Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:33 AM
Study NCT ID:
NCT07380451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-02
First Post:
2025-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modular Intervention for Depression Study
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Study Overview
Official Title:
Modular Optimization of Psychotherapy for Individuals With Depression Complicated by Personality Dysfunction and Complex Trauma: A Pilot Study in the Chilean Public Health System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIND
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
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
Detailed Description:
This randomized controlled clinical trial evaluates an algorithm-based personalized modular psychotherapy designed for adults with major depressive disorder whose condition is complicated by long-standing emotional, interpersonal, and self-related difficulties associated with early life adversity or personality functioning problems. These individuals often have poorer outcomes with standard psychotherapeutic approaches offered in public mental health services.
The experimental intervention consists of a modular psychotherapy approach. All participants in this group receive a core, evidence-based depression treatment. Additional short therapy modules are added based on each participant's baseline clinical profile following a module-assignment algorithm, targeting specific difficulties such as problems with emotion regulation, sensitivity to rejection and interpersonal threat, difficulties in social functioning, or disturbances in self-concept and self-worth. The number and type of modules are personalized for each participant, allowing the treatment to be tailored while remaining feasible within routine public mental health care.
The comparison group receives usual individual psychotherapy, which reflects standard care provided in community mental health centers in Chile. These treatments are delivered weekly by trained clinicians and are not guided by the modular protocol.
150 adults aged 18 to 65 will be recruited from public mental health centers. Eligible participants have major depressive disorder along with evidence of personality-related dysfunction and/or moderate to severe early life trauma. Participants are randomly assigned in a 1:1 ratio to either modular psychotherapy or usual care.
The primary outcomes of the study are clinically meaningful reduction in depressive symptoms and remission from depression following treatment. Secondary outcomes include changes in emotional regulation, interpersonal functioning, daily emotional and interpersonal experiences assessed through brief smartphone-based daily reports, quality of the therapeutic alliance, and satisfaction with treatment from both patients and therapists.
The purpose of this pilot trial is to determine whether a personalized algorithm-based modular psychotherapy approach improves clinical and functional outcomes compared to usual psychotherapy for people with complex depression in the Chilean public health system, and to inform future implementation and scaling of personalized mental health interventions.
The experimental intervention consists of a modular psychotherapy approach. All participants in this group receive a core, evidence-based depression treatment. Additional short therapy modules are added based on each participant's baseline clinical profile following a module-assignment algorithm, targeting specific difficulties such as problems with emotion regulation, sensitivity to rejection and interpersonal threat, difficulties in social functioning, or disturbances in self-concept and self-worth. The number and type of modules are personalized for each participant, allowing the treatment to be tailored while remaining feasible within routine public mental health care.
The comparison group receives usual individual psychotherapy, which reflects standard care provided in community mental health centers in Chile. These treatments are delivered weekly by trained clinicians and are not guided by the modular protocol.
150 adults aged 18 to 65 will be recruited from public mental health centers. Eligible participants have major depressive disorder along with evidence of personality-related dysfunction and/or moderate to severe early life trauma. Participants are randomly assigned in a 1:1 ratio to either modular psychotherapy or usual care.
The primary outcomes of the study are clinically meaningful reduction in depressive symptoms and remission from depression following treatment. Secondary outcomes include changes in emotional regulation, interpersonal functioning, daily emotional and interpersonal experiences assessed through brief smartphone-based daily reports, quality of the therapeutic alliance, and satisfaction with treatment from both patients and therapists.
The purpose of this pilot trial is to determine whether a personalized algorithm-based modular psychotherapy approach improves clinical and functional outcomes compared to usual psychotherapy for people with complex depression in the Chilean public health system, and to inform future implementation and scaling of personalized mental health interventions.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1251070 | OTHER_GRANT | ANID - FONDECYT | View |