A Randomized Controlled Trial (RCT) to Asses the Efficacy of Community Reinforcement Approach (CRA) in the Treatment of Cannabis Users
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Time Line Follow-Back Interview (Assessing Change)
研究概览
简要总结
Substance abuse is not a new phenomenon in Pakistan. Its prevalence is increasing day by day due to multi-factorial reasons including psychological, cultural, biological, environmental, social and personal factors. Recent statistics shows an alarming increase in the use of substance. The last survey conducted indicates there are 3.6 million substance users in Pakistan and 3.6 percent among them are cannabis users. Furthermore, cannabis is found to be the most prevalent abused drug with adverse impact on the mental health among university students in Pakistan. However, there is a dearth of literature which could indicate a well-established treatment policy with proven efficacy model available in Pakistan. This study aims to investigate the efficacy of Community Reinforcement Approach (CRA) as evidence based remedy for Cannabis Users. The study is designed in a Randomized Controlled Trial (RCT) consisting of groups: Active Treatment (AT; with nine sessions of CRA intervention) and Treatment as Usual (TAU; routine treatment). After screening and baseline, participants will be assigned to the either Active Treatment group or Treatment As Usual group. Participants in both groups will be assessed on completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up). The primary outcome measure will be the frequency of usage, abstinence period and quantity of cannabis by using Timeline Follow Back Interview. The duration of the study is two and half years
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 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current, regular cannabis use, defined as the use of any cannabis product at least twice per week over the course of the past 12 months.
- •Participant able to provide informed consent and willing to participate in the study.
排除标准
- •ICD-11 dependence (in the previous 12 months) on alcohol or any other illicit drug (apart from cannabis) with symptoms of withdrawal, tolerance or craving.
- •Current use of opiate substitution or sedative-hypnotic medication.
- •Having been treated for cannabis use problems with any other treatment within the previous three months.
- •Participant with lifetime psychotic disorder.
- •Participants with moderate, severe and extremely severe scores on (DASS-21) will be excluded. Severe learning disability or a pervasive developmental disorder.
- •Signs of severe non-cannabis-related intoxication.
结局指标
主要结局
Time Line Follow-Back Interview (Assessing Change)
时间窗: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
In order to gather additional information about the frequency, patterns, mode and quantity of cannabis use, we will use the Time Line Follow-Back Interview (TLFB; Sobell \& Sobell, 1992) as modified by the Marijuana Treatment Project Research Group, 2004, at baseline, prior to each therapy session, at post-treatment as well as at the follow-up assessments.
The Severity of Dependence Scale (Assessing Change)
时间窗: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
The Severity of Dependence Scale (SDS; Gossop, Darke, Griffiths, Hando, Powis, Hall, \& Strang, 1995) will used to measure the degree of physical dependence the cannabis users experienced as well as the psychological components of their dependence. The scale will be used both at the time of screening and follow-ups.
次要结局
- EQ-5D-5L(Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).)
- Depression Stress and Anxiety Questionnaire(Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).)
研究者
Muhammad Tahir Khalily
Professor of Clinical Psychology
International Islamic University, Islamabad