The Impact of CBT-I on Cannabis Cessation Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments
研究概览
简要总结
The purpose of this study is to investigate the efficacy of a group-based behavioral sleep intervention, and the incremental benefit provided by an adjunct sleep mobile app, on cannabis and sleep outcomes among cannabis dependent Veterans.
详细描述
The Prevalence of cannabis use disorder (CUD) has been steadily increasing within the Veteran Health Administration (VHA), along with the related significant physical, cognitive, and psychological sequelae. Even in patients with a strong motivation to quit and the presence of empirically-supported interventions, Veterans who receive treatment for CUD have high rates of lapse (63% by 6-months post-treatment) and relapse (71% within 6-months post-treatment). Thus, identifying strategies to improve response to CUD treatment is in the interest of all VHA stakeholders.
Disturbed sleep is common among individuals with CUD and has been shown to result in increased rates of lapse/relapse to cannabis. Providing a behavioral sleep intervention within the context of CUD treatment, and prior to a cessation attempt, has the potential to improve these cessation outcomes.
Cognitive behavioral therapy for insomnia (CBT-I) is a well-established first-line treatment for insomnia. While CBT-I is being disseminated throughout VHA, it is rarely received by Veterans with substance use disorders (SUDs) and, among those that do receive it, it is almost always delivered following a cessation attempt. While CBT-I has been shown to be an effective treatment for improving sleep among individuals with insomnia and co-occurring conditions, including SUDs, there has yet to be an investigation of the impact of providing CBT-I prior to CUD treatment with the goal of improving cessation outcomes. In addition, the development of an adjunct behavioral intervention delivered via mobile app technology within VA holds great promise to bolster outcomes.
The current study seeks to fill this gap by conducting a randomized prospective study designed to evaluate the efficacy of CBT-I, as well as the incremental benefit of including an adjunct sleep mobile app (CBT-I-MA), on both cannabis and sleep outcomes among Veterans with CUD.
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 (Participant)
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
- •To be included in the current study individuals must
- •be a Veteran 18 years or older
- •meet Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria for cannabis use disorder;
- •meet Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for insomnia;
排除标准
- •Individuals will be excluded based on evidence of the following:
- •inability to provide fully-informed written consent to participate;
- •history of, or current, psychotic symptoms;
- •current pregnancy;
- •Sleep apnea (>5 on the STOP-Bang assessment);
- •active suicidal/homicidal intent.
研究组 & 干预措施
CBT-I
Group Cognitive-Behavioral Therapy for Insomnia (CBT-I)
干预措施: Cognitive Behavioral Therapy for Insomnia (CBT-I) (Behavioral)
CBT-I-MA
Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)
干预措施: Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA) (Behavioral)
PC
Desensitization Treatment for Insomnia (DTI)
干预措施: Desensitization Treatment for Insomnia (Behavioral)
结局指标
主要结局
Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments
时间窗: 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
point prevalence abstinence will be assessed using the Timeline Follow-back measure for cannabis count of number abstinent
Change in Self-reported Sleep Quality Over Time
时间窗: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit
Self-reported sleep quality will be measured using the Consensus Sleep Diary
Change in Objective Sleep Quality Over Time
时间窗: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit
Objective sleep quality will be measured via actigraphy
Change in Cannabis Use Frequency Over Time
时间窗: baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
Measures will include the Timeline Followback for cannabis. All of these measures are standard 7-day point prevalence estimates. In other words, the baseline measure is the number of uses in the 7 days prior to the baseline assessment day. The 6-weeks post-baseline is the number of uses in the 7 days prior to the 6-weeks post-baseline day, and so on.
次要结局
未报告次要终点