Ready2Change-Methamphetmine (R2C-M): A Randomised Controlled Trial of a Telephone-delivered Intervention to Reduce Methamphetamine Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Methamphetamine problem severity
研究概览
简要总结
Australia has one of the highest rates of methamphetamine use in the world; however, uptake of face-to-face psychological treatment remains extremely low due to numerous individual (e.g. stigma, shame) and structural (e.g. service availability, geography) barriers to accessing care. Addressing these barriers through the provision of alternative treatment delivery models is imperative, particularly as effective and earlier intervention is likely to reduce the need for more costly and intensive treatment resulting from escalating methamphetamine use.
In this project, the investigators will conduct the first double-blind, parallel-group, randomised controlled trial (RCT) examining the effectiveness of the structured telephone-delivered intervention, Ready2Change (R2C), among participants with methamphetamine use problems (R2C-M). Cost effectiveness of R2C-M will also be investigated. Factors influencing program implementation will be evaluated to inform the scalability of this intervention for practice nationally, and for replication internationally.
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
- Double (Participant, Outcomes Assessor)
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
- •Age 18+ years
- •Mild or moderate methamphetamine use disorder (DSM-5 diagnosis confirmed at baseline assessment using the Structured Clinical Interview for DSM-5 Disorders - Research Version, SCID-5-RV)
- •Used methamphetamine on at least two occasions in the past month
- •Seeking to reduce methamphetamine use
- •Able to provide informed consent, and comply with the requirements of the treatment protocol
- •Willing to provide the contact details of their general practitioner or other treating physician, for follow-up
- •English as a first language or fluent
- •Educated to high school level (literacy)
- •Regular access to a telephone
- •Postal/email address to receive intervention materials
排除标准
- •Currently receiving treatment for substance use disorder (e.g. medically supervised detoxification, residential rehabilitation, drug counselling, pharmacotherapy - this criterion applies only at trial enrolment, and does not preclude the participant from entering treatment/receiving usual care during the trial)
- •Requiring acute care for severe substance use disorder (DSM-5 diagnosis confirmed at baseline using the SCID-5-RV, with oversight from the Principal Investigator or Study Clinician)
- •Requiring acute care for active suicidality or unstable psychiatric condition
- •A diagnosed primary psychotic disorder (schizophrenia, schizoaffective disorder, bipolar disorder)
- •Pregnancy
- •Hearing impairment that would prohibit participation in telephone intervention / follow-up assessments
研究组 & 干预措施
R2C-M intervention
R2C-M telephone intervention - Six approximately weekly sessions of R2C-M telephone-delivered intervention (50 minutes in duration), delivered by the same R2C-M Counsellor each session (a qualified clinical psychologist trained in the R2C protocol by the developer, Dr Kate Hall). Call duration will be recorded. Sessions will be digitally recorded, and an independent researcher will randomly select and rate fidelity of intervention sessions for 20% of participants.
R2C-M workbooks - Two workbooks to facilitate counsellor-delivered exercises within sessions, and between-session practice, will be mailed/emailed to participants.
Self-help booklet - (as in control group) R2C-M participants will also receive a booklet of information and self-help strategies for methamphetamine use problems.
干预措施: R2C-M (Behavioral)
R2C-M intervention
R2C-M telephone intervention - Six approximately weekly sessions of R2C-M telephone-delivered intervention (50 minutes in duration), delivered by the same R2C-M Counsellor each session (a qualified clinical psychologist trained in the R2C protocol by the developer, Dr Kate Hall). Call duration will be recorded. Sessions will be digitally recorded, and an independent researcher will randomly select and rate fidelity of intervention sessions for 20% of participants.
R2C-M workbooks - Two workbooks to facilitate counsellor-delivered exercises within sessions, and between-session practice, will be mailed/emailed to participants.
Self-help booklet - (as in control group) R2C-M participants will also receive a booklet of information and self-help strategies for methamphetamine use problems.
干预措施: Self-help booklet (Other)
Control
Self-help booklet - Control participants will receive (by mail/email) a booklet of information and self-help strategies for methamphetamine use problems.
Telephone check-ins + information on further support - (to control for frequency of contact across treatment arms) Participants in this group will receive 6 telephone calls from the research team (lasting maximum 5 minutes, call duration will be recorded). During these calls, participants will be asked about their use of the booklet. Whenever required, the researcher will provide participants with information on further support (e.g. DirectLine or other state/territory AOD helpline for advice or referral).
干预措施: Self-help booklet (Other)
结局指标
主要结局
Methamphetamine problem severity
时间窗: 3-months post-randomisation
Change in methamphetamine problem severity (Drug Use Disorders Identification Test; DUDIT)
次要结局
- Amount of methamphetamine used(6 weeks, and 3-, 6- and 12-months post-randomisation)
- Cost-effectiveness - health care costs(Over 12 months)
- Adverse events(Up to 6 weeks post-randomisation)
- Methamphetamine craving(6 weeks, and 3-, 6- and 12-months post-randomisation)
- Quality of life(6 weeks, and 3-, 6- and 12-months post-randomisation)
- Cost-effectiveness - QALYs(Over 12 months)
- Cost-effectiveness - work-related losses(Over 12 months)
- Methamphetamine problem severity(6- and 12-months post-randomisation)
- Number of methamphetamine use days(6 weeks, and 3-, 6- and 12-months post-randomisation)
- Number of DSM-5 methamphetamine use disorder criteria met(3-, 6- and 12-months post-randomisation)
- Days of other drug use(6 weeks, and 3-, 6- and 12-months post-randomisation)
- Psychological functioning(6 weeks, and 3-, 6- and 12-months post-randomisation)
- Psychotic-like experiences(6 weeks, and 3-, 6- and 12-months post-randomisation)