The Impact of CBT for Insomnia on Substance Use Treatment Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Recruitment
研究概览
简要总结
Project STAR aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to outpatient alcohol and substance use treatment.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Recruitment
时间窗: Assessed at Post-Treatment (week 6)
The number of participants who complete baseline.
Retention
时间窗: Assessed at Post-Treatment (week 6)
The number of participants who complete all treatment sessions
Treatment Satisfaction
时间窗: 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.
次要结局
- Insomnia severity(Change from baseline to post-treatment (week 6) to follow-up (week 12))
- Heavy-Drinking Days(Change from baseline to post-treatment (week 6) to follow-up (week 12))
- Substance Use Days(Change from baseline to post-treatment (week 6) to follow-up (week 12))
- Abstinence(Change from baseline to post-treatment (week 6) to follow-up (week 12))
- Alcohol or Other Drugs as Sleep Aids(Change from baseline to post-treatment (week 6) to follow-up (week 12))
- Sleep quality(Change from baseline to post-treatment (week 6) to follow-up (week 12))
- Dysfunctional beliefs(Change from baseline to post-treatment (week 6) to follow-up (week 12))
- Alcohol Problems(Change from baseline to post-treatment (week 6) to follow-up (week 12))
- Total Wake Time(Change from baseline to post-treatment (week 6) to follow-up (week 12))
研究者
Mary E Miller
Professor, Psychiatry
University of Missouri-Columbia