Guided Group Telehealth to Deliver Evidence-based Therapeutic Care to Black College Students
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Depressive Symptoms (PHQ-9)
研究概览
简要总结
The goal of this study is to address the mental health crisis among college students by creating a promising solution for group teletherapy, which is equivalent to individual teletherapy in terms of treatment outcomes.The main question it aims to answer is: if participants' outcome measures in TheraGroup are in line with participants' outcome measures in individual therapy. The goal of the current SBIR is to test TheraGroup, the first large scale virtual group platform for evidenced-based mental health therapy. The TheraGroup application addresses the market surge in the demand for care and the shortage of mental health professionals as it represents an economically viable treatment alternative to individual teletherapy.
详细描述
Mental illness among college students has become a public health crisis. Even before the pandemic, many college campuses lacked the resources to support students' mental health needs. College campus counseling centers have begun to think creatively about how to meet the growing demand for services as the number of available therapists is insufficient to treat the number of students seeking help. TheraGroup is the solution to leverage innovative group technology to provide Guided Group Therapy (GGT) in which students receive evidenced-based Cognitive Behavioral Therapy (CBT) coping skills training to address the high demand for mental health services and bridge the gap in services on college campuses. TheraGroup is the first large scale virtual group real-time platform for evidenced-based mental health therapy. TheraGroup is a HIPAA-compliant, platform-agnostic tool that provides the channel through which GGT will be facilitated to service college students to improve student mental health outcomes. In Aim 1, researchers will develop the TheraGroup platform. Researchers will achieve this by optimizing the existing platform, which is therapy enabled for one-to-one therapy, to enable one-to-many communication in a large group context. In addition, researchers will develop other proprietary features that create an anonymous and interactive group discussion experience. The proof of concept will be demonstrated with high usage across multiple devices. In Aim 2, researchers will implement a feasibility study to assess the impact of GGT via TheraGroup on measures of engagement, user experience, and mental health outcomes in college students. If participants' outcome measures in the GGT group are in line with participants' outcome measures in the IT group, the feasibility study will serve as a precursor to testing the effects of GGT via TheraGroup using a larger scale randomized control trial. Achieving these aims could suggest TheraGroup is a new actionable tool to supplement existing mental health interventions to address the ever-growing need for mental health services college students.
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 (Participant)
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
- •Individuals at PVAMU 18 years and older
排除标准
- •Individuals younger than 18 years of age will be excluded from the clinical trial.
研究组 & 干预措施
Guided Group Therapy (GGT) via TheraGroup
Participants in the GGT group will receive the same psychoeducational information and reading resources about the CBT coping skills and encouragement of reflection on homework assignments in a group online chat environment. Participants in GGT will also receive support in the form of direct asynchronous communication with the therapist and asynchronous communication with peers struggling with similar issues.
干预措施: Cognitive Behavioral Therapy (CBT) Coping Skills Training (Behavioral)
Individual Teletherapy (IT)
Participants in the IT group will receive 1 one 1 teletherapy using the 12-week structured modules. The therapist will be providing psychoeducational information and reading resources about the CBT coping skills and encouragement of reflection on homework assignments in session (via video, audio or text therapy).
干预措施: Cognitive Behavioral Therapy (CBT) Coping Skills Training (Behavioral)
结局指标
主要结局
Depressive Symptoms (PHQ-9)
时间窗: Week 12
Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report measure. Items are rated on a 4-point scale ranging from 0 ("not at all") to 3 ("nearly every day"). Item responses are summed to compute a total score. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Engagement (8-item Scale)
时间窗: Week 4
Participant engagement was assessed using a self-report engagement measure administered at post-intervention. Items were rated on a 5-point Likert-type scale ranging from 1 to 5, with higher scores indicating greater engagement. Mean engagement scores are reported as scores on a scale. Engagement scores represent the mean of all item responses, yielding a possible score range from 1 to 5.
Engagement (8-item Scale)
时间窗: Week 8
Participant engagement was assessed using a self-report engagement measure administered at post-intervention. Items were rated on a 5-point Likert-type scale ranging from 1 to 5, with higher scores indicating greater engagement. Mean engagement scores are reported as scores on a scale. Engagement scores represent the mean of all item responses, yielding a possible score range from 1 to 5.
Engagement (8-item Scale)
时间窗: Week 12
Participant engagement was assessed using a self-report engagement measure administered at post-intervention. Items were rated on a 5-point Likert-type scale ranging from 1 to 5, with higher scores indicating greater engagement. Mean engagement scores are reported as scores on a scale. Engagement scores represent the mean of all item responses, yielding a possible score range from 1 to 5.
Anxiety Symptoms (GAD-7)
时间窗: Week 12
Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). Items are rated on a 4-point scale ranging from 0 ("not at all") to 3 ("nearly every day"). Item responses are summed to compute a total score. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Anxiety Symptoms (GAD-7)
时间窗: Week 8
Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). Items are rated on a 4-point scale ranging from 0 ("not at all") to 3 ("nearly every day"). Item responses are summed to compute a total score. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Anxiety Symptoms (GAD-7)
时间窗: Week 4
Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). Items are rated on a 4-point scale ranging from 0 ("not at all") to 3 ("nearly every day"). Item responses are summed to compute a total score. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Anxiety Symptoms (GAD-7)
时间窗: Baseline
Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). Items are rated on a 4-point scale ranging from 0 ("not at all") to 3 ("nearly every day"). Item responses are summed to compute a total score. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Depressive Symptoms (PHQ-9)
时间窗: Baseline
Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report measure. Items are rated on a 4-point scale ranging from 0 ("not at all") to 3 ("nearly every day"). Item responses are summed to compute a total score. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Depressive Symptoms (PHQ-9)
时间窗: Week 4
Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report measure. Items are rated on a 4-point scale ranging from 0 ("not at all") to 3 ("nearly every day"). Item responses are summed to compute a total score. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Depressive Symptoms (PHQ-9)
时间窗: Week 8
Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report measure. Items are rated on a 4-point scale ranging from 0 ("not at all") to 3 ("nearly every day"). Item responses are summed to compute a total score. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
次要结局
- Completion Rate(12 weeks)
- User Feedback Sentiment(Week 4)
- User Feedback Sentiment(Week 8)
- User Feedback Sentiment(Week 12)
研究者
Dr. Veronica Tetterton
Principal Investigator
The Sweet I AM