Sleep Treatment for Addiction Recovery
STAR
The Impact of CBT for Insomnia on Substance Use Treatment Outcomes
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2019
CompletedFirst Posted
Study publicly available on registry
December 13, 2019
CompletedStudy Start
First participant enrolled
August 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedOctober 10, 2022
March 1, 2022
2.3 years
December 9, 2019
October 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (9)
Abstinence
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Heavy-Drinking Days
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Substance Use Days
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Alcohol Problems
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Alcohol or Other Drugs as Sleep Aids
Change from baseline to post-treatment (week 6) to follow-up (week 12)
- +4 more secondary outcomes
Other Outcomes (4)
Treatment-related Learning
Change from baseline to post-treatment (week 6)
Executive Functioning - Delayed Discounting
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Executive Functioning - Working Memory
Change from baseline to post-treatment (week 6) to follow-up (week 12)
- +1 more other outcomes
Study Arms (1)
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
EXPERIMENTALIndividual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks
Interventions
CBT-I will be delivered individually, in five weekly sessions. Intervention components include sleep hygiene, sleep restriction, stimulus control, relaxation, cognitive therapy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Missouri-Columbia
Columbia, Missouri, 65212, United States
Related Publications (1)
Miller MB, Freeman LK, Helle AC, Hall NA, DiBello AM, McCrae CS. Comparative feasibility and preliminary efficacy of CBT for insomnia among adults seeking and not seeking addiction treatment. J Sleep Res. 2024 Apr;33(2):e13969. doi: 10.1111/jsr.13969. Epub 2023 Jul 9.
PMID: 37423902DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Psychiatry
Study Record Dates
First Submitted
December 9, 2019
First Posted
December 13, 2019
Study Start
August 26, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
October 10, 2022
Record last verified: 2022-03