CBT-I on Alcohol Treatment Outcomes Among Veterans

NCT ID: NCT03806491

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2022-07-31

Brief Summary

Project SAVE aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to alcohol treatment of Veterans.

Detailed Description

Alcohol use disorders (AUDs) are prevalent among Veterans and result in significant physical and psychological burden. Among those who receive treatment for AUDs, 1 in 3 relapses to problematic drinking within one year of treatment. Thus, additional strategies are needed to enhance alcohol treatment outcomes. One promising approach involves providing concurrent treatment for a common complaint - difficulty falling or staying asleep. Up to 74% of Veterans seeking treatment for AUD report co-occurring symptoms of insomnia. Given the negative impact of insomnia on attention and emotion regulation, insomnia symptoms may decrease patients' abilities to attend to alcohol treatment and manage negative emotions that lead to craving and relapse. Moreover, approximately 50% of individuals with AUDs report using alcohol to help them sleep, making relapse more likely for those with no other tools or skills to help them sleep. Indeed, sleep disturbance has been identified as a risk factor for relapse among individuals in alcohol treatment. Thus, effective treatment of sleep problems may enhance alcohol treatment. Cognitive Behavioral Therapy for Insomnia (CBT-I) has been effective in reducing insomnia severity in individuals with AUDs; however, no investigations have examined the efficacy of CBT-I delivered concurrently with AUD treatment to determine its impact on treatment outcomes. This R21 aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to ongoing alcohol treatment. A randomized pilot trial with 80 Veterans who meet diagnostic criteria for AUD and Insomnia Disorder will be conducted. Participants will be randomly assigned to receive Cognitive Behavioral Therapy for Insomnia (CBT-I) or minimal treatment (educational handout only; EDU) in addition to alcohol treatment as usual. Outcomes will be assessed at the end of the active intervention period (6 weeks) and 6 weeks post-intervention. Preliminary process outcomes include recruitment/retention rates and treatment satisfaction (feasibility and acceptability, respectively). Primary outcomes are insomnia severity, percentage of heavy drinking days, and alcohol-related problems; and we plan to examine post-treatment changes in insomnia severity as a mediator of treatment effects on alcohol use outcomes. We will also assess treatment effects on a variety of secondary clinical and mechanistic outcomes (e.g., PTSD symptoms, attention, working memory, treatment-related learning). Multiple imputation will be used for missing data, and analyses will be intent-to-treat.

Conditions

Insomnia; Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBT-I + AUD-TAU

Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type: BEHAVIORAL

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.

Alcohol Use Disorder Treatment as Usual

Intervention Type: BEHAVIORAL

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.

Sleep Hygiene + AUD-TAU

Sleep hygiene education delivered once to all participants

Group Type: ACTIVE_COMPARATOR

Sleep Hygiene

Intervention Type: BEHAVIORAL

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.

Alcohol Use Disorder Treatment as Usual

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

AUD-TAU

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harry S. Truman Memorial Veterans' Hospital

FED

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Mary E Miller

Professor, Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Beth Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri-Columbia

Columbia, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37342036 (View on PubMed)

Miller 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.

Reference Type: DERIVED

PMID: 34103317 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2012262

Identifier Type: -

Identifier Source: org_study_id