R2C-M: A Telephone-delievered Intervention to Reduce Methamphetamine Use

Sponsor

Turning Point (Other)

Overall Status

Recruiting

CT.gov ID

NCT04713124

Collaborator

Eastern Health (Other), Monash University (Other), Deakin University (Other)

188

Enrollment

Location

Arms

26.2

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Use Disorder	Behavioral: R2C-M Other: Self-help booklet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

188 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised controlled trialRandomised controlled trial

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 4, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: R2C-M 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. Other: Self-help booklet A booklet of information and self-help strategies for methamphetamine use problems.
Active Comparator: 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).	Other: Self-help booklet A booklet of information and self-help strategies for methamphetamine use problems.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: R2C-M

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.

Other: Self-help booklet

A booklet of information and self-help strategies for methamphetamine use problems.

Active Comparator: 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).

Other: Self-help booklet

A booklet of information and self-help strategies for methamphetamine use problems.

Outcome Measures

Primary Outcome Measures

Methamphetamine problem severity [3-months post-randomisation]
Change in methamphetamine problem severity (Drug Use Disorders Identification Test; DUDIT)

Secondary Outcome Measures

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)
Amount of methamphetamine used [6 weeks, and 3-, 6- and 12-months post-randomisation]
Change in amount of methamphetamine used (TLFB)
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 craving [6 weeks, and 3-, 6- and 12-months post-randomisation]
Change in craving for methamphetamine (Craving Experience Questionnaire; CEQ)
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)
Quality of life [6 weeks, and 3-, 6- and 12-months post-randomisation]
Change in quality of life (EUROHIS-QOL single item)
Days of other drug use [6 weeks, and 3-, 6- and 12-months post-randomisation]
Change in days of other drug use (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 - health care costs [Over 12 months]
Difference in health care costs (3Mg Health-care Resource Use Questionnaire)
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)
Adverse events [Up to 6 weeks post-randomisation]
Occurrence of adverse events (AEs) and significant adverse events (SAEs)

Other Outcome Measures

Program evaluation [Through study completion, approximately 28 months]
Mixed-methods program evaluation (Glasgow et al.'s RE-AIM framework)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Turning Point	Richmond	Victoria	Australia	3121

Sponsors and Collaborators

Turning Point
Eastern Health
Monash University
Deakin University

Investigators

Principal Investigator: Dan I Lubman, Turning Point, Eastern Health; Monash University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Turning Point

ClinicalTrials.gov Identifier:

NCT04713124

Other Study ID Numbers:

E20/011/61428

First Posted:

Jan 19, 2021

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 17, 2022