The Feasibility and Effects of Mindfulness Based Relapse Prevention (MBRP) on Reducing Craving and Addictive Behaviour in Adults With Substance Abuse Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 9
- 主要终点
- Self report of any drug abuse and usage
研究概览
简要总结
Mindfulness-base interventions are promising interventions as an adjunctive therapy to be integrated into current existing anti-drug services. The advantages of MBRP can include: 1) having very low stigma as mindfulness courses are already widely accepted and used among different populations including healthy populations. The running of mindfulness courses can be more acceptable by the community; 2) it could be more accessible and cost-effective as it can be provided in group and in community settings; 3) it is a skill that can be learned and be used after the 8 week course , e.g. when the drug user is triggered in unforeseen circumstances, they may apply the learnt mindfulness skills to help themselves overcome the difficulties when timely professional help is not available; 4) Drug Abuse Statistics from Narcotics Division, Security Bureau of the government of Hong Kong showed that the most common reasons for recurrent drug use were to avoid discomfort of its absence (62%) and relief of depression/stress/boredom (30%).
The study objectives are as follow:
- To evaluate the feasibility of using mindfulness- based relapse prevention (MBRP) programme among adults with substance abuse in Hong Kong;
- To examine the changes of craving, substance use, mood symptoms, self-efficacy, acceptance, level of mindfulness and quality of life between those who have enrolled in the MBRP as compared to those in the usual care control group;
- To evaluate the correlations between changes in substance use and craving and changes in mood symptoms, self-efficacy, acceptance, level of mindfulness, and quality of life; and
- To study participants' characteristics related to adherence and benefits associated with MBRP.
详细描述
Overall Study Design This is a feasibility study and it is a single-blinded, randomized controlled trial with two study arms: the mindfulness-based relapse prevention (MBRP) programme led by trained mindfulness instructors and a usual care control group (UCCG). The MBRP will last for 8 weeks and outcome measures will be collected at similar time points in both the MBRP and UCCG groups (baseline, immediately post intervention, at 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention) . Qualitative focus group discussions or individual interviews will be conducted to obtain feedback of the MBRP programme from participants after the MBRP course. The study design, implementation and result reporting will follow the recommendations from the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT), Consolidated Standards of Reporting Trials (CONSROT), and Consolidated criteria for reporting qualitative research (COREQ).
Subjects Recruitment Process To increase the representativeness of the recruited participants with substance abuse disorder, study team will recruit the study's participants from the Counselling Centres for Psychotropic Substance Abusers (CCPSAs), residential detoxification centres, other non-governmental organisations (NGOs) that provide outreach or counselling services to psychotropic substance users, and substance abuse clinics (SACs). Similar approaches for recruitment have been adopted in previous local studies. Clients who receive services at the CCPSAs or the participating NGOs and SACs will be invited to be screened by the senior research assistant (RA) to determine eligibility to enrol in the study. The senior research assistant will visit the centres to identify all eligible subjects, invite them to participate and they will then be invited to be screened further for eligibility by a clinician and obtain their written consent.
Intervention and Control Mindfulness-based Relapses Prevention (MBRP) The MBRP program will be delivered by an instructor with training in MBSR/MBCT who has more than two years of teaching experience in MBSR/MBCT. MBRP programme consists of two-and-a-half-hour weekly sessions for eight weeks with the objective and activity of each session described in Appendix A and the manualized MBRP programme will be used with each session having a central theme, with meditation practices and related relapse prevention exercises and discussions. Themes will include the concept of "automatic pilot" and its relationship to addiction relapse, recognizing thoughts and emotions in relation to triggers of relapse, integrating mindfulness practices into daily activities, practicing mindfulness skills in high risk situations and the role of thoughts and emotions in relapse. Each class will consist of between 10-12 participants. The program will also include daily homework exercises that consist of guided (taped) or unguided awareness exercises directed at increasing moment-by-moment non-judgmental awareness of bodily sensations, thoughts and feelings, together with exercises designed to integrate the application of awareness skills into daily life. The mindfulness curriculum will include training in mindfulness through (1) a body scan, the gradual moving of attention through the body from head to feet while lying on a mat on the floor, brining awareness particularly to bodily sensations; (2) sitting meditation, in which attention is brought to breathing sensations and the flow of bodily sensations, thoughts, and emotions; and (3) mindful stretching exercises, to cultivate awareness during simple stretching movement. The key themes of MBRP will include the empowerment of participants and a focus on awareness and acceptance of experience at the present moment. Participants are guided to develop a "decentered" perspective on thoughts and feelings, in which these are viewed as passing events in the mind. Two to four mindfulness instructors will be hired for the MBRP courses, which can provide with better generalisibility of the intervention.
Fidelity Check of MBRP Fidelity check will be conducted by randomly selecting 25% of the MBRP courses and scoring the courses using a checklist specifically designed for the MBRP course with reference to our previous mindfulness-based interventional course checklists.
Usual Care Control Group (UCCG) Participants in the UCCG condition will remain in their standard outpatient aftercare provided by the treatment agency with an aim to maintain their abstinence with the help from social workers or other healthcare professionals through different activities, such as topics on life training skills such as rational thinking skills, grief and loss, assertiveness, self esteem, goal setting, effects of drugs on interpersonal relationships and experience. Frequency of their visits to / contacts with healthcare professionals will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
In this open-label study, blinding of therapists and participants will not be possible. However, all data collection will be performed by a trained research assistant blinded to the allocation status of the participants. The research assistant will receive rigorous training in standardized data collection procedures. Data entry will be prepared so that the person can conduct the statistical analyses without referring to allocation information, thus ensuring blinding during data analysis.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in Cantonese;
- •Has ever fulfilled the Structured Clinical Interview for DSM-IV/DSM-5 (SCID) drug module criteria for substance use disorder diagnoses; and
- •Has completed outpatient or inpatient treatment for substance abuse in the previous 6 months.
排除标准
- •Inability to provide valid consent;
- •Current or lifetime psychotic disorder assessed by the Structured Clinical interview for DSM-IV/DSM-5;
- •Imminent suicidal risk; or
- •Dementia.
结局指标
主要结局
Self report of any drug abuse and usage
时间窗: Post intervention (after 8 weeks of intervnetion from baseline)
Self-reports of no substance use to confirm abstinence status
Urine drug test (also known as Urine drug screen or UDS)
时间窗: Post intervention (after 8 weeks of intervnetion from baseline)
Urine test for the presence of illegal drugs and prescription medications
次要结局
- The Addiction Severity Index (ASI) - Lite Version(baseline, post intervention (after 8 weeks of intervnetion from baseline), 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention)
- The Acceptance and Action Questionnaire - second edition (AAQ-II)(baseline, post intervention (after 8 weeks of intervnetion from baseline), 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention)
- Urine drug test (also known as Urine drug screen or UDS)(baseline, 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention)
- The Penn Alcohol Craving Scale(baseline, post intervention (after 8 weeks of intervnetion from baseline), 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention)
- Drug Avoidance Self-Efficacy Scale(baseline, post intervention (after 8 weeks of intervnetion from baseline), 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention)
- 5-item EuroQol EQ-5D-5L (EQ5D)(baseline, post intervention (after 8 weeks of intervnetion from baseline), 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention)
- Self report of any drug abuse and usage(baseline, 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention)
- the 9-item Patient Health Questionnaire (PHQ-9)(baseline, post intervention (after 8 weeks of intervnetion from baseline), 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention)
- the 7-item Generalised Anxiety Disorder (GAD-7)(baseline, post intervention (after 8 weeks of intervnetion from baseline), 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention)
- Five Facet Mindfulness Questionnaire(baseline, post intervention (after 8 weeks of intervnetion from baseline), 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention)
- Meditation practice worksheet(baseline, post intervention (after 8 weeks of intervnetion from baseline), 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention)
研究者
Daisy Dexing Zhang
Research Assistant Professor
Chinese University of Hong Kong