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

N/ANot Yet RecruitingNCT07717320

Fundación Judío Panameña (JUPA)300 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Suicide Risk

Interventions

Mentalization-Based Therapy (MBT)BEHAVIORAL

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.

Treatment as Usual (TAU)BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (2)

Consultorio Inter Cambio

Panama City, Provincia de Panamá, Panama

Panama City Health Ministry Clinics

Panama City, Provincia de Panamá, Panama

Outcomes

Primary Outcomes

Suicidality

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.

Time frame: 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

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).

Anxiety symptoms

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).

Data from ClinicalTrials.gov

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