Protocol for a cluster randomised crossover pilot trial of Goal Management Training+ (GMT+) for methamphetamine use disorder

Background: Methamphetamine use disorder (MUD) is associated with executive dysfunctions, which are linked with poorer treatment outcomes. However, current treatments for MUD do not directly address cognition. We recently modified Goal Management Training (now Goal Management Training+; GMT+), a gro...

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Main Authors: Alexandra C. Anderson, Alex H. Robinson, Dan I. Lubman, Antonio Verdejo-Garcia
Format: Article
Language:English
Published: Elsevier 2022-10-01
Series:Contemporary Clinical Trials Communications
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865422000862
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author Alexandra C. Anderson
Alex H. Robinson
Dan I. Lubman
Antonio Verdejo-Garcia
author_facet Alexandra C. Anderson
Alex H. Robinson
Dan I. Lubman
Antonio Verdejo-Garcia
author_sort Alexandra C. Anderson
collection DOAJ
description Background: Methamphetamine use disorder (MUD) is associated with executive dysfunctions, which are linked with poorer treatment outcomes. However, current treatments for MUD do not directly address cognition. We recently modified Goal Management Training (now Goal Management Training+; GMT+), a group-based intervention originally designed to improve executive functions after brain injury, to enhance suitability for MUD. Here, we describe the rationale and design of a trial which aims to determine the acceptability and feasibility of GMT+ during residential rehabilitation for MUD, and its impact on executive functions and clinical outcomes. Methods: We used a cluster randomised crossover design: participants are randomised at the cluster level to receive either GMT+ or psychoeducation-control (Brain Health Workshop; BHW). GMT+ is delivered in four 90-min weekly sessions and includes a between-session journal with 10-min daily activities. The program targets attention, impulse control, goal-setting, and decision-making. BHW is a health-oriented intervention that delivers information about the brain and promotes healthy exercise, diet, and sleep. It is matched to GMT+ on program format, length, and time with therapists. We will recruit forty-eight participants with MUD from residential treatment services. Our primary outcomes are acceptability, feasibility, and self-reported executive functioning. Secondary outcomes include craving, quality of life and cognitive performance. Outcome assessments are performed at baseline, post-interventions, 4-week follow-up, and 12-week follow-up. Conclusions: This study will provide GMT+ feasibility and acceptability data and will indicate initial efficacy on executive functions and clinical outcomes in residential treatment for MUD. Information from this pilot trial will inform a powered RCT.
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spelling doaj.art-d46fa9e94b074e63b660f2955f74e93d2022-12-22T04:26:08ZengElsevierContemporary Clinical Trials Communications2451-86542022-10-0129100969Protocol for a cluster randomised crossover pilot trial of Goal Management Training+ (GMT+) for methamphetamine use disorderAlexandra C. Anderson0Alex H. Robinson1Dan I. Lubman2Antonio Verdejo-Garcia3School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia; Monash Addiction Research Centre, Monash University, Victoria, Australia; Corresponding authors. Turner Institute for Brain and Mental Health, Monash University, 18 Innovation Walk, Clayton, VIC, 3800, Australia.School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia; Monash Addiction Research Centre, Monash University, Victoria, AustraliaMonash Addiction Research Centre, Monash University, Victoria, Australia; Turning Point, Eastern Health Clinical School, Monash University, Victoria, AustraliaSchool of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia; Monash Addiction Research Centre, Monash University, Victoria, Australia; Corresponding authors. Turner Institute for Brain and Mental Health, Monash University, 18 Innovation Walk, Clayton, VIC, 3800, Australia.Background: Methamphetamine use disorder (MUD) is associated with executive dysfunctions, which are linked with poorer treatment outcomes. However, current treatments for MUD do not directly address cognition. We recently modified Goal Management Training (now Goal Management Training+; GMT+), a group-based intervention originally designed to improve executive functions after brain injury, to enhance suitability for MUD. Here, we describe the rationale and design of a trial which aims to determine the acceptability and feasibility of GMT+ during residential rehabilitation for MUD, and its impact on executive functions and clinical outcomes. Methods: We used a cluster randomised crossover design: participants are randomised at the cluster level to receive either GMT+ or psychoeducation-control (Brain Health Workshop; BHW). GMT+ is delivered in four 90-min weekly sessions and includes a between-session journal with 10-min daily activities. The program targets attention, impulse control, goal-setting, and decision-making. BHW is a health-oriented intervention that delivers information about the brain and promotes healthy exercise, diet, and sleep. It is matched to GMT+ on program format, length, and time with therapists. We will recruit forty-eight participants with MUD from residential treatment services. Our primary outcomes are acceptability, feasibility, and self-reported executive functioning. Secondary outcomes include craving, quality of life and cognitive performance. Outcome assessments are performed at baseline, post-interventions, 4-week follow-up, and 12-week follow-up. Conclusions: This study will provide GMT+ feasibility and acceptability data and will indicate initial efficacy on executive functions and clinical outcomes in residential treatment for MUD. Information from this pilot trial will inform a powered RCT.http://www.sciencedirect.com/science/article/pii/S2451865422000862Cognitive remediationGoal management trainingMethamphetamineAddictionPilot trialExecutive functions
spellingShingle Alexandra C. Anderson
Alex H. Robinson
Dan I. Lubman
Antonio Verdejo-Garcia
Protocol for a cluster randomised crossover pilot trial of Goal Management Training+ (GMT+) for methamphetamine use disorder
Contemporary Clinical Trials Communications
Cognitive remediation
Goal management training
Methamphetamine
Addiction
Pilot trial
Executive functions
title Protocol for a cluster randomised crossover pilot trial of Goal Management Training+ (GMT+) for methamphetamine use disorder
title_full Protocol for a cluster randomised crossover pilot trial of Goal Management Training+ (GMT+) for methamphetamine use disorder
title_fullStr Protocol for a cluster randomised crossover pilot trial of Goal Management Training+ (GMT+) for methamphetamine use disorder
title_full_unstemmed Protocol for a cluster randomised crossover pilot trial of Goal Management Training+ (GMT+) for methamphetamine use disorder
title_short Protocol for a cluster randomised crossover pilot trial of Goal Management Training+ (GMT+) for methamphetamine use disorder
title_sort protocol for a cluster randomised crossover pilot trial of goal management training gmt for methamphetamine use disorder
topic Cognitive remediation
Goal management training
Methamphetamine
Addiction
Pilot trial
Executive functions
url http://www.sciencedirect.com/science/article/pii/S2451865422000862
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