Navarro Capilla, Yáñez Aina M, Garcia Aurora, Seguí Andrea, Gazquez Francisco, Marino Jose Antonio, Ibarra Olga, Serrano-Ripoll Maria J, Gomez-Juanes Rocio, Bennasar-Veny Miquel, Salva Joan, Oliván Bárbara, Roca Miquel, Gili Margalida, Garcia-Toro Mauro
Research Institute of Health Sciences (IUNICS-IDISBA).
Department of Nursing and Physiotherapy and Research Group on Global Health and Human Development.
Medicine (Baltimore). 2020 Nov 6;99(45):e22958. doi: 10.1097/MD.0000000000022958.
Treatment-resistant depression (TRD) has a high prevalence and can be exacerbated by poor physical health and economic hardships, which have become common stressors during the current COVID-19 pandemic. The therapeutic approaches used to treat these patients are not always available, may be not be accepted by some patients, and often require face-to-face interactions.
The main aim of this study will be to evaluate the effectiveness of an Internet-based adjuvant lifestyle-based intervention for patients with TRD.
This will be a parallel, randomized, and controlled clinical trial. A total of 180 patients with TRD will be randomly allocated (1:1:1) to 1 of 3 groups: treatment prescribed by the mental health team and written suggestions for lifestyle changes (placebo control group); treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week mindfulness-based cognitive therapy program (active control group); or treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week lifestyle change promotion program (intervention group). We will perform this study during the COVID-19 pandemic, and will administer interventions by teletherapy, and contact participants by telephone calls, text messages, and/or teleconferences. We will collect patient data using questionnaires administered at baseline, immediately after the intervention, and after 6 and 12 months. The primary outcome will be score on the Beck Depression Inventory-II. The secondary outcomes will be score on the Clinical Global Impressions Scale (used to quantify and track patient progress and treatment response over time) and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire.
Patients with TRD are especially vulnerable when face-to-face psychotherapy is unavailable. The main strength of the proposed study is the novelty of the intervention to be used as an adjuvant therapy. Our results may provide guidance for treatment of patients with TRD in future situations that require lockdown measures.
NCT04428099.
难治性抑郁症（TRD）患病率很高，身体健康状况不佳和经济困难会使其恶化，而在当前新冠疫情期间，这些已成为常见的压力源。用于治疗这些患者的治疗方法并不总是可用，可能不被一些患者接受，且通常需要面对面交流。
本研究的主要目的是评估基于互联网的辅助生活方式干预对TRD患者的有效性。
这将是一项平行、随机、对照临床试验。总共180例TRD患者将被随机分配（1:1:1）至3组中的1组：由心理健康团队开的治疗方案以及关于生活方式改变的书面建议（安慰剂对照组）；由心理健康团队开的治疗方案、关于生活方式改变的书面建议以及一个为期8周的基于正念的认知疗法项目（积极对照组）；或由心理健康团队开的治疗方案、关于生活方式改变的书面建议以及一个为期8周的生活方式改变促进项目（干预组）。我们将在新冠疫情期间开展本研究，并通过远程治疗进行干预，通过电话、短信和/或电话会议与参与者联系。我们将使用在基线、干预后立即以及6个月和12个月后发放的问卷收集患者数据。主要结局将是贝克抑郁量表第二版的得分。次要结局将是临床总体印象量表的得分（用于量化和跟踪患者随时间的进展和治疗反应）以及使用欧洲生活质量五维度问卷测量的健康相关生活质量。
当无法进行面对面心理治疗时，TRD患者特别脆弱。拟议研究的主要优势在于用作辅助治疗的干预措施的新颖性。我们的结果可能为未来需要封锁措施的情况下TRD患者的治疗提供指导。
NCT04428099。
