Attempted Suicide Intervention Treatment and Prevention (SAMIT Program) — SAMIT  

Suicide, Attempted Clinical Trial

Official title: Attempted Suicide Intervention Treatment and Prevention: a Randomised Controlled Trial

Status Recruiting

Clinical Trial Summary

Suicide has become a first-order public health concern after the negative impact of coronavirus disease 2019 (COVID-19) on the mental health of the general population. Few studies have analyzed the effects of early psychotherapeutic interventions on subjects who have attempted suicide, and even fewer focus on those hospitalized in nonpsychiatric units after a medically serious suicide attempt (MSSA). The most important risk factor for attempting suicide is having made a previous suicide attempt. Subjects are also at higher risk the first year after the attempt.

The main aim of this study is to evaluate the effectiveness of individual psychological treatment with patients hospitalized after a MSSA. The secondary objectives are: 1) acknowledge the evolution of the incidence of MSSA hospitalized during the pandemic; 2) analyze the impact of the psychological intervention using biological, psychosocial, and clinical variables. An experimental, controlled, and randomized trial will be conducted with patients older than 16 admitted to two general hospitals. The case group will receive an 8- session of individual psychotherapy while the control group received treatment as usual. Longitudinal assessment will be conducted at baseline, post-treatment, and 3, 6, and 12 months after.

The main outcome variable will be re-attempting suicide during the follow-up.

Clinical Trial Description

In the last decades, many studies have tried to analyse the risk and protective factors related to suicidal behaviors. However, there are fewer studies evaluating the effectiveness of early psychotherapeutic interventions with subjects who have attempted suicide, and even fewer based on subjects who have been hospitalised after a medically serious suicide attempt (MSSA). This type of attempt can be considered a nearly lethal suicide attempt, and it usually has serious medical and psychological consequences. On the other hand, having a previous suicide attempt is known to be the most important risk factor for a subsequent attempt. Moreover, the first year after the attempts is the highest-risk period to re-attempt.

The main objective of this study is to evaluate the effectiveness of an early individual psychotherapeutic intervention with subjects hospitalised after a MSSA. The secondary objectives are: 1) to study how the incidence of MSSA needing hospitalisation has evolved during the pandemic; and 2) to study the impact of the psychotherapeutic intervention on several biological, psychosocial, and clinical variables.

This study is expected reducing the risk of re-attempting suicide and improving their quality of life and wellbeing. It may also provide valuable insight with regards to the relationship between this improvement and some correlated biological and psychosocial changes.

A randomised, controlled trial will be conducted with patients at 2 general hospitals in Catalonia (Hospital Vall d'Hebron and Hospital Clinic) after a MSSA. The case-intervention group will receive an 8-session early individual psychotherapy and the control group will receive the treatment-as-usual intervention (TAU). The intervention consists of eight face-to-face sessions that include techniques from dialectical-behavioural (DBT), cognitive-behavioural (CBT), mentalization treatment (MBT), and narrative approaches, based on an adaptation of the Attempted Suicide Short Intervention Program (ASSIP). The sessions will be conducted by a psychologist with expertise in psychotherapy. There will be two 60-minute sessions per week.

The subjects will be periodically assessed at baseline (before the treatment) and post-treatment. We also monitored during the follow-up period, at 3, 6, and 12 months after the end of the treatment.

In order to ascertain the effects of the psychotherapeutic intervention, several types of variables will be studied: biological (blood inflammatory biomarkers), psychosocial (quality of life, reasons for living, and personality dimensions), and clinical (related to the psychopathological status and to suicidal behaviors). The incidence of patients needing hospitalisation after a MSSA during the pandemic will also be analysed.

Socio-demographic variables will also collected during the baseline assessment. It will include information on: age; sex; nationality; civil status; educational level; employment status; family situation; history of child/adolescent/adult trauma or abuse; history of personal medical or surgical conditions; and current medical or surgical conditions.

Blood samples will be drawn before and after treatment, by an experienced nurse between 7.00 and 10.00 a.m. of the scheduled day after an overnight fasting. Laboratory analyses will be conducted on the same day as the clinical assessments.Complete and differential white blood cell (WBC) count (by an automated analyzer) acute-phase reactants (i.e., high-sensitivity C-reactive protein (hsCRP)) (by an automated analyzer) - Pro-inflammatory cytokines [Interleukine 6 (IL-6)]. Lipid profile (i.e., cholesterol, LDL, HDL, very low density lipoprotein (VLDL), triglycerides, Poly-Unsaturated Fatty Acids (PUFA's) (by an automated analyzer). In addition, serum and/or plasma will be separated by centrifugation, aliquoted, and immediately placed at -80°C until the time of analysis of the following metabolites: Tryptophan and Kynurenine pathway metabolites (i.e., Tryptophan (TRP), serotonin (5-HT), Kynurenine (KYN), kynurenic acid (KYNA), Xanthurenic acid (XA), 3-hydroxykynurenine (3-HK), 3-hydroxyanthranilic acid (3-HAA), Quinolinic acid (QUIN), Picolinic acid (PIC) by liquid chromatography-tandem mass spectrometry (LCMS/MS). Blood samples will be obtained at each hospital and kept frozen at -80 °C. Once the study is completed, the Clinic Hospital samples will be sent to the University Vall d'Hebron Hospital laboratory for analysis, along with all other samples. ;

Related Conditions & MeSH terms

• Suicide
• Suicide Prevention
• Suicide, Attempted

• NCT number: NCT06238414
• Study type: Interventional
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Anna Beneria Gonzàlez
• Phone: +34932746087
• Email: anna.beneria@vallhebron.cat
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Completion date: April 27, 2026