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

2026년 7월 23일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

300

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 파나마
    • Provincia de Panamá
      • Panama City, Provincia de Panamá, 파나마
        • Consultorio Inter Cambio
        • 연락하다:
        • 수석 연구원:
          • Vali R Maduro Fernandez, Ph.D.
      • Panama City, Provincia de Panamá, 파나마
        • Panama City Health Ministry Clinics
        • 연락하다:
        • 수석 연구원:
          • Roberto Gonzalez De La Lastra, M.D.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: Mentalization-Based Therapy (MBT)
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.
다른 이름들:
  • MBT
실험적: 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.
행동: Mentalization-Based Therapy (MBT)
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.
다른 이름들:
  • MBT
활성 비교기: 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.
행동: Treatment as Usual (TAU)
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Suicidality
기간: 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.
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
기간: 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 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
기간: 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.
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
기간: 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.
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
기간: 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.
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
기간: 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.
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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Fundación Judío Panameña (JUPA)

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 1일

기본 완료 (추정된)

2028년 5월 1일

연구 완료 (추정된)

2028년 5월 1일

연구 등록 날짜

최초 제출

2026년 7월 12일

QC 기준을 충족하는 최초 제출

2026년 7월 16일

처음 게시됨 (실제)

2026년 7월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 23일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • JUPA-2026
  • U1111-1342-5972 (기타 식별자: World Health Organization (WHO))

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

For confidentiality

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다