Anderson Alexandra C, Robinson Alex H, Lubman Dan I, Verdejo-Garcia Antonio
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.
Contemp Clin Trials Commun. 2022 Aug 11;29:100969. doi: 10.1016/j.conctc.2022.100969. eCollection 2022 Oct.
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.
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.
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.
甲基苯丙胺使用障碍(MUD)与执行功能障碍有关,而执行功能障碍又与较差的治疗结果相关。然而,目前针对MUD的治疗并未直接解决认知问题。我们最近对目标管理训练(现称为目标管理训练;GMT)进行了调整,该训练最初是为改善脑损伤后的执行功能而设计的一种基于小组的干预措施,以提高其对MUD的适用性。在此,我们描述一项试验的基本原理和设计,该试验旨在确定GMT在MUD住院康复期间的可接受性和可行性,以及其对执行功能和临床结果的影响。
我们采用整群随机交叉设计:参与者在整群水平上被随机分配接受GMT或心理教育对照(脑健康工作坊;BHW)。GMT通过每周四个90分钟的课程进行,包括一份课程间日志,其中包含每天10分钟的活动。该项目针对注意力、冲动控制、目标设定和决策制定。BHW是一种以健康为导向的干预措施,提供有关大脑的信息,并促进健康的运动、饮食和睡眠。它在课程形式、时长和与治疗师接触的时间方面与GMT相匹配。我们将从住院治疗服务机构招募48名患有MUD的参与者。我们的主要结果是可接受性、可行性和自我报告的执行功能。次要结果包括渴望、生活质量和认知表现。在基线、干预后、4周随访和12周随访时进行结果评估。
本研究将提供GMT的可行性和可接受性数据,并将表明其在MUD住院治疗中对执行功能和临床结果的初步疗效。来自这项试点试验的信息将为一项有充分样本量的随机对照试验提供参考。