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Completed

NCT Number: NCT07237217

Guided Group Telehealth to Deliver Evidence-based Therapeutic Care to Black College Students

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.

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Key information

Conditions

Anxiety Depression Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PVAMU

Prairie View, Texas, 77446, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals at PVAMU 18 years and older

Exclusion criteria

  • Individuals younger than 18 years of age will be excluded from the clinical trial.

Treatment and study plan

Cognitive Behavioral Therapy (CBT) Coping Skills Training

Behavioral

12 Week CBT Coping Skills Training Modules

Primary outcomes

  1. Engagement (8-item Scale)

    Time frame: 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.

  2. Engagement (8-item Scale)

    Time frame: 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.

  3. Engagement (8-item Scale)

    Time frame: 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.

  4. Anxiety Symptoms (GAD-7)

    Time frame: 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.

  5. Anxiety Symptoms (GAD-7)

    Time frame: 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.

  6. Anxiety Symptoms (GAD-7)

    Time frame: 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.

  7. Anxiety Symptoms (GAD-7)

    Time frame: 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.

  8. Depressive Symptoms (PHQ-9)

    Time frame: 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.

  9. Depressive Symptoms (PHQ-9)

    Time frame: 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.

  10. Depressive Symptoms (PHQ-9)

    Time frame: 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.

Secondary outcomes

  1. Completion Rate

    Time frame: 12 weeks

    Out of the 20 participants in each clinical trial arm, this outcome reflects the number of participants who completed the engagement component by Week 12 of the intervention.

  2. User Feedback Sentiment

    Time frame: Week 4

    Sentiment was quantified using a continuous sentiment score ranging from 0 to 1, with higher values indicating more positive sentiment. Sentiment scores were derived from open-ended responses collected at Week 4. Due to non-normal distributions, sentiment scores are summarized using medians and interquartile ranges and are reported as scores on a scale.

  3. User Feedback Sentiment

    Time frame: Week 8

    Sentiment was quantified using a continuous sentiment score ranging from 0 to 1, with higher values indicating more positive sentiment. Sentiment scores were derived from open-ended responses collected at Week 8. Due to non-normal distributions, sentiment scores are summarized using medians and interquartile ranges and are reported as scores on a scale.

  4. User Feedback Sentiment

    Time frame: Week 12

    Sentiment was quantified using a continuous sentiment score ranging from 0 to 1, with higher values indicating more positive sentiment. Sentiment scores were derived from open-ended responses collected at Week 12. Due to non-normal distributions, sentiment scores are summarized using medians and interquartile ranges and are reported as scores on a scale.

Sponsors and collaborators

Lead sponsor

Dr. Veronica Tetterton

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2025
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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