Clinical trial NCT05118594: Testing a Precision Psychotherapy System for Low-income Patients
Official title: Open-trial to Prospectively Test the Feasibility of a Precision Psychotherapy System for Low-income Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Dysthymic Disorder
Specific Phobia
Social Anxiety Disorder
Panic Disorder
Agoraphobia
Generalized Anxiety Disorder
Keywords: Depressive disorders
Anxiety disorders
Lead sponsor: National Council of Scientific and Technical Research, Argentina
Sponsor class: OTHER_GOV
First posted: 2021-11-12
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline in Depressive Severity on the Patient Health Questionnaire (PHQ-9) at Week 15
timeFrame: Baseline and Week 15
measure: Change from Baseline in Anxiety Severity on the General Anxiety Disorder-7 (GAD-7) at Week 15
timeFrame: Baseline and Week 15
measure: Change from Baseline in Overall Functioning on the World Health Organization Disability Assessment Schedule (WHODAS) at Week 15
timeFrame: Baseline and Week 15
measure: Average Adherence to the Recommended Interventions on the Multitheoretical List of Therapeutic Interventions (MULTI-30) Across Treatment
timeFrame: Week 1 and Week 15
Secondary outcomes:
measure: Diagnostic Status at Week 15 in the Primary Diagnoses Identified at Baseline with the Mini-International Neuropsychiatric Interview
timeFrame: Baseline and Week 15
Other outcomes:
Locations:
Study officials:
affiliation: National Council of Scientific and Technical Research
name: Juan M Gomez Penedo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.