Clinical trial NCT03806491: CBT-I on Alcohol Treatment Outcomes Among Veterans
Official title: The Impact of CBT for Insomnia on Alcohol Treatment Outcomes Among Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Alcohol Use Disorder
Keywords: veteran
alcohol
insomnia
sleep
drinking
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Harry S. Truman Memorial Veterans' Hospital
First posted: 2019-01-16
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In addition to Cognitive Behavioral Therapy for Alcohol Use Disorder (CBT-AUD), participants will be randomized to receive sleep education or to participate in 5 individual sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Insomnia Severity
timeFrame: Baseline to post-treatment (week 6) to follow up (week 12)
measure: Percent of Heavy-drinking Days
timeFrame: Baseline to post-treatment (week 6) to follow-up (week 12)
measure: Alcohol Problems
timeFrame: Baseline to post-treatment (week 6) to follow-up (week 12)
Secondary outcomes:
measure: Sleep Efficiency
timeFrame: Baseline to post-treatment (week 6) to follow up (week 12)
measure: Post-Traumatic Stress Disorder Symptoms
timeFrame: Baseline to post-treatment (week 6) to follow up (week 12)
measure: Symptoms of Depression
timeFrame: Baseline to post-treatment (week 6) to follow up (week 12)
measure: Symptoms of Anxiety
timeFrame: Baseline to post-treatment (week 6) to follow up (week 12)
measure: Treatment-Related Learning
timeFrame: Change from baseline to post-treatment (week 6)
measure: Percentage of Days Where Alcohol Was Used to Help With Sleep
timeFrame: Baseline to post-treatment (week 6) to follow up (week 12)
measure: Alcohol Craving
timeFrame: Baseline to post-treatment (week 6) to follow up (week 12)
measure: Negative Affect
timeFrame: Baseline to post-treatment (week 6) to follow up (week 12)
measure: Emotion Regulation
timeFrame: Baseline to post-treatment (week 6) to follow up (week 12)
measure: Delay Discounting
timeFrame: Baseline to post-treatment (week 6) to follow up (week 12)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Mary Beth Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.