Modular Intervention for Depression Study

NCT07380451 | Recruiting

• 2 other identifiers: 2405310101251070
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

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

Conditions

Major Depression

Keywords

Complicated Depression; Early Life Adversity; Personality Dysfunction

Outcome Measures

Primary Outcomes (2)

• Depression remission.

  Primary depression outcomes will be assessed using the MINI International Neuropsychiatric Interview. The MINI is a structured interview. Remission is defined as a negative MINI assessment for major depressive disorder.

  Baseline (pre-intervention), end of treatment (session 15; approximately 3 months), and 3-month post-treatment (approximately 6 months after baseline assessment).

• Clinically significant symptom reduction

  Clinically significant symptom reduction will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 has a range between 0 and 27. Higher scores indicate more symptom severity. Clinically significant symptom reduction is defined as a reduction of at least 5 points on the PHQ-9 from baseline and a post-treatment PHQ-9 score ≤9.

  Baseline (pre-intervention), end of treatment (session 15; approximately 3 months), and 3-month post-treatment (approximately 6 months after baseline assessment).

Secondary Outcomes (13)

• Emotional regulation difficulties

  Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).

• Interpersonal sensitivity and rejection sensitivity

  Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).

• Interpersonal functioning and social problems

  Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up (approximately 6 months after baseline).

• Daily emotional and interpersonal functioning

  One week prior to treatment initiation and one week following treatment completion (after 15 sessions; approximately 3 months after baseline assessment).

• Therapeutic alliance

  After each treatment session, from session 1 through session 15 (approximately 3 months)

Other Outcomes (1)

• Mentalizing Capacity

  Baseline (pre-intervention); during treatment at sessions 5, 10, and 15; and 3-month post-treatment follow-up

Study Arms (2)

Modular Psychotherapy (MIND)

EXPERIMENTAL

Participants assigned to the MIND arm receive a personalized modular psychotherapy designed for depression complicated by personality dysfunction and/or complex trauma. All participants receive a core evidence-based depression treatment, including behavioral activation, cognitive, and interpersonal psychotherapy strategies. Additional short therapy modules are selected and added based on each participant's baseline emotional and interpersonal functioning profile following a module assignment algorithm. These modules target specific areas: emotion regulation difficulties, sensitivity to rejection and interpersonal threat, social functioning problems. Treatment is delivered as weekly individual psychotherapy sessions, with the number and combination of modules tailored to individual clinical needs.

Behavioral: Modular Intervention for Depression Therapy (MIND Therapy)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participants assigned to the treatment as usual (TAU) arm receive individual psychotherapy as typically provided in public community mental health centers in Chile. This treatment reflects routine clinical practice and may vary in therapeutic approach according to the therapist's usual orientation. Sessions are delivered individually and on a weekly basis, without the use of the modular psychotherapy protocol.

Behavioral: Psychotherapy as Usual (TAU)

Interventions

Modular Intervention for Depression Therapy (MIND Therapy) BEHAVIORAL

The MIND intervention is an algorithm-based, personalized, modular psychotherapy for adults with depression complicated by personality dysfunction and/or complex trauma. All participants receive a core evidence-based depression treatment that includes behavioral activation, cognitive, and interpersonal psychotherapy strategies. Additional short therapy modules are selected based on each participant's baseline emotional, interpersonal, and self-related functioning profile, using a predefined clinical algorithm. These modules target specific difficulties such as emotion regulation problems (DBT Module), sensitivity to rejection and interpersonal threat (MBT and CBASP Modules), social functioning difficulties (Social Thinning Module). The type and number of modules are tailored to individual needs following an algorithm based on baseline measures (DERS, A-RSQ, OQ-45-IR). Treatment is delivered as weekly individual psychotherapy sessions.

Also known as: Psychotherapy

Modular Psychotherapy (MIND)

Psychotherapy as Usual (TAU) BEHAVIORAL

Psychotherapy as usual (TAU) consists of individual psychotherapy delivered in public community mental health centers according to routine clinical practice. Treatment is provided weekly by trained clinicians and may vary in therapeutic orientation, techniques, and structure depending on the therapist and center. TAU is not guided by the modular psychotherapy protocol or algorithm used in the experimental intervention and reflects standard care available in the Chilean public mental health system.

Also known as: Psychotherapy

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• MIDAP Millennium Institute for Research in Depression and Personality: collaborator

Study Sites (5)

CDT CASR

Santiago, Chile

RECRUITING

COSAM La Bandera

Santiago, Chile

ACTIVE NOT RECRUITING

COSAM La Granja

Santiago, Chile

RECRUITING

COSAM La Pintana

Santiago, Chile

RECRUITING

COSAM Rinconada

Santiago, Chile

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Central Study Contacts

Alex J Behn, PhD

CONTACT

+56942152484; albehn@uc.cl

Jorge Matamala, Bachelor of Psychology

CONTACT

+56982504691; jmatamale@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study uses blinded outcome assessment and blinded statistical analysis. Primary outcome assessors are masked to participants' treatment assignment. In addition, the statistical analyst is masked to treatment allocation and does not have access to treatment assignment information during data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a randomized, parallel-group clinical trial in which eligible participants are assigned in a 1:1 ratio to either an algorithm-based personalized modular psychotherapy or usual individual psychotherapy. Participants receive only the intervention to which they are assigned, and outcomes are compared between groups over the course of treatment and follow-up.

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: February 2, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (5)