for CBT-I (mania or seizure disorder)
moderate to severe sleep apnea that is untreated
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy for Insomnia
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.
Treatment groups
256 Participants
are divided into 2 treatment groupsGroup A: CBT-IExperimental treatment 1 intervention
Group B: Waitlist controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Insomnia Symptoms
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.
Time frame
Change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups2
Drinking quantity
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.
Time frame
Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups3
Alcohol-related consequences
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.
Time frame
Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-upsSecondary outcomes
1
Treatment willingness (alcohol)
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.
Time frame
Change from baseline to post-treatment (week 6)2
Alcohol craving
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.
Time frame
Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups3
Negative emotionality
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.
Time frame
Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups4
Response inhibition
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.
Time frame
Change from baseline to post (week 6) to 3-month follow-upSponsors and contacts
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Source ClinicalTrials.gov