Suicidal Risk in Adults in Panama: Validation of a Clinical Intervention Protocol
23 de julho de 2026 atualizado por: Vali Ruth Maduro Fernandez, Fundación Judío Panameña (JUPA)
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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
300
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Provincia de Panamá
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Panama City, Provincia de Panamá, Panamá
- Consultorio Inter Cambio
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Contato:
- Vali R Maduro Fernandez, Ph.D.
- Número de telefone: +507 6568-8144
- E-mail: valimaduro@gateno.net
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Investigador principal:
- Vali R Maduro Fernandez, Ph.D.
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Panama City, Provincia de Panamá, Panamá
- Panama City Health Ministry Clinics
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Contato:
- Roberto Gonzalez De La Lastra, M.D.
- Número de telefone: +507 6070-7573
- E-mail: regonzalez@minsa.gob.pa
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Investigador principal:
- Roberto Gonzalez De La Lastra, M.D.
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: MBT_Private
100 eligible applicants selected from a pool of responders to an open call who will be administered the MBT intervention by private practice mental health proffesionals.
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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 an inquisitive, rather than interpretive, stance on the part of the therapist to encourage the patient to develop their own understanding.
In the proposed study, a 12-session MBT protocol of 45-minute individual psychotherapy sessions will be used, with an intervention frequency of one session per week.
Outros nomes:
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Experimental: MBT_Public
100 eligible applicants selected from a pool of responders to an open call who will be administered the MBT intervention by public mental health proffesionals.
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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 an inquisitive, rather than interpretive, stance on the part of the therapist to encourage the patient to develop their own understanding.
In the proposed study, a 12-session MBT protocol of 45-minute individual psychotherapy sessions will be used, with an intervention frequency of one session per week.
Outros nomes:
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Comparador Ativo: TAU
100 eligible applicants selected from a pool of responders to an open call who will be administered treatment as usual (TAU) by public mental health proffesionals.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Suicidality
Prazo: 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.
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Suicidality will be measured using the Columbia-Suicide Severity Rating Scale (C-SSRS).
The C-SSRS is a standardized and validated semi-structured clinical interview designed to accurately assess the presence, severity, and frequency of suicidal ideation and behavior.
It evaluates four constructs: the severity of suicidal ideation, the intensity of suicidal ideation, the occurrence of suicidal behavior, and the lethality of suicidal behavior.
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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.
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Depressive symptomatology
Prazo: 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.
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Depressive symptomatology will be assessed using the Patient Health Questionnaire-9 (PHQ-9, Kroenke, Spitzer & Williams, 2001).
The PHQ-9 is a nine-item self-report questionnaire that assesses the presence and severity of depressive symptoms over the past two weeks, based on DSM diagnostic criteria.
For each item, the person indicates how frequently they experience the indicated condition using a four-point Likert scale (0 = "Not at all" to 3 = "Almost every day").
The total score (range: 0-27) categorizes severity as: minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).
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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.
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Anxiety symptoms
Prazo: 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.
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The Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) will be used.
The GAD-7 is a seven-item self-report questionnaire designed to assess the severity of generalized anxiety symptoms.
For each item, the person must indicate how frequently they experience the indicated condition using a four-point Likert scale (0 = "Not at all" to 3 = "Almost every day").
The total score (range: 0-21) categorizes the intensity of symptoms as minimal anxiety (0-4), mild (5-9), moderate (10-14), and severe (15-21).
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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.
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Reflective function
Prazo: 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.
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The investigators will assess reflective function using the Reflective Functioning Questionnaire (RFQ; Fonagy et al., 2016).
The investigators will use the eight-item abbreviated version (RFQ-8), which assesses an individual's ability to understand their own and others' behavior in terms of underlying mental states.
Each item is rated by the participant on a seven-point Likert scale (1 = "Strongly disagree" to 7 = "Strongly agree").
The result includes two subscales that measure the degree of uncertainty (RFQ_U) and the degree of certainty (RFQ_C) about mental states.
It also yields an overall score, where high values indicate uncertainty about mental states (hypomentalization) and low values indicate genuine mentalization.
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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.
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Protective factors against suicide
Prazo: 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.
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The investigators will assess factors that counteract suicidal vulnerability using the Reasons for Living Inventory (RFLI; Linehan et al., 1983).
The RFLI is a self-report questionnaire consisting of 48 items that assess the importance of various reasons a person may have for choosing to remain alive.
The items are organized into six subscales, including beliefs about coping; Concerns related to family responsibilities; concerns related to children; fear of suicide; fear of social disapproval and moral objections.
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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.
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Impulsive behavior
Prazo: 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.
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The investigators will assess impulsive behavior using the Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency Brief Impulsivity Scale (UPPS-P; (Cándido Ortiz et al., 2012)).
The UPPS-P is a self-report scale that assesses impulsivity as a multidimensional construct, including five dimensions: positive urgency, negative urgency, lack of premeditation, lack of perseverance, and sensation seeking.
The scale contains 20 items answered on a four-point Likert scale.
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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.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
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Publicações e links úteis
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Publicações Gerais
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de novembro de 2026
Conclusão Primária (Estimado)
1 de maio de 2028
Conclusão do estudo (Estimado)
1 de maio de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
12 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de julho de 2026
Primeira postagem (Real)
21 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- JUPA-2026
- U1111-1342-5972 (Outro identificador: World Health Organization (WHO))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
For confidentiality
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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