About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Mentalization-Based Therapy (MBT)
BehavioralThis 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)
BehavioralPatients 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.
Treatment groups
Trial 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.
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).
Reflective function
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.
Sponsors and contacts
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