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

NCT ID: NCT07237217

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-22
• Study Completion Date: 2025-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Anxiety Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy (CBT) Coping Skills Training

Intervention Type: BEHAVIORAL

12 Week CBT Coping Skills Training Modules

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).

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (CBT) Coping Skills Training

Intervention Type: BEHAVIORAL

12 Week CBT Coping Skills Training Modules

Interventions

Cognitive Behavioral Therapy (CBT) Coping Skills Training

12 Week CBT Coping Skills Training Modules

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Dr. Veronica Tetterton

OTHER

Sponsor Role: lead

Responsible Party

Dr. Veronica Tetterton

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

PVAMU

Prairie View, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1R43MD020009-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024-44

Identifier Type: -

Identifier Source: org_study_id