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 disease F32 F33

Carli V, Petros NG, Hadlaczky G, Vitcheva T, Berchialla P, Bianchi S, Carletto S, Christinaki E, Citi L, Dinis S, Gentili C, Geraldes V, Giovinazzo L, Gonzalez-Martinez S, Meyer B, Ostacoli L, Ottaviano M, Ouakinin S, Papastylianou T, Paradiso R, Poli R, Rocha I, Settanta C, Scilingo EP, Valenza G.

2022-05-0610 citations

10.1016/j.eclinm.2022.101423

Sociodemographic Characteristics Associated With an eHealth System Designed to Reduce Depressive Symptoms Among Patients With Breast or Prostate Cancer: Prospective Study

Nuhamin Gebrewold Petros, Gergö Hadlaczky, Sara Carletto, Sergio González-Martínez, Luca Ostacoli et al. (9 authors)

JMIR Formative Research2022-03-1816 citations

10.2196/33734

A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions.

Carli V, Wasserman D, Hadlaczky G, Petros NG, Carletto S, Citi L, Dinis S, Gentili C, Gonzalez-Martinez S, Aldo De Leonibus, Meyer B, Ostacoli L, Ottaviano M, Ouakinin S, Paradiso R, Poli R, Rocha I, Settanta C, Waldmeyer MTA, Valenza G, Scilingo EP.

2020-03-028 citations

10.1186/s12888-020-02494-3

Interventions

Group 1: 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, i

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

Italy, Portugal

Contacts

Public ContactEnzo Pasquale Scilingo

Research Center “E.Piaggio”, Faculty of Engineering

e.scilingo@ing.unipi.it+39.050.2217050

Outcome results

None listed