N/A
Completed N=67
CBT-I on Alcohol Treatment Outcomes Among Veterans
Source: ClinicalTrials.gov NCT03806491 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Insomnia Severity — 17.97; 19.26; 5.69; 10.96 score on a scale
Summary
Project SAVE aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to alcohol treatment of Veterans.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity |
17.97; 19.26; 5.69; 10.96; 8.07; 12.42 | — |
| PRIMARY Percent of Heavy-drinking Days |
16.97; 17.14; 2.07; 1.34; 5.92; 6.57 | — |
| PRIMARY Alcohol Problems |
25.44; 22.00; 4.42; 5.12; 4.38; 7.00 | — |
| SECONDARY Sleep Efficiency |
68.47; 71.44; 87.30; 82.41; 90.62; 75.31 | — |
| SECONDARY Post-Traumatic Stress Disorder Symptoms |
34.3; 32.0; 20.1; 25.2; 21.0; 28.2 | — |
| SECONDARY Symptoms of Depression |
10.9; 12.3; 4.7; 7.4; 7.3; 8.9 | — |
| SECONDARY Symptoms of Anxiety |
9.8; 10.8; 4.9; 7.0; 7.2; 8.7 | — |
| SECONDARY Treatment-Related Learning |
— | — |
| SECONDARY Percentage of Days Where Alcohol Was Used to Help With Sleep |
3.68; 2.94; 4.08; 4.76; 8.09; 3.16 | — |
| SECONDARY Alcohol Craving |
11.44; 10.76; 7.88; 7.15; 9.31; 9.21 | — |
| SECONDARY Negative Affect |
20.0; 20.3; 15.2; 16.5; 18.2; 20.0 | — |
| SECONDARY Emotion Regulation |
20.0; 20.3; 15.2; 18.2; 18.2; 20.0 | — |
| SECONDARY Delay Discounting |
— | — |
Eligibility Criteria
Inclusion Criteria
- Participation in alcohol treatment at the Truman VA (Columbia, MO)
- DSM-5 criteria for moderate to severe Alcohol Use Disorder
- Substance use in the past 2 months
- DSM-5 episodic criterion (duration at least 1 month) for Insomnia Disorder
Exclusion Criteria
- unable to provide informed consent
- cognitive impairment
- continuous sobriety for 2+ months at baseline
- manic episode or seizure in the past year (contraindications for CBT-I)
- severe psychiatric disorder that requires immediate clinical attention
- initiation of a sleep medication in the past six (6) weeks
Data sourced from ClinicalTrials.gov (NCT03806491). 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.