Sleep Treatment for Addiction Recovery

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

Detailed Description
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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

Official Title
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The Impact of CBT for Insomnia on Substance Use Treatment Outcomes

Conditions
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Insomnia, Alcohol Use Disorder, Substance Use Disorders

Intervention / Treatment
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* Behavioral: CBT-I


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects will participate in sessions individual Cognitive Behavioral Therapy for Insomnia (CBT-I).
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol, sleep, drinking, insomnia, outpatient, inpatient, drug use