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

Background Depressive symptoms are common in individuals suffering from severe somatic conditions. There is a lack of interventions and evidence-based interventions aiming to reduce depressive symptoms in patients with severe somatic conditions. The aim of the NEVERMIND project is to address these issues and provide evidence by testing the NEVERMIND system, designed to reduce and prevent depressive symptoms in comparison to treatment as usual. Methods The NEVERMIND study is a parallel-groups, pragmatic randomised controlled trial to assess the effectiveness of the NEVERMIND system in reducing depressive symptoms among individuals with severe somatic conditions. The NEVERMIND system comprises a smart shirt and a user interface, in the form of a mobile application. The system 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 study includes 330 patients who have a diagnosis of myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants are randomised in blocks of ten to either the NEVERMIND intervention or treatment as usual as the control group. Clinical interviews and structured questionnaires are administered at baseline, at 12 weeks, and 24 weeks to assess whether the NEVERMIND system is superior to treatment as usual. The endpoint of primary interest is Beck Depression Inventory II (BDI-II) at 12 weeks defined as (i) the severity of depressive symptoms as measured by the BDI-II. Secondary outcomes include prevention of the onset of depressive symptoms, changes in quality of life, perceived stigma, and self-efficacy. Discussion There is a lack of evidence-based interventions aiming to reduce and prevent depressive symptoms in patients with severe somatic conditions. If the NEVERMIND system is effective, it will provide healthcare systems with a novel and innovative method to attend to depressive symptoms in patients with severe somatic conditions. Trial registration DRKS00013391. Registered 23 November 2017

The NEVERMIND e-health system in the treatment of depressive symptoms among patients with severe somatic conditions: A multicentre, pragmatic randomised controlled trial

Background This study assessed the effectiveness of the NEVERMIND e-health system, consisting of a smart shirt and a mobile application with lifestyle behavioural advice, mindfulness-based therapy, and cognitive behavioural therapy, in reducing depressive symptoms among patients diagnosed with severe somatic conditions. Our hypothesis was that the system would significantly decrease the level of depressive symptoms in the intervention group compared to the control group. Methods This pragmatic, randomised controlled trial included 425 patients diagnosed with myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants were recruited from hospitals in Turin and Pisa (Italy), and Lisbon (Portugal), and were randomly assigned to either the NEVERMIND intervention or to the control group. Clinical interviews and structured questionnaires were administered at baseline, 12 weeks, and 24 weeks. The primary outcome was depressive symptoms at 12 weeks measured by the Beck Depression Inventory II (BDI-II). Intention-to-treat analyses included 425 participants, while the per-protocol analyses included 333 participants. This trial is registered in the German Clinical Trials Register, DRKS00013391. Findings Patients were recruited between Dec 4, 2017, and Dec 31, 2019, with 213 assigned to the intervention and 212 to the control group. The sample had a mean age of 59·41 years (SD=10·70), with 44·24% women. Those who used the NEVERMIND system had statistically significant lower depressive symptoms at the 12-week follow-up (mean difference=-3·03, p<0·001; 95% CI -4·45 to -1·62) compared with controls, with a clinically relevant effect size (Cohen's d=0·39). Interpretation The results of this study show that the NEVERMIND system is superior to standard care in reducing and preventing depressive symptoms among patients with the studied somatic conditions. Funding The NEVERMIND project received funding from the European Union's Horizon 2020 Research and Innovation Programme under grant agreement No. 689691

Can Doll therapy preserve or promote attachment in people with cognitive, behavioral, and emotional problems? A pilot study in institutionalized patients with dementia

Doll therapy is a non-pharmacological intervention aimed at reducing behavioral and psychological disorders in institutionalized patients with dementia. This therapy as a care tool has been integrated into the context of long-term care institutions, in which the need to find solutions to cognitive, behavioral and emotional problems showed by people with dementia meets the primary objective of developing good care practices focusing on patients and their needs. In the present work we adopt the Bowlby’s theory of attachment to investigate the effectiveness of Doll therapy. The hypothesis that we here propose is that the emotional experience of the person with dementia during Doll therapy activates caregiving and exploration systems together with the attachment one. To test this hypothesis we compared institutionalized patients with dementia undergoing Doll therapy with a control group and assessed measures of the relational dimension with the environment, such as gaze direction, behaviors of exploration, and behaviors of caregiving. We used an experimental protocol consisting of 10 non-consecutive sessions structured with the goal of recreating a situation of (1) separation from a known figure and (2) interaction with the environment in order to partially recreate the prototypical phases of the “Strange situation.” All sessions were videotaped and analyzed through an observational grid. Results support the effectiveness of Doll therapy in promoting and maintaining the affective-relational dimension of attachment-caregiving and the attentive dimension of exploration in patients with advanced stage of dementia. Thus, our results suggest that the use of Doll therapy promotes clinically significant improvements in the ability to relate with the surrounding world. This may be important for managing and caring for patients with dementia in institutionalized context

Neurobiological features and response to eye movement desensitization and reprocessing treatment of posttraumatic stress disorder in patients with breast cancer

Background: Breast cancer (BC) is one of the most common invasive types of cancer among women, with important consequences on both physical and psychological functioning. Patients with BC have a great risk of developing posttraumatic stress disorder (PTSD), but few studies have evaluated the efficacy of psychological interventions to treat it. Furthermore, no neuroimaging studies have evaluated the neurobiological effects of psychotherapeutic treatment for BC-related PTSD. Objective: The study aimed to evaluate the efficacy of Eye Movement Desensitization and Reprocessing therapy (EMDR) as compared to Treatment as Usual (TAU) in BC patients with PTSD, identifying by electroencephalography (EEG) the neurophysiological changes underlying treatments effect and their correlation with clinical symptoms. Method: Thirty patients with BC and PTSD diagnosis were included, receiving either EMDR (n = 15) or TAU (n = 15). Patients were assessed before and after treatments with clinical questionnaires and EEG. The proportion of patients who no longer meet criteria for PTSD after the intervention and changes in clinical scores, both between and within groups, were evaluated. Two-sample permutation t-tests among EEG channels were performed to investigate differences in power spectral density between groups. Pearson correlation analysis was carried out between power bands and clinical scores. Results: At post-treatment, all patients treated with EMDR no longer met criteria for PTSD, while all patients treated with TAU maintained the diagnosis. A significant decrease in depressive symptoms was found only in the EMDR group, while anxiety remained stable in all patients. EEG results corroborated these findings, showing significant differences in delta and theta bands in left angular and right fusiform gyri only in the EMDR group. Conclusions: It is essential to detect PTSD symptoms in patients with BC, in order to offer proper interventions. The efficacy of EMDR therapy in reducing cancer-related PTSD is supported by both clinical and neurobiological findings