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Trial registered on ANZCTR


Registration number
ACTRN12621000172808
Ethics application status
Approved
Date submitted
18/12/2020
Date registered
18/02/2021
Date last updated
18/02/2021
Date data sharing statement initially provided
18/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Goal Management Training for Methamphetamine Addiction
Scientific title
Determining the feasibility and efficacy of Goal Management Training for executive functions, and treatment retention and outcomes during residential treatment for methamphetamine use disorder
Secondary ID [1] 303227 0
None
Universal Trial Number (UTN)
Trial acronym
GMT4MA (Goal Management Training for Methamphetamine Addiction)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Methamphetamine Use Disorder 316095 0
Condition category
Condition code
Mental Health 314385 314385 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Goal Management Training+ (GMT) – active intervention

GMT+ (i.e., an abbreviated and population [methamphetamine use disorder]-tailored adaptation of GMT [Levine et al., 2011]) is a therapist-guided group-based cognitive remediation intervention that includes instruction and practise tasks to train the executive functions that facilitate goal setting, self-regulation and advantageous decision-making.

The program includes 4 modules / sessions delivered via PowerPoint presentations, and a take-home “paper and pencil” journal to practise between sessions. Each session trains a specific executive function. Session 1 (Be Aware) trains sustained attention; participants are taught to notice when their thoughts are drifting and to apply mindfulness strategies to stay in the present moment. Session 2 (Pause) trains inhibitory control; participants are taught to ‘pause’ and refocus on a current task. Session 3 (Envision Goals) trains working memory; participants are taught strategies to maintain their goals “on line”. Session 4 (Decide) trains decision-making; participants are taught to apply future-based thinking and to use long-term goals to guide current decision-making. Each session provides instructional content, interactive activities to demonstrate how cognition-related errors can contribute to substance use, and related discussions. Facilitators will lead discussions about how these errors occur in everyday life and then provide strategies to strengthen cognitive control skills. In addition to the 4 sessions, participants are provided with a journal to engage in daily practise of the GMT+ strategies, aiding transfer of these skills to everyday life goals.

The first session will be conducted after each participant has undergone detoxification. GMT+ will be facilitated by clinical psychology doctoral students with a minimum of 6 years of training in psychology. The program will be delivered in a face to face group setting at urban residential rehabilitation centres and will include between 4-6 participants. There are four 90-minute weekly sessions, and four weeks of daily journal activities, which take approximately 10 minutes per day to complete.

Intervention adherence will be monitored with a session attendance checklist. The facilitators will mark down participant attendance at the beginning and end of each session, in order to record entire session attendance.
Intervention code [1] 319322 0
Treatment: Other
Comparator / control treatment
Brain Health Workshop – control intervention

Brain Health Workshop (BHW) is a therapist-guided group psychoeducation program designed to match GMT+ in terms of format, group discussions, time spent with facilitators, and between-session homework duration. BHW will serve as an active control while maintaining a health promotion orientation.

BHW includes 4 sessions that provide PowerPoint content, group-based discussions and interactive activities, and a journal to reflect on the health-related content in between sessions. Each week focuses on a different element of brain health and healthy living. Week 1 delivers content on basic brain anatomy and cognition, the impact of long-term methamphetamine use on cognition, and an introduction to neuroplasticity. Weeks 2-4 deliver content on healthy lifestyle practices that are related to neuroplasticity. Week 2 focuses on healthy exercise, Week 3 focuses on healthy diet, and Week 4 focuses on healthy sleep. Each session provides information about the benefit of a health-oriented lifestyle on the brain and includes interactive activities to foster active participation in the program. These activities provide health-oriented educational content but will not actively train cognition. Facilitators will lead discussions about participants’ current lifestyles and how to enhance healthy living in everyday life. Participants are provided with a journal to engage in daily reflections of healthy living suggestions (e.g., reflecting on sleep quality or diet changes).

The first session will be conducted after each participant has undergone detoxification. BHW will be facilitated by clinical psychology doctoral students with a minimum of 6 years of training in psychology. The program will be delivered in a face to face group setting at urban residential rehabilitation centres and will include between 4-6 participants. There are four 90-minute weekly sessions, and four weeks of daily journal activities, which take approximately 10 minutes per day to complete.

Intervention adherence will be monitored with a session attendance checklist. The facilitators will mark down participant attendance at the beginning and end of each session, in order to record entire session attendance.
Control group
Active

Outcomes
Primary outcome [1] 326030 0
Change in executive function from pre-post interventions, assessed using the overall summary score on the Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A).
Timepoint [1] 326030 0
Baseline: One week before the interventions.
Post-intervention: Within one week following completion of the interventions.
Primary outcome [2] 326031 0
Feasibility of the program assessed by the proportion of participants who complete GMT+, indicated by an audit of the study database.
Timepoint [2] 326031 0
Within one week following completion of the interventions
Primary outcome [3] 326263 0
Acceptability of the program compared to the control interventions, assessed by the proportion of people who withdraw consent prior to engaging in GMT+, indicated by an audit of study databases, and participants positive rating of GMT+ on a 4-item acceptability scale.
Timepoint [3] 326263 0
Within one week following completion of the interventions
Secondary outcome [1] 389919 0
Change in impulsivity from pre-post interventions, assessed using the Cognitive Impulsivity Suite. The Cognitive Impulsivity Suite includes three separate tasks, measuring attentional control, information gathering, and monitoring of feedback/shifting. Performance measures for each task include: reaction times, number of errors, and modelling-based parameters (i.e. signal detection theory based criterion and discriminability in the attentional control task, drift diffusion modelling drift rate and decision boundary in the information gathering task, and reinforcement learning based win/stay and loss/shift in the monitoring of feedback/shifting task.
Timepoint [1] 389919 0
Baseline: One week before the interventions.
Post-intervention: Within one week following completion of the interventions.
Secondary outcome [2] 389934 0
Change in delay discounting from pre-post intervention, assessed using the 27-item Monetary Choice Questionnaire.
Timepoint [2] 389934 0
Baseline: One week before the interventions.
Post-intervention: Within one week following completion of the interventions.
Secondary outcome [3] 389935 0
Change in decision-making from pre-post interventions, assessed using the Two-Stage Task.
Timepoint [3] 389935 0
Baseline: One week before the interventions.
Post-intervention: Within one week following completion of the interventions.
Secondary outcome [4] 389936 0
Change in working memory capacity, assessed using the Letter-Number Sequencing task.
Timepoint [4] 389936 0
Baseline: One week before the interventions
Post-intervention: Within one week following completion of the interventions.
Secondary outcome [5] 389937 0
Change in self-reported impulsivity, assessed using the UPPS-P scale.
Timepoint [5] 389937 0
Baseline: One week before the interventions;
Post-intervention: Within one week following completion of the interventions; 4 weeks following completion of the interventions
Secondary outcome [6] 389938 0
Intervention session ratings, assessed using the Group Session Rating Scale.
Timepoint [6] 389938 0
At the end of each session (for 4 sessions).
Secondary outcome [7] 389940 0
Goal achievement, assessed using the Goal Attainment Scale (GAS 2.0).
Timepoint [7] 389940 0
Post-intervention: 4-weeks following completion of the interventions.
Secondary outcome [8] 389941 0
Treatment retention, assessed by performing an audit of the study database for the proportion of participants who are still enrolled at the treatment facility 4 weeks after the interventions
Timepoint [8] 389941 0
Post-intervention: 4 weeks following completion of the interventions.
Secondary outcome [9] 389942 0
Quality of life, assessed using the 26-item WHO Quality of Life-BREF, which provides domain scores for physical health, psychological, social relationships, and environment.
Timepoint [9] 389942 0
Baseline: One week before the interventions.
Post-intervention: 4 weeks following completion of the interventions; 12 weeks following completion of the interventions.
Secondary outcome [10] 389943 0
Methamphetamine craving, assessed using a modified version of the Penn Alcohol Craving Scale.
Timepoint [10] 389943 0
Baseline: One week before the interventions.
Post-intervention: 4 weeks following completion of the interventions; 12 weeks following completion of the interventions.
Secondary outcome [11] 389944 0
Severity of dependence on methamphetamine, assessed with the Severity of Dependence Scale.
Timepoint [11] 389944 0
Baseline: One week before the interventions.
Post-intervention: 4 weeks following completion of the interventions; 12 weeks following completion of the interventions.
Secondary outcome [12] 389965 0
Abstinence from methamphetamine at 4 weeks and 12 weeks after the interventions, assessed by self-report with the timeline follow-back interview.
Timepoint [12] 389965 0
Post-intervention: 4 weeks following completion of the interventions; 12 weeks following completion of the interventions.
Secondary outcome [13] 389966 0
Self-reported reduction in methamphetamine use, measured using timeline follow-back interview.
Timepoint [13] 389966 0
Baseline: One week before the interventions.
Post-intervention: 4 weeks following completion of the interventions.; 12 weeks following completion of the interventions
Secondary outcome [14] 390824 0
Change in decision-making from pre-post interventions, assessed using the Iowa Gambling Task.
Timepoint [14] 390824 0
Baseline: One week before the interventions
Post-intervention: Within one week following completion of the interventions.
Secondary outcome [15] 390826 0
Abstinence from methamphetamine at 4 weeks and 12 weeks after the interventions, assessed by an objective biomarker (hair toxicology).
Timepoint [15] 390826 0
Post-intervention: 4 weeks following completion of the interventions; 12 weeks following completion of the interventions.

Eligibility
Key inclusion criteria
(1) aged 18-50; (2) meet Diagnostic and Statistical Manual, Fifth Edition (DSM 5) criteria for methamphetamine use disorder measured with the Mini-International Neuropsychiatric Interview (MINI); (3) seeking and/or engaged in addiction treatment; (4) sufficient English language proficiency to understand the intervention content; (5) able to provide a phone number for follow-up outcomes; (6) intending to stay in the treatment setting for long enough to complete the intervention.
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Individuals who meet DSM-5 criteria for psychosis or schizophrenia; (2) have severe cognitive impairment indicated by a score below 16 in the Montreal Cognitive Assessment (MOCA); or 3) are currently taking benzodiazepines.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clusters of 4 to 6 participants are allocated to groups and groups are assigned to treatments in accordance with the sequence that is randomly allocated to a setting or site.

Allocation concealment will be blinded. Settings (sites) will be randomised by a sequence determined by an independent statistician and provided to the principal investigator. The research team will contact the principal investigator to determine which intervention (GMT+ or BHW) will be administered during the first intervention period at the first setting. The research team will be blinded to the allocation of each setting (site) prior to this first intervention period.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Both the control and intervention treatments are delivered in group settings and so the design of the pilot trial is a cluster-randomised design. Two settings (sites) are available so in order to increase the number of groups or clusters, a cluster-randomised crossover (CRXO) design is envisaged with two sequences randomly assigned to two settings:

Setting 1: Period 1 (A), Period 2 (B), Period 3 (B), Period 4 (A)
Setting 2: Period 1 (B), Period 2 (A), Period 3 (A), Period 4 (B)

A = control (BHW), B = intervention (GMT+)

To avoid “leakage” of information or “contamination” from one group to another, only one trial group at a time (i.e. in a period) is managed in each setting. Each treatment is replicated 4 times (i.e. each treatment is allocated to 4 groups and the size of a group can range from 4 to 6 participants). Each group is convened for 4 weeks but to allow for assessments pre and post exposure to the group-delivered treatments the “periods” are likely to have a duration of 6 weeks. An additional week or two may be required as a “wash-out” or buffer between periods 1 and 2, periods 2 and 3, and periods 3 and 4 within a setting. The periods need not be aligned across the settings but if they are, it will be possible to check and adjust for “global” changes over time due to external events. Each treatment appears once in each period or position and each treatment follows immediately after the other treatment twice and follows itself once.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features

Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size justification:
The primary outcome is the BRIEF-A General Executive Composite (GEC) score. In a recent study (Marceau et al, 2017, http://dx.doi.org/10.1016/j.drugalcdep.2017.04.023) of cognitive remediation in residents of a substance use disorder therapeutic community, the baseline mean (SD) GEC was 59.44 (11.19) and the covariate-adjusted, post-intervention mean was 53.07 (6.94). The sample size in our pilot trial is pragmatically determined (2 sites or settings, 4 sequential groups at each site and a maximum of 6 participants in each group). As a consequence, and assuming a similar post-intervention effect and 4 to 6 participants (or subjects) in each of the 8 groups, the pilot trial has 80% power to detect treatment differences in three scenarios outlined in the attached 'Statistical Methods' file.

The target effect sizes are considered to be reasonable for a pilot study which aims to get a preliminary estimate of the effect of GMT+ on BRIEF-A GEC as well as information on the components of variation associated with this therapist-guided, group-based intervention.

Statistical methods/analysis:
This is a proof-of-concept pilot trial. The sample size has been selected based on feasibility within the funding and time constraints of this trial. Following positive outcomes related to GMT+, a larger randomised clinical trial will be conducted, and the sample size justification for the larger trial will use the components of variance observed in this pilot trial.
The primary outcome (improved executive functioning) will be assessed using linear mixed models. The random effects in the model are sites, groups within sites, subjects or participants within groups and repeated observations or assessments within participants. The fixed effects are time (pre versus post), treatment (control versus intervention), their interaction and, if the periods are aligned across the sites, “periods” (4 levels). If diagnostic plots of residuals indicate departures from assumptions (e.g. homogeneity of variance) analyses may be conducted on transformed data (e.g. the empirical logit transformation). Hedge’s g effect size calculations will then be performed to quantify pre-post changes in the GMT+ group relative to baseline differences and pre-post changes in the psychoeducation-control group, yielding the net effect of the GMT+ intervention on outcome measures. Similar repeated measures analyses will be conducted to assess the secondary outcomes, including changes in impulsivity, craving, methamphetamine use (Timeline Follow Back), severity of dependence, and quality of life. Feasibility, treatment retention and abstinence (proportion data) and acceptability (dimensional ratings data) will be analysed using descriptive statistics, and Chi square or t-test analyses comparing the GMT+ and psychoeducation-control groups. For certain outcomes (decision-making on Iowa Gambling Task, Two Stage Task), the identification and selection of which variables to include in the linear mixed effect models will be described in separate data analyses plans, made available prior to the researcher team’s access to the results.

In the case of non-significant results in the above outcomes, a post-hoc Bayesian analyses will be used to identify whether the data likely reflected a null result (BF10 < .3) or were inconclusive (.3 < BF10 < 3; Keysers et al., 2020).
Primary analyses will be conducted based on intention-to-treat (ITT), where we will attempt to follow-up all participants who completed at least one intervention session. Missing outcomes will not be imputed. We will also perform “per-protocol” analyses for comparison including only the data from participants that completed all four intervention sessions and follow up assessments.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 304854 0
University
Name [1] 304854 0
Monash Addiction Research Centre
Address [1] 304854 0
Monash University
Peninsula Campus
Level 3, Building G
Moorooduc Hwy
Frankston
VIC 3199
Country [1] 304854 0
Australia
Funding source category [2] 307447 0
Other Collaborative groups
Name [2] 307447 0
National Centre for Clinical Research on Emerging Drugs
Address [2] 307447 0
22-32 King Street
Randwick, NSW
2031
Country [2] 307447 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University
Wellington Road
Clayton VIC 3800
Australia
Country
Australia
Secondary sponsor category [1] 305195 0
None
Name [1] 305195 0
Address [1] 305195 0
Country [1] 305195 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305266 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 305266 0
Monash Research Office,
26 Sports Walk,
Monash University,
Wellington Road, Clayton, VIC, 3800
Ethics committee country [1] 305266 0
Australia
Date submitted for ethics approval [1] 305266 0
28/02/2019
Approval date [1] 305266 0
07/03/2019
Ethics approval number [1] 305266 0
Ethics committee name [2] 307525 0
Eastern Health Human Research Ethics Committee
Ethics committee address [2] 307525 0
Level 2, 5 Arnold Street
Box Hill, VIC, 3128
Ethics committee country [2] 307525 0
Australia
Date submitted for ethics approval [2] 307525 0
19/03/2019
Approval date [2] 307525 0
08/04/2019
Ethics approval number [2] 307525 0

Summary
Brief summary
Recovery following current treatment for methamphetamine use disorder (MUD) is poor. Only 14% of individuals report continued abstinence at one-year follow-up, which decreases again to 6% after three years. One of the critical limitations of existing treatment approaches is that they do not address the cognitive deficits that result from long-term methamphetamine use, which is critical to recovery from methamphetamine addiction.

Goal Management Training (GMT), originally designed for individuals with brain injury, is a well-validated evidence-based intervention for executive dysfunction (i.e. impulsivity, working memory and decision-making deficits). Proof of concept studies conducted in Europe have shown that GMT improves cognition in stimulant (cocaine/amphetamine) users. However, we do not know if GMT is a feasible intervention in the context of methamphetamine treatment in Australia, or if it can improve clinical outcomes such as treatment retention and abstinence rates. We have modified this program (now GMT+) to reduce the content to four weeks (so that it is better aligned with average treatment duration for MUD in Australia) and improve relevance and engagement for consumers with MUD. We intend to conduct a proof of concept trial to test GMT+ within a residential addiction rehabilitation setting for individuals with MUD. Participants will receive follow-up testing immediately after the intervention (cognitive performance, acceptability), 4-weeks after the intervention (treatment retention, quality of life, impulsivity, severity of dependence, reduced methamphetamine use or abstinence), and 12-weeks after the intervention (quality of life, impulsivity, severity of dependence, reduced methamphetamine use or abstinence) to assess the benefit of GMT+ compared to psychoeducation-control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99818 0
Prof Antonio Verdejo-Garcia
Address 99818 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk,
Clayton campus, VIC 3800
Country 99818 0
Australia
Phone 99818 0
+61 3 9905 5374
Fax 99818 0
Email 99818 0
antonio.verdejo@monash.edu
Contact person for public queries
Name 99819 0
Prof Antonio Verdejo-Garcia
Address 99819 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk,
Clayton campus, VIC 3800
Country 99819 0
Australia
Phone 99819 0
+61 3 9905 5374
Fax 99819 0
Email 99819 0
antonio.verdejo@monash.edu
Contact person for scientific queries
Name 99820 0
Prof Antonio Verdejo-Garcia
Address 99820 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk,
Clayton campus, VIC 3800
Country 99820 0
Australia
Phone 99820 0
+61 3 9905 5374
Fax 99820 0
Email 99820 0
antonio.verdejo@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the deidentified individual participant data (including computer task performance data and questionnaire data), will be made available to other researchers upon reasonable request to the principal investigator.
When will data be available (start and end dates)?
Following publication for a 7-year period.
Available to whom?
Other researchers may request access to this information by contacting the principal investigator.
Available for what types of analyses?
Analyses of interest to the researcher may be requested.
How or where can data be obtained?
Individual data may be requested by contacting the principal investigator, Antonio Verdejo-Garcia, by emailing Antonio.verdejo@monash.edu
What supporting documents are/will be available?
Statistical analysis plan
Informed consent form
Ethical approval
Other
'Other' documents specified
Statistical Methods. This document outlines the sample size justification.
How or where can supporting documents be obtained?
Type [1] 10072 0
Ethical approval
Citation [1] 10072 0
Link [1] 10072 0
Email [1] 10072 0
Other [1] 10072 0
Ethical approval may be requested by contacting the principal investigator, Antonio Verdejo-Garcia, by emailing Antonio.verdejo@monash.edu
Attachment [1] 10072 0
Type [2] 10073 0
Informed consent form
Citation [2] 10073 0
Link [2] 10073 0
Email [2] 10073 0
Other [2] 10073 0
Informed consent form may be requested by contacting the principal investigator, Antonio Verdejo-Garcia, by emailing Antonio.verdejo@monash.edu
Attachment [2] 10073 0
Type [3] 10074 0
Statistical analysis plan
Citation [3] 10074 0
Link [3] 10074 0
Email [3] 10074 0
Other [3] 10074 0
Statistical analysis plan may be requested by contacting the principal investigator, Antonio Verdejo-Garcia, by emailing Antonio.verdejo@monash.edu
Attachment [3] 10074 0
Type [4] 10089 0
Other
Citation [4] 10089 0
Link [4] 10089 0
Email [4] 10089 0
Other [4] 10089 0
Summary results
No Results