Major Depressive DisorderML_LMICNCT05118594
Testing a Precision Psychotherapy System for Low-income Patients
A study testing Pre-treatment psychotherapy recommendations in people with Major Depressive Disorder and Dysthymic Disorder, run by National Council of Scientific and Technical Research, Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Dysthymic Disorder, Specific Phobia
- What is being tested?
- Pre-treatment psychotherapy recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychosis
- Mania
- Suicidal ideation with intent and/or plan
- Substance abuse disorders
- History of organic mental disease.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Open-trial to Prospectively Test the Feasibility of 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.
Read the 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.
- Conditions
- Major Depressive Disorder, Dysthymic Disorder, Specific Phobia, Social Anxiety Disorder, Panic Disorder, Agoraphobia
- Being tested
- Pre-treatment psychotherapy recommendations
- Keywords
- Depressive disorders, Anxiety disorders
- Medical subject headings
- Depressive Disorder, Major, Dysthymic Disorder, Phobia, Specific, Phobia, Social, Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-treatment psychotherapy recommendationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-treatment recommendations | Experimental | 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. Receives: Behavioral: Pre-treatment psychotherapy recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and Week 15
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
Measured: Baseline and Week 15
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
Measured: Baseline and Week 15
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.
Measured: 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
Measured: Baseline and Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study startFeb 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Council of Scientific and Technical Research, Argentina
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Juan Martin Gomez Penedo, National Council of Scientific and Technical Research, Argentina
- Investigators
- Juan M Gomez Penedo, PhD, Principal investigator, National Council of Scientific and Technical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118594
- Sponsor's protocol ID
- ML_LMIC_2021
- Acronym
- ML_LMIC
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 29336228Sheehan 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.
PubMed 9881538Ustun 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.
PubMed 21076562Kroenke 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.
PubMed 11556941Spitzer 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.
PubMed 16717171
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-trial to Prospectively Test the Feasibility of a Precision Psychotherapy System for Low-income Patients
- ClinicalTrials.gov ID
- NCT05118594
- Acronym / sponsor ID
- ML_LMIC / ML_LMIC_2021
- Conditions
- Major Depressive Disorder, Dysthymic Disorder, Specific Phobia, Social Anxiety Disorder, Panic Disorder, Agoraphobia
- Keywords
- Depressive disorders, Anxiety disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- National Council of Scientific and Technical Research, ArgentinaOther government
- Study start
- Feb 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pre-treatment recommendations | Experimental | Behavioral: Pre-treatment psychotherapy recommendationsTherapists 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Psychosis
- Mania
- Suicidal ideation with intent and/or plan
- Substance abuse disorders
- History of organic mental disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-treatment psychotherapy recommendationsAfter 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. | Behavioural | Pre-treatment recommendations |
Primary outcome
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
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
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
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.
1 secondary outcome
Diagnostic Status at Week 15 in the Primary Diagnoses Identified at Baseline with the Mini-International Neuropsychiatric Interview
Time frame: Baseline and Week 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Background: PubMed 29336228Solomonov 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.
- Background: PubMed 9881538Sheehan 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.
- Background: PubMed 21076562Ustun 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.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 16717171Spitzer 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan M Gomez Penedo, PhD principal investigator
National Council of Scientific and Technical Research
Questions about this trial
What is this clinical trial studying?
A study testing Pre-treatment psychotherapy recommendations in people with Major Depressive Disorder and Dysthymic Disorder, run by National Council of Scientific and Technical Research, Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan M Gomez Penedo, PhD (+5491165257053, jmgomezpenedo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Depressive Severity on the Patient Health Questionnaire (PHQ-9) at Week 15 (time frame: Baseline and Week 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05118594, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.