Clinical trial NCT04198311: Sleep Treatment for Addiction Recovery
Official title: The Impact of CBT for Insomnia on Substance Use Treatment Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Alcohol Use Disorder
Substance Use Disorders
Keywords: sleep
alcohol
drinking
insomnia
outpatient
inpatient
drug use
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will participate in sessions individual Cognitive Behavioral Therapy for Insomnia (CBT-I).
Primary purpose: TREATMENT

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment
timeFrame: Assessed at Post-Treatment (week 6)
measure: Retention
timeFrame: Assessed at Post-Treatment (week 6)
measure: Treatment Satisfaction
timeFrame: Assessed at Post-Treatment (week 6)
Secondary outcomes:
measure: Abstinence
timeFrame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
measure: Heavy-Drinking Days
timeFrame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
measure: Substance Use Days
timeFrame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
measure: Alcohol Problems
timeFrame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
measure: Alcohol or Other Drugs as Sleep Aids
timeFrame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
measure: Insomnia severity
timeFrame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
measure: Total Wake Time
timeFrame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
measure: Sleep quality
timeFrame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
measure: Dysfunctional beliefs
timeFrame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
Other outcomes:
measure: Treatment-related Learning
timeFrame: Change from baseline to post-treatment (week 6)
measure: Executive Functioning - Delayed Discounting
timeFrame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
measure: Executive Functioning - Working Memory
timeFrame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
measure: Executive Functioning - Attention
timeFrame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
References: