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| Name | Class |
|---|---|
| American Academy of Sleep Medicine | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| SOC Group | No Intervention | Participants will receive their usual substance abuse treatment as part of their intensive outpatient treatment of substance use recovery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Behavioral Therapy for Insomnia (BBTI) | Behavioral | 4 in-person sessions; 1 individual and 3 group sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Outreach | The success rate of outreach is measured by:
If overall score from the three parameters above is greater than 50%, outreach is feasible | 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:
If overall score from the parameters above is greater than 80%, adoption is feasible | 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 | 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. | Baseline and post intervention up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Traci J Speed, MD/PHD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornerstone at Helping Up Mission Clinic | Baltimore | Maryland | 21203 | United States |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| 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. | 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. | Baseline and post intervention up to 4 weeks |
| Treatment Adherence Rate as Assessed by Treatment Adherence |
Treatment adherence is a measurement of BBTI sessions attended. |
| 5 Weeks |
| Maintenance of Intervention | Maintenance of intervention is a measurement of treatment availability over one year. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and post intervention up to 4 weeks |
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |