Suicidal Risk in Adults in Panama: Validation of a Clinical Intervention Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Suicidality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Mentalization-Based Therapy (MBT) (Behavioral)
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.
干预措施: Mentalization-Based Therapy (MBT) (Behavioral)
结局指标
主要结局
Suicidality
时间窗: Time Frame: We 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.
Depressive symptomatology
时间窗: Time Frame: We 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).
Anxiety symptoms
时间窗: Time Frame: We 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).
Reflective function
时间窗: Time Frame: We 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.
We will assess reflective function using the Reflective Functioning Questionnaire (RFQ; Fonagy et al., 2016). We 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.
Protective factors against suicide
时间窗: Time Frame: We 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.
We 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.
Impulsive behavior
时间窗: Time Frame: We 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.
We 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.
Suicidality
时间窗: 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.
Depressive symptomatology
时间窗: 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).
Anxiety symptoms
时间窗: 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).
Reflective function
时间窗: 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.
Protective factors against suicide
时间窗: 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.
Impulsive behavior
时间窗: 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.
次要结局
未报告次要终点
研究者
Vali Ruth Maduro Fernandez
Board Member
Fundación Judío Panameña (JUPA)