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Sleep Treatment for Addiction Recovery (STAR)

Primary Purpose

Insomnia, Alcohol Use Disorder, Substance Use Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT-I
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring sleep, alcohol, drinking, insomnia, outpatient, inpatient, drug use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Missouri-ColumbiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive-Behavioral Therapy for Insomnia (CBT-I)

Arm Description

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

Outcomes

Primary Outcome Measures

Recruitment
The number of participants who complete baseline.
Retention
The number of participants who complete all treatment sessions
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.

Secondary Outcome Measures

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.
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.
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.
Alcohol Problems
Assessed using the Short Inventory of Problems (SIP); SIP measures adverse consequences of substance use.
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
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).
Total Wake Time
The amount of time the participant is awake after they try to go to sleep. Measured using Daily Diaries and actigraphy.
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.
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.

Full Information

First Posted
December 9, 2019
Last Updated
October 6, 2022
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04198311
Brief Title
Sleep Treatment for Addiction Recovery
Acronym
STAR
Official Title
The Impact of CBT for Insomnia on Substance Use Treatment Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Alcohol Use Disorder, Substance Use Disorders
Keywords
sleep, alcohol, drinking, insomnia, outpatient, inpatient, drug use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects will participate in sessions individual Cognitive Behavioral Therapy for Insomnia (CBT-I).
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Arm Type
Experimental
Arm Description
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks
Intervention Type
Behavioral
Intervention Name(s)
CBT-I
Other Intervention Name(s)
Cognitive-Behavioral Therapy for Insomnia
Intervention Description
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 Information:
Title
Recruitment
Description
The number of participants who complete baseline.
Time Frame
Assessed at Post-Treatment (week 6)
Title
Retention
Description
The number of participants who complete all treatment sessions
Time Frame
Assessed at Post-Treatment (week 6)
Title
Treatment Satisfaction
Description
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.
Time Frame
Assessed at Post-Treatment (week 6)
Secondary Outcome Measure Information:
Title
Abstinence
Description
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.
Time Frame
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Title
Heavy-Drinking Days
Description
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.
Time Frame
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Title
Substance Use Days
Description
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.
Time Frame
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Title
Alcohol Problems
Description
Assessed using the Short Inventory of Problems (SIP); SIP measures adverse consequences of substance use.
Time Frame
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Title
Alcohol or Other Drugs as Sleep Aids
Description
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
Time Frame
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Title
Insomnia severity
Description
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).
Time Frame
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Title
Total Wake Time
Description
The amount of time the participant is awake after they try to go to sleep. Measured using Daily Diaries and actigraphy.
Time Frame
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Title
Sleep quality
Description
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.
Time Frame
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Title
Dysfunctional beliefs
Description
Assessed using the Dysfunctional Beliefs and Attitudes about Sleep questionnaire (DBAS;Morin, 1994). The DBAS is designed to measure sleep and insomnia-related cognitions.
Time Frame
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Other Pre-specified Outcome Measures:
Title
Treatment-related Learning
Description
Assessed using the Project STAR alcohol quiz
Time Frame
Change from baseline to post-treatment (week 6)
Title
Executive Functioning - Delayed Discounting
Description
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.
Time Frame
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Title
Executive Functioning - Working Memory
Description
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.
Time Frame
Change from baseline to post-treatment (week 6) to follow-up (week 12)
Title
Executive Functioning - Attention
Description
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.
Time Frame
Change from baseline to post-treatment (week 6) to follow-up (week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary E Miller, PhD
Phone
573-882-1813
Email
millmary@health.missouri.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elise M Blanke, BA
Phone
573-882-8598
Email
eblanke@health.missouri.edu
Facility Information:
Facility Name
University of Missouri-Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Beth Miller, PhD
Phone
573-882-1813
Email
millmary@health.missouri.edu

12. IPD Sharing Statement

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Sleep Treatment for Addiction Recovery

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