Testing a Precision Psychotherapy System for Low-income Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNational Council of Scientific and Technical Research, Argentina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Psychosis

Mania

Suicidal ideation with intent and/or plan

Substance abuse disorders

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

111 Participants
are divided into 1 treatment group
Group A: Pre-treatment recommendationsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline and Week 15
2

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

Time frame
Baseline and Week 15
3

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

Time frame
Baseline and Week 15
4

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

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.

Time frame
Week 1 and Week 15

Secondary outcomes

1

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

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

Time frame
Baseline and Week 15

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: