Suicidal Risk in Adults in Panama: Validation of a Clinical Intervention Protocol

Обзор

This study aims to validate MBT as an effective and viable intervention for implementation in public health services, with the potential to directly impact suicide prevention policies in the region.

Подробное описание

Suicide is a critical public health problem that requires effective, evidence-based interventions. The investigators propose a pragmatic, multicenter, longitudinal, non-randomized clinical trial to compare the effectiveness of Mentalization-Based Treatment (MBT) versus Treatment Usual (TAU) in reducing suicidality in adults. Three hundred participants (18-60 years old) with suicidal ideation or active suicidal behavior will be recruited and assigned to one of three groups: (a) MBT in a private setting, (b) MBT in a public setting, or (c) TAU in a public setting. All participants will receive 12 psychotherapy sessions, one per week.

The primary outcome variable will be suicidality. Secondary outcome variables include depressive (PHQ-9) and anxious (GAD-7) symptoms, reflective function (RFQ), protective factors (RFL), and impulsivity (UPPS-P). Measurements will be taken at baseline (T0), session 6 (T1), final session (T2), and at 3 months of follow-up (T3). Psychotherapy process variables will also be assessed in all sessions: therapeutic alliance (SAI), psychological distress (CORE-10), affective regulation (DERS-8), and sense of belonging and burden (INQ).

The analysis, guided by the intention-to-treat principle, will employ Bayesian regression models to evaluate the superiority of MBT over TAU and the non-inferiority of public MBT compared to private MBT. Trajectories of change will be explored using Hidden Markov Models to model the process variables.

Вмешательства

• Поведенческое Mentalization-Based Therapy (MBT)
  This is evidence-based psychotherapy that helps people improve their ability to mentalize: understanding their own and others' mental states, including thoughts, feelings, beliefs, and intentions, and connecting them to behavior. MBT aims to improve self-reflection, emotional regulation, and the establishment of more stable and satisfying relationships, especially in people with borderline personality disorder (BPD) or complex trauma. The treatment consists of individual therapy and prioritizes
• Поведенческое Treatment as Usual (TAU)
  Patients referred to participating Health Centers will receive Usual Treatment. The investigators will adjust this treatment to match the dosage and frequency of administration to that of MBT. The treatment will consist of 12 weekly sessions of 50 minutes each.

Первичные конечные точки

• Suicidality [Срок оценки: Time Frame: The investigators will administer outcome measures on day one (baseline), at week 6 (midpoint), at week 12 (end of treatment), and in a follow-up interview three months after the end of treatment.]
• Depressive symptomatology [Срок оценки: Time Frame: The investigators will administer outcome measures on day one (baseline), at week 6 (midpoint), at week 12 (end of treatment), and in a follow-up interview three months after the end of treatment.]
• Anxiety symptoms [Срок оценки: Time Frame: The investigators will administer outcome measures on day one (baseline), at week 6 (midpoint), at week 12 (end of treatment), and in a follow-up interview three months after the end of treatment.]
• Reflective function [Срок оценки: Time Frame: The investigators will administer outcome measures on day one (baseline), at week 6 (midpoint), at week 12 (end of treatment), and in a follow-up interview three months after the end of treatment.]
• Protective factors against suicide [Срок оценки: Time Frame: The investigators will administer outcome measures on day one (baseline), at week 6 (midpoint), at week 12 (end of treatment), and in a follow-up interview three months after the end of treatment.]
• Impulsive behavior [Срок оценки: Time Frame: The investigators will administer outcome measures on day one (baseline), at week 6 (midpoint), at week 12 (end of treatment), and in a follow-up interview three months after the end of treatment.]

Критерии участия

Критерии включения

• Age and consent
• Presence of suicidal ideation or active behavior in the last month, assessed using the C-SSRS (e.g., intentional ideation, plan, or preparatory behavior)
• Depressive or anxious symptoms (Score ≥ 10 on the PHQ-9, indicating at least moderate depressive symptoms, or Score ≥ 10 on the GAD-7, suggesting clinically significant anxiety.)
• Availability and commitment to participate in the full assessment using all the aforementioned scales.

Критерии исключения

• Clinical Safety (exclude and refer immediately)
• Imminent suicide risk according to the C-SSRS (e.g., attempt within the last 7 days, current intentional plan, access to lethal means, and low ambivalence).
• PHQ-9 item 9 = 3 ("almost every day") with clinical corroboration of imminent risk.
• Current self-harm with lethality/high-harm moderator requiring acute restraint.
• Refusal to establish a safety plan or allow emergency contact.
• Acute Psychiatric Conditions/Contraindications of Assessment
• Active psychosis or unstabilized manic episode.
• Substance use disorder in intoxication or acute withdrawal (e.g., last 24-72 hours) that precludes valid assessment.
• Uncontrolled risk of severe other-directed violence.
• Medical or neurological conditions that preclude valid participation
• Severe cognitive impairment (e.g., dementia, recent moderate-to-severe traumatic brain injury) that prevents understanding/answering scales.
• Decompensated medical illness (e.g., desaturation, delirium, severe uncontrolled pain).
• Unstable neurological condition (e.g., uncontrolled seizures).
• Methodological interferences
• Recent changes in baseline psychotropic medications within the last 2 weeks.
• Concurrent intensive psychotherapy initiated within the last 4 weeks.
• Simultaneous participation in another trial that could contaminate results.
• Language other than that of the scales without available validation.
• Logistical impossibility for follow-up (no telephone/stable contact; imminent relocation plan).
• Legal aspects/consent
• Incapacity to consent (legal or clinical) and no available representative.
• Legal restrictions that prevent participation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Panama · 2 центра

• Consultorio Inter Cambio — Panama City
• Panama City Health Ministry Clinics — Panama City

Публикации

• Ordóñez-Carrasco, J. L., et al. (2018). Propiedades psicométricas de la versión en español del Cuestionario de Necesidades Interpersonales en pacientes... Anales de Psicología, 34(2), 245-251.
• Silva C, Hurtado G, Hartley C, Rangel JN, Hovey JD, Pettit JW, Chorot P, Valiente RM, Sandin B, Joiner TE. Spanish translation and validation of the Interpersonal Needs Questionnaire. Psychol Assess. 2018 Oct;30(10):e21-e37. doi: 10.1037/pas0000643. PMID 30284876
• Van Orden KA, Cukrowicz KC, Witte TK, Joiner TE. Thwarted belongingness and perceived burdensomeness: construct validity and psychometric properties of the Interpersonal Needs Questionnaire. Psychol Assess. 2012 Mar;24(1):197-215. doi: 10.1037/a0025358. Epub 2011 Sep 19. PMID 21928908
• Delaigue Baechler, S. (2017). Translation of the Working Alliance Inventory Short Revised (WAI-SR) from English into Spanish, using a forward backward translation and a Delphi consensus method. Life Sciences [q-bio]. ⟨dumas-01616390)
• Falkenstrom F, Hatcher RL, Skjulsvik T, Larsson MH, Holmqvist R. Development and validation of a 6-item working alliance questionnaire for repeated administrations during psychotherapy. Psychol Assess. 2015 Mar;27(1):169-83. doi: 10.1037/pas0000038. Epub 2014 Oct 27. PMID 25346997
• Bordin, E. S. (1979). The generalizability of the psychoanalytic concept of the working alliance. Psychotherapy: Theory, Research & Practice, 16(3), 252-260.
• Whiteside, S. P., & Lynam, D. R. (2001). The Five Factor Model and impulsivity: Using a structural model of personality to understand impulsivity. Personality and Individual Differences, 30(4), 669-689. https://doi.org/10.1016/S0191-8869(00)00064-7
• Verdejo-Garcia A, Lozano O, Moya M, Alcazar MA, Perez-Garcia M. Psychometric properties of a Spanish version of the UPPS-P impulsive behavior scale: reliability, validity and association with trait and cognitive impulsivity. J Pers Assess. 2010 Jan;92(1):70-7. doi: 10.1080/00223890903382369. PMID 20013458

Идентификаторы

NCT: NCT07717320 · JUPA-2026 · U1111-1342-5972

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗