Sleep Treatment for Addiction Recovery (STAR)

The Impact of CBT for Insomnia on Substance Use Treatment Outcomes

Project STAR aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to outpatient alcohol and substance use treatment.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Substance Use Disorders; Alcohol Use Disorder
• Intervention / Treatment: Behavioral: CBT-I

Detailed Description

Among those who receive treatment for alcohol use disorder (AUD), one in three relapses to problematic drinking within one year of treatment. Thus, additional treatment strategies are needed. Notably, up to 74% of individuals seeking treatment for AUD report co-occurring symptoms of insomnia, while 85% of those seeking SUD treatment report insomnia symptoms. Given the negative impact of insomnia on attention and emotion regulation, insomnia symptoms may decrease patients' abilities to attend to treatment for substance use and manage negative emotions that lead to craving and relapse. This project aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to substance use treatment. Forty adults who meet diagnostic criteria for AUD or SUD and Insomnia Disorder will receive Cognitive Behavioral Therapy for Insomnia (CBT-I). In order to generate hypotheses regarding the efficacy of CBT-I for individuals who are and are not engaged in substance use treatment, we aim to recruit 20 participants who are engaged in substance use treatment through the community at baseline and 20 participants who are not. Outcomes will be assessed at the end of the active intervention period (6 weeks) and at 6 weeks post-intervention

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary E Miller, PhD; Phone Number: 573-882-1813; Email: millmary@health.missouri.edu
• Study Contact Backup: Name: Elise M Blanke, BA; Phone Number: 573-882-8598; Email: eblanke@health.missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Recruiting
      • University of Missouri-Columbia
      • Contact: Mary Beth Miller, PhD; Phone Number: 573-882-1813; Email: millmary@health.missouri.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participation in alcohol or substance use treatment in the Columbia, MO area
• DSM-5 criteria for moderate to severe Alcohol Use Disorder of Substance Use Disorder
• 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
• untreated sleep disorder requiring more than behavioral treatment for insomnia
• 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive-Behavioral Therapy for Insomnia (CBT-I); Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks	Behavioral: CBT-I; CBT-I will be delivered individually, in five weekly sessions. Intervention components include sleep hygiene, sleep restriction, stimulus control, relaxation, cognitive therapy.; Other Names: Cognitive-Behavioral Therapy for Insomnia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	The number of participants who complete baseline.	Assessed at Post-Treatment (week 6)
Retention	The number of participants who complete all treatment sessions	Assessed at Post-Treatment (week 6)
Treatment Satisfaction	The satisfaction rating participants give the treatment.Assessed using the Client Satisfaction Questionnaire; The Client Satisfaction Questionnaire is an 8-item measure of satisfaction with treatment that has been validated in substance use treatment settings. Items are scores from 1 to 4, with higher scores indicating greater satisfaction with treatment.	Assessed at Post-Treatment (week 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abstinence	The percentage of days during the past 6 weeks that the participant is abstinent from their drug of choice (alcohol or other substance). Assessed using the Timeline Followback (TLFB); TLFB allows participants to trace their alcohol and drug use back 42 days.	Change from baseline to post-treatment (week 6) to follow-up (week 12)
Heavy-Drinking Days	The percentage of days during the past 6 weeks that the participant engages in heavy drinking (>4/5 drinks/day for women/men). Assessed using the Timeline Followback (TLFB) for alcohol; TLFB allows participants to trace their alcohol use back 42 days.	Change from baseline to post-treatment (week 6) to follow-up (week 12)
Substance Use Days	The percentage of days during the past 6 weeks that the participant engages in drug/substance use. Assessed using the Timeline Followback (TLFB) ; TLFB allows participants to trace their drug/substance use back 42 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)
Alcohol or Other Drugs as Sleep Aids	Assessed using the daily sleep diary; Sleep Diaries are quotidian questionnaires that measure self-reported sleep quality, sleep time, and daily habits concerning substance use. Diaries will be used to determine if participants used alcohol or other substances specifically to go to sleep	Change from baseline to post-treatment (week 6) to follow-up (week 12)
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)
Total Wake Time	The amount of time the participant is awake after they try to go to sleep. Measured using Daily Diaries and actigraphy.	Change from baseline to post-treatment (week 6) to follow-up (week 12)
Sleep quality	Assessed using the daily sleep diary; Sleep Diaries are quotidian questionnaires that measure self-reported sleep quality, sleep time, and daily habits concerning substance use. Diaries will be used to determine if participants used alcohol or other substances specifically to go to sleep.	Change from baseline to post-treatment (week 6) to follow-up (week 12)
Dysfunctional beliefs	Assessed using the Dysfunctional Beliefs and Attitudes about Sleep questionnaire (DBAS;Morin, 1994). The DBAS is designed to measure sleep and insomnia-related cognitions.	Change from baseline to post-treatment (week 6) to follow-up (week 12)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-related Learning	Assessed using the Project STAR alcohol quiz	Change from baseline to post-treatment (week 6)
Executive Functioning - Delayed Discounting	Assessed delayed discounting using the Monetary Choice Questionnaire (Kirby, Petry, & Bickel, 1999). Participants are instructed to choose between hypothetically receiving one amount of money today or a larger amount of money in the future.	Change from baseline to post-treatment (week 6) to follow-up (week 12)
Executive Functioning - Working Memory	Assessed using the Adaptive N-Back task (Jaeggi et al., 2010).Participants are instructed to indicate if the image they see is the same shape that was presented earlier.	Change from baseline to post-treatment (week 6) to follow-up (week 12)
Executive Functioning - Attention	Assessed using the Psycho-motor Vigilance Task (Thomann et al., 2014). Participants are instructed to react to a visual stimulus by quickly pressing a key.	Change from baseline to post-treatment (week 6) to follow-up (week 12)

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

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

More Information

Terms related to this study

• Keywords: sleep; insomnia; alcohol; drinking; outpatient; drug use; inpatient
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Nervous System Diseases; Alcohol-Related Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Substance-Related Disorders; Alcoholism; Disease; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2016896

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No