Modular Intervention for Depression Study
Recruiting · NCT07380451 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
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.
Where it is running
5 locations listed.
- CDT CASR - Santiago, Chile
- COSAM La Bandera - Santiago, Chile
- COSAM La Granja - Santiago, Chile
- COSAM La Pintana - Santiago, Chile
- COSAM Rinconada - Santiago, Chile