Protocol for a cluster randomised crossover pilot trial of Goal Management Training + (GMT + ) for methamphetamine use disorder.
| Autor: | Anderson AC; School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.; Monash Addiction Research Centre, Monash University, Victoria, Australia., Robinson AH; School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.; Monash Addiction Research Centre, Monash University, Victoria, Australia., Lubman DI; Monash Addiction Research Centre, Monash University, Victoria, Australia.; Turning Point, Eastern Health Clinical School, Monash University, Victoria, Australia., Verdejo-Garcia A; School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.; Monash Addiction Research Centre, Monash University, Victoria, Australia. |
|---|---|
| Jazyk: | angličtina |
| Zdroj: | Contemporary clinical trials communications [Contemp Clin Trials Commun] 2022 Aug 11; Vol. 29, pp. 100969. Date of Electronic Publication: 2022 Aug 11 (Print Publication: 2022). |
| DOI: | 10.1016/j.conctc.2022.100969 |
| Abstrakt: | 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. Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: AVG has received funding from Servier for consultancy work and Elsevier for editorial work. No pharmaceutical grants were received in the development of this study. DL has provided consultancy advice to Lundbeck and Indivior, and has received travel support and speaker honoraria from Camurus, Indivior, Janssen, Lundbeck, Shire, and Servier. These organisations do not stand to benefit from this project. DL has been an investigator on an untied education grant from Sequirus, as well as an investigator-led grant from Camurus, both unrelated to the current work. (© 2022 The Authors.) |
| Databáze: | MEDLINE |
| Externí odkaz: |
|