Comparison of Delivery Format of Cognitive Behavioral Therapy Materials on Engagement and Symptom Reduction: AI-Enabled App vs PDF Workbook
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 540
- 试验地点
- 2
- 主要终点
- Therapy Completion
研究概览
简要总结
The goal of this clinical trial is to compare two different ways of delivering cognitive behavioral therapy (CBT) materials to people with symptoms of anxiety and depression. The main questions it aims to answer are:
- Do people using the app experience greater reductions in anxiety and depression symptoms compared to those using the workbook?
- Does the personalization offered by the app increase engagement with CBT materials compared to the workbook?
Participants will be given access to either the Limbic Care app or an equivalent PDF workbook and will be asked to engage with the materials for several days each week over a period of 6 weeks. Each week, participants will complete a survey about their anxiety and depression symptoms and report any new health issues and their experiences with the materials.
详细描述
Motivation
Homework is a crucial component of cognitive-behavioral therapy (CBT) as it allows patients to actively implement therapeutic techniques and skills outside of sessions, promoting long-term mental health improvements. However, patient engagement with CBT homework can be challenging due to a lack of motivation, forgetfulness, or a lack of personalization, which can hinder the overall effectiveness of the therapy and retention in a therapy program.
Design
This randomized controlled trial (RCT) aims to evaluate the efficacy, acceptability, and safety of an AI-enabled smartphone application (Limbic Care) compared to a standard digital workbook (PDF format) in delivering cognitive behavioral therapy (CBT) materials to individuals with clinically significant symptoms of anxiety and/or depression. The study will involve 500 participants, who will be randomly allocated in a 3:2 ratio to either the intervention group (Limbic Care app) or the control group (PDF workbook).
A large cohort (~2,000 participants) will initially be screened for inclusion and exclusion criteria. Eligible participants will be invited to participate in a baseline survey (capped at 550 to account for attrition and reach a target of 500 participants for the final data collection point). This survey will measure multiple validated symptom scales (e.g., for anxiety, depression, obsessive-compulsive disorder, health anxiety disorder) and gather subjective ratings on variables such as familiarity with CBT, previous experience with mental health apps, preferences for apps vs. PDF workbooks, medication status, and more.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has a personal smartphone with Internet access with an accepted operating system: iOS (any) or Android (10 or later)
- •Has a GAD-7 score >= 8 OR a PHQ-9 score >= 10 (indicating anxiety and/or depression symptoms above a clinical threshold, according to NHS Talking Therapies guidelines)
- •US resident
- •Fluent in English
排除标准
- •Currently undergoing mental health therapy
- •Changed psychotropic medication in the past 8 weeks (this includes starting/stopping medication or increasing/decreasing dosage)
- •Self-identify as being at risk of harming themselves or others
- •Have used the Limbic app before
- •Use recreational drugs more frequently than once per week
- •Consume >= 10 alcohol units per week
结局指标
主要结局
Therapy Completion
时间窗: Summed across Week 1 to Week 6
Proportion of therapy content viewed (exercises in-app, or PDF pages viewed)
Engagement Duration
时间窗: Summed across Week 1 to Week 6
Time spent in the Limbic Care application (intervention) or viewing workbook pages (control).
Change in PHQ-9 (Depression)
时间窗: Baseline to Week 6, and weekly (from Baseline to Week 6)
The PHQ-9 (Patient Health Questionnaire-9) is a 9-item self-report screening and diagnostic tool for depression.
Change in GAD-7 (Anxiety)
时间窗: Baseline to Week 6, and weekly (from Baseline to Week 6)
The GAD-7 (Generalized Anxiety Disorder-7) is a 7-item self-report questionnaire used to screen for and measure the severity of generalized anxiety disorder (GAD).
次要结局
- Incidence of Adverse Health Events(Summed across Week 1 to Week 6)