NCT07380451 Modular Intervention for Depression Study
| NCT ID | NCT07380451 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pontificia Universidad Catolica de Chile |
| Condition | Major Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-05-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this psychotherapy clinical trial is to evaluate whether a algorithm-based personalized modular psychotherapy is more effective than usual individual psychotherapy in treating major depressive disorder complicated by personality dysfunction and/or complex trauma in adults aged 18 to 65 receiving care in the Chilean public mental health system. The main questions it aims to answer are: * Does algorithm-based modular psychotherapy lead to greater clinically significant reduction and remission of depressive symptoms compared to usual psychotherapy? * Does algorithm-based modular psychotherapy lead to greater improvement in emotional regulation, interpersonal functioning, and self-related functioning, including changes observed in daily life? Researchers will compare algorithm-based modular psychotherapy to usual individual psychotherapy provided in public community mental health centers to see if the modular, personalized approach results in better clinical outcomes, stronger therapeutic alliance, and higher treatment satisfaction. Participants will: * Be randomly assigned to receive either algorithm-based modular psychotherapy or usual individual psychotherapy * Attend weekly individual psychotherapy sessions * Complete structured diagnostic interviews and self-report questionnaires before, during, and after treatment * Provide brief daily reports on mood, emotions, and interpersonal experiences using a smartphone before and after treatment
Eligibility Criteria
Inclusion Criteria: * Current diagnosis of major depressive disorder, defined as: * Positive diagnosis on the MINI diagnostic interview, and * PHQ-9 score greater than 10 * Evidence of personality dysfunction, defined as a score above the cutoff on the Level of Personality Functioning Scale-Brief Form (LPFS-BF 2.0). * History of moderate to severe early life adversity, defined as elevated scores on at least one scale of the Childhood Trauma Questionnaire (CTQ), and/or clinically significant alterations in self-organization. * Presence of at least one elevated domain of alteration of self-organization, including emotion regulation difficulties, interpersonal sensitivity, and/or interpersonal functioning problems, as assessed by standardized self-report measures (DERS, A-RSQ, OQ-45-IR). * Receiving care at a participating public community mental health center in Chile. * Ownership of a smartphone (Android or iOS) with internet access and an active data plan. * Ability to provide written informed consent. Exclusion Criteria: * Acute suicide risk requiring immediate intensive intervention, as assessed by the MINI. * Any severe psychiatric disorder other than major depressive disorder that is the primary clinical diagnosis, including: * Schizophrenia or other psychotic disorders * Bipolar I disorder * Severe substance use disorder, active within the past 6 months. * Diagnosis of post-traumatic stress disorder (PTSD) meeting full diagnostic criteria, as assessed by standardized instruments (ITEM and ITQ). * Meeting diagnostic criteria for: * Antisocial personality disorder (two or more criteria), or * Borderline personality disorder with more than three diagnostic criteria * Severe medical, cognitive, or psychosocial condition that would interfere with participation in weekly psychotherapy. * Concurrent participation in another active psychotherapy or initiation/change of psychotropic medication during the study period, except for: * Stable antidepressant treatment * Medications prescribed for sleep * Benzodiazepines used only on an as-needed (PRN) basis. * Inability to comply with study procedures or assessments.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07380451 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07380451 currently recruiting?
Yes, NCT07380451 is actively recruiting participants. Contact the research team at albehn@uc.cl for enrollment information.
Where is the NCT07380451 trial being conducted?
This trial is being conducted at Santiago, Chile, Santiago, Chile, Santiago, Chile, Santiago, Chile and 1 additional location.
Who is sponsoring the NCT07380451 clinical trial?
NCT07380451 is sponsored by Pontificia Universidad Catolica de Chile. The trial plans to enroll 150 participants.
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