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.
- Conditions
- Depression in patients with a severe somatic diseaseF32F33Depressive episodeRecurrent depressive disorder
- Registration Number
- DRKS00013391
- Lead Sponsor
- Research Center E.Piaggio, Faculty of Engineering
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 425
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method There are two main hypotheses in the study as follows:<br>Hypothesis 1: NEVERMIND will significantly decrease the level of depression in the intervention group in comparison to treatment as usual;<br>Outcome measure: the severity of depression as measured by the Beck Depression Inventory II (BDI-II) and the Hamilton Rating Scale for Depression (HAM-D) after 12 week from initiation of using the sysetm and again at 24 weeks after using the system.<br><br>Hypothesis 2: The NEVERMIND intervention will prevent (i.e. lower incidence rate of) depression to a significantly greater extent than treatment as usual.<br>Outcome measure: the incidence of depression, i.e. the number of patients developing depressive symptoms (BDI-II score of > 13 or HAM-D score of > 7) throughout the trial period.<br><br>
- Secondary Outcome Measures
Name Time Method