Contemporary Clinical Trials Communications (Oct 2022)
Protocol for a cluster randomised crossover pilot trial of Goal Management Training+ (GMT+) for methamphetamine use disorder
Abstract
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.
