CBT-I on Alcohol Treatment Outcomes Among Veterans
NCT03806491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2025-04-18
Summary
Project SAVE aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to alcohol treatment of Veterans.
Conditions
Interventions
- BEHAVIORAL
-
Cognitive Behavioral Therapy for Insomnia
Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
- BEHAVIORAL
-
Sleep Hygiene
Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
- BEHAVIORAL
-
Alcohol Use Disorder Treatment as Usual
CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
Sponsors & Collaborators
-
Harry S. Truman Memorial Veterans' Hospital
collaborator FED -
University of Missouri-Columbia
lead OTHER
Principal Investigators
-
Mary Beth Miller, PhD · University of Missouri-Columbia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-07-15
- Primary Completion
- 2022-07-31
- Completion
- 2022-07-31
Countries
- United States
Study Locations
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