NCT07717320

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Nov 2026

Geographic Reach
1 country

2 active sites

Status
not yet 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

First Submitted

Initial submission to the registry

July 12, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

July 12, 2026

Last Update Submit

July 23, 2026

Conditions

Suicide Risk

Keywords

PsychotherapyClinical TrialReflective FunctionPublic Health

Outcome Measures

Primary Outcomes (6)

  • 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: 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).

    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

    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).

    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

    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.

    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

    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.

    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

    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.

    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.

Study Arms (3)

MBT_Private

EXPERIMENTAL

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.

Behavioral: Mentalization-Based Therapy (MBT)

MBT_Public

EXPERIMENTAL

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.

Behavioral: Mentalization-Based Therapy (MBT)

TAU

ACTIVE COMPARATOR

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.

Behavioral: Treatment as Usual (TAU)

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.

Also known as: MBT
MBT_PrivateMBT_Public
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.

TAU

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Consultorio Inter Cambio

Panama City, Provincia de Panamá, Panama

Location

Panama City Health Ministry Clinics

Panama City, Provincia de Panamá, Panama

Location

Related Publications (56)

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MeSH Terms

Interventions

Mentalization-Based TherapyTherapeutics

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study aims to determine whether Mentalization-Based Treatment (MBT) is statistically superior to treatments in reducing suicidality in adults at risk of suicide. The investigators will evaluate effectiveness variables at four time points: before treatment (initial interview), midway through treatment (session 6), at the end of treatment (session 12), and at a follow-up (three months after the end of treatment). The study will be conducted in three groups of independent clinical centers. The first group (MBT\_Private) will consist of psychologists trained in MBT by Rompamos el Silencio, who will administer MBT to participants referred to these centers. The second group (MBT\_Public) of centers will consist of health centers affiliated with the Ministry of Health where MBT will be administered. The third group (TAU) of centers will consist of health centers affiliated with the Ministry of Health where TAU will be administered, who will receive TAU.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Board Member

Study Record Dates

First Submitted

July 12, 2026

First Posted

July 21, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

July 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

For confidentiality

Locations

PA(2)