CBT-I on Alcohol Treatment Outcomes Among Veterans
Project SAVE
The Impact of CBT for Insomnia on Alcohol Treatment Outcomes Among Veterans
1 other identifier
interventional
67
1 country
1
Brief Summary
Project SAVE aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to alcohol treatment of Veterans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2019
CompletedFirst Posted
Study publicly available on registry
January 16, 2019
CompletedStudy Start
First participant enrolled
July 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedResults Posted
Study results publicly available
April 18, 2025
CompletedApril 18, 2025
April 1, 2025
3 years
January 8, 2019
June 7, 2023
April 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Insomnia Severity
Assessed using the Insomnia Severity Index (ISI); ISI will be used as a 7-item measure of insomnia severity in the past two weeks. Items assess difficulty falling or staying asleep, satisfaction with current sleep pattern, interference with daily functioning, the extent to which others notice their sleep problems, and worry/distress related to sleep problems. Response options for each item range from 0 (not at all worried) to 4 (very much worried). Individual item scores are summed to a total score - the highest possible score being 28. Higher scores indicate more severe insomnia. Participants scoring 10 or higher will be classified as screening positive for insomnia.
Baseline to post-treatment (week 6) to follow up (week 12)
Percent of Heavy-drinking Days
Assessed using the Timeline Followback (TLFB) for alcohol; TLFB allows participants to trace their alcohol use back 30 days.
Baseline to post-treatment (week 6) to follow-up (week 12)
Alcohol Problems
Assessed using the Short Inventory of Problems (SIP). SIP measures adverse consequences of substance use. Scores range 0 to 45, where higher scores indicate more frequent problems.
Baseline to post-treatment (week 6) to follow-up (week 12)
Secondary Outcomes (10)
Sleep Efficiency
Baseline to post-treatment (week 6) to follow up (week 12)
Post-Traumatic Stress Disorder Symptoms
Baseline to post-treatment (week 6) to follow up (week 12)
Symptoms of Depression
Baseline to post-treatment (week 6) to follow up (week 12)
Symptoms of Anxiety
Baseline to post-treatment (week 6) to follow up (week 12)
Treatment-Related Learning
Change from baseline to post-treatment (week 6)
- +5 more secondary outcomes
Study Arms (2)
CBT-I + AUD-TAU
EXPERIMENTALIndividual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Sleep Hygiene + AUD-TAU
ACTIVE COMPARATORSleep hygiene education delivered once to all participants
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Missouri-Columbia
Columbia, Missouri, 65212, United States
Related Publications (2)
Miller MB, Carpenter RW, Freeman LK, Dunsiger S, McGeary JE, Borsari B, McCrae CS, Arnedt JT, Korte P, Merrill JE, Carey KB, Metrik J. Effect of Cognitive Behavioral Therapy for Insomnia on Alcohol Treatment Outcomes Among US Veterans: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Sep 1;80(9):905-913. doi: 10.1001/jamapsychiatry.2023.1971.
PMID: 37342036DERIVEDMiller MB, Metrik J, McGeary JE, Borsari B, McCrae CS, Maddoux J, Arnedt JT, Merrill JE, Carey KB. Protocol for the Project SAVE randomised controlled trial examining CBT for insomnia among veterans in treatment for alcohol use disorder. BMJ Open. 2021 Jun 8;11(6):e045667. doi: 10.1136/bmjopen-2020-045667.
PMID: 34103317DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Mary Beth Miller
- Organization
- University of Missouri
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Beth Miller, PhD
University of Missouri-Columbia
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The project manager will inform study therapists of participant assignment to conditions. PI Miller and study therapists will be blinded to assessment outcomes, and the assessment RA will be blinded to participant condition.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Psychiatry
Study Record Dates
First Submitted
January 8, 2019
First Posted
January 16, 2019
Study Start
July 15, 2019
Primary Completion
July 31, 2022
Study Completion
July 31, 2022
Last Updated
April 18, 2025
Results First Posted
April 18, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be shared after data collection is complete and results have been published (anticipated July 2022).
- Access Criteria
- De-identified data will be made available to other qualified investigators who aim to verify data, conduct meta-analyses, or collaborate with the research team on analyses that are not already planned.
After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the research team to ensure that it meets reasonable demands of scientific integrity.