The Thrive Care Study: Computer-Delivered Cognitive Behavioral Therapy as Care Augmentation for Depressed Primary Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- PHQ-9 score change
研究概览
简要总结
This project will study the effectiveness of computerized cognitive behavioral therapy (CBT) in reducing depression symptoms. The design is a two-arm randomized controlled trial comparing (i) control arm, which is treatment as usual with (ii) treatment arm, which is treatment as usual plus computerized CBT. The primary outcome measure is change in depression symptom severity. The name of the computerized CBT program to be used in the study is Thrive.
详细描述
Population:
- As identified in Epic, Kaiser Permanente Southern California (KPSC) Fontana Family Medicine patients with a depression diagnosis recorded during the prior week (rolling basis).
- Target study enrollment: 150 participants per arm (300 total)
Recruitment:
- Kaiser Permanente (KP) will send eligible patients a postal letter inviting them to participate in study. Interested patients will be directed to the Enrollment/Assessment Website, a website to be developed by vendor Waypoint Health Innovations. The recruitment letter will contain (i) a description of the study, (ii) the web address for the Enrollment/Assessment Website, (iii) the patient's Study Identifier (ID).
- Additionally, KP will send eligible patients for whom KP has an email address an email inviting them to participate in the study.
Screening and Enrollment (Enrollment/Assessment Website):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
The primary care physician will not receive feedback about which arm the patient was assigned to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Per EPIC (or other system) records, clinical depression was addressed during the prior week by a KPSC Fontana Family Medicine physician , reflected by an ICD-9 or ICD-10 diagnosis of Depression, Major Depressive Disorder, Dysthymia, Adjustment Disorder with Depressed Mood, and Depression Not Otherwise Specified. This does not have to be the patient's first depression diagnosis.
- •Screening Patient Health Questionnaire (PHQ-9) score of ≥5 as measured in Assessment Website (see Section 4 for information on Assessment Website)
排除标准
- •History or current diagnosis indicating any Schizophrenia spectrum or other psychotic disorder, any Neurocognitive disorder, Delirium, Bipolar disorder, Intellectual disability, or Personality disorder, or any active substance abuse, as defined by DSM-5
- •Member is not proficient in English
- •Member answered "more than half the days" or "nearly every day" on the Patient Health Questionnaire ninth item and did not subsequently answer (regarding suicidal ideations) "Yes" to the question "are you sure you can stay safe?"
研究组 & 干预措施
Control Arm
After enrollment in the study, the subject will continue to receive treatment as usual for their depression from their primary care physician. They then will be asked to complete 2-month and 6-month assessments about their emotional well-being.
Intervention Arm
After enrollment in the study, the subject will be granted 8 weeks of access to "Thrive", an online self-help tool designed to assess for depressive symptoms and give therapeutic suggestions based on Cognitive Behavioral Therapy. During the first 4 weeks, they will receive 4 coaching emails and/or phone calls encouraging their participation in the study, and answering any program-related questions. The subject will also continue to receive treatment as usual for their depression from their primary care physician. They then will be asked to complete 2-month and 6-month assessments about their emotional well-being.
干预措施: Thrive (Behavioral)
结局指标
主要结局
PHQ-9 score change
时间窗: 0-6 months after enrollment
Change in score on the 9-item Patient Health Questionnaire
次要结局
- Psychiatric specialty utilization(0-6 months after enrollment)
- Workplace productivity change(0-6 months after enrollment)
- Psychotherapy utilization(12 months prior to enrollment, through 6 months after enrollment)
- Quality of Life change(0-6 months after enrollment)
- Satisfaction with Thrive(2 months after enrollment)
- Satisfaction with Kaiser Permanente Southern California(0-6 months after enrollment)
- Medication adherence(0-6 months after enrollment)
- Thrive Adherence(0-2 months after enrollment)
- GAD-7 score change(0-6 months after enrollment)