Suicidal Risk in Adults in Panama: Validation of a Clinical Intervention Protocol
23 июля 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
300
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Provincia de Panamá
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Panama City, Provincia de Panamá, Панама
- Consultorio Inter Cambio
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Контакт:
- Vali R Maduro Fernandez, Ph.D.
- Номер телефона: +507 6568-8144
- Электронная почта: valimaduro@gateno.net
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Главный следователь:
- Vali R Maduro Fernandez, Ph.D.
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Panama City, Provincia de Panamá, Панама
- Panama City Health Ministry Clinics
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Контакт:
- Roberto Gonzalez De La Lastra, M.D.
- Номер телефона: +507 6070-7573
- Электронная почта: regonzalez@minsa.gob.pa
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Главный следователь:
- Roberto Gonzalez De La Lastra, M.D.
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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.
Другие имена:
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Экспериментальный: 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.
Другие имена:
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Активный компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Suicidality
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
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- Barkham, M., Bewick, B., Mullin, T., Gilbody, S., Connell, J., Cahill, J., Mellor-Clark, J., Richards, D., Unsworth, G. & Evans, C. (2012). The CORE-10: A short measure of psychological distress for routine use in the psychological therapies. Counselling and Psychotherapy Research, 1-11. http://doi.org/10.1080/14733145.2012.729069.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 ноября 2026 г.
Первичное завершение (Оцененный)
1 мая 2028 г.
Завершение исследования (Оцененный)
1 мая 2028 г.
Даты регистрации исследования
Первый отправленный
12 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
16 июля 2026 г.
Первый опубликованный (Действительный)
21 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
27 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
23 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- JUPA-2026
- U1111-1342-5972 (Другой идентификатор: World Health Organization (WHO))
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
For confidentiality
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .