Anxiety Depression
Conditions
Keywords
mental health, college students, asynchronous group therapy
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy (CBT) Coping Skills Training
12 Week CBT Coping Skills Training Modules
Sponsors
Dr. Veronica Tetterton
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engagement (8-item Scale) | 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. |
| Anxiety Symptoms (GAD-7) | 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. |
| Depressive Symptoms (PHQ-9) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion Rate | 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. |
| User Feedback Sentiment | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
To obtain a subset of students that meet these qualifications, we will first collect baseline data. via a Qualtrics survey where they will access the informed consent, demographic questions, and the PHQ-9 and GAD-7. Participants who score a 5 or more on the GAD-7 or the PHQ-9 will qualify for the therapeutic intervention aspect of the study and will be given a link to complete a 12 week telehealth intervention in the form of either Guided Group Therapy or Individual Therapy.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| GAD-7 total score at baseline | 9.43 Points STANDARD_DEVIATION 4.1 |
| PHQ-9 total score at baseline | 10.38 points STANDARD_DEVIATION 4.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
None listed