NCT07655986

Brief Summary

Background: Suicidal behavior represents a major public health problem worldwide. According to the World Health Organization (WHO), approximately 720.000 people die by suicide annually, and many more attempt it. Suicide is a personal tragedy associated with extreme suffering that has a serious impact on the deceased's immediate circle and on society as a whole. In this context, there is an urgent need to design effective and humane intervention strategies that offer an evidence-based, preventive, specialized, and community-oriented response to suicidal behavior. Objective: To evaluate the impact of a multidisciplinary, specialized, and high-resolution program for the prevention of suicidal behavior in adults aged 18 and over in the Salamanca Health Area. Methods: A quasi-experimental, ambispective cohort study with two parallel groups: an intervention group, receiving the specific suicide prevention program (SPP) with a pre-test/post-test design, and a control group, receiving usual care (TC). Adult patients (≥ 18 years) will be referred from the Emergency Department of the University Hospital of Salamanca after an initial psychiatric evaluation. Patients will be assigned to the intervention group according to established inclusion criteria. The program lasts 3 months, during which each participant will receive intensive and individualized follow-up from a multidisciplinary team composed of two psychiatrists, two mental health nurses, two psychologists, and two social workers at two community mental health centers. Participants will also attend 10 weekly group therapy sessions. Follow-up evaluations will be conducted at the end of the program (three months) and six months after the first contact. Discussion: This study will contribute to the scientific evidence base on the effectiveness of intensive and specific suicide prevention programs in the community setting, optimizing healthcare resources, improving treatment adherence, and aligning with the Spanish National Suicide Prevention Plan 2025-2027. Ethics and dissemination: This study has been approved by the Clinical Research Ethics Committee of the Salamanca Health Area (CEIm code: PI 2025 11 2102 - TD) Keywords: Suicidal behavior; Suicide prevention; Suicidal ideation; Community mental health services; Quasi-experimental study; Cohort study; Psychiatric emergency services; Patient care team.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
May 2025May 2027

Study Start

First participant enrolled

May 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

May 15, 2026

Last Update Submit

June 15, 2026

Conditions

Keywords

Suicidal behaviorSuicide preventionSuicidal ideationCommunity mental health servicesQuasi-experimental studyCohort studyPsychiatric emergency servicesPatient care team

Outcome Measures

Primary Outcomes (1)

  • Recurrence of Clinically Significant Suicidal Behavior

    Proportion of participants experiencing at least one clinically significant suicidal event during follow-up, defined as: (1) a new suicide attempt documented in the emergency department or clinical records; (2) urgent psychiatric hospitalization in a Short-Stay Inpatient Unit (UHB) due to suicidal behavior; or (3) completed suicide. Assessment Tool: Prospective registry via electronic clinical records (SACYL). For suicide attempts: emergency department records. For hospitalizations: inpatient admission records. For completed suicide: civil registry and/or clinical team notification. Scale: Dichotomous outcome (presence/absence of recurrence) and discrete quantitative variable (number of events: 0, 1, 2, 3...).

    3 months (end of program) and 12 months from first contact.

Secondary Outcomes (16)

  • Type of Suicidal Behavior

    Baseline.

  • Suicidal Ideation Severity.

    Baseline, 3 months, 12 months.

  • Emergency Department Visits due to Suicidal Ideation

    3 months, 12 months.

  • Global Clinical Impression of Suicidal Risk - Severity (CGI-SS-S)

    Baseline, 3 months, 12 months.

  • Global Clinical Impression of Suicidal Risk - Improvement (CGI-SS-I)

    3 months, 12 months.

  • +11 more secondary outcomes

Study Arms (2)

Intervention group (PPS)

EXPERIMENTAL

Intervention group with application of the high-resolution program for the prevention of suicidal behavior in adults at risk.

Behavioral: PPS; SUICIDE PREVENTION PROGRAM

Control group (TH)

NO INTERVENTION

Control group with application of usual treatment in patients with suicidal behaviors

Interventions

The Suicide Prevention Program (PPS) is a high-resolution, outpatient program delivered by a multidisciplinary team consisting of two mental health nurses, two psychiatrists, two psychologists, and two social workers. It operates in two community mental health centers in Salamanca, belonging to the Specialized Care Management, over a three-month period. The first contact with the patient will be made by telephone within 24 hours of referral by a mental health nurse. The first in-person appointment will take place in a nursing consultation within 72 hours. The patient will have a maximum of 72 psychiatric appointments, a maximum of seven days for the first appointment with a psychologist, and a maximum of 14 days for the first appointment with a social worker. The program also includes 10 group sessions, in-person and telephone follow-up, and crisis intervention.

Intervention group (PPS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 18 years of age.
  • No prior active follow-up by the mental health team.
  • Prior stabilization by the emergency psychiatry team.
  • Columbia Severity Rating Scale (C-SSRS) score corresponding to moderate-to-high risk.
  • Absence of criteria for urgent hospital admission.
  • Signed informed consent.
  • Exclusión Criteria:
  • Self-harm without suicidal intent.
  • Mild suicide risk (mild C-SSRS).
  • Extremely high suicide risk requiring urgent hospital admission.
  • Patient under active follow-up at another mental health unit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Salamanca

Salamanca, Salamanca, 37185, Spain

RECRUITING

Related Publications (14)

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    PMID: 17175981BACKGROUND
  • Kondziella D, Hammer J, Sletvold O, Sonnewald U. The pentylenetetrazole-kindling model of epilepsy in SAMP8 mice: glial-neuronal metabolic interactions. Neurochem Int. 2003 Dec;43(7):629-37. doi: 10.1016/s0197-0186(03)00093-7.

    PMID: 12892650BACKGROUND
  • O'Neill LP, Turner BM. Immunoprecipitation of native chromatin: NChIP. Methods. 2003 Sep;31(1):76-82. doi: 10.1016/s1046-2023(03)00090-2.

    PMID: 12893176BACKGROUND
  • Linehan MM, Goodstein JL, Nielsen SL, Chiles JA. Reasons for staying alive when you are thinking of killing yourself: the reasons for living inventory. J Consult Clin Psychol. 1983 Apr;51(2):276-86. doi: 10.1037//0022-006x.51.2.276. No abstract available.

    PMID: 6841772BACKGROUND
  • Stanley B, Brown GK, Brenner LA, Galfalvy HC, Currier GW, Knox KL, Chaudhury SR, Bush AL, Green KL. Comparison of the Safety Planning Intervention With Follow-up vs Usual Care of Suicidal Patients Treated in the Emergency Department. JAMA Psychiatry. 2018 Sep 1;75(9):894-900. doi: 10.1001/jamapsychiatry.2018.1776.

    PMID: 29998307BACKGROUND
  • Bostwick JM, Pabbati C, Geske JR, McKean AJ. Suicide Attempt as a Risk Factor for Completed Suicide: Even More Lethal Than We Knew. Am J Psychiatry. 2016 Nov 1;173(11):1094-1100. doi: 10.1176/appi.ajp.2016.15070854. Epub 2016 Aug 13.

    PMID: 27523496BACKGROUND
  • Herrero MJ, Blanch J, Peri JM, De Pablo J, Pintor L, Bulbena A. A validation study of the hospital anxiety and depression scale (HADS) in a Spanish population. Gen Hosp Psychiatry. 2003 Jul-Aug;25(4):277-83. doi: 10.1016/s0163-8343(03)00043-4.

    PMID: 12850660BACKGROUND
  • Goni-Sarries A, Yarnoz-Goni N, Lopez-Goni JJ. Psychiatric Hospitalization for Attempted Suicide and Reattempt at the One-Year Follow-Up. Psicothema. 2022 Aug;34(3):375-382. doi: 10.7334/psicothema2021.455.

    PMID: 35860999BACKGROUND
  • Des Jarlais DC, Lyles C, Crepaz N; TREND Group. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health. 2004 Mar;94(3):361-6. doi: 10.2105/ajph.94.3.361.

    PMID: 14998794BACKGROUND
  • Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.

    PMID: 22193671BACKGROUND
  • Stanley B, Brodsky B, Monahan M. Brief and Ultra-Brief Suicide-Specific Interventions. Focus (Am Psychiatr Publ). 2023 Apr;21(2):129-136. doi: 10.1176/appi.focus.20220083. Epub 2023 Apr 14.

    PMID: 37201146BACKGROUND
  • Fakhari A, Azizi H, Farahbakhsh M, Esmaeili ED. Effective Programs on Suicide Prevention: Combination of Review of Systematic Reviews with Expert Opinions. Int J Prev Med. 2022 Mar 12;13:39. doi: 10.4103/ijpvm.IJPVM_454_20. eCollection 2022.

    PMID: 35529514BACKGROUND
  • Zalsman G, Hawton K, Wasserman D, van Heeringen K, Arensman E, Sarchiapone M, Carli V, Hoschl C, Barzilay R, Balazs J, Purebl G, Kahn JP, Saiz PA, Lipsicas CB, Bobes J, Cozman D, Hegerl U, Zohar J. Suicide prevention strategies revisited: 10-year systematic review. Lancet Psychiatry. 2016 Jul;3(7):646-59. doi: 10.1016/S2215-0366(16)30030-X. Epub 2016 Jun 8.

    PMID: 27289303BACKGROUND
  • Pompili M, De Berardis D, Dell'osso B, Forte A, Innamorati M, Rogante E, Sarli G, Serafini G, Amore M. Suicide and suicidal behaviors: insight into clinical challenges and preventive measures. Expert Rev Neurother. 2025 Sep;25(9):1011-1026. doi: 10.1080/14737175.2025.2542764. Epub 2025 Aug 17.

    PMID: 40754653BACKGROUND

MeSH Terms

Conditions

Suicide PreventionSuicidal Ideation

Interventions

Pentosan Sulfuric Polyester

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sulfuric AcidsSulfur AcidsSulfur CompoundsOrganic ChemicalsPolysaccharidesCarbohydrates

Central Study Contacts

Lourdes Ollero Malagón, Mental health nurse specialist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor doctor, University of Salamanca

Study Record Dates

First Submitted

May 15, 2026

First Posted

June 18, 2026

Study Start

May 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be publicly shared to protect patient confidentiality. Only aggregated and anonymized results will be disseminated through scientific publications or presentations.

Locations