Attempted Suicide Intervention Treatment and Prevention (SAMIT Program)

NCT06238414 | Recruiting

• 1 other identifier: PR(AG)463/2022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide, Attempted; Suicide Prevention

Keywords

Medically serious suicide attempts (MSSA); Psychotherapy; Intervention; Randomized controlled trial

Outcome Measures

Primary Outcomes (4)

• Number of suicide attempts (recurrence)

  The recurrence of the suicide attempt will be monitored by two mechanisms: 1. During follow-up evaluations at 3, 6, and 12 months through a telephone call to the patient 2. Reviewing the patient's medical history through the hospital's public health system program. The variable will be recorded by a dicotomic answer: "YES" if the patient had an intent during the follow-up period (3, 6, and 12 months) and "NO" if the patient did not have an intent. In cases of reattempt, the C-SSRS, SCS, and SALSA scales will be administered. In case of consummated attempts, information will be collected through clinical history and family interviews if it's required. We expected that the "case-intervention group" would have fewer re-attempts than the control group.

  1 year

• Severity of suicide behaviour

  The investigators will evaluate the suicide severity through the C-SSRS scale in the pre-treatment phase only if the patient makes a suicide attempt or has a suicide ideation during the study pre and post-treatment and follow up perios (3,6 and 12 months) . Columbia Suicide Severity Rating Scale (C-SSRS) is a semi-structured interview with dicothomic answers (yes or no) that captures the occurrence, severity, and frequency of suicide-related behaviour and thoughts during the assessment period.

  1 year

• Suicide behaivour

  The investigators evaluated the suicide attempt trought the SCS scale in pre treatment phase and only if the patient makes a suicide attempt or has a suicide ideation during the study pre and post-treatment and follow up perios (3,6 and 12 months) . Suicidal Crisis Syndrome (SCS): This is an interview with dichotomous responses that assess conditions linked to imminent suicidal behavior characterized by (a) affective disturbance, loss of cognitive control, hyperarousal and social withdrawal (Criterion B) and (b) a generalized sense of entrapment in which leaving an intolerable life situation is perceived as both urgent and impossible.

  1 year

• Lethality of suicide attempt

  In the baseline phase, before treatment, we assess the lethality of the suicide attempt through the Scale for Assessment of the Lethality of the Suicide Attempt (SALSA). The investigators will only administer the scale again in case of re-attempt during the follow-up. SALSA consists of two parts: The first component has four items indicating seriousness of the attempt and its likely consequences and the second component is the global impression of lethality. All the items are scored from 1 to 5, higher scores suggestive of increased lethality

  1 year

Secondary Outcomes (17)

• Well-being: Intrapsychic functions, Interpersonal relationships, Instrumental role, Use of common objects and daily activities.

  1 year

• Psychological Pain

  1 year

• Anxiety and Depression

  1 year

• Impulsivity

  1 year

• Interleukin 6 (IL-6)

  1 month

Study Arms (2)

Intervention/case participant

EXPERIMENTAL

The case group will receive an 8-session early psychological intervention

Other: Early psychotherapeutic intervention

Control case/participant

NO INTERVENTION

The control group will be treated as usual (TAU)

Interventions

Early psychotherapeutic intervention OTHER

The case group will receive an 8-session early psychological intervention The intervention consists of eight face-to-face sessions that include techniques from the dialectical behavioral (DBT), mentalization based therapy orientation (MBT), and narrative approach, concretely an adaptation from the ASSIP therapy. The sessions will be conducted by a clinical psychologist with expertise in psychotherapy. There will be two 60-minutes sessions per week.

Intervention/case participant

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Hospital Clinic of Barcelona: collaborator

Study Sites (1)

Anna Beneria

Barcelona, 08035, Spain

RECRUITING

Related Publications (1)

• Beneria A, Motger-Alberti A, Quesada-Franco M, Arteaga-Henriquez G, Santesteban-Echarri O, Ibanez P, Parramon-Puig G, Sanz-Correcher P, Galynker I, Ramos-Quiroga JA, Pintor L, Bruguera P, Braquehais MD. A Suicide Attempt Multicomponent Intervention Treatment (SAMIT Program): study protocol for a multicentric randomised controlled trial. BMC Psychiatry. 2024 Oct 8;24(1):666. doi: 10.1186/s12888-024-06113-3.

  PMID: 39379877 DERIVED

MeSH Terms

Conditions

Suicide, Attempted; Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Maria Dolores Braquehais

  VHIR

  PRINCIPAL INVESTIGATOR

• Pol Bruguera

  Hospital Clínic-IDIBAPS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Beneria Gonzàlez

CONTACT

+34932746087; anna.beneria@vallhebron.cat

Anna Motger-Albertí

CONTACT

+34932746087; anna.motger.ext@vhir.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: February 2, 2024
• Study Start: December 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: April 27, 2026
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

ES (1)