Sleep Treatment for Addiction Recovery (STAR)

University of Missouri (MU)

Status: Unknown

Conditions: Substance Use Disorders; Insomnia; Alcohol Use Disorder

Treatments: Behavioral: CBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT04198311

2016896

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Cognitive-Behavioral Therapy for Insomnia (CBT-I)

Experimental group

Description:

Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks

Treatment:

Behavioral: CBT-I