A multi-centre, parallel-group, randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with a severe somatic disease. - NEVERMIND

Research Center E.Piaggio, Faculty of Engineering0 个研究点目标入组 425 人开始时间: 2017年11月23日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Eligible participants are adults aged 18 or older with a diagnosis of one of five somatic diseases: myocardial infarction; breast cancer; prostate cancer; kidney failure; leg amputees and who are proficient in the language of the country where recruited.
•Patients with myocardial infarction are included if there is a diagnosis of myocardial infarction (MI) type I including chest pain for more than 20 minutes (or equivalent symptoms), acute ECG alterations, diagnostic increase of myocardial necrosis biomarkers.
•Breast cancer patients are recruited either at stage II, III or IV.
•Prostate cancer patients are recruited either at stage II, III or IV.
•Kidney failure patients are recruited if they are in a stable clinical condition with chronic kidney failure of stages 3, 4 and 5 as defined by the KDOQI guidelines. This corresponds to an estimated glomerular filtration rate (eGFR) below 60mL/min/1.73 m2 of body-surface area.
•Amputee patients are recruited if they have had a lower limb amputation at any level and are within the 6 months post-surgical intervention.

•Patients are excluded if they have a past diagnosis of a major psychiatric disorder other than depression, such as bipolar disorder, psychosis, recent and active severe suicidality or if they had been in treatment with stable drug therapy for at least 2 months. Patients should also be excluded if they have any cognitive impairment, such as dementia. Moreover, individuals are excluded if they have been involved in other structured psychological treatments involving mindfulness, other relaxation techniques or other structured psychotherapy within the three months preceding enrolment. An individual will also be ineligible if they have participated or are participating in any clinical trial that might interfere with the study objectives and/or the safety of the patient. A lack of capability to participate in study procedures including giving consent will also result in ineligibility. Finally, individuals will be ineligible if they demonstrate an inability to use Smartphone technology, especially touch screen interaction and basic maintenance procedures of the devices. This includes charging, switching on and off, reading notifications, making calls, and sending and receiving text messages.

发起方

Research Center E.Piaggio, Faculty of Engineering