Open-trial to Prospectively Test the Feasibility of a Precision Psychotherapy System for Low-income Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 111
- 主要终点
- Change from Baseline in Depressive Severity on the Patient Health Questionnaire (PHQ-9) at Week 15
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Psychosis
- •Suicidal ideation with intent and/or plan
- •Substance abuse disorders
- •History of organic mental disease.
结局指标
主要结局
Change from Baseline in Depressive Severity on the Patient Health Questionnaire (PHQ-9) at Week 15
时间窗: 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 Overall Functioning on the World Health Organization Disability Assessment Schedule (WHODAS) at Week 15
时间窗: 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
时间窗: 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.
Change from Baseline in Anxiety Severity on the General Anxiety Disorder-7 (GAD-7) at Week 15
时间窗: 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
次要结局
- Diagnostic Status at Week 15 in the Primary Diagnoses Identified at Baseline with the Mini-International Neuropsychiatric Interview(Baseline and Week 15)
研究者
Juan Martin Gomez Penedo
Assistant Researcher
National Council of Scientific and Technical Research, Argentina