An Exploratory Study of the Relationship Between Substance Use, Sleep Disturbances and Reward Sensitivity - A Randomized Control Trial of Cognitive Behavioral Therapy for Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
According to foreign medical studies, substance use is closely related to reward sensitivity and sleep patterns. The purpose of this research is to understand the relationship between these three factors, which will help improve medical treatment and overall care for substance misuse in the future. Participants will be randomized into CBTi and sleep education groups, and their substance/ alcohol use, sleep parameters and reward sensitivity will be measured at multiple time points.
详细描述
The study will invite approximately 154 individuals who have misused alcohol or drugs in the past three months and have symptoms of insomnia to participate. After completing the screening, participants who meet the study criteria will be asked to fill out five additional research questionnaires and take a 15-minute computer-based reward sensitivity test. Participants will then be randomly assigned, in a 1:1 ratio, to one of the following groups:
- A three-session cognitive behavioral therapy (CBT) group (the first session lasts 60 minutes, with subsequent sessions not exceeding 30 minutes) and two follow-up phone calls (each lasting around 20 minutes).
- A three-session sleep education group (the first session lasts 60 minutes, with subsequent sessions not exceeding 30 minutes) and two follow-up phone calls (each lasting around 20 minutes).
All participants will be invited to complete additional research questionnaires and computer-based tests in the 4th and 8th weeks after the group sessions begin.
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
- 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
- •Individuals who receive treatment services at Substance Abuse Assessment Clinic and other psychiatric out-patient clinics of Kwai Chung Hospital;
- •Individuals who have problematic substance or alcohol use in the past 3 months, confirmed by scores higher than or equal to 1 in both part 1 and part 2 of Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS);
- •Individuals who have sleep disturbances, confirmed by a score higher than or equal to 8 on the Insomnia Severity Index (ISI).
排除标准
- •Individuals who cannot understand Cantonese, or cannot read Traditional Chinese
- •Individuals who cannot provide informed consent due to, for example, intoxication or abnormal mental state
- •Individuals who report abnormal or unstable mental states, such as active psychotic symptoms or acute intoxication, at any point of the study
- •Individuals who work overnight or have rotating shifts
- •Individuals who report pregnancy or medical conditions (including sleep apnea) that may have a severe impact on sleep
- •Individuals who use hypnotics regularly
研究组 & 干预措施
Sleep Education Group
Sleep Education
干预措施: Sleep Education (Behavioral)
CBTi Group
Cognitive Behavioral Therapy for Insomnia
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
结局指标
主要结局
Insomnia Severity Index
时间窗: From enrollment to the end of treatment at 8 weeks
Pittsburgh Sleep Quality Index
时间窗: From enrollment to the end of treatment at 8 weeks
Drug Use Disorders Identification Test
时间窗: From enrollment to the end of treatment at 8 weeks
Alcohol Use Disorders Identification Test
时间窗: From enrollment to the end of treatment at 8 weeks
次要结局
- Sensitivity to Reward Scales from Sensitivity to Reward and Sensitivity to Punishment Questionnaire(From enrollment to the end of treatment at 8 weeks)
- Computerized Iowa Gambling Task(From enrollment to the end of treatment at 8 weeks)
研究者
Fritz Yeung
Clinical Psychologist
Kwai Chung Hospital