Suicidal Risk in Adults in Panama: Validation of a Clinical Intervention Protocol
23. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
300
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Provincia de Panamá
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Panama City, Provincia de Panamá, Panama
- Consultorio Inter Cambio
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Ta kontakt med:
- Vali R Maduro Fernandez, Ph.D.
- Telefonnummer: +507 6568-8144
- E-post: valimaduro@gateno.net
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Hovedetterforsker:
- Vali R Maduro Fernandez, Ph.D.
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Panama City, Provincia de Panamá, Panama
- Panama City Health Ministry Clinics
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Ta kontakt med:
- Roberto Gonzalez De La Lastra, M.D.
- Telefonnummer: +507 6070-7573
- E-post: regonzalez@minsa.gob.pa
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Hovedetterforsker:
- Roberto Gonzalez De La Lastra, M.D.
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
Andre navn:
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Eksperimentell: 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.
|
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.
Andre navn:
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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Suicidality
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. november 2026
Primær fullføring (Antatt)
1. mai 2028
Studiet fullført (Antatt)
1. mai 2028
Datoer for studieregistrering
Først innsendt
12. juli 2026
Først innsendt som oppfylte QC-kriteriene
16. juli 2026
Først lagt ut (Faktiske)
21. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- JUPA-2026
- U1111-1342-5972 (Annen identifikator: World Health Organization (WHO))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
For confidentiality
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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