A Telephone-delievered Intervention to Reduce Methamphetamine Use
- Conditions
- Methamphetamine Use Disorder
- Interventions
- Behavioral: R2C-MOther: Self-help booklet
- Registration Number
- NCT04713124
- Lead Sponsor
- Turning Point
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description R2C-M intervention R2C-M 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. R2C-M intervention Self-help booklet 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. Control Self-help booklet 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).
- Primary Outcome Measures
Name Time Method Methamphetamine problem severity 3-months post-randomisation Change in methamphetamine problem severity (Drug Use Disorders Identification Test; DUDIT)
- Secondary Outcome Measures
Name Time Method Adverse events Up to 6 weeks post-randomisation Occurrence of adverse events (AEs) and significant adverse events (SAEs)
Methamphetamine craving 6 weeks, and 3-, 6- and 12-months post-randomisation Change in craving for methamphetamine (Craving Experience Questionnaire; CEQ)
Quality of life 6 weeks, and 3-, 6- and 12-months post-randomisation Change in quality of life (EUROHIS-QOL single item)
Amount of methamphetamine used 6 weeks, and 3-, 6- and 12-months post-randomisation Change in amount of methamphetamine used (TLFB)
Cost-effectiveness - QALYs Over 12 months Difference in quality-adjusted life years (QALYs) (abridged version of the 5-level EQ-5D version, EQ-5D-5L+)
Cost-effectiveness - work-related losses Over 12 months Difference in work-related losses (World Health Organization Health and Performance Questionnaire Clinical Trials Version; WHO HPQ28-Day)
Number of DSM-5 methamphetamine use disorder criteria met 3-, 6- and 12-months post-randomisation Change in the number of DSM-5 methamphetamine use disorder criteria met (Structured Clinical Interview for DSM-5 Disorders - Research Version; SCID-5-RV)
Methamphetamine problem severity 6- and 12-months post-randomisation Change in methamphetamine problem severity (DUDIT)
Number of methamphetamine use days 6 weeks, and 3-, 6- and 12-months post-randomisation Change in number of methamphetamine use days (Timeline Followback; TLFB)
Days of other drug use 6 weeks, and 3-, 6- and 12-months post-randomisation Change in days of other drug use (TLFB)
Psychological functioning 6 weeks, and 3-, 6- and 12-months post-randomisation Change in psychological functioning (Depression Anxiety and Stress Scale; DASS-12)
Psychotic-like experiences 6 weeks, and 3-, 6- and 12-months post-randomisation Change in psychotic-like experiences (Community Assessment of Psychic Experiences 15, CAPE15)
Cost-effectiveness - health care costs Over 12 months Difference in health care costs (3Mg Health-care Resource Use Questionnaire)
Trial Locations
- Locations (1)
Turning Point
🇦🇺Richmond, Victoria, Australia