N/A Completed N=71 Randomized Double-blind Treatment

The iTAP Study for Veterans

Insomnia · Alcohol; Harmful Use

Source: ClinicalTrials.gov NCT03804788 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcomePrimary: Recruitment — 71 Participants

Summary

This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.

Outcome Measures

Outcome	Result	p-value
PRIMARY Recruitment	71	—
PRIMARY Retention	33; 33	—
PRIMARY Drinking Quantity	18.63; 17.94; 15.29; 12.00; 15.12; 15.73	—
PRIMARY Alcohol-related Consequences	7.92; 8.45; 2.45; 4.46; 3.31; 5.28	—
PRIMARY Insomnia Symptoms	17.29; 16.88; 7.24; 12.27; 6.97; 12.30	—
PRIMARY Sleep Quality	1.92; 1.73; 2.49; 2.13; 2.53; 2.14	—
PRIMARY Sleep Efficiency	71.94; 68.82; 87.89; 77.89; 87.10; 79.90	—
PRIMARY Client Satisfaction	3.59; 2.72	—
SECONDARY Delay Discounting	.028; .022; .037; .009; .033; .011	—
SECONDARY Negative Affect	16.82; 16.39; 14.18; 18.29; 15.77; 16.48	—
SECONDARY Emotion Regulation	34.53; 32.85; 27.14; 35.79; 30.00; 34.88	—
SECONDARY Alcohol Craving	9.29; 9.70; 6.46; 7.62; 7.30; 7.04	—
SECONDARY Percentage of Days Using Alcohol to Help With Sleep	16.71; 6.73; 3.22; 6.89; 2.24; 9.12	—
SECONDARY Percentage of Days Using Sleep Medication	30.92; 23.15; 14.04; 28.44; 11.55; 20.36	—

Eligibility Criteria

Inclusion criteria

Veteran deployed for military service after September 11, 2001
1+ heavy drinking episode (4/5+ drinks in 2 hours for women/men) in past 30 days
DSM-5 and research diagnostic criteria for Insomnia Disorder

Exclusion Criteria

Inability to provide informed consent
Cognitive impairment
Contraindications for CBT-I (mania or seizure disorder)
Untreated sleep disorder requiring more than behavioral treatment for insomnia
Engagement in overnight shift work at baseline
Care of a child under 1 year of age
Severe or untreated psychiatric disorder that requires immediate clinical attention
Current behavioral treatment for insomnia or alcohol use
Initiation of sleep medication in the past 6 weeks

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03804788). 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. Informational only — not medical advice.