Using Implementation Science to Examine the Feasibility and Efficacy of Brief Behavioral Therapy for Insomnia (BBTI) in Substance Use Disorder Recovery Programs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Changes in Substance Used Outcome as Measured by Treatment Retention [days]
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •client of Cornerstone Clinic (CC); resident at Helping Up Mission (HUM)
- •active SUD
- •≥ 18 years old
- •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
排除标准
- •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
- •moderate-severe sleep apnea based on WatchPAT
- •restless legs syndrome based on SIS-D
- •discharged from HUM
研究组 & 干预措施
BBTI Group
Participants will receive 4 in-person sessions of Brief Behavioral Therapy for insomnia as part of their intensive outpatient treatment of substance use recovery
干预措施: Brief Behavioral Therapy for Insomnia (BBTI) (Behavioral)
SOC Group
Participants will receive their usual substance abuse treatment as part of their intensive outpatient treatment of substance use recovery
结局指标
主要结局
Changes in Substance Used Outcome as Measured by Treatment Retention [days]
时间窗: 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.
Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Adoption
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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.
Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Outreach
时间窗: 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
次要结局
- Change in Depression Measured by PROMIS Depression Scale(Baseline and post intervention up to 4 weeks)
- Change in Quality of life as Measured by PROMIS Global Health Scale(Baseline and post intervention up to 4 weeks)
- Treatment Adherence Rate as Assessed by Treatment Adherence(5 Weeks)
- Maintenance of Intervention(Up to 1 year)
- Change in Anxiety Measured by PROMIS Anxiety Scale(Baseline and post intervention up to 4 weeks)
- Change in Pain Measured by PROMIS Pain Interference Scale(Baseline and post intervention up to 4 weeks)
- Treatment Satisfaction Rate as Assessed by Treatment Satisfaction Survey(5 Weeks)
- Post-treatment Substance Use Disorder Relapse Rate as Assessed by Treatment Retention [days](Up to 4 weeks post intervention)
- Change in Pain Measured by PROMIS Pain Severity Scale(Baseline and post intervention up to 4 weeks)