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.

Both childhood adversity (CA) and first-episode psychosis (FEP) have been linked to alterations in cortical thickness (CT). The interactive effects between different types of CAs and FEP on CT remain understudied.

One-hundred sixteen individuals with FEP (mean age = 23.8 ± 6.9 years, 34% females, 80.2% non-affective FEP) and 98 healthy controls (HCs) (mean age = 24.4 ± 6.2 years, 43% females) reported the presence/absence of CA <17 years using an adapted version of the Childhood Experience of Care and Abuse (CECA.Q) and the Retrospective Bullying Questionnaire (RBQ) and underwent magnetic resonance imaging (MRI) scans. Correlation analyses were used to assess associations between brain maps of CA and FEP effects. General linear models (GLMs) were performed to assess the interaction effects of CA and FEP on CT.

Eighty-three individuals with FEP and 83 HCs reported exposure to at least one CA. CT alterations in FEP were similar to those found in participants exposed to separation from parents, bullying, parental discord, household poverty, and sexual abuse (r = 0.50 to 0.25). Exposure to neglect (β = −0.24, 95% CI [−0.37 to −0.12], p = 0.016) and overall maltreatment (β = −0.13, 95% CI [−0.20 to −0.06], p = 0.043) were associated with cortical thinning in the right medial orbitofrontal region.

Cortical alterations in individuals with FEP are similar to those observed in the context of socio-environmental adversity. Neglect and maltreatment may contribute to CT reductions in FEP. Our findings provide new insights into the specific neurobiological effects of CA in early psychosis.

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

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

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

Numerous countries, notably within Europe, have sanctioned the practice of euthanasia. Extant legal frameworks meticulously define the extent, essence, and application of euthanasia, encompassing divergent characterizations, explications of entitlements, procedural modalities, and provisions for access. Nonetheless, the precise function of psychiatrists within these legislative contours remains conspicuously nebulous.

The present inquiry undertakes a comprehensive evaluative review of the euthanasia phenomenon vis-à-vis the intricate tapestry of European legislative paradigms, with an emphasis on elucidating the multifaceted involvement of psychiatry within this evolving landscape.

A nuanced narrative review is undertaken, encapsulating the contemporary state-of-affairs, fundamental conceptual architectures, the tenets of the Spanish Organic Law 03/2021, and the pharmaceutic armamentarium deployed in the orchestration of euthanasic practices. Additionally, the methodological blueprint employed within a prominent tertiary healthcare institution situated in Madrid is meticulously expounded.

To date, euthanasia has garnered legal imprimatur across diverse jurisdictions including, but not limited to, the Netherlands, Belgium, Colombia, Canada, Spain, and New Zealand. The ambit of assisted death and its application to the domain of mental infirmities is meticulously deconstructed. Within the overarching realm of foundational concepts, a rigorous delineation is rendered between euthanasia, medical succor in the throes of mortality, assisted self-termination, facilitated demise, provision of mortal release, judicious calibration of therapeutic enterprise, and the contours of palliative sedation. Distinction between the principal executor and the advisory consultant is rendered salient. The rubric of conscientious objection emerges as an inviolable entitlement of healthcare practitioners enmeshed in the provisionary matrix.

The enduring incumbency of the psychiatrist as a pivotal appraiser of cognitive and volitional faculties holds firm. The conspicuous influence of psychopathological constellations upon the contours of euthanasia eligibility precipitates cogent deliberation.

As the frontiers of euthanasia expand to encompass an augmented array of legal jurisdictions, this study underscores the increasingly intricate role inhabited by psychiatrists in the matrix of evaluative assessments. The proclivity of mental maladies to exert a substantial gravitational pull upon determinations of eligibility for euthanasia accentuates the exigency for refined explication of roles and responsibilities within this evolving sphere, a clarion call resonant not only within the precincts of psychiatry but reverberating across the broader firmament of medical praxis.

None Declared