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NCT Number: NCT05118594

Testing a Precision Psychotherapy System for Low-income Patients

The purpose of this study is to evaluate the feasibility of an evidence-based system to recommend core interventions, before the beginning of treatment, to psychotherapists treating low-income patients with depressive or anxiety disorders.

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Key information

Conditions

Major Depressive Disorder Agoraphobia Anxiety Disorders Depressive Disorder Depressive Disorder, Major Dysthymic Disorder Generalized Anxiety Disorder Mental Disorders Mood Disorders Panic Disorder Phobia, Social Phobia, Specific Phobic Disorders Social Anxiety Disorder Specific Phobia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

After providing a written inform consent, potential patients will undergo a 2-weeks screening period to determine if they meet eligibility criteria. Baseline information (i.e., derived from semi-structured intake interviews and baseline clinical measures) from patients who meet eligibility criteria and consent to participate in the study, will be use to feed a machine learning algorithm, developed in a previous study, to perform individual predictions and determine which interventions (i.e., cognitive, behavioral, interpersonal, or patient-centered) will be recommended for the individual patient. This recommendation (i.e., about the most personally well-suited intervention for a given patient) will be provided to therapists before the beginning of treatment. Patients will be treated with 15 sessions of psychotherapy. The investigators will examine the extent to which therapists adhered to the recommended interventions as the primary outcome. The investigators will also examine patient symptomatic/functional improvement as a secondary outcome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnoses of a depressive disorder (i.e., major depressive disorder or dysthymic disorder) or an anxiety disorder (i.e., specific phobia, social anxiety disorder, panic disorder, agoraphobia or generalized anxiety disorder) determined with the Mini-International Neuropsychiatric Interview (MINI)
  • A score of at least two (mild) in any the five items from the depression and anxiety domains of the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult
  • A total family income below the poverty index threshold, determined by a Licensed Social Worker
  • Aged 18 to 65
  • Fluency in Spanish language
  • Capacity to consent

Exclusion criteria

  • Psychosis
  • Mania
  • Suicidal ideation with intent and/or plan
  • Substance abuse disorders
  • History of organic mental disease.

Treatment and study plan

Pre-treatment psychotherapy recommendations

Behavioral

After patients complete an intake evaluation and prior to starting therapy, the assigned therapist will receive automatized feedback that consists of recommendations regarding the most suitable interventions (i.e., cognitive, behavioral, interpersonal or patient-centered) for each individual patients, based on patients' baseline characteristics and a machine learning algorithm developed in a previous study. Besides the interventions recommended, therapist will receive within the system guideline and tutorial videos showing how to deliver adequately the specific interventions recommended.

Primary outcomes

  1. Change from Baseline in Depressive Severity on the Patient Health Questionnaire (PHQ-9) at Week 15

    Time frame: Baseline and Week 15

    The PHQ-9 is a validated 9-item self-reported measure of depression severity grounded on the diagnostic criteria from the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV), with higher scores representing greater severity. Items are rated on a four-point Likert scale ranging from 0 ("Not at all") to 3 ("Nearly every day").

    Change= Estimated weekly change from Baseline to Week 15 from a multilevel growth curve model

  2. Change from Baseline in Anxiety Severity on the General Anxiety Disorder-7 (GAD-7) at Week 15

    Time frame: Baseline and Week 15

    The GAD-7 is a self-reported measure that evaluates the overall anxiety severity with seven items rated on a four-point Likert scale ranging from 0 ("Not at all) to 3 ("Nearly every day"). Greater scores represents higher severity.

    Change= Estimated weekly change on severity from Baseline to Week 15 from a multilevel growth curve model

  3. Change from Baseline in Overall Functioning on the World Health Organization Disability Assessment Schedule (WHODAS) at Week 15

    Time frame: Baseline and Week 15

    The WHODAS is a validated self-reported measure that evaluates overall functioning with 12 items rated on a five-point Likert scale ranging from 0 ("None") to 4 ("Extreme"). Greater scores represents higher disability.

    Change= Estimated weekly change on severity from Baseline to Week 15 from a multilevel growth curve model

  4. Average Adherence to the Recommended Interventions on the Multitheoretical List of Therapeutic Interventions (MULTI-30) Across Treatment

    Time frame: Week 1 and Week 15

    The MULTI-30 is a validated and reliable measure to assessed the adherence to therapeutic interventions in a given session. Items are rated on a 5-point Likert scale ranging from 1 ("Not at all typical to the session") to 5 ("Very typical to the session"). For the project the investigators will test the following MULTI-30 subscales: Cognitive, Behavioral, Interpersonal, and Person-centered. In this study the investigators will use the therapist version of the MULTI-30.

    Average Adherence= Mean Score of the Recommended Interventions Across all the Sessions of the Treatment.

Secondary outcomes

  1. Diagnostic Status at Week 15 in the Primary Diagnoses Identified at Baseline with the Mini-International Neuropsychiatric Interview

    Time frame: Baseline and Week 15

    The MINI is a brief structured diagnostic interview for psychiatric disorders developed based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) and the International Classification of Diseases (ICD) diagnostic criteria. Several studies have positioned the MINI as a highly reliable and valid instrument for determine psychiatric disorders.

    Diagnostic Status= Determine if the primary diagnoses remain at Week 15

Study contacts

Contact information is provided by the study sponsor or research team.

Juan M Gomez Penedo, PhD

CONTACT

[email protected]

+5491165257053

Sponsors and collaborators

Lead sponsor

National Council of Scientific and Technical Research, Argentina

Other Gov

Registry information

Official study title

Open-trial to Prospectively Test the Feasibility of a Precision Psychotherapy System for Low-income Patients

Acronym: ML_LMIC

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2021
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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