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

NCT07237217 | Completed Results

• 2 other identifiers: 2024-441R43MD020009-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Depression

Keywords

mental health; college students; asynchronous group therapy

Outcome Measures

Primary Outcomes (10)

• Engagement (8-item Scale)

  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.

  Week 4

• Engagement (8-item Scale)

  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.

  Week 8

• Engagement (8-item Scale)

  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.

  Week 12

• Anxiety Symptoms (GAD-7)

  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.

  Week 12

• Anxiety Symptoms (GAD-7)

  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.

  Week 8

• Anxiety Symptoms (GAD-7)

  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.

  Week 4

• Anxiety Symptoms (GAD-7)

  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.

  Baseline

• Depressive Symptoms (PHQ-9)

  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.

  Baseline

• Depressive Symptoms (PHQ-9)

  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.

  Week 4

• Depressive Symptoms (PHQ-9)

  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.

  Week 8

Secondary Outcomes (4)

• Completion Rate

  12 weeks

• User Feedback Sentiment

  Week 4

• User Feedback Sentiment

  Week 8

• User Feedback Sentiment

  Week 12

Study Arms (2)

Guided Group Therapy (GGT) via TheraGroup

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy (CBT) Coping Skills Training

Individual Teletherapy (IT)

ACTIVE COMPARATOR

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).

Behavioral: Cognitive Behavioral Therapy (CBT) Coping Skills Training

Interventions

Cognitive Behavioral Therapy (CBT) Coping Skills Training BEHAVIORAL

12 Week CBT Coping Skills Training Modules

Guided Group Therapy (GGT) via TheraGroup; Individual Teletherapy (IT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals at PVAMU 18 years and older

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Veronica Tetterton: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

PVAMU

Prairie View, Texas, 77446, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Anne Lippert
• Organization: Prairie View A&M University

amlippert@pvamu.edu

5058009144

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 19, 2025
• Study Start: September 22, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: February 23, 2026
• Results First Posted: February 23, 2026

Record last verified: 2025-12

Locations

US (1)