Inadequate recruitment and retention impede clinical trial goals. Emerging decentralized clinical trials (DCTs) leveraging digital health technologies (DHTs) for remote recruitment and data collection aim to address barriers to participation in traditional trials. The ACTIV-6 trial is a DCT using DHTs, but participants’ experiences of such trials remain largely unknown. This study explored participants’ perspectives of the ACTIV-6 DCT that tested outpatient COVID-19 therapeutics.

Participants in the ACTIV-6 study were recruited via email to share their day-to-day trial experiences during 1-hour virtual focus groups. Two human factors researchers guided group discussions through a semi-structured script that probed expectations and perceptions of study activities. Qualitative data analysis was conducted using a grounded theory approach with open coding to identify key themes.

Twenty-eight ACTIV-6 study participants aged 30+ years completed a virtual focus group including 1–4 participants each. Analysis yielded three major themes: perceptions of the DCT experience, study activity engagement, and trust. Participants perceived the use of remote DCT procedures supported by DHTs as an acceptable and efficient method of organizing and tracking study activities, communicating with study personnel, and managing study medications at home. Use of social media was effective in supporting geographically dispersed participant recruitment but also raised issues with trust and study legitimacy.

While participants in this qualitative study viewed the DCT-with-DHT approach as reasonably efficient and engaging, they also identified challenges to address. Understanding facilitators and barriers to DCT participation and DHT interaction can help improve future research design.

The Clinical and Translational Science Awards (CTSA) Program supports a national network of medical research institutions working to expedite the development of treatments and interventions. High-performing translational teams (TTs) involving inter-institutional collaborations are critical for advancing these evidence-based approaches. However, management of these complex teams can be difficult, and tailored project management may help TTs overcome the unique challenges they face.

We conducted qualitative interviews with 14 dedicated project managers (PMs) from six CTSAs to learn more about their experiences with TTs. Information derived from the thematic analysis of the data was used to identify barriers and facilitators for effective project management.

Barriers included a lack of institutional support, communication issues, pushback, role confusion, and a need for agility. Facilitators included transparent communication, supportive team environments, shared leadership with autonomy, and opportunities for professional development. The PMs interviewed for this study provided descriptions of their work that depicted a more expansive view of project management than the more traditional approach focused on meeting deadlines and managing deliverables.

Our findings have been used to inform development, training, and guidance for an innovative project management resource, the Project Management Innovation Center of Excellence (PROMICE) recently launched at the UW-Madison Institute for Clinical and Translational Research (ICTR). Through the development of a dedicated career path, PROMICE recognizes the value that PMs bring to translational science and provides the support that they need to be innovative, leading their teams to success.

The goals of this investigation were to 1) identify and measure exposures inside homes of individuals with chemical intolerance (CI), 2) provide guidance for reducing these exposures, and 3) determine whether our environmental house calls (EHCs) intervention could reduce both symptoms and measured levels of indoor air contaminants.

CI is an international public health and clinical concern, but few resources are available to address patients’ often disabling symptoms. Numerous studies show that levels of indoor air pollutants can be two to five (or more) times higher than outdoor levels. Fragranced consumer products, including cleaning supplies, air fresheners, and personal care products, are symptom triggers commonly reported by susceptible individuals.

A team of professionals trained and led by a physician/industrial hygienist and a certified indoor air quality specialist conducted a series of 5 structured EHCs in 37 homes of patients reporting CI.

We report three case studies demonstrating that an appropriately structured home intervention can teach occupants how to reduce indoor air exposures and associated symptoms. Symptom improvement, documented using the Quick Environmental Exposure and Sensitivity Inventory Symptom Star, corresponded with the reduction of indoor air volatile organic compounds, most notably fragrances. These results provide a deeper dive into 3 of the 37 cases described previously in Perales et al. (2022).

We address the long-standing dilemma that worldwide reports of fragrance sensitivity have not previously been confirmed by human or animal challenge studies. Our ancient immune systems’ ‘first responders’, mast cells, which evolved 500 million years ago, can be sensitized by synthetic organic chemicals whose production and use have grown exponentially since World War II. We propose that these chemicals, which include now-ubiquitous fragrances, trigger mast cell degranulation and inflammatory mediator release in the olfactory-limbic tract, thus altering cerebral blood flow and impairing mood, memory, and concentration (often referred to as ‘brain fog’). The time has come to translate these research findings into clinical and public health practice.

Adherence to treatment for addictive disorders remains a clinical challenge. Despite detoxification admissions being scheduled and initiated voluntarily by the patient, several factors may contribute to treatment discontinuation.1 Understanding these factors will enable the development of specific interventions for a more effective approach.2

To identify and analyze the relationship between specific clinical factors and voluntary treatment discontinuation.

An observational and descriptive study was conducted using a retrospective database of 1146 patients admitted to the “Hospital Universitari Vall d’Hebron” Detoxification Unit between June 2008 and December 2019. Bivariate analysis was conducted to identify individual associations between clinical factors and voluntary discharge. Subsequently, a multivariate analysis was performed to assess the combined influence of these factors while controlling for potential confounding variables.

A total of 135 patients (11.8%) requested voluntary discharge. Significant differences were found between the voluntary discharge and non-voluntary discharge groups in patients with dual diagnosis (91.1% vs 80.9%, p<0.0001), specifically the presence of psychotic disorder (18.7% vs 12%, p<0.05) and cluster B personality disorder (66.7% vs 31%, p<0.0001). Significant associations were also observed with prior detoxification admissions (64.5% vs 54.1%, p<0.05), heroin as the main admission substance (29.6% vs 13.3%, p<0.0001), lifetime use of more than three substances (65.3% vs 45.3%, p<0.0001), and pre-admission binge-pattern substance use (72.1% vs 51.4%, p<0.0001). A significant relationship was found with therapeutic discharge in the diagnosis of major depressive disorder (14.6% vs. 24.8%, p<0.05), admission for alcohol detoxification (25.9% vs. 42.8%, p<0.0001), and participation in group therapy during admission (27.4% vs. 49.9%, p<0.0001).In the multivariate analysis, it was found that cluster B personality disorder (p<0.0001), heroin as the primary substance of admission (p<0.05), and pre-admission binge-pattern substance use (p<0.05) were independently related to voluntary discharge.

Cluster B personality disorder, admission for heroin detoxification, and pre-admission binge-pattern substance use are factors associated with voluntary treatment discontinuation.

None Declared

Mental health in the deaf community is a complex issue. Challenges in diagnosis and treatment arise from a lack of experienced interpreters and difficulties in translating Sign Language to spoken language. Deaf individuals, due to auditory limitations, are more vulnerable to abuse, increasing their risk of mental health disorders, including bipolar affective disorder (BPAD). BPAD is a prevalent, debilitating condition with varied prevalence estimates. Managing it is tough due to its lifelong, unpredictable nature. A new approach called Psychiatric Home Hospitalization Unit aims to provide acute mental health care at home as an alternative to hospitalization.

To show the management of severe bipolar disorder with comorbidity from a Psychiatric Home Hospitalization Unit

A clinical case of bipolar disorder with deafness attended at the Psychiatric Home Hospitalization Unit of our hospital is presented.

A 24-year-old deaf woman borned in Pakistan and later moving to Catalonia, she faced educational challenges but ultimately completed her studies with sign language support. Afterward, she struggled to find suitable employment, and her family had a history of bipolar disorder.

She exhibited a sudden change in behavior, characterized by irritability, paranoia, and distrust. Communication was challenging due to her speech difficulties, but assessments using sign language and observation were conducted. Her physical examination was normal, but her speech was disorganized and pressured, suggesting possible auditory hallucinations and thought disturbances. She was hospitalized and diagnosed with bipolar disorder with psychotic features.

During her initial hospitalization, she received lithium, olanzapine, clotiapine and benzodiacepines. After discharge, she continued treatment through a home hospitalization service during almost 4 month. During follow-up she presented a course with high affective instability, rapid cycling alternating brief periods of stability with other presenting manic and mixed features with high disorganization.

Due to the rapid cycling pattern Valproic acid was considered. Valproic acid was introduced up to 700 mg/d (97.1 mcg/mL). Treatment with lithium carbonate 800 mg/d (0.91 mEq/L) was maintained. Previous antipsychotic regimen was changed to quetiapine 400mg/d, olanzapine 5mg/d. Her condition improved significantly with the adjusted treatment regimen. She was discharged to an outpatient service.

Diagnosing and treating bipolar affective disorder (BPAD) in a deaf and mute patient posed unique challenges. The rapid mood cycling pattern and complexity of her case made treatment challenging. Family information and interpreter support were vital. Cultural factors were considered, and home hospitalization was crucial in managing symptoms that lasted over four months.

None Declared

The expression of sexuality in the adult with mental disorders depends on the early incorporation of factors for promoting social inclusion. It is fundamental that sexual educators and advisors, in addition to working with the clients, also work with close family members. Intervention programs should establish objectives for developing a positive attitude towards sexuality in people with mental disorders and improving self-esteem (Katz G,Salud Publica Mex. 2008;50 Suppl 2:s239-54).

Achieving support for people with mental health problems and/or substance use disorder admitted to the Social Rehabilitation Process of a psychiatric hospital so that they develop their sexuality satisfactorily. The right to privacy must be taken into account.

Promoting a healthy and satisfactory development of sexuality in people with severe mental disorders. Raising awareness among healthcare teams, families and legal representatives regarding the need and suitability for support. Introducing the concept of sexuality as a dignifying perspective. Promoting sexual education that avoids disadvantages and situations of abuse in the target group. Coordinating the continuity of the project with non-health social services after discharge.

Possibility of receiving support in the development of sexuality through training, information and improvement in the management of emotions/feelings in people who express the need or willingness to receive it, will contribute to overcoming limitations or difficulties.

Detecting people who during 2021 wish to work on the objectives through the care team. Searching for community resources aimed at attending sexuality issues in people with mental health problems. Proposing the hospital a collaboration with a non-profit entity that develops a specialized program for attention to sexuality in disability. Coordination between Treatment team and Entity. Quantitative and qualitative assessment of one year of experience according to the parameters of the entity.

All patients included have a diagnosis of psychosis. Experience was very positive for the participants. Community intervention projects that lead to an education in healthy and respectful relationships in the field of sexuality and affectivity are necessary. This would allow to prevent behaviours and situations at risk of abuse as well as social and emotional instability.

None Declared

Women experiencing severe perinatal mental health problems require specialized services and care. Perinatal mental disorders are common and can contribute to maternal mortality, affecting neonatal, infant, and child outcomes. Home treatment can prevent hospital admissions and promote strategies within the patient’s support network.

Our aim is to describe a clinical case in perinatal psychiatry managed by a Psychiatric Home Treatment Unit.

We present a case of perinatal psychotic depression in a 26-year-old pregnant woman.

We describe the case of a patient with no prior history of mental health issues. She was 25 weeks pregnant when she first sought psychiatric help in July 2023 and was diagnosed with depressive disorder with psychotic symptoms. She reported symptoms such as low mood, psychomotor inhibition, delusional guilt thoughts, and auditory hallucinations beginning three weeks before her initial visit. Due to her clinical presentation, the patient was admitted to the hospital, where pharmacological treatment was initiated with Olanzapine 5 mg, Sertraline 50 mg, and Lorazepam 1.5 mg. She remained in the hospital for four days, during which she showed gradual improvement but did not achieve full recovery.

Considering the improvement observed, home treatment was proposed and accepted by the patient and her relatives. During home treatment, she continued to exhibit persistent depressive and psychotic symptoms, including low mood, inhibition, and delusional thoughts of ruin and catastrophe. Therefore, her treatment was adjusted, with Olanzapine increased to 10 mg, Sertraline raised to 100 mg, and Lorazepam reduced to 0.75 mg. Over time, significant improvement in her clinical symptoms was noted. Throughout the follow-up period, she reported no significant side effects from the pharmacological treatment. After a month of follow-up in our department, she was discharged with outpatient care provided by a specialized community perinatal psychiatric unit.

We illustrate the possibility of home treatment for perinatal psychiatric disorders. The potential benefits of remaining close to one’s support network and developing coping strategies can be advantageous during the course of illness. Further studies should be conducted to explore these potential benefits.

None Declared

Cannabinoid hyperemesis syndrome (CHS) is an underrecognized condition characterized by acute episodes of intractable nausea and vomiting, colic abdominal pain and restlessness related to chronic cannabis use. Antiemetics commonly fail to alleviate the severe nausea and vomiting. A very particular finding is the symptomatic relief with hot water. Antipsychotics (such as haloperidol), benzodiazepines and/or capsaicin cream appear to be the most efficacious in the treatment of this unique disorder. Precisely, it has been studied that transient relief of symptoms with topic capsaicin or hot water share the same pathophysiology. Nevertheless, abstinence from cannabis remains the most effective way of mitigating morbidity associated with CHS.

The objective is to study this phenomenom in our hospital and to alert of its existence in order to avoid a suspected misdiagnosis and overdiagnosis.

We report a case series of seven patients who attended the Emergency Room (ER) of a third level hospital located in Cantabria (Spain) where a psychiatric evaluation was demanded.

The reasons for consultation were agitation and/or compulsive vomit provocation and showers. They were all women, with a median age of 29 years (range 21 to 38), who all smoked cannabis and in probable high doses (seven to up to twenty joints per day, information was missing in three of the patients) and probable long duration of consumption (more than nine years up to twenty-three, information was missing in three of the patients).

One of the most striking findings is the time to diagnosis, being the median of years of more than eight (range from two to twenty-one). In all of the cases there is a hyperfrequentation to the ER for this reason (not counting other emergency centres we have in Cantabria which we don´t have access to), being the average of almost twenty-two times (thirteen up to thirty times), not diagnosing it until last visits. Another interesting fact is that Psychiatric evaluation is done approximately in a third of the visits, being the department that makes all of the diagnosis except in one case. In all of the cases there are a lot of diagnostic orientation doubts from different medical departments, being the two most common psychiatric misdiagnosis: Other Specified Anxiety Disorder and Other Specified Feeding or Eating Disorder. Two of the patients were hospitalized in an acute psychiatric unit for this reason, one of them nine times and the other patient, twice.

CHS has a very particular presentation which makes its recognition very simple. From our experience, it is an unknown entity for most of the doctors, something that needs to change in order to make a correct therapeutic management. Larger studies need to be done to make this findings more solid and for further information.

None Declared

Hospital at home for psychiatric patients is a new emerging resource of delivering acute mental health care in the community. The main objective of this program is to provide intense care to patients with severe mental disorders at home as an alternative to acute admission.

Although home hospitalisation has begun to develop widely in recent years there is a notable lack of studies

The CAEM Psychiatric Home Hospitalization Unit (HAD-CAEM) has been operating since 2018 and takes place in Santa Coloma de Gramenet; and from March 2022 also in a part of Badalona. Both are sociodemographically depressed areas near Barcelona.

The aim of this study is to describe the characteristics of patients attended at the Psychiatric Home Hospitalization Unit of our hospital and to study differences according to area and place of referral.

Socio-demographic and clinical data were collected retrospectively at admission and discharge of all patients treated at HAD-CAEM between March 2022 to february 2023.

Statistical analysis was performed by using SPSS program.

85 patients were included in the study. 45.9% were women. The mean age was 45.5 years (SD 15.58 years). The main diagnoses of the sample were psychosis and schizophrenia (38.8%), Bipolar disorder (23.53%), Depressive disorder (21.18%), schizoaffective disorder (8.24%) and others (8,24%).

54 (63.53%) patients were from Santa Coloma area and 35 (41.18%) from Badalona area.

The total mean duration of admission was 40.22 days (SD 26.18 days), with a mean follow-up of 10.09 visits (SD 5.39 visits) and 2.41 teleassistence (SD 2.62).

The mean duration of admission for Santa Coloma patients was 43.98 days (SD 28.59), and for Badalona patients 33.68 days (SD 20.13). Trend without significance is observed (t= 1.77, p=0.08)

We found differences in the mean duration of admission according to referral location. Acute psychiatric unit 33.25 days (SD 18.06), Mental health Center 51.93 days (SD 33.45), Emergencies 34.28 days (SD 19.69) (F=5.1, p=0.008).

Sociodemografic and clinical característics obtained in our study are consistent with those reported in previous studies. The duration of admission of patients referred from the mental health center is longer than those referred from the acute psychiatric or emergency unit. Home hospitalization teams have been increasing in recent years, being an alternative to traditional hospitalization.

None Declared

Suicidal behaviors are frequently observed among patients with substance use disorder, including suicidal ideation (SI) (1). Alcohol use disorder (AUD) is one of the most prevalent addictions and may be related to suicidal behaviors (2,3). However, the association between AUD and SI requires a deeper analysis which includes several clinical features observed among AUD patients.

To analyze the clinical characteristics and features associated with lifetime SI among patients who had AUD.

This is a cross-sectional study performed in an outpatient center for addiction treatment in patients seeking for treatment who met the criteria for AUD between 01/01/2010 and 12/31/2021. Patients were evaluated with an ad-hoc questionnaire and the European Addiction Severity Index (EuropASI), SI was evaluated using the item for SI in EuropASI.

From a potential sample of n=3729 patients, only n=1082 (73.8% males; mean age 42.82±12.51) met inclusion criteria and had data for the current analysis. Lifetime SI was present in 50.9% of the AUD patients. Several clinical features were related to SI, including: sex differences, any type of lifetime abuse, polyconsumption, benzodiazepine use disorder, any psychiatric diagnosis aside from SUD, and higher addiction severity according to the EuropASI.

Image:

SI among AUD patients is related to several clinical features which indicate a higher addiction severity, more polyconsumption, and a higher prevalence of psychiatric comorbidities. These findings may contribute to the understanding of suicidal behaviors in AUD patients but it is required further investigations, including longitudinal studies.

REFERENCES

1 Rodríguez-Cintas L, et al. Factors associated with lifetime suicidal ideation and suicide attempts in outpatients with substance use disorders. Psychiatry Res. 2018;262:440-445. doi:10.1016/j.psychres.2017.09.021

2. MacKillop J, et al. Hazardous drinking and alcohol use disorders. Nat Rev Dis Primers. 2022;8(1):80. doi:10.1038/s41572-022-00406-1

3.Darvishi N, et al. Alcohol-related risk of suicidal ideation, suicide attempt, and completed suicide: a meta-analysis [published correction appears in PLoS One. 2020;15(10):e0241874]. PLoS One. 2015;10(5):e0126870. doi:10.1371/journal.pone.0126870

None Declared

Suicidal behaviors are frequently observed among patients with substance use disorder, including suicidal ideation (SI) (1). Alcohol use disorder (AUD) is one of the most prevalent addictions and may be related to suicidal behaviors (2,3). However, the association between AUD and SI requires a deeper analysis which includes several clinical features observed among AUD patients.

To analyze the clinical characteristics and features associated with lifetime SI among patients who had AUD.

This is a cross-sectional study performed in an outpatient center for addiction treatment in patients seeking treatment who met the criteria for AUD between 01/01/2010 and 12/31/2021. Patients were evaluated with an ad-hoc questionnaire and the European addiction severity index (EuropASI). SI was evaluated by using the item for SI in EuropASI.

From a potential sample of n=3729 patients, only n=1082 (73.8% males; mean age 42.82±12.51) met inclusion criteria and had data for the current analysis. Lifetime SI was present in 50.9% of the AUD patients. Several clinical features were related to SI, including: sex differences, any type of lifetime abuse, polyconsumption, benzodiazepine use disorder, any psychiatric diagnosis aside of SUD, and higher addiction severity according to the EuropASI (See table)

Image:

SI among AUD patients is related to several clinical features which indicate a higher addiction severity, more polyconsumption, and a higher prevalence of psychiatric comorbidities. These findings may contribute to the understanding of suicidal behaviors in AUD patients but it is required further investigations, including longitudinal studies.

REFERENCES

1. Rodríguez-Cintas L, et al. Factors associated with lifetime suicidal ideation and suicide attempts in outpatients with substance use disorders. Psychiatry Res. 2018;262:440-445. doi:10.1016/j.psychres.2017.09.02

2. MacKillop J, et al. Hazardous drinking and alcohol use disorders. Nat Rev Dis Primers. 2022;8(1):80. doi:10.1038/s41572-022-00406-1 3. Darvishi N, et al. Alcohol-related risk of suicidal ideation, suicide attempt, and completed suicide: a meta-analysis [published correction appears in PLoS One. 2020;15(10):e0241874]. PLoS One. 2015;10(5):e0126870. doi:10.1371/journal.pone.0126870

R. Palma-Alvarez Speakers bureau of: RFPA has received speaker honorariums from Angelini, Cassen Recordati, Exeltis, Lundbeck, MSD, Rubió, Servier, and Takeda., A. Rios-Landeo: None Declared, G. Ortega-Hernandez Speakers bureau of: GOH has received speaker honorariums from Rubió., E. Ros-Cucurull Speakers bureau of: ERC has received speaker honorariums from Janssen-Cilag, Lundbeck, Otsuka, Pfizer, Lilly, Servier, Rovi, Juste., C. Daigre: None Declared, M. Perea-Ortueta: None Declared, L. Grau-Lopez Speakers bureau of: LGL has received fees to give talks for Janssen-Cilag, Lundbeck, Servier, Otsuka, and Pfizer., J. Ramos-Quiroga Speakers bureau of: JARQ has been on the speakers’ bureau and/or acted as consultant for Janssen-Cilag, Novartis, Shire, Takeda, Bial, Shionogi, Sincrolab, Novartis, BMS, Medice, Rubió, Uriach and Raffo.

The glucagon-like peptide-1 (GLP-1) receptor agonist Semaglutide has been widely used to manage type 2 diabetes due to its favourable effects on glycemic control and weight reduction. Proved to be safe in adults and elderly patients with renal or hepatic disorders demanding no dose modification. Affective symptoms are not listed as side effects in the product information. However, there is a recent investigation going on by the European Medicines Agency (EMA) after three flagged cases of suicidal thoughts in Iceland. In contrast, the Food and Drug Administration (FDA) recommend that patients with this treatment are monitored for suicidal thoughts or behaviour.

This case study explores the possible relationship between Semaglutide treatment and the onset of a manic episode in a 57-year-old male with no history of psychiatric disorders.

We present a 57-year-old male with no psychiatric history of interests, with a previous good functioning. A one-week history of disruptive behaviours started, characterized by excessive cheerfulness, heightened euphoria, and reduced need for sleep. Family members describe a complex situation at home, with frequent outings by the patient, engaging in conversations with strangers, getting lost, and becoming more irritable with them. The patient and family relate this mood change after initiating Semaglutide for diabetes control, starting at 7mg doses. The temporal relationship between the initiation of Semaglutide therapy, precisely a dose escalation to 7mg, and the onset of manic symptoms prompted family members to notify the patient’s endocrinologist. Due to the inability to manage the patient at home and his unpredictability, they sought help at the emergency department, resulting in a psychiatric admission. Imaging and analytical tests show no significant abnormalities.

During his stay in the psychiatry department, semaglutide dosage was reduced, and treatment with Aripiprazole was initiated at doses of 5mg, given the metabolic profile associated with medical comorbidities (obesity, chronic renal failure and diabetes). Subsequent clinical observations showed a gradual resolution of manic symptoms and an improvement in the patient’s overall mental state.

This case highlights the importance of monitoring and recognizing potential neuropsychiatric side effects associated with Semaglutide therapy, particularly in individuals without a prior psychiatric history. Further research is warranted to elucidate the underlying mechanisms linking Semaglutide with mood disturbances and to identify risk factors that may predispose certain patients to develop manic states in response to this GLP-1RA. Clinicians should remain vigilant and consider alternative treatment options if such side effects occur, ensuring comprehensive management of patients receiving Semaglutide for diabetes control.

None Declared

Unipolar depression is a growing global Public Health challenge. During last years, life factors such as diet, have been identified as a target for the development of adjunctive treatment that could reduce the rates of depression. The Mediterranean Diet (MD) is one of the most studied dietary factors that has been inversely associated with depression (Rahe et al. Eur J Nutr. 2014;53:997–1013). The PREDIDEP study is an ongoing secondary prevention trial aimed at assessing the effect of a MD enriched with extra virgin olive oil (EVOO) on depression recurrence (Sánchez-Villegas et al. BMC Psychiatry. 2019 Feb 11;19(1):63).

This study aims to assess the effectiveness of a remote Mediterranean diet–based nutritional intervention in the context of a trial of depression.

The PREDIDEP study is a 2-year multicenter, randomized, single-blinded trial designed to analyse the effect of the MD enriched with extra virgin olive oil (EVOO) on the prevention of depression recurrence. The inervention group received phone contacts with dietist and had access to web-based information, and the control group had usual care for depressed patients. The 14-item MD Adherence Screener (MEDAS) questionnaire and a semiquantitative food frequency questionnaire (FFQ) were collected by dietitians at baseline and at 1-year and 2-year of follow-up. We used mixed effects linear models to assess changes in nutritional variables according to the group of intervention. The trial was registered at ClinicalTrials.gov NCT03081065.

We observed that participants in the MD group increased their adherence to MD (between-group difference: 2.50; 95% CI 1.88-3.12; p<0.001) after one and two years (between-group difference: 2.57; 95% CI 1.93-3.22; p<0.001) of intervention compared with control group.

We found that this multifaceted remote nutritional intervention is a useful tool kit to maintain the quality of the diet according to the goals of the MD among patients at risk of depression.

None Declared