CBT-I on Alcohol Treatment Outcomes Among Veterans (Project SAVE)

The Impact of CBT for Insomnia on Alcohol Treatment Outcomes Among Veterans

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

Study Overview

• Status: Completed
• Conditions: Insomnia; Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Alcohol Use Disorder Treatment as Usual; Behavioral: Sleep Hygiene

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri-Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT-I + AUD-TAU; Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.	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: 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.; Other Names: AUD-TAU
Active Comparator: Sleep Hygiene + AUD-TAU; Sleep hygiene education delivered once to all participants	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.; Other Names: AUD-TAU; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 range from 0 (not at all worried) to 4 (very much worried), with possible total scores ranging from 0 to 28. Participants scoring 10 or higher will be classified as screening positive for insomnia (Morin et al., 2011).114 Notably, self-report is the recommended method of assessment for symptoms of insomnia in adults (Schutte-Rodin et al., 2008).	Change from 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.	Change from 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.	Change from baseline to post-treatment (week 6) to follow-up (week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep efficiency	Assessed using daily sleep diaries. Sleep Diaries are quotidian questionnaires that measure self-reported sleep quality, sleep & wake time, and daily habits concerning substance use.	Change from baseline to post-treatment (week 6) to follow up (week 12)
Post-Traumatic Stress Disorder symptoms	Assessed using the Post-Traumatic Stress Disorder Checklist from the Diagnostic and Statistical Manual-5 (PCL-5); PCL-5 is a 20-item measure of Post-Traumatic Stress Disorder (PTSD). On a scale of not at all (0) to extremely (4), participants indicate how frequently in the past month they were bothered by stressful experiences such as disturbing dreams, hyper-alertness, strong negative beliefs, and irritability. PCL-5 is scored by summing the responses. Possible scores range from 0-80, where higher scores indicate higher PTSD severity. Symptoms may also be gleaned into clusters of Intrusion, Avoidance, Negative alterations in cognition/mood, and Alterations in arousal/reactivity.	Change from baseline to post-treatment (week 6) to follow up (week 12)
Symptoms of depression	Assessed using the Patient Health Questionnaire-9 (PHQ-9); PHQ-9 will be used as a 9-item measure of depressed mood and functioning that has demonstrated good sensitivity and specificity across adult samples. Participants will indicate how many days in the past two weeks (not at all, several days, more than half the days, or every day or nearly every day) they have experienced each problem. Scores will be summed and classified as minimal symptoms of depressed mood (<10), moderate levels of depressed mood (10-14), high levels of depressed mood (15-19), or very high levels of depressed mood (20-27)	Change from baseline to post-treatment (week 6) to follow up (week 12)
Symptoms of anxiety	Assessed using the Generalized Anxiety Disorder-7 (GAD-7); GAD-7 is a 7-item measure of anxiety with strong criterion and predictive validity. On a scale from not at all (0) to nearly every day (3), participants indicate how often in the past two weeks they have experienced problems such as having trouble relaxing and being so restless that it is hard to sit still. Possible total scores range from 0-21. Scores will be summed and classified as minimal anxiety (<3), moderate anxiety (4-7), high anxiety (12-15), or severe anxiety (16-21).	Change from baseline to post-treatment (week 6) to follow up (week 12)
Treatment-Related Learning	Assessed using the Project SAVE alcohol quiz	Change from baseline to post-treatment (week 6)
Use of alcohol to help with sleep	Assessed using the daily sleep diary; Did you use alcohol specifically to help with sleep?	Change from baseline to post-treatment (week 6) to follow up (week 12)
Alcohol craving	Assessed using the Penn Alcohol Craving Scale (PACS); The Penn Alcohol Craving Scale is a 5-item measure of alcohol craving in the past week. Participants rate the intensity, frequency, and duration of cravings, as well as their ability to resist acting on those cravings and their overall "average alcohol craving" for the past week. This measure has demonstrated good internal consistency and construct validity (Flannery, Volpicelli, & Pettinati, 1999)	Change from baseline to post-treatment (week 6) to follow up (week 12)
Negative affect	Assessed using the Positive and Negative Affect Schedule (PANAS); Negative affect subscale scores range from 10-50, with higher scores indicating more extreme negative affect (measured "right now").	Change from baseline to post-treatment (week 6) to follow up (week 12)
Emotion regulation	Assessed using the Brief Difficulties in Emotion Regulation Scale (DERS-16). The 16-item Difficulties in Emotion Regulation Scale has demonstrated good convergent and discriminant validity in clinical and community samples (Bjureberg et al., 2015). On a scale from 1 (almost never) to 5 (almost always), participants will indicate how often in the past 6 weeks they would endorse items such as, "I have difficulty making sense out of my feelings," and, "When I am upset, I become out of control."	Change from baseline to post-treatment (week 6) to follow up (week 12)
Attention	Assessed using the Psychomotor Vigilance Test (PVT); PVT measures behavioral alertness by analyzing the reaction to visual stimuli	Change from baseline to post-treatment (week 6) to follow up (week 12)
Working memory	Assessed using the N-back task; N-Back measures the capacity for working memory	Change from baseline to post-treatment (week 6) to follow up (week 12)
Delay discounting	Assessed using the Monetary Choice Questionnaire (MCQ); The MCQ (Kirby, Petry, & Bickel, 1999) will be used as a self-report measure of delay discounting. In 27 trials, participants will be asked to choose between a smaller, immediate reward or a larger, delayed reward. For example, "Would you prefer $54 today or $55 in 117 days?" Data will be used to calculate participants' discounting-rate parameter (k).	Change from baseline to post-treatment (week 6) to follow up (week 12)
Impulsivity	Assessed using the 20-item UPPS-P Impulsive Behaviors Scale; UPPS is a 20-item measure of impulsivity and self-control. Participants indicate on a scale of not at all (0) to very (4) if statements such as "I like to stop and think things over before I do them," "When I am upset I often act without thinking," and "I have a reserved and cautious attitude towards life" are representative of him/her. Scoring is completed by summing items in the five subscales (sensation seeking, premeditation, perseverance, positive/negative urgency).	Change from baseline to post-treatment (week 6) to follow up (week 12)

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Collaborators: Harry S. Truman Memorial Veterans' Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: sleep; insomnia; alcohol; drinking; veteran
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Nervous System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Alcoholism; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2012262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be shared after data collection is complete and results have been published (anticipated July 2022).
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No