Sleep Treatment for Addiction Recovery

Insomnia Clinical Trial

— STAR  

Official title:

The Impact of CBT for Insomnia on Substance Use Treatment Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04198311
• Other study ID #: 2016896
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: University of Missouri-Columbia
• Contact: Mary E Miller, PhD
• Phone: 573-882-1813
• Email: millmary[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Disease
• Insomnia
• Sleep Initiation and Maintenance Disorders
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment-related Learning	Assessed using the Project STAR alcohol quiz	Change from baseline to post-treatment (week 6)
Other	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)
Other	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)
Other	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)
Primary	Recruitment	The number of participants who complete baseline.	Assessed at Post-Treatment (week 6)
Primary	Retention	The number of participants who complete all treatment sessions	Assessed at Post-Treatment (week 6)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)