Suicide RiskNCT07717320
Suicidal Risk in Adults in Panama: Validation of a Clinical Intervention Protocol
A study testing Mentalization-Based Therapy (MBT) and Treatment as Usual (TAU) in people with Suicide Risk, run by Fundación Judío Panameña (JUPA) at 2 sites in Panama.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Suicide Risk
- What is being tested?
- Mentalization-Based Therapy (MBT) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesPanama
- Study dates
- 1 Nov 2026to 1 May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Panama2 sites
Consultorio Inter Cambio
Panama City, Provincia de Panamá
Vali R Maduro Fernandez, Ph.D., +507 6568-8144, valimaduro@gateno.net
Vali R Maduro Fernandez, Ph.D.
Panama City Health Ministry Clinics
Panama City, Provincia de Panamá
Roberto Gonzalez De La Lastra, M.D., +507 6070-7573, regonzalez@minsa.gob.pa
Roberto Gonzalez De La Lastra, M.D.
About this study
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.
Read the detailed description
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.
- Conditions
- Suicide Risk
- Being tested
- Mentalization-Based Therapy (MBT), Treatment as Usual (TAU)
- Keywords
- Psychotherapy, Clinical Trial, Reflective Function, Public Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalization-Based Therapy (MBT)Behavioural
Also called 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.
Treatment as Usual (TAU)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Suicide RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Judío Panameña (JUPA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vali Ruth Maduro Fernandez, Fundación Judío Panameña (JUPA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717320
- Sponsor's protocol ID
- JUPA-2026
- Other IDs
- U1111-1342-5972
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For confidentiality
Publications
Ordóñez-Carrasco, J. L., et al. (2018). Propiedades psicométricas de la versión en español del Cuestionario de Necesidades Interpersonales en pacientes... Anales de Psicología, 34(2), 245-251.
Silva C, Hurtado G, Hartley C, Rangel JN, Hovey JD, Pettit JW, Chorot P, Valiente RM, Sandin B, Joiner TE. Spanish translation and validation of the Interpersonal Needs Questionnaire. Psychol Assess. 2018 Oct;30(10):e21-e37. doi: 10.1037/pas0000643.
PubMed 30284876Van Orden KA, Cukrowicz KC, Witte TK, Joiner TE. Thwarted belongingness and perceived burdensomeness: construct validity and psychometric properties of the Interpersonal Needs Questionnaire. Psychol Assess. 2012 Mar;24(1):197-215. doi: 10.1037/a0025358. Epub 2011 Sep 19.
PubMed 21928908Delaigue Baechler, S. (2017). Translation of the Working Alliance Inventory Short Revised (WAI-SR) from English into Spanish, using a forward backward translation and a Delphi consensus method. Life Sciences [q-bio]. ⟨dumas-01616390)
Falkenstrom F, Hatcher RL, Skjulsvik T, Larsson MH, Holmqvist R. Development and validation of a 6-item working alliance questionnaire for repeated administrations during psychotherapy. Psychol Assess. 2015 Mar;27(1):169-83. doi: 10.1037/pas0000038. Epub 2014 Oct 27.
PubMed 25346997Bordin, E. S. (1979). The generalizability of the psychoanalytic concept of the working alliance. Psychotherapy: Theory, Research & Practice, 16(3), 252-260.
Whiteside, S. P., & Lynam, D. R. (2001). The Five Factor Model and impulsivity: Using a structural model of personality to understand impulsivity. Personality and Individual Differences, 30(4), 669-689. https://doi.org/10.1016/S0191-8869(00)00064-7
Verdejo-Garcia A, Lozano O, Moya M, Alcazar MA, Perez-Garcia M. Psychometric properties of a Spanish version of the UPPS-P impulsive behavior scale: reliability, validity and association with trait and cognitive impulsivity. J Pers Assess. 2010 Jan;92(1):70-7. doi: 10.1080/00223890903382369.
PubMed 20013458NovoPsych. (n.d.). Short UPPS-P Impulsive Behavior Scale (S-UPPS-P). Retrieved from https://novopsych.com.au/assessments/formulation/short-upps-p-impulsive-behaviour-scale-s-upps-p/ (This is the psychological assessment platform mentioned in your text that hosts the test for clinical use.)
Cyders MA, Smith GT, Spillane NS, Fischer S, Annus AM, Peterson C. Integration of impulsivity and positive mood to predict risky behavior: development and validation of a measure of positive urgency. Psychol Assess. 2007 Mar;19(1):107-18. doi: 10.1037/1040-3590.19.1.107.
PubMed 17371126Cyders MA, Littlefield AK, Coffey S, Karyadi KA. Examination of a short English version of the UPPS-P Impulsive Behavior Scale. Addict Behav. 2014 Sep;39(9):1372-6. doi: 10.1016/j.addbeh.2014.02.013. Epub 2014 Mar 3.
PubMed 24636739Linehan MM, Goodstein JL, Nielsen SL, Chiles JA. Reasons for staying alive when you are thinking of killing yourself: the reasons for living inventory. J Consult Clin Psychol. 1983 Apr;51(2):276-86. doi: 10.1037//0022-006x.51.2.276. No abstract available.
PubMed 6841772García, J., Palacio, C. A., Vargas, G., & García, H. I. (2009). Validation of the Reasons to Live Inventory (RFL) in subjects with suicidal behavior in Colombia. Colombian Journal of Psychiatry, 38(1), 66-84. http://www.scielo.org.co/scielo.php?script=sci_arttext&pid=S0034-74502009000100006
Echávarri, O., Morales, S., Taylor, T., Barros, J., Maino, M., et al. (2018). Validation of the Reasons to Live Scale in mental health patients in the Metropolitan Region of Chile. Psychological Therapy, 36(2), 101-112. https://doi.org/10.4067/s0718-48082018000200101
Dube P, Kurt K, Bair MJ, Theobald D, Williams LS. The p4 screener: evaluation of a brief measure for assessing potential suicide risk in 2 randomized effectiveness trials of primary care and oncology patients. Prim Care Companion J Clin Psychiatry. 2010;12(6):PCC.10m00978. doi: 10.4088/PCC.10m00978blu.
PubMed 21494337