An interventional study of Cognitive Behavioral Therapy (CBT) Coping Skills Training in Anxiety Depression, sponsored by Dr. Veronica Tetterton. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Dr. Veronica Tetterton · Not applicable, Interventional, and Treatment
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.
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.
971 studies on the registry are indexed under Psychological Well-Being; 502 are open to participants now.
This study's enrollment of 40 is below the median of 116 across 830 interventional studies indexed under Psychological Well-Being.
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Exclusion Criteria:
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
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
12 Week CBT Coping Skills Training Modules
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 8
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.
Time frame: Week 12
Completion Rate
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.
Time frame: 12 weeks
User Feedback Sentiment
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.
Time frame: Week 4
User Feedback Sentiment
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.
Time frame: Week 8
User Feedback Sentiment
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.
Time frame: Week 12
This study will recruit 40 Black college students attending Prairie View A\&M University (PVAMU) who are at least 18 years of age, and who qualify for the clinical intervention based on their current levels of depression and anxiety. Recruitment will occur by distributing flyers to the psychology participant pool, posting flyers around campuses, referrals from the student health center, and through word of mouth.
| Milestone | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| Started | 20 | 20 |
| Completed | 15 | 17 |
| Not completed | 5 | 3 |
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.
| Engagement completers | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| Completion Rate | 15 | 17 |
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.
| Mean engagement score | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| Engagement (8-item Scale) | 3.90 ± .12 | 4.62 ± .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.
| Mean engagement score | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| Engagement (8-item Scale) | 4.11 ± .12 | 4.70 ± .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.
| Mean engagement score | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| Engagement (8-item Scale) | 3.74 ± .12 | 4.79 ± .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.
| GAD-7 total score | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| Anxiety Symptoms (GAD-7) | 7.37 ± 1.12 | 4.80 ± 1.31 |
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.
| GAD-7 total score | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| Anxiety Symptoms (GAD-7) | 6.65 ± 1.09 | 5.94 ± 1.06 |
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.
| scores on a scale | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| User Feedback Sentiment | 0.134 (0.044 to 0.170) | 0.217 (0.100 to 0.365) |
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.
| scores on a scale | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| User Feedback Sentiment | 0.38 (0.18 to 0.56) | 0.45 (0.26 to 0.63) |
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.
| scores on a scale | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| User Feedback Sentiment | 0.39 (0.281 to 0.476) | 0.393 (0.255 to 0.476) |
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.
| GAD-7 total score | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| Anxiety Symptoms (GAD-7) | 5.91 ± 1.15 | 7.06 ± 1.04 |
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.
| GAD-7 total score | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| Anxiety Symptoms (GAD-7) | 10.00 ± 0.90 | 8.85 ± 0.93 |
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.
| PHQ-9 total score | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| Depressive Symptoms (PHQ-9) | 10.20 ± 1.04 | 10.55 ± 0.96 |
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.
| PHQ-9 total score | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| Depressive Symptoms (PHQ-9) | 8.10 ± 1.17 | 7.01 ± 1.11 |
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.
| PHQ-9 total score | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| Depressive Symptoms (PHQ-9) | 6.05 ± 1.15 | 7.17 ± 1.13 |
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.
| PHQ-9 total score | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) |
|---|---|---|
| Depressive Symptoms (PHQ-9) | 6.78 ± 1.17 | 5.58 ± 1.30 |
Collected over From enrollment until completion of the study, up to 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
Baseline characteristics include all participants enrolled and assigned to a study arm at baseline prior to receipt of intervention. All enrolled participants who completed baseline assessments are included. Differences between baseline Ns and Ns reported for outcome analyses reflect attrition and missing data at follow-up timepoints.
| Age, Categorical(Participants) | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 20 | 40 |
| >=65 years | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 20 | 20 | 40 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) | Total |
|---|---|---|---|
| Female | 18 | 19 | 37 |
| Male | 2 | 1 | 3 |
| PHQ-9 total score at baseline(points) | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) | Total |
|---|---|---|---|
| Mean | 10.38 ± 4.42 | 10.38 ± 4.42 | 10.38 ± 4.42 |
| GAD-7 total score at baseline(Points) | Guided Group Therapy (GGT) Via TheraGroup | Individual Teletherapy (IT) | Total |
|---|---|---|---|
| Mean | 9.43 ± 4.10 | 9.43 ± 4.10 | 9.43 ± 4.10 |
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