Suicide, AttemptedSAMITNCT06238414
Attempted Suicide Intervention Treatment and Prevention (SAMIT Program)
A study testing Early psychotherapeutic intervention in people with Suicide, Attempted and Suicide Prevention, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Suicide, Attempted, Suicide Prevention
- What is being tested?
- Early psychotherapeutic intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attempted Suicide Intervention Treatment and Prevention: a Randomised Controlled Trial
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.
Read the 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), 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; gender; 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.
An interim analysis was conducted after approximately 44 participants had completed pre-post treatment. This analysis was not pre-specified in the original trial registration. It was undertaken to support presentation at a scientific conference in Boston (2025-International summit on suicide research) and to assess whether study procedures and the novel intervention were proceeding as expected, including a general review of safety and data quality.
No formal efficacy testing was performed. The interim analyses did not lead to modifications in study design, endpoints, sample size, or conduct.
- Conditions
- Suicide, Attempted, Suicide Prevention
- Being tested
- Early psychotherapeutic intervention
- Keywords
- Medically serious suicide attempts (MSSA), Psychotherapy, Intervention, Randomized controlled trial
- Medical subject headings
- Suicide, Attempted, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early psychotherapeutic interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention/case participant | Experimental | The case group will receive an 8-session early psychological intervention Receives: Other: Early psychotherapeutic intervention |
| Control case/participant | No intervention | The control group will be treated as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of suicide attempts (recurrence)
The recurrence of the suicide attempt will be monitored by two mechanisms:
- During follow-up evaluations at 3, 6, and 12 months through a telephone call to the patient
- 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 year
Secondary outcomes (17)
Well-being: Intrapsychic functions, Interpersonal relationships, Instrumental role, Use of common objects and daily activities.
After psychotherapeutic intervention, the investigators expected to improve the well-being of the patients. We compared between pre- and post-treatment. This variable will be mesured through the Quality of life test (QoL) in the follow-up (3, 6, and 12 months).It consists of 21 items that are grouped into the following 4 categories or factors: Intrapsychic functions: cognition, cognition and affectivity (items 13-17, 20-21).Interpersonal relationships: interpersonal and social experience (items 1-8).Instrumental role: work, study, parental duties (items 9-11).Use of common objects and daily activities (items 18-19).Item 12 (satisfaction) does not score in any of the factors. Each item is scored according to a 7-value Likert scale, ranging from 0 (highest degree of dysfunction in that item) to 6 (normal). The time frame of reference is the previous 4 weeks.
The higher the score, the higher the quality of life in each dimension.
Measured: 1 year
Psychological Pain
After psychotherapeutic intervention, the investigators expected to improve the psychological pain of the patients. This variable will be compared between pre- and post-treatment through the Psychological Pain Scale (PS-E) and will also be assessed in the follow-up (3, 6, and 12 months).
The scale evaluates psychological pain as a subjective experience. It is composed of 13 items with a Likert-type response format (1-5) from lowest (1) to highest pain score (5).
The higher scores higher psychological pain.
Measured: 1 year
Anxiety and Depression
After psychotherapeutic intervention, the investigators expected to improve the anxiety and depression symptoms. This variable will be compared between pre- and post-treatment and also assessed through the Hospital Anxiety and Depression Scale (HADS) in the follow-up (3, 6, and 12 months).
Anxiety and Depression Scale (HADS) : consists in 14 items on a 4-point Likert scale (range 0-3) with three denoting highest anxiety or depression level. Its seven items for each subscale (anxiety and depression). The sum of the 14 items makes up the overall score.
Measured: 1 year
Impulsivity
After psychotherapeutic intervention, the investigators expected to decrease the impulsivity of the patients. This variable will be compared between pre- and post-treatment and also assessed through the Barrat Impulsiveness Scale (BIS-11) in the follow-up (3, 6, and 12 months).
BIS-11 is a widely used 30 question self-report measure of impulsiveness. It includes six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness). It is rated on a four-point Likert scale of 1 = Rarely/Never to 4 = Almost Always/Always. The total scores can range from 30 to 120. However, higher scores on the BIS-11 reflect higher levels of impulsiveness.
Measured: 1 year
Interleukin 6 (IL-6)
The change in a set of IL-6 (pg/mL) will be assessed from baseline to the end of the intervention at week 4.
Measured: 1 month
Suicide intentionality
In the baseline phase, before treatment, we assess the suicide intentonality through the Beck suicidal intentionality scale (SIS). The investigators will only administer the scale again in case of re-attempt during the follow-up.
SIS: is a semi-structured scale consisting of 20 items, which are rated on a 3-point scale (0 to 2 points). Scores can range from 0 to 38, with higher values indicating a greater risk of suicide.
Measured: 1 year
Reflective capacity
After psychotherapeutic intervention, the investigators expected to improve the reflective functioning of the patients. This variable will be compared between pre- and post-treatment and also assessed through the Reflective Functioning Questionnaire (RFQ-8) in the follow-up (3, 6, and 12 months).
RFQ-8 is a self-administered questionnaire that consists of 8 items. It provides responses for each item on a seven-point scale between "strongly disagree" and "strongly agree" response options. The higher the score, the worse the reflective capacity.
Measured: 1 year
Suicide ideation
After psychotherapeutic intervention,the investigators expected to decrease and/or eliminate the suicide ideation. This variable will be compared between pre- and post-treatment and during follow-up evaluations at 3, 6, and 12 months through the the Scale for Suicide Ideation (SSI).
SSI evaluates the presence and intensity of suicidal thoughts in a week before evaluation. It is composed of 19 items that are scored from 0 to 2, where 0 corresponds to moderate to strong, 1 to weak, and 2 to no suicide ideation.
Measured: 1 year
Hopelessness
After psychotherapeutic intervention, the investigators expected to improve the anxiety and depression symptoms. This variable will be compared between pre- and post-treatment and also assessed through the Beck Hopelessness Scale (BHS) tests in the follow-up (3, 6, and 12 months).
Beck Hopelessness Scale (BHS): is a 20-item with true-false test answers. Scores ranging from: 0 to 3 as are considered within the normal range, 4 to 8 identify mild hopelessness, scores from 9 to 14 identify moderate hopelessness, and scores greater than 14 identify severe hopelessness.
Measured: 1 year
C-reactive protein
The change in a set of C-reactive protein (mg/dL) will be assessed from baseline to the end of the intervention at week 4:
Measured: 1 month
White Blood Cells (x10E9/L)
The change in a set of White Blood Cell count (x10E9/L) will be assessed from baseline to the end of the intervention at week 4:
Measured: 1 month
Cholesterol (mg/dL)
The change in a set of Cholesterol, will be assessed from baseline to the end of the intervention at week 4.
Measured: 1 month
High-Density Lipoprotein (HDL) (mg/dL)
The change in a set of HDL (mg/dL) will be assessed from baseline to the end of the intervention at week 4.
Measured: 1 month
Low -Density Lipoprotein (LDL) (mg/dL)
The change in a set of LDL will be assessed from baseline to the end of the intervention at week 4.
Measured: 1 month
Tryglycerides (mg/dL)
The change in a set of tryglycerides will be assessed from baseline to the end of the intervention at week 4.
Measured: 1 month
Attachment
In the pre-treatment phase, the investigators will assess the attachment of the patient with the CAMI-R short version test in order to study the relationship between the type of attachment and suicide behaviour.
Short version of CaMir questionnaire (CaMir-R)(65)) is a self-questionnaire that measures attachment representations. It is based on the subject's evaluations of past and present attachment experiences and family functioning. It consists of 32 items to be answered by the participant on a 5-point Likert-type scale (1 = strongly disagree, 5 = strongly agree). The questionnaire consists of seven dimensions, five of which refer to attachment representations (security: availability and support of attachment figures; family preoccupation; parental interference; self-sufficiency and resentment against parents; and childhood trauma), and the remaining two refer to representations of family structure (value of parental authority and parental permissiveness).
Measured: 1 month
Cognition
Before starting the treatment, the patient will undergo the Montreal Cognitive Assessment (MOCA) to control for cognitive impairment. MOCA will be administered again in the post-treatment phase.
The MoCA Test, also known as the Montreal Cognitive Assessment, has been proven to be an extremely sensitive method for identifying moderate cognitive impairment (MCI) in its early stages. The MoCA exam is scored, with a maximum of thirty being possible. It takes ten to twelve minutes to finish. The MoCA test uses a total of 11 distinct exercises and tasks to assess seven domains (aspects) of cognitive function: attention and executive function, language domains, memory, abstraction, calculation, and orientation.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Dec 2023
- Primary completion19 Apr 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Sponsor
- Investigators
- Maria Dolores Braquehais, Principal investigator, VHIRPol Bruguera, Principal investigator, Hospital Clínic-IDIBAPS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238414
- Sponsor's protocol ID
- PR(AG)463/2022
- Acronym
- SAMIT
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39379877
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attempted Suicide Intervention Treatment and Prevention: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06238414
- Acronym / sponsor ID
- SAMIT / PR(AG)463/2022
- Conditions
- Suicide, Attempted, Suicide Prevention
- Keywords
- Medically serious suicide attempts (MSSA), Psychotherapy, Intervention, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 19 Apr 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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), 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; gender; 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.
An interim analysis was conducted after approximately 44 participants had completed pre-post treatment. This analysis was not pre-specified in the original trial registration. It was undertaken to support presentation at a scientific conference in Boston (2025-International summit on suicide research) and to assess whether study procedures and the novel intervention were proceeding as expected, including a general review of safety and data quality.
No formal efficacy testing was performed. The interim analyses did not lead to modifications in study design, endpoints, sample size, or conduct.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention/case participant | Experimental | Other: Early psychotherapeutic interventionThe case group will receive an 8-session early psychological intervention |
| Control case/participant | No intervention | –The control group will be treated as usual (TAU) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early psychotherapeutic interventionThe 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. | Other | Intervention/case participant |
Primary outcome
Number of suicide attempts (recurrence)
Time frame: 1 year
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.
Severity of suicide behaviour
Time frame: 1 year
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.
Suicide behaivour
Time frame: 1 year
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.
Lethality of suicide attempt
Time frame: 1 year
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
17 secondary outcomes
Well-being: Intrapsychic functions, Interpersonal relationships, Instrumental role, Use of common objects and daily activities.
Time frame: 1 year
Psychological Pain
Time frame: 1 year
Anxiety and Depression
Time frame: 1 year
Impulsivity
Time frame: 1 year
Interleukin 6 (IL-6)
Time frame: 1 month
Suicide intentionality
Time frame: 1 year
Reflective capacity
Time frame: 1 year
Suicide ideation
Time frame: 1 year
Hopelessness
Time frame: 1 year
C-reactive protein
Time frame: 1 month
White Blood Cells (x10E9/L)
Time frame: 1 month
Cholesterol (mg/dL)
Time frame: 1 month
High-Density Lipoprotein (HDL) (mg/dL)
Time frame: 1 month
Low -Density Lipoprotein (LDL) (mg/dL)
Time frame: 1 month
Tryglycerides (mg/dL)
Time frame: 1 month
Attachment
Time frame: 1 month
Cognition
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Derived from this study: PubMed 39379877Beneria 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Dolores Braquehais principal investigator
VHIR
Pol Bruguera principal investigator
Hospital Clínic-IDIBAPS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early psychotherapeutic intervention in people with Suicide, Attempted and Suicide Prevention, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of suicide attempts (recurrence) (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06238414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.