Substance Use DisordersgCBTINCT03208855
Cognitive Behavioral Therapy for Insomnia in Substance Use Disorders
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Substance Use Disorders and Insomnia, run by Johns Hopkins University at 1 site in United States.
Trial summary
Substance Use Disorders (SUDs) and insomnia are major public health concerns, and each are independently linked to reduced quality of life, disability, and high healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Substance Use Disorders, Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2017to 13 Oct 2020
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males > 18 years of age
- Active substance use disorder of any type
- Enrolled in the Cornerstone at Helping Up Mission clinic for less than 3 weeks
- ISI > 8
- Report either latency to sleep onset > 30 minutes or > 2 awakenings/night or > 15 min duration or wake after sleep onset (WASO) time > 30 minutes
- Insomnia symptom frequency self-reported as > 3 night/week for > 1 month
Who cannot join
- Self-report of Bipolar Disorder
- Self-report of Epilepsy or seizure disorder
- Suicidal ideation
- Acute Alcohol Withdrawal requiring medical attention
Trial locations and contacts
1 site in 1 country.
United States1 site
Cornerstone at Helping Up Mission Clinic
Baltimore, Maryland, 21203
About this study
Official title: Cognitive Behavioral Therapy for Insomnia in Substance Use Disorders at an Urban Residential Recovery Program
Substance Use Disorders (SUDs) and insomnia are major public health concerns, and each are independently linked to reduced quality of life, disability, and high healthcare costs. Insomnia, characterized by difficulty initiating or maintaining sleep, or nonrestorative sleep, is prevalent in 10% of the general population and is co-morbid in 70% of patients with SUDs. Primary insomnia and SUDs are chronic, unremitting diseases and have a complex bidirectional relationship. Insomnia symptoms may predate the onset of SUDs and may explain high prevalence of self-treatment. Insomnia may also be a direct effect of intoxication, withdrawal, or abstinence from the substance of abuse. Subjective and objective measures of sleep disruption have been shown in various stages of abuse and recovery. Insomnia is the most well documented predictor of substance use relapse. Treatment specifically targeting chronic insomnia is essential for improved clinical outcomes. Although, chronic insomnia is a well-established, modifiable risk factor, to our knowledge, there are no interdisciplinary residential treatment programs that specifically treat chronic insomnia during acute SUDs treatment. We propose that improved treatment of insomnia as part of a comprehensive reinforcement-based outpatient treatment program will provide an efficient and cost effective opportunity to improve standard outpatient SUD. Converging evidence suggests that prophylactic CBT-I during SUD treatment may have short and long-term efficacy for sleep, and improve attrition. In the proposed study, patients with co-morbid SUDs and insomnia will engage in an 8-week group CBT-I (gCBT-I) program in addition to receiving treatment as usual for SUDs. This study may provide new hope to effectively treat insomnia in SUD and lead to a new standardization of outpatient care. We hypothesize that a CBT-I intervention can be implemented as part of an evidence-based SUD treatment program within a residential facility.
Read the detailed description
Substance use disorders (SUDs) are a leading cause of global disease burden with significant epidemiological and economic consequences. Sleep disturbances (i.e., difficulty initiating or maintaining sleep) are nearly ubiquitous in individuals with SUDs and may arise from direct effects of the substance or from withdrawal of the substance. Sleep disturbances are reported in up to 70% of individuals entering both detoxification and early recovery programs and may persist for months to years during abstinence. Objective and subjective measures of sleep disturbances are among the best predictors of relapse. Treatment of insomnia (i.e., difficulty initiating or maintaining sleep, with significant daytime impairment) during early recovery may improve relapse rates. Insomnia is a modifiable risk factor and responds to psychological interventions. Given the abuse potential of many medications utilized for sleep disturbances and the likelihood of drug-drug interactions over the course of detoxification, a non-pharmacological approach to insomnia remains promising. To date, few studies have evaluated non-pharmacological approaches to insomnia during early substance abuse recovery. One study has evidenced improved self-reported sleep quality in men who were assigned to 2 weeks of daily progressive muscle relaxation training. Robust evidence indicates that cognitive behavioral therapy for insomnia (CBT-I) is effective, and in fact is first line treatment for primary insomnia. A preponderance of randomized controlled trials of CBT-I in co-morbid populations suggests it is efficacious to address insomnia in context of ongoing medical and psychiatric illnesses. Despite the possibility that treating insomnia may improve relapse and attrition rates, and evidence that CBT-I is efficacious in improving sleep, there is a dearth of empirical data regarding the prophylactic benefit of initiating CBT-I as part of acute abstinence treatment. This study aims to test the feasibility of implementing a non-pharmacological insomnia intervention for individuals at the Cornerstone clinic at the Helping Up Mission, a residential SUD residential recovery program for men in Baltimore, MD. Participants will be recruited from the Cornerstone clinic, an accredited behavioral health clinic directed by Johns Hopkins faculty and staff, which provides evidence-based SUD treatment to residents of the Helping Up Mission. CBT-I will be incorporated into the outpatient reinforcement-based SUD treatment. The investigators hypothesize that implementation of CBT-I during early SUD recovery is feasible and will lead to improved sleep parameters and improved clinical outcomes compared with those receiving treatment as usual (TAU). The investigators propose a proof of concept study which would first demonstrate feasibility of administering CBT-I for individuals residing in a men's homeless shelter, and will further evaluate the short- and long-term efficacy of CBT for insomnia in individuals with SUDs. This investigation will provide important and novel information regarding potential psychological interventions that may be incorporated into evidence-based SUD treatment.
- Conditions
- Substance Use Disorders, Insomnia
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Keywords
- Cognitive Behavioral Therapy
- Medical subject headings
- Substance-Related Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural
Also called gCBT-I
8 week 1-hour sessions of group CBT-I with each group including 3-4 men.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Experimental | Participants will receive 8 1-hour sessions of group Cognitive Behavioral Therapy for insomnia as part of their intensive outpatient treatment of substance use recovery Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| Treatment as Usual | No intervention | Participants will receive treatment as usual for substance abuse treatment as part of their intensive outpatient treatment of substance use recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in sleep.
Participants in both study arms will record subjective sleep measures via self-report sleep diary. They will also complete the Insomnia Severity Index (ISI)) at both pre-and post-treatment and over 6-month follow-up period.
Measured: Up to 6-month follow-up period.
Secondary outcomes (1)
Attrition in a substance abuse treatment program.
Attrition rates for the SUDs treatment program will be compared between the CBT-I and the treatment as usual group at 3-month follow-up.
Measured: Up to 3-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start31 Jul 2017
- Primary completion13 Apr 2020
- Study completion13 Oct 2020
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 Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Traci Speed, MD/PHD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208855
- Sponsor's protocol ID
- IRB00117179
- Acronym
- gCBTI
- Status last verified
- Jan 2022
- First submitted
- 28 Jun 2017
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Speed TJ, Hanks L, Turner G, Gurule E, Kearson A, Buenaver L, Smith MT, Antoine D. A comparison of cognitive behavioral therapy for insomnia to standard of care in an outpatient substance use disorder clinic embedded within a therapeutic community: a RE-AIM framework evaluation. Trials. 2022 Nov 28;23(1):965. doi: 10.1186/s13063-022-06885-7.
PubMed 36443869
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia in Substance Use Disorders at an Urban Residential Recovery Program
- ClinicalTrials.gov ID
- NCT03208855
- Acronym / sponsor ID
- gCBTI / IRB00117179
- Conditions
- Substance Use Disorders, Insomnia
- Keywords
- Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 13 Apr 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 6 Jul 2017 (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.
Substance Use Disorders (SUDs) and insomnia are major public health concerns, and each are independently linked to reduced quality of life, disability, and high healthcare costs. Insomnia, characterized by difficulty initiating or maintaining sleep, or nonrestorative sleep, is prevalent in 10% of the general population and is co-morbid in 70% of patients with SUDs. Primary insomnia and SUDs are chronic, unremitting diseases and have a complex bidirectional relationship. Insomnia symptoms may predate the onset of SUDs and may explain high prevalence of self-treatment. Insomnia may also be a direct effect of intoxication, withdrawal, or abstinence from the substance of abuse. Subjective and objective measures of sleep disruption have been shown in various stages of abuse and recovery. Insomnia is the most well documented predictor of substance use relapse. Treatment specifically targeting chronic insomnia is essential for improved clinical outcomes. Although, chronic insomnia is a well-established, modifiable risk factor, to our knowledge, there are no interdisciplinary residential treatment programs that specifically treat chronic insomnia during acute SUDs treatment. We propose that improved treatment of insomnia as part of a comprehensive reinforcement-based outpatient treatment program will provide an efficient and cost effective opportunity to improve standard outpatient SUD. Converging evidence suggests that prophylactic CBT-I during SUD treatment may have short and long-term efficacy for sleep, and improve attrition. In the proposed study, patients with co-morbid SUDs and insomnia will engage in an 8-week group CBT-I (gCBT-I) program in addition to receiving treatment as usual for SUDs. This study may provide new hope to effectively treat insomnia in SUD and lead to a new standardization of outpatient care. We hypothesize that a CBT-I intervention can be implemented as part of an evidence-based SUD treatment program within a residential facility.
Detailed description
Substance use disorders (SUDs) are a leading cause of global disease burden with significant epidemiological and economic consequences. Sleep disturbances (i.e., difficulty initiating or maintaining sleep) are nearly ubiquitous in individuals with SUDs and may arise from direct effects of the substance or from withdrawal of the substance. Sleep disturbances are reported in up to 70% of individuals entering both detoxification and early recovery programs and may persist for months to years during abstinence. Objective and subjective measures of sleep disturbances are among the best predictors of relapse. Treatment of insomnia (i.e., difficulty initiating or maintaining sleep, with significant daytime impairment) during early recovery may improve relapse rates. Insomnia is a modifiable risk factor and responds to psychological interventions. Given the abuse potential of many medications utilized for sleep disturbances and the likelihood of drug-drug interactions over the course of detoxification, a non-pharmacological approach to insomnia remains promising. To date, few studies have evaluated non-pharmacological approaches to insomnia during early substance abuse recovery. One study has evidenced improved self-reported sleep quality in men who were assigned to 2 weeks of daily progressive muscle relaxation training. Robust evidence indicates that cognitive behavioral therapy for insomnia (CBT-I) is effective, and in fact is first line treatment for primary insomnia. A preponderance of randomized controlled trials of CBT-I in co-morbid populations suggests it is efficacious to address insomnia in context of ongoing medical and psychiatric illnesses. Despite the possibility that treating insomnia may improve relapse and attrition rates, and evidence that CBT-I is efficacious in improving sleep, there is a dearth of empirical data regarding the prophylactic benefit of initiating CBT-I as part of acute abstinence treatment. This study aims to test the feasibility of implementing a non-pharmacological insomnia intervention for individuals at the Cornerstone clinic at the Helping Up Mission, a residential SUD residential recovery program for men in Baltimore, MD. Participants will be recruited from the Cornerstone clinic, an accredited behavioral health clinic directed by Johns Hopkins faculty and staff, which provides evidence-based SUD treatment to residents of the Helping Up Mission. CBT-I will be incorporated into the outpatient reinforcement-based SUD treatment. The investigators hypothesize that implementation of CBT-I during early SUD recovery is feasible and will lead to improved sleep parameters and improved clinical outcomes compared with those receiving treatment as usual (TAU). The investigators propose a proof of concept study which would first demonstrate feasibility of administering CBT-I for individuals residing in a men's homeless shelter, and will further evaluate the short- and long-term efficacy of CBT for insomnia in individuals with SUDs. This investigation will provide important and novel information regarding potential psychological interventions that may be incorporated into evidence-based SUD treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)Participants will receive 8 1-hour sessions of group Cognitive Behavioral Therapy for insomnia as part of their intensive outpatient treatment of substance use recovery |
| Treatment as Usual | No intervention | –Participants will receive treatment as usual for substance abuse treatment as part of their intensive outpatient treatment of substance use recovery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males > 18 years of age
- Active substance use disorder of any type
- Enrolled in the Cornerstone at Helping Up Mission clinic for less than 3 weeks
- ISI > 8
- Report either latency to sleep onset > 30 minutes or > 2 awakenings/night or > 15 min duration or wake after sleep onset (WASO) time > 30 minutes
Key exclusion criteria (4 listed)
- Self-report of Bipolar Disorder
- Self-report of Epilepsy or seizure disorder
- Suicidal ideation
- Acute Alcohol Withdrawal requiring medical 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 |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I)Also: gCBT-I8 week 1-hour sessions of group CBT-I with each group including 3-4 men. | Behavioural | CBT-I |
Primary outcome
Improvement in sleep.
Time frame: Up to 6-month follow-up period.
Participants in both study arms will record subjective sleep measures via self-report sleep diary. They will also complete the Insomnia Severity Index (ISI)) at both pre-and post-treatment and over 6-month follow-up period.
1 secondary outcome
Attrition in a substance abuse treatment program.
Time frame: Up to 3-month follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Derived from this study: PubMed 36443869Speed TJ, Hanks L, Turner G, Gurule E, Kearson A, Buenaver L, Smith MT, Antoine D. A comparison of cognitive behavioral therapy for insomnia to standard of care in an outpatient substance use disorder clinic embedded within a therapeutic community: a RE-AIM framework evaluation. Trials. 2022 Nov 28;23(1):965. doi: 10.1186/s13063-022-06885-7.
- Individual participant dataSharing planned: No
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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.
Traci Speed, MD/PHD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Substance Use Disorders and Insomnia, run by Johns Hopkins University 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 1 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in sleep. (time frame: Up to 6-month follow-up period.). 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 NCT03208855, 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 1 Feb 2022.