Vaag J R, Lara-Cabrera M L, Hjemdal O, Gjervan B, Torgersen T
1Faculty of Nursing and Health Science, Nord University, Levanger, Norway.
2Department of Psychology, Faculty of Social and Educational Sciences, Norwegian University of Science and Technology, Trondheim, Norway.
Pilot Feasibility Stud. 2019 Jan 23;5:17. doi: 10.1186/s40814-019-0401-1. eCollection 2019.
Psychoeducation is included in the Norwegian national guidelines for treatment of adult ADHD. Despite some promising results for the treatment of other conditions and ADHD, little is known about the efficacy of such interventions. This paper presents a protocol for a pilot randomized controlled trial featuring a psychoeducational group program for patients with ADHD. The main objective of this pilot trial is to investigate adherence, feasibility, and preliminary efficacy of a ten-session psychoeducational group designed to address specific challenges faced by adults diagnosed with ADHD.
This pilot study will evaluate patient satisfaction and preliminary efficacy of a psychoeducational group treatment using a randomized waitlist-controlled trial at two different outpatient clinics in mid-Norway. All participants will receive treatment as usual, concomitant with the intervention and waitlist period. Client satisfaction (CSQ 8), general self-efficacy (GSE-6), ADHD-related quality of life (AAQoL), symptoms of ADHD (SCL-9; ASRS), and work participation will be assessed at the time of recruitment prior to randomization (T0), pre-intervention (T1), post-intervention (T2), and at 10 weeks follow-up (T3). Recruitment and dropout rates along with treatment adherence will also be evaluated.
This study offers valuable insight into the preliminary efficacy of educational programs implemented in outpatient clinics. The aim of the trial is to evaluate adherence, feasibility, patient satisfaction, and the preliminary efficacy of a psychoeducational group intervention for patients with adult ADHD and provide further insight into the design and construction of a large-scale trial. The results also offer preliminary empirical evidence to inform the development of larger and more complex studies.
NCT03337425, Registered 9 November 2017.
心理教育被纳入挪威成人注意力缺陷多动障碍（ADHD）治疗的国家指南。尽管在治疗其他疾病和ADHD方面取得了一些有前景的成果，但对于此类干预措施的疗效知之甚少。本文介绍了一项试点随机对照试验的方案，该试验为ADHD患者设计了一个心理教育小组项目。这项试点试验的主要目的是调查一个为期十节的心理教育小组的依从性、可行性和初步疗效，该小组旨在应对被诊断患有ADHD的成年人所面临的特定挑战。
这项试点研究将在挪威中部的两个不同门诊诊所，采用随机等待名单对照试验来评估心理教育小组治疗的患者满意度和初步疗效。所有参与者在干预期和等待期都将接受常规治疗。将在随机分组前的招募时（T0）、干预前（T1）、干预后（T2）以及10周随访时（T3）评估客户满意度（CSQ - 8）、一般自我效能感（GSE - 6）、ADHD相关生活质量（AAQoL）、ADHD症状（SCL - 9；ASRS）以及工作参与情况。还将评估招募率和退出率以及治疗依从性。
本研究为门诊实施的教育项目的初步疗效提供了有价值的见解。该试验的目的是评估针对成人ADHD患者的心理教育小组干预的依从性、可行性、患者满意度和初步疗效，并为大规模试验的设计和构建提供进一步的见解。研究结果还提供了初步的实证证据，为开展更大规模、更复杂的研究提供参考。
NCT03337425，于2017年11月9日注册。
