School of Health Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
Trials. 2021 Sep 19;22(1):640. doi: 10.1186/s13063-021-05578-x.
Time management skills are essential for living in modern society. People with mental or neurodevelopmental disorders typically have cognitive limitations, including affected time management, which might lead to poor occupational balance, low self-efficacy, and poor parental sense of competence. "Let's Get Organized" (LGO) is a recently developed manual-based group intervention to train time management skills. The aim of this trial is to evaluate the efficiency of the Swedish version of LGO (LGO-S) compared to treatment as usual (individual occupational therapy) to improve time management for adults with impaired time management skills due to mental or neurodevelopmental disorders. Furthermore, to evaluate if the intervention is a cost-effective way to improve the quality of life and time management skills of these individuals, we will conduct a health economic evaluation.
The trial will have a multi-centre, open, parallel randomised controlled design. A total of 104 adults with cognitive limitations due to mental or neurodevelopmental disorders will be recruited from open psychiatric or habilitation care units. Outcomes will be measured before and after a 10-week intervention, with a follow-up 3 months after completing the intervention. The primary outcome will be self-assessed time management skills. Secondary outcomes will be e.g. self-assessed skills in organisation and planning, regulation of emotions, satisfaction with daily occupations, occupational balance, self-efficacy, and quality-adjusted life years.
A recent feasibility study has shown promising results for LGO-S, and a randomised trial will provide robust evidence for the possible efficacy of LGO-S in comparison to treatment as usual.
ClinicalTrials.gov NCT03654248 . Registered on 20 August 2018.
时间管理技能对于现代社会的生活至关重要。患有精神或神经发育障碍的人通常存在认知限制,包括受影响的时间管理,这可能导致职业平衡不佳、自我效能感低和父母能力感差。“让我们变得有条理”(LGO)是一种最近开发的基于手册的小组干预措施,旨在训练时间管理技能。本试验的目的是评估瑞典版 LGO(LGO-S)与常规治疗(个体职业治疗)相比,改善因精神或神经发育障碍而导致时间管理技能受损的成年人的时间管理的效果。此外,为了评估干预措施是否是改善这些个体的生活质量和时间管理技能的一种具有成本效益的方法,我们将进行健康经济评估。
该试验将采用多中心、开放、平行随机对照设计。共有 104 名因精神或神经发育障碍而存在认知限制的成年人将从开放的精神科或康复护理单位招募。结果将在 10 周干预前后进行测量,并在完成干预后 3 个月进行随访。主要结果将是自我评估的时间管理技能。次要结果将包括自我评估的组织和规划技能、情绪调节、对日常职业的满意度、职业平衡、自我效能感和质量调整生命年等。
最近的一项可行性研究表明 LGO-S 具有良好的效果,而随机试验将为 LGO-S 与常规治疗相比可能的疗效提供有力证据。
ClinicalTrials.gov NCT03654248。于 2018 年 8 月 20 日注册。