Trial document




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  DRKS00013391

Trial Description

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Title

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.

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Trial Acronym

NEVERMIND

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URL of the Trial

http://www.nevermindproject.eu

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Brief Summary in Lay Language

NEVERMIND is a system designed for patients with severe somatic diseases to help them manage their own physical and mental health. The system uses a smart shirt and mobile app which provides support based on user input and predictive computer modelling. The aim is to help prevent depression and treat depressive symptoms if they arise.

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Brief Summary in Scientific Language

The NEVERMIND system is a real-time decision support system (DSS), aiming to predict the severity and onset of depressive symptoms by modelling the well-being condition of patients based on physiological data, body movement and the recurrence of social interactions. The aim is to evaluate whether the NEVERMIND system is superior to treatment as usual.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013391
  •   2017/11/23
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  •   yes
  •   Approved
  •   912/2015, Comitato Etico di Area Vasta Nord Ovest (Comitato Etico Spermentazione Farmaco – CESF)
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Secondary IDs

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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   Depression in patients with a severe somatic disease
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Interventions/Observational Groups

  •   The patients will receive the NEVERMIND system for a minimum of 12 weeks.
    The NEVERMIND system is a multifaceted, two-component system that comprises of a smart shirt and a user interface, in the form of a mobile application. The interface includes sections on dietary and exercise recommendations and preferences to provide lifestyle guidance to improve their physical health tailored to their primary somatic disease. The interface also monitors the patient’s mental health daily and treats mental health issues as they arise.

    The smart shirt collects physiological data (biomedical data) including electrocardiogram (ECG), accelerometer data and respiration data, from which biomedical features are extracted based on signal processing techniques. These features are from 3 categories: movement dynamics, ECG-heart rate variability and respiration dynamics. The patient is encouraged to use the shirt as much as they like but should use it a minimum of twice a week, ideally when sleeping or when practicing mindfulness.

    The system as a whole is a real-time decision support system, aiming to predict the severity and onset of depressive symptoms by modelling the well-being condition of patients based on physiological data, body movement and the recurrence of social interactions.
    The combined data from the interface and the shirt will trigger different responses encouraging the patient to conduct or alter activities or lifestyle choices in order to reduce the occurrence and severity of depressive symptoms based on their likelihood of depression.
  •   The control group will receive treatment as usual in accordance with the standard guidelines at the respective clinics.
    In the Nephrology ward at the Pisa University Hospital patients undergo clinical consultations with physicians on a regular basis. The frequency is based on the type of disease and stage of disease of each patient. For patients in pre-dialysis the visit is schedule monthly, for patients in dialysis the visit takes place before every dialysis session, often three times a week. During the visit an evaluation of mood and anxiety symptoms is performed. If patients reports a change of mood or an increased in anxiety level, then a visit with a psychiatrist is schedule within one week. If necessary, patients are prescribed medication for the relevant psychiatric symptomatology which is compatible with clinical status of the patient.
    In the clinics in Turin, treatment as usual in terms of preventing and treating comorbid mental illness consists of standard clinical management. This includes clinical interviews with the oncologist and eventually referral to the consultation liaison service, providing assessment and, if necessary, medications and/or brief psychological support.
    The Santa Maria Hospital in Lisbon is a tertiary care unit which has no specific protocol for treating mental health problems. There is a liaison psychiatrist and psychologist in each clinical department which the patient can meet with on request. However, treatment for mental ill-health is usually done at the primary care level, at the local hospital to the patient.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Other
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

There are two main hypotheses in the study as follows:
Hypothesis 1: NEVERMIND will significantly decrease the level of depression in the intervention group in comparison to treatment as usual;
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.

Hypothesis 2: The NEVERMIND intervention will prevent (i.e. lower incidence rate of) depression to a significantly greater extent than treatment as usual.
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.

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Secondary Outcome

Secondary outcomes to be measured include general wellbeing, suicidal ideation and attempt, patient self-efficacy and management of primary somatic disease, illness perception, self-perceived stigma and physical activity.
Measured by the following scales which will be measured at baseline, after 12 weeks from receiving the system and again after 24 weeks from receiving the system.


• WHO Well-being Scale (WHO-5) which evaluates mood, vitality and general interests
• the Paykel Suicide Scale (PSS) which determines suicidal ideation and behaviour
• the Chronic Illness Anticipated Stigma Scale (CIASS) which measures perceived stigma
• the Self-Efficacy for Managing Chronic Disease Scale which evaluates self-efficacy in managing a chronic disease
• the Neuro-QoL (Quality of Life in Neurological Disorders) Satisfaction with Social Roles and Activities (8-item) which assesses satisfaction with daily life when living with a chronic illness
• the Brief Illness Perception Questionnaire which assesses illness perception
• the Self-Compassion Scale (Short Form) which measures self-compassion
• the Rapid Assessment of Physical Activity (RAPA) which assesses levels of physical activity

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Countries of Recruitment

  •   Italy
  •   Portugal
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/12/01
  •   330
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

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.

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Exclusion Criteria

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.

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Addresses

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    • Research Center "E.Piaggio", Faculty of Engineering
    • Mr.  PhD  Enzo Pasquale  Scilingo 
    • Largo Lucio Lazzarino 1
    • 56122  Pisa
    • Italy
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    • Research Center “E.Piaggio”, Faculty of Engineering
    • Mr.  PhD  Enzo Pasquale  Scilingo 
    • Largo Lucio Lazzarino 1
    • 56122  Pisa
    • Italy
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    • Research Center “E.Piaggio”, Faculty of Engineering
    • Mr.  PhD  Enzo Pasquale  Scilingo 
    • Largo Lucio Lazzarino 1
    • 56122  Pisa
    • Italy
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Sources of Monetary or Material Support

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    • European Comission, Project Nevermind Grant N. 689691
    • 1040  Brussels
    • Belgium
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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