Substance Use DisordersBBTI_SUDsNCT05935735
Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) in SUD Recovery
A study testing Brief Behavioral Therapy for Insomnia (BBTI) in people with Substance Use Disorders and Insomnia, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this clinical study is to learn whether treating sleep problems is helpful in people with substance abuse problems who are living in a residential treatment program. Another goal is to study whether treating sleep problems will help individuals stay in substance abuse recovery treatment for a greater… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders, Insomnia
- What is being tested?
- Brief Behavioral Therapy for Insomnia (BBTI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2023to 2 Apr 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- client of Cornerstone Clinic (CC); resident at Helping Up Mission (HUM)
- active SUD
- ≥ 18 years old
- ISI ≥ 8
- insomnia disorder as determined by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Sleep Disorders (SIS-D)
- able to understand English proficiently
Who cannot join
- medical or psychiatric condition interfering with treatment or requiring hospitalization
- inability to provide informed consent
- declines behavioral health treatment at CC
- suicidal ideation
- acute alcohol withdrawal requiring medical attention
- pregnant or breastfeeding
Show all 9Show fewer
- moderate-severe sleep apnea based on WatchPAT
- restless legs syndrome based on SIS-D
- discharged from HUM
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: Using Implementation Science to Examine the Feasibility and Efficacy of Brief Behavioral Therapy for Insomnia (BBTI) in Substance Use Disorder Recovery Programs
The goal of this clinical study is to learn whether treating sleep problems is helpful in people with substance abuse problems who are living in a residential treatment program. Another goal is to study whether treating sleep problems will help individuals stay in substance abuse recovery treatment for a greater amount of time.
Participants will be asked to complete surveys at the time of enrollment and every week for the next 9 weeks for a total of 8 times. Participants will be asked to wear a watch that measures sleep (sleep watch) while the participants are in the group and for a 2-week period after the participants complete the group. Participants may also be asked to participate in an interview about the experience with the group and wearing the watch. Participants will also have "homework" throughout a 4 week period. Homework is to complete a sleep diary each morning.
The first group of 50 participants will be enrolled in the brief behavioral treatment for insomnia (BBTI) group where the participants receive typical treatment plus the sleep intervention program. The investigators will use qualitative and quantitative data to identify implementation facilitators and barriers, then further modify BBTI to improve feasibility. After modifying the BBTI protocol and re-training staff, study procedures will remain intact with the exception that the investigators will double the recruitment and randomize participants to the modified BBTI (N=50) or standard-of-care (SOC) (N=50). All participants will complete all assessments except the SOC group will not complete treatment satisfaction surveys.
Read the detailed description
Brief behavioral treatment for insomnia (BBTI) is an efficacious evidence-based sleep intervention derived from cognitive behavioral therapy for insomnia (CBT-I) that may address barriers to widespread dissemination of insomnia therapy because it is brief (4 weeks), easily deliverable without need for specialty training (uses a hard-copy workbook) and behaviorally-focused. This proposal has the following two aims:
- To use the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, a well-established implementation framework that informs evaluation of health-related programs, including in community and substance use treatment settings, to evaluate the feasibility of implementing a modified BBTI among underserved special population of individuals in a residential recovery program;
- To conduct a clinical trial to evaluate the efficacy of the modified BBTI on subjective and objective sleep outcomes compared with conventional standard-of-care. The end goal of this project is to provide empirical evidence of a modified BBTI's value in SUD recovery for individuals of diverse racial backgrounds. Successful completion of this study will promote the dissemination and sustainable adoption of an evidence-based, pragmatic, and accessible insomnia intervention in real-world SUD recovery programs.
- Conditions
- Substance Use Disorders, Insomnia
- Being tested
- Brief Behavioral Therapy for Insomnia (BBTI)
- Keywords
- Brief Behavioral Therapy for Insomnia
- 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.
Brief Behavioral Therapy for Insomnia (BBTI)Behavioural
4 in-person sessions; 1 individual and 3 group sessions
| Study group | Role | What they receive |
|---|---|---|
| BBTI Group | Experimental | Participants will receive 4 in-person sessions of Brief Behavioral Therapy for insomnia as part of their intensive outpatient treatment of substance use recovery Receives: Behavioral: Brief Behavioral Therapy for Insomnia (BBTI) |
| SOC Group | No intervention | Participants will receive their usual 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.
Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Outreach
The success rate of outreach is measured by:
- Percent of eligible Helping Up Mission (HUM) residents who were referred to study
- Percent of eligible HUM residents who consented to study
- Percent of HUM residents who attended BBTI Session 1
If overall score from the three parameters above is greater than 50%, outreach is feasible
Measured: Up to 1 year
Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Adoption
The success rate of adoption is measured by:
- Provider satisfaction with training as assessed by semi-structured interviews with Cornerstone Clinic researchers and staff, HUM leadership, and providers
- Provider satisfaction with facilitating BBTI as assessed by semi-structured interviews with participants
If overall score from the parameters above is greater than 80%, adoption is feasible
Measured: Up to 1 year
Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Treatment Integrity
The success rate of treatment integrity is measured by percent of maintaining treatment based on fidelity checklist.
If overall score is above 85% treatment integrity is feasible
Measured: Up to 1 year
Changes in the Symptoms of Insomnia after Brief Behavioral Therapy for Insomnia (BBTI) as Measured by Insomnia Severity Index (ISI)
Participants will complete ISI. Investigators will compare pre- and post-intervention primary outcomes. ISI is a 7-item questionnaire assessing the nature and symptoms of insomnia. ISI total score is the sum of all item scores which ranges from 0-28 and is interpreted as follows: no clinically significant insomnia (0-7), subthreshold insomnia (8-14), moderate clinical insomnia (15-21), and severe clinical insomnia (22-28). Negative changes in scores indicate improvement.
Measured: Baseline and post intervention up to 4 weeks
Changes in Sleep Efficiency after Brief Behavioral Therapy for Insomnia (BBTI) as Measured by Actigraphy
Participants in both arms will complete daily sleep diaries and wear an actiwatch. Sleep Efficiency is a measure of total sleep time over time in bed. Higher sleep efficiency indicates improved sleep.
Measured: Baseline and post intervention up to 4 weeks
Changes in Substance Used Outcome as Measured by Treatment Retention [days]
Treatment retention is number of days in substance used treatment. Treatment retention days will be counted by the number of days that the client is in treatment at the Helping Up Mission.
Measured: Baseline and post intervention up to 4 weeks
Secondary outcomes (9)
Treatment Satisfaction Rate as Assessed by Treatment Satisfaction Survey
Participants will complete a treatment satisfaction survey at the end of each BBTI session. Response options are coded from 1 to 4. The total score ranges from 5 to 20 with a higher score indicating a greater satisfaction rate.
Measured: 5 Weeks
Treatment Adherence Rate as Assessed by Treatment Adherence
Treatment adherence is a measurement of BBTI sessions attended.
Measured: 5 Weeks
Maintenance of Intervention
Maintenance of intervention is a measurement of treatment availability over one year.
Measured: Up to 1 year
Post-treatment Substance Use Disorder Relapse Rate as Assessed by Treatment Retention [days]
Relapse Rate is percent of positive urine toxicology results. Treatment retention days will be counted by the number of days that the client is in treatment at the Helping Up Mission.
Measured: Up to 4 weeks post intervention
Change in Quality of life as Measured by PROMIS Global Health Scale
Participants will complete the PROMIS Global Health Scale post-intervention. This is a 10-item patient-reported questionnaire that assesses healthcare-related quality of life measures. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health Score. The scores are standardized to the general population, using the "T-score" which is 50 points with a standard deviation of 10. Higher scores indicate better health.
Measured: Baseline and post intervention up to 4 weeks
Change in Depression Measured by PROMIS Depression Scale
Participants will complete PROMIS Depression Scale questionnaires at pre-treatment and post-treatment. This is a 4-item questionnaire that assesses depressed mood in the past 7 days. The total score ranges from 8 to 40 with higher scores indicating greater severity of depression. Then, the total score is converted into T-score which is 50 points with a standard deviation of 10. Negative changes in the score indicate improvement.
Measured: Baseline and post intervention up to 4 weeks
Change in Anxiety Measured by PROMIS Anxiety Scale
Participants will complete the PROMIS Anxiety Scale questionnaires at pre-treatment and post-treatment. This is a 4-item questionnaire that assesses the severity of the individual's anxiety in the past 7 days. The total score ranges from 7 to 35 with higher scores indicating greater severity of anxiety. Then, the total score is converted into T-score which is 50 points with a standard deviation of 10. Negative changes in the score indicate improvement.
Measured: Baseline and post intervention up to 4 weeks
Change in Pain Measured by PROMIS Pain Interference Scale
Participants will complete the PROMIS Pain Interference questionnaire at pre-treatment and post-treatment This is a 4-item questionnaire that assesses pain interference in the last 7 days. The total score ranges from 4 to 20 with higher scores indicating greater pain interference with daily activities. Then, the total score is converted into T-score which is 50 points with a standard deviation of 10. Negative changes in the score indicate improvement.
Measured: Baseline and post intervention up to 4 weeks
Change in Pain Measured by PROMIS Pain Severity Scale
Participants will complete the PROMIS Pain Severity questionnaire at pre-treatment and post-treatment This is a 4-item questionnaire that assesses pain intensity in the past 7 days. The total score ranges from 3 to 9 with higher scores indicating severe pain. Then, the total score is converted into T-score which is 50 points with a standard deviation of 10. Negative changes in the score indicate improvement.
Measured: Baseline and post intervention up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start26 Jul 2023
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Responsible party
- Sponsor
- Investigators
- Traci J Speed, MD/PHD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935735
- Sponsor's protocol ID
- IRB00343251
- Acronym
- BBTI_SUDs
- Status last verified
- Apr 2026
- First submitted
- 29 Jun 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Implementation Science to Examine the Feasibility and Efficacy of Brief Behavioral Therapy for Insomnia (BBTI) in Substance Use Disorder Recovery Programs
- ClinicalTrials.gov ID
- NCT05935735
- Acronym / sponsor ID
- BBTI_SUDs / IRB00343251
- Conditions
- Substance Use Disorders, Insomnia
- Keywords
- Brief Behavioral Therapy for Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 7 Jul 2023 (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.
The goal of this clinical study is to learn whether treating sleep problems is helpful in people with substance abuse problems who are living in a residential treatment program. Another goal is to study whether treating sleep problems will help individuals stay in substance abuse recovery treatment for a greater amount of time.
Participants will be asked to complete surveys at the time of enrollment and every week for the next 9 weeks for a total of 8 times. Participants will be asked to wear a watch that measures sleep (sleep watch) while the participants are in the group and for a 2-week period after the participants complete the group. Participants may also be asked to participate in an interview about the experience with the group and wearing the watch. Participants will also have "homework" throughout a 4 week period. Homework is to complete a sleep diary each morning.
The first group of 50 participants will be enrolled in the brief behavioral treatment for insomnia (BBTI) group where the participants receive typical treatment plus the sleep intervention program. The investigators will use qualitative and quantitative data to identify implementation facilitators and barriers, then further modify BBTI to improve feasibility. After modifying the BBTI protocol and re-training staff, study procedures will remain intact with the exception that the investigators will double the recruitment and randomize participants to the modified BBTI (N=50) or standard-of-care (SOC) (N=50). All participants will complete all assessments except the SOC group will not complete treatment satisfaction surveys.
Detailed description
Brief behavioral treatment for insomnia (BBTI) is an efficacious evidence-based sleep intervention derived from cognitive behavioral therapy for insomnia (CBT-I) that may address barriers to widespread dissemination of insomnia therapy because it is brief (4 weeks), easily deliverable without need for specialty training (uses a hard-copy workbook) and behaviorally-focused. This proposal has the following two aims:
- To use the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, a well-established implementation framework that informs evaluation of health-related programs, including in community and substance use treatment settings, to evaluate the feasibility of implementing a modified BBTI among underserved special population of individuals in a residential recovery program;
- To conduct a clinical trial to evaluate the efficacy of the modified BBTI on subjective and objective sleep outcomes compared with conventional standard-of-care. The end goal of this project is to provide empirical evidence of a modified BBTI's value in SUD recovery for individuals of diverse racial backgrounds. Successful completion of this study will promote the dissemination and sustainable adoption of an evidence-based, pragmatic, and accessible insomnia intervention in real-world SUD recovery programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BBTI Group | Experimental | Behavioral: Brief Behavioral Therapy for Insomnia (BBTI)Participants will receive 4 in-person sessions of Brief Behavioral Therapy for insomnia as part of their intensive outpatient treatment of substance use recovery |
| SOC Group | No intervention | –Participants will receive their usual substance abuse treatment as part of their intensive outpatient treatment of substance use recovery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- client of Cornerstone Clinic (CC); resident at Helping Up Mission (HUM)
- active SUD
- ≥ 18 years old
- ISI ≥ 8
- insomnia disorder as determined by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Sleep Disorders (SIS-D)
Key exclusion criteria (9 listed)
- medical or psychiatric condition interfering with treatment or requiring hospitalization
- inability to provide informed consent
- declines behavioral health treatment at CC
- 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 |
|---|---|---|
| Brief Behavioral Therapy for Insomnia (BBTI)4 in-person sessions; 1 individual and 3 group sessions | Behavioural | BBTI Group |
Primary outcome
Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Outreach
Time frame: Up to 1 year
The success rate of outreach is measured by: * Percent of eligible Helping Up Mission (HUM) residents who were referred to study * Percent of eligible HUM residents who consented to study * Percent of HUM residents who attended BBTI Session 1 If overall score from the three parameters above is greater than 50%, outreach is feasible
Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Adoption
Time frame: Up to 1 year
The success rate of adoption is measured by: * Provider satisfaction with training as assessed by semi-structured interviews with Cornerstone Clinic researchers and staff, HUM leadership, and providers * Provider satisfaction with facilitating BBTI as assessed by semi-structured interviews with participants If overall score from the parameters above is greater than 80%, adoption is feasible
Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Treatment Integrity
Time frame: Up to 1 year
The success rate of treatment integrity is measured by percent of maintaining treatment based on fidelity checklist. If overall score is above 85% treatment integrity is feasible
Changes in the Symptoms of Insomnia after Brief Behavioral Therapy for Insomnia (BBTI) as Measured by Insomnia Severity Index (ISI)
Time frame: Baseline and post intervention up to 4 weeks
Participants will complete ISI. Investigators will compare pre- and post-intervention primary outcomes. ISI is a 7-item questionnaire assessing the nature and symptoms of insomnia. ISI total score is the sum of all item scores which ranges from 0-28 and is interpreted as follows: no clinically significant insomnia (0-7), subthreshold insomnia (8-14), moderate clinical insomnia (15-21), and severe clinical insomnia (22-28). Negative changes in scores indicate improvement.
Changes in Sleep Efficiency after Brief Behavioral Therapy for Insomnia (BBTI) as Measured by Actigraphy
Time frame: Baseline and post intervention up to 4 weeks
Participants in both arms will complete daily sleep diaries and wear an actiwatch. Sleep Efficiency is a measure of total sleep time over time in bed. Higher sleep efficiency indicates improved sleep.
Changes in Substance Used Outcome as Measured by Treatment Retention [days]
Time frame: Baseline and post intervention up to 4 weeks
Treatment retention is number of days in substance used treatment. Treatment retention days will be counted by the number of days that the client is in treatment at the Helping Up Mission.
9 secondary outcomes
Treatment Satisfaction Rate as Assessed by Treatment Satisfaction Survey
Time frame: 5 Weeks
Treatment Adherence Rate as Assessed by Treatment Adherence
Time frame: 5 Weeks
Maintenance of Intervention
Time frame: Up to 1 year
Post-treatment Substance Use Disorder Relapse Rate as Assessed by Treatment Retention [days]
Time frame: Up to 4 weeks post intervention
Change in Quality of life as Measured by PROMIS Global Health Scale
Time frame: Baseline and post intervention up to 4 weeks
Change in Depression Measured by PROMIS Depression Scale
Time frame: Baseline and post intervention up to 4 weeks
Change in Anxiety Measured by PROMIS Anxiety Scale
Time frame: Baseline and post intervention up to 4 weeks
Change in Pain Measured by PROMIS Pain Interference Scale
Time frame: Baseline and post intervention up to 4 weeks
Change in Pain Measured by PROMIS Pain Severity Scale
Time frame: Baseline and post intervention up to 4 weeks
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 17 Apr 2026.
- 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 J 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 Brief Behavioral Therapy for Insomnia (BBTI) 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 9 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 17 Apr 2026. 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?
Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Outreach (time frame: Up to 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.