Modular Intervention for Depression Study (MIND)

Pontificia Universidad Catolica de Chile

Status: Begins enrollment in 1 month

Conditions: Major Depression

Treatments: Behavioral: Psychotherapy as Usual (TAU); Behavioral: Modular Intervention for Depression Therapy (MIND Therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT07380451

1251070 (Other Grant/Funding Number)

240531010

Details and patient eligibility

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Modular Psychotherapy (MIND)

Experimental group

Description:

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.

Treatment:

Behavioral: Modular Intervention for Depression Therapy (MIND Therapy)

Treatment as Usual (TAU)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psychotherapy as Usual (TAU)