InsomniaSTARNCT04198311
Sleep Treatment for Addiction Recovery
A study testing CBT-I in people with Insomnia and Alcohol Use Disorder, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Project STAR aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to outpatient alcohol and substance use treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Alcohol Use Disorder, Substance Use Disorders
- What is being tested?
- CBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Missouri-Columbia
Columbia, Missouri, 65212
Mary Beth Miller, PhD, 573-882-1813, millmary@health.missouri.edu
About this study
Official title: The Impact of CBT for Insomnia on Substance Use Treatment Outcomes
Project STAR aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to outpatient alcohol and substance use treatment.
Read the 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
- Conditions
- Insomnia, Alcohol Use Disorder, Substance Use Disorders
- Being tested
- CBT-I
- Keywords
- sleep, alcohol, drinking, insomnia, outpatient, inpatient, drug use
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-IBehavioural
Also called Cognitive-Behavioral Therapy for Insomnia
CBT-I will be delivered individually, in five weekly sessions. Intervention components include sleep hygiene, sleep restriction, stimulus control, relaxation, cognitive therapy.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Experimental | Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks Receives: Behavioral: CBT-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
The number of participants who complete baseline.
Measured: Assessed at Post-Treatment (week 6)
Retention
The number of participants who complete all treatment sessions
Measured: 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.
Measured: Assessed at Post-Treatment (week 6)
Secondary outcomes (9)
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.
Measured: Change from baseline to post-treatment (week 6) to follow-up (week 12)
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.
Measured: Change from baseline to post-treatment (week 6) to follow-up (week 12)
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.
Measured: Change from baseline to post-treatment (week 6) to follow-up (week 12)
Alcohol Problems
Assessed using the Short Inventory of Problems (SIP); SIP measures adverse consequences of substance use.
Measured: Change from baseline to post-treatment (week 6) to follow-up (week 12)
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
Measured: Change from baseline to post-treatment (week 6) to follow-up (week 12)
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).
Measured: Change from baseline to post-treatment (week 6) to follow-up (week 12)
Total Wake Time
The amount of time the participant is awake after they try to go to sleep. Measured using Daily Diaries and actigraphy.
Measured: Change from baseline to post-treatment (week 6) to follow-up (week 12)
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.
Measured: Change from baseline to post-treatment (week 6) to follow-up (week 12)
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.
Measured: Change from baseline to post-treatment (week 6) to follow-up (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start26 Aug 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will participate in sessions individual Cognitive Behavioral Therapy for Insomnia (CBT-I).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary E Miller, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198311
- Sponsor's protocol ID
- 2016896
- Acronym
- STAR
- Status last verified
- Mar 2022
- First submitted
- 9 Dec 2019
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37423902
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of CBT for Insomnia on Substance Use Treatment Outcomes
- ClinicalTrials.gov ID
- NCT04198311
- Acronym / sponsor ID
- STAR / 2016896
- Conditions
- Insomnia, Alcohol Use Disorder, Substance Use Disorders
- Keywords
- sleep, alcohol, drinking, insomnia, outpatient, inpatient, drug use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will participate in sessions individual Cognitive Behavioral Therapy for Insomnia (CBT-I).
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Experimental | Behavioral: CBT-IIndividual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-IAlso: Cognitive-Behavioral Therapy for InsomniaCBT-I will be delivered individually, in five weekly sessions. Intervention components include sleep hygiene, sleep restriction, stimulus control, relaxation, cognitive therapy. | Behavioural | Cognitive-Behavioral Therapy for Insomnia (CBT-I) |
Primary outcome
Recruitment
Time frame: Assessed at Post-Treatment (week 6)
The number of participants who complete baseline.
Retention
Time frame: Assessed at Post-Treatment (week 6)
The number of participants who complete all treatment sessions
Treatment Satisfaction
Time frame: Assessed at Post-Treatment (week 6)
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.
9 secondary outcomes
Abstinence
Time frame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
Heavy-Drinking Days
Time frame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
Substance Use Days
Time frame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
Alcohol Problems
Time frame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
Alcohol or Other Drugs as Sleep Aids
Time frame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
Insomnia severity
Time frame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
Total Wake Time
Time frame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
Sleep quality
Time frame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
Dysfunctional beliefs
Time frame: Change from baseline to post-treatment (week 6) to follow-up (week 12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Derived from this study: PubMed 37423902Miller 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.
Related trials for Insomnia
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Not yet recruitingPhase 2
A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia in a Randomized, Controlled, Dose-finding Study
Chronic Insomnia
Active, not recruiting
Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia
Insomnia
Enrolling by invitation
Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression
Insomnia, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I in people with Insomnia and Alcohol Use Disorder, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary E Miller, PhD (573-882-1813, millmary@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Assessed at Post-Treatment (week 6)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04198311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.