Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07380451

Modular Intervention for Depression Study

Led by Pontificia Universidad Catolica de Chile · Updated on 2026-05-12

150

Participants Needed

5

Research Sites

95 weeks

Total Duration

On this page

Sponsors

P

Pontificia Universidad Catolica de Chile

Lead Sponsor

M

MIDAP Millennium Institute for Research in Depression and Personality

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Modular Intervention for Depression Study

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Current diagnosis of major depressive disorder confirmed by MINI interview and PHQ-9 score over 10
  • Evidence of personality dysfunction with elevated Level of Personality Functioning Scale-Brief Form score
  • History of moderate to severe early life adversity or clinically significant self-organization alterations
  • At least one elevated difficulty in emotion regulation, interpersonal sensitivity, or interpersonal functioning
  • Receiving care at a participating public community mental health center in Chile
  • Ownership of a smartphone with internet access and active data plan
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Acute suicide risk requiring immediate intensive intervention
  • Severe psychiatric disorders other than major depressive disorder, including schizophrenia, other psychotic disorders, or Bipolar I disorder
  • Severe substance use disorder active within past 6 months
  • Diagnosis of PTSD meeting full criteria
  • Meeting criteria for antisocial personality disorder (two or more criteria) or borderline personality disorder with more than three criteria
  • Severe medical, cognitive, or psychosocial conditions interfering with weekly psychotherapy
  • Concurrent participation in other active psychotherapy or changes in psychotropic medication during study except stable antidepressants, sleep medications, or as-needed benzodiazepines
  • Inability to comply with study procedures or assessments

AI-Screening

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Trial Site Locations

Total: 5 locations

1

CDT CASR

Santiago, Chile

Actively Recruiting

2

COSAM La Bandera

Santiago, Chile

Active, Not Recruiting

3

COSAM La Granja

Santiago, Chile

Actively Recruiting

4

COSAM La Pintana

Santiago, Chile

Actively Recruiting

5

COSAM Rinconada

Santiago, Chile

Actively Recruiting

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Research Team

A

Alex J Behn, PhD

CONTACT

J

Jorge Matamala, Bachelor of Psychology

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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