A Telephone-delievered Intervention to Reduce Methamphetamine Use

Study Overview
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Brief Summary
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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.

Official Title
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Ready2Change-Methamphetmine (R2C-M): A Randomised Controlled Trial of a Telephone-delivered Intervention to Reduce Methamphetamine Use

Conditions
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Methamphetamine Use Disorder

Intervention / Treatment
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* Behavioral: R2C-M
* Other: Self-help booklet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R2C-M intervention<br>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. | Behavioral: R2C-M<br>* R2C-M comprises 12 modules addressing core practice elements and skills from evidence-based cognitive and behavioural interventions. Modules include: (i) self-monitoring, goal setting and behaviour change skills; (ii) identification of strengths and motivational enhancement; (iii) relapse prevention; (iv) psychoeducation and harm reduction; (v) emotion regulation skills; (vi) anger management skills; (vii) urges and cravings management skills; (viii) sleep hygiene skills; (ix) mindfulness skills; (x) interpersonal skills; (xi) anxiety management skills; (xii) depressed mood management skills. The R2C-M workbooks contain psychoeducation and intervention exercises, to facilitate counsellor-delivered exercises within sessions, and between-session practice.<br>Other: Self-help booklet<br>* A booklet of information and self-help strategies for methamphetamine use problems.<br>|
| Active Comparator: Control<br>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). | Other: Self-help booklet<br>* A booklet of information and self-help strategies for methamphetamine use problems.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methamphetamine problem severity | Change in methamphetamine problem severity (Drug Use Disorders Identification Test; DUDIT) | 3-months post-randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methamphetamine problem severity | Change in methamphetamine problem severity (DUDIT) | 6- and 12-months post-randomisation | 
| Number of methamphetamine use days | Change in number of methamphetamine use days (Timeline Followback; TLFB) | 6 weeks, and 3-, 6- and 12-months post-randomisation | 
| Amount of methamphetamine used | Change in amount of methamphetamine used (TLFB) | 6 weeks, and 3-, 6- and 12-months post-randomisation | 
| Number of DSM-5 methamphetamine use disorder criteria met | Change in the number of DSM-5 methamphetamine use disorder criteria met (Structured Clinical Interview for DSM-5 Disorders - Research Version; SCID-5-RV) | 3-, 6- and 12-months post-randomisation | 
| Methamphetamine craving | Change in craving for methamphetamine (Craving Experience Questionnaire; CEQ) | 6 weeks, and 3-, 6- and 12-months post-randomisation | 
| Psychological functioning | Change in psychological functioning (Depression Anxiety and Stress Scale; DASS-12) | 6 weeks, and 3-, 6- and 12-months post-randomisation | 
| Psychotic-like experiences | Change in psychotic-like experiences (Community Assessment of Psychic Experiences 15, CAPE15) | 6 weeks, and 3-, 6- and 12-months post-randomisation | 
| Quality of life | Change in quality of life (EUROHIS-QOL single item) | 6 weeks, and 3-, 6- and 12-months post-randomisation | 
| Days of other drug use | Change in days of other drug use (TLFB) | 6 weeks, and 3-, 6- and 12-months post-randomisation | 
| Cost-effectiveness - QALYs | Difference in quality-adjusted life years (QALYs) (abridged version of the 5-level EQ-5D version, EQ-5D-5L+) | Over 12 months | 
| Cost-effectiveness - health care costs | Difference in health care costs (3Mg Health-care Resource Use Questionnaire) | Over 12 months | 
| Cost-effectiveness - work-related losses | Difference in work-related losses (World Health Organization Health and Performance Questionnaire Clinical Trials Version; WHO HPQ28-Day) | Over 12 months | 
| Adverse events | Occurrence of adverse events (AEs) and significant adverse events (SAEs) | Up to 6 weeks post-randomisation |