Ignite Creation Date:
2025-12-18 @ 9:53 AM
Ignite Modification Date:
2025-12-23 @ 10:50 PM
Study NCT ID:
NCT06238414
Status:
None
Last Update Posted:
2024-03-20 00:00:00
First Post:
2023-11-20 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Attempted Suicide Intervention Treatment and Prevention (SAMIT Program)
Sponsor:
None
Organization:
Study Overview
Official Title:
Attempted Suicide Intervention Treatment and Prevention: a Randomised Controlled Trial
Status:
None
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAMIT
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: