Testing a Precision Psychotherapy System for Low-income Patients (ML_LMIC)
Primary Purpose
Major Depressive Disorder, Dysthymic Disorder, Specific Phobia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pre-treatment psychotherapy recommendations
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depressive disorders, Anxiety disorders
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pre-treatment recommendations
Arm Description
Therapists receive automatized feedback at the beginning of the treatments with recommendations regarding the most appropriate interventions to use with their patients based on a machine learning algorithm developed on a previous study.
Outcomes
Primary Outcome Measures
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
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
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
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05118594
First Posted
November 2, 2021
Last Updated
November 11, 2021
Sponsor
National Council of Scientific and Technical Research, Argentina
1. Study Identification
Unique Protocol Identification Number
NCT05118594
Brief Title
Testing a Precision Psychotherapy System for Low-income Patients
Acronym
ML_LMIC
Official Title
Open-trial to Prospectively Test the Feasibility of a Precision Psychotherapy System for Low-income Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2026 (Anticipated)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
November 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Council of Scientific and Technical Research, Argentina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Dysthymic Disorder, Specific Phobia, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Generalized Anxiety Disorder
Keywords
Depressive disorders, Anxiety disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Therapists will receive patient-specific treatment recommendations (based on a machine-learning based algorithm developed in a previous study) regarding the most suitable interventions to be used to treat each study patient.
Masking
None (Open Label)
Allocation
N/A
Enrollment
111 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre-treatment recommendations
Arm Type
Experimental
Arm Description
Therapists receive automatized feedback at the beginning of the treatments with recommendations regarding the most appropriate interventions to use with their patients based on a machine learning algorithm developed on a previous study.
Intervention Type
Behavioral
Intervention Name(s)
Pre-treatment psychotherapy recommendations
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline in Depressive Severity on the Patient Health Questionnaire (PHQ-9) at Week 15
Description
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
Title
Change from Baseline in Anxiety Severity on the General Anxiety Disorder-7 (GAD-7) at Week 15
Description
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
Title
Change from Baseline in Overall Functioning on the World Health Organization Disability Assessment Schedule (WHODAS) at Week 15
Description
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
Title
Average Adherence to the Recommended Interventions on the Multitheoretical List of Therapeutic Interventions (MULTI-30) Across Treatment
Description
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 Outcome Measure Information:
Title
Diagnostic Status at Week 15 in the Primary Diagnoses Identified at Baseline with the Mini-International Neuropsychiatric Interview
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan M Gomez Penedo, PhD
Phone
+5491165257053
Email
jmgomezpenedo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan M Gomez Penedo, PhD
Organizational Affiliation
National Council of Scientific and Technical Research
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share individual participant data (IPD) underlying the results of publications of the project, upon request. Furthermore, following the particular scientific journals' standards, we will share analytic code of published results.
IPD Sharing Time Frame
Upon request, we will start sharing IPD 6 months after the publication of the main outcome paper in a peer-reviewed scientific journal. We will maintain our de-identified database indefinitely for potential future requests.
IPD Sharing Access Criteria
For meta-analyses or replications, we will share de-identified IPD, an associated data dictionary, and supporting information to scientific colleagues showing a track record of publications in psychotherapy research following ethical guidelines. We can also share IPD for secondary analyses, grounded on previously agreed collaborations and under a clear establishment of manuscript authorship arrangements.
Requests should be send via email to the PI, Dr. Juan Martín Gómez Penedo (jmgomezpenedo@gmail.com). If the data usage details are unclear or questionable Dr. Gómez Penedo reserves the right to deny individual data share requests.
Citations:
PubMed Identifier
29336228
Citation
Solomonov N, McCarthy KS, Gorman BS, Barber JP. The Multitheoretical List of Therapeutic Interventions - 30 items (MULTI-30). Psychother Res. 2019 Jul;29(5):565-580. doi: 10.1080/10503307.2017.1422216. Epub 2018 Jan 16.
Results Reference
background
PubMed Identifier
9881538
Citation
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
Results Reference
background
PubMed Identifier
21076562
Citation
Ustun TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, Saxena S, von Korff M, Pull C; WHO/NIH Joint Project. Developing the World Health Organization Disability Assessment Schedule 2.0. Bull World Health Organ. 2010 Nov 1;88(11):815-23. doi: 10.2471/BLT.09.067231. Epub 2010 May 20.
Results Reference
background
PubMed Identifier
11556941
Citation
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Results Reference
background
PubMed Identifier
16717171
Citation
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Results Reference
background
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Testing a Precision Psychotherapy System for Low-income Patients
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