Attempted Suicide Intervention Treatment and Prevention (SAMIT Program)
Spain120 participantsStarted 2023-12-01
Plain-language 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of suicide attempts (recurrence)
Timeframe: 1 year
2
Severity of suicide behaviour
Timeframe: 1 year
3
Suicide behaivour
Timeframe: 1 year
4
Lethality of suicide attempt
Timeframe: 1 year
Trial details
NCT IDNCT06238414
SponsorHospital Universitari Vall d'Hebron Research Institute