Modular Intervention for Depression Study

ConditionMajor Depression

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorPontificia Universidad Catolica de Chile

About this trial

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

Qualifiers

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.

Disqualifiers

Acute suicide risk requiring immediate intensive intervention, as assessed by the MINI.

Schizophrenia or other psychotic disorders

Bipolar I disorder

Severe substance use disorder, active within the past 6 months.

Trial design

Treatments tested in this trial

Modular Intervention for Depression Therapy (MIND Therapy)
Psychotherapy as Usual (TAU)

Treatment groups

150 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Pontificia Universidad Catolica de Chile

Lead sponsor

MIDAP Millennium Institute for Research in Depression and Personality

Collaborator

Source ClinicalTrials.gov