Recruiting

Sleep Treatment

Sponsor:

University of Missouri-Columbia

Code:

NCT04198311

Conditions

Insomnia

Alcohol Use Disorder

Substance Use Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CBT-I

Study Details

Brief summary:

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

Conditions

Insomnia

Alcohol Use Disorder

Substance Use Disorders

Study ID

NCT04198311

Start date

Aug 26, 2020

Status verified date

Mar, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive-Behavioral Therapy for Insomnia (CBT-I)

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

Interventions

CBT-I

CBT-I will be delivered individually, in five weekly sessions. Intervention components include sleep hygiene, sleep restriction, stimulus control, relaxation, cognitive therapy.

Primary outcome measure

  • Recruitment [ Time Frame: Assessed at Post-Treatment (week 6) ]
  • Retention [ Time Frame: Assessed at Post-Treatment (week 6) ]
  • Treatment Satisfaction [ Time Frame: Assessed at Post-Treatment (week 6) ]

Central Contacts and Locations

Central contacts

Mary E Miller, PhD

573-882-1813millmary@health.missouri.edu

Elise M Blanke, BA

573-882-8598eblanke@health.missouri.edu

Locations

University of Missouri-Columbia

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Mary Beth Miller, PhD

573-882-1813millmary@health.missouri.edu

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Oct 10, 2022

Last verified

Mar, 2022

Keywords

  • sleep
  • alcohol
  • drinking
  • insomnia
  • outpatient
  • inpatient
  • drug use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2022-10-10.