Clinical trial NCT06238414: Attempted Suicide Intervention Treatment and Prevention (SAMIT Program)
Official title: Attempted Suicide Intervention Treatment and Prevention: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide, Attempted
Suicide Prevention
Keywords: Medically serious suicide attempts (MSSA)
Psychotherapy
Intervention
Randomized controlled trial
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
First posted: 2024-02-02
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An experimental, randomized controlled trial will be conducted with patients hospitalized after a MSSA. The case group will receive an 8-session early psychological intervention while the control group will be treated as usual. The intervention consists of eight face-to-face sessions that include techniques from the narrative theory, dialectical behavioral (DBT), mentalization-based therapy orientation (MBT) and narrative approach, concretely an adaptation from the ASSIP therapy. Longitudinal assessment will be conducted at baseline and 3, 6 and 12 months after the early psychological intervention. The main outcome will be re-attempting suicide during the follow-up period. Secondary outcomes measures will be related to: biological (biomarkers), psychosocial (quality of life and reasons for living) and clinical (psychometric assessments, psychopathological status and suicidiological variables) factors.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Older than 16 years.
* Remaining hospitalized for 24 hours or more at HUVH and HCP after a MSSA for 24 or more (\> = 24 hours).
* Needing specialized care units (including Intensive Care Units, Hyperbaric Camera Units, Burned Units, Semicritical Units)
* Needing specialized surgical treatment, excluding superficial cuts
* Needing extensive medical treatment and observation (gastric lavage, activated charcoal, observation of neurological tests or other complementary tests)
* MSSA with high lethality methods (precipitation, hanging, firearm, stabbing) needing hospitalization for 24 or more hours, regardless of the treatment unit.

Exclusion Criteria:

* Patients with suicide attempts who were discharged in \<24 h
* Patients under 16 years.
* Patients with mild to severe cognitive impairment.
* Lack of informed consent.

Primary outcomes:
measure: Number of suicide attempts (recurrence)
timeFrame: 1 year
measure: Severity of suicide behaviour
timeFrame: 1 year
measure: Suicide behaivour
timeFrame: 1 year
measure: Lethality of suicide attempt
timeFrame: 1 year
Secondary outcomes:
measure: Well-being: Intrapsychic functions, Interpersonal relationships, Instrumental role, Use of common objects and daily activities.
timeFrame: 1 year
measure: Psychological Pain
timeFrame: 1 year
measure: Anxiety and Depression
timeFrame: 1 year
measure: Impulsivity
timeFrame: 1 year
measure: Interleukin 6 (IL-6)
timeFrame: 1 month
measure: Suicide intentionality
timeFrame: 1 year
measure: Reflective capacity
timeFrame: 1 year
measure: Suicide ideation
timeFrame: 1 year
measure: Hopelessness
timeFrame: 1 year
measure: C-reactive protein
timeFrame: 1 month
measure: White Blood Cells (x10E9/L)
timeFrame: 1 month
measure: Cholesterol (mg/dL)
timeFrame: 1 month
measure: High-Density Lipoprotein (HDL) (mg/dL)
timeFrame: 1 month
measure: Low -Density Lipoprotein (LDL) (mg/dL)
timeFrame: 1 month
measure: Tryglycerides (mg/dL)
timeFrame: 1 month
measure: Attachment
timeFrame: 1 month
measure: Cognition
timeFrame: 1 month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Anna Beneria
Study officials:
affiliation: VHIR
name: Maria Dolores Braquehais
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínic-IDIBAPS
name: Pol Bruguera
role: PRINCIPAL_INVESTIGATOR
References: