Testing a Precision Psychotherapy System for Low-income Patients

NCT05118594 | Not Yet Recruiting DMC

• 1 other identifier: ML_LMIC_2021
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder; Dysthymic Disorder; Specific Phobia; Social Anxiety Disorder; Panic Disorder; Agoraphobia; Generalized Anxiety Disorder

Keywords

Depressive disorders; Anxiety disorders

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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.

  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

  Baseline and Week 15

Study Arms (1)

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.

Behavioral: Pre-treatment psychotherapy recommendations

Interventions

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.

Pre-treatment recommendations

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Council of Scientific and Technical Research, Argentina: lead

Related Publications (5)

• 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.

  PMID: 29336228 BACKGROUND

• 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.

  PMID: 9881538 BACKGROUND

• 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.

  PMID: 21076562 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Dysthymic Disorder; Phobia, Specific; Phobia, Social; Panic Disorder; Agoraphobia; Generalized Anxiety Disorder; Depressive Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Phobic Disorders

Study Officials

• Juan M Gomez Penedo, PhD

  National Council of Scientific and Technical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan M Gomez Penedo, PhD

CONTACT

+5491165257053; jmgomezpenedo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Researcher

Model Details: 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.

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 12, 2021
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• 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.