N/A
N=56
Insomnia Treatment and Problems (the iTAP Study)
Insomnia · Alcohol; Harmful Use
Bottom Line
View on ClinicalTrials.gov: NCT03627832 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Insomnia Severity — 6.86; 10.84; 6.58; 9.32 units on scale, Insomnia Severity Index
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behavioral Therapy for Insomnia (CBT-I) (Behavioral); Sleep Hygiene (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity |
6.86; 10.84; 6.58; 9.32 | — |
| PRIMARY Sleep Efficiency |
79.27; 76.48; 76.22; 76.54 | — |
| PRIMARY Sleep Quality |
2.25; 2.32; 2.49; 2.29 | — |
| PRIMARY Drinking Quantity |
11.45; 11.80; 8.7; 9.33 | — |
| PRIMARY Alcohol-related Consequences |
4.18; 5.01; 5.04; 3.47 | — |
| SECONDARY Delay Discounting |
— | — |
| SECONDARY Negative Affect |
— | — |
| SECONDARY Emotion Regulation |
— | — |
| SECONDARY Alcohol Craving |
— | — |
Summary
This project aims to evaluate the efficacy of insomnia treatment in improving insomnia symptoms and alcohol-related problems among heavy-drinking young adults.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03627832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.