Trial Outcomes & Findings for Guided Group Telehealth to Deliver Evidence-based Therapeutic Care to Black College Students (NCT NCT07237217)
NCT ID: NCT07237217
Last Updated: 2026-02-23
Results Overview
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.
COMPLETED
NA
40 participants
Week 8
2026-02-23
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Guided Group Telehealth to Deliver Evidence-based Therapeutic Care to Black College Students
Baseline characteristics by cohort
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=20 Participants
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.
|
Individual Teletherapy (IT)
n=20 Participants
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).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=58 Participants
|
20 Participants
|
40 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=58 Participants
|
20 Participants
|
40 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=58 Participants
|
19 Participants
|
37 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=58 Participants
|
1 Participants
|
3 Participants
n=1 Participants
|
|
PHQ-9 total score at baseline
|
10.38 points
STANDARD_DEVIATION 4.42 • n=58 Participants
|
10.38 points
STANDARD_DEVIATION 4.42
|
10.38 points
STANDARD_DEVIATION 4.42 • n=1 Participants
|
|
GAD-7 total score at baseline
|
9.43 Points
STANDARD_DEVIATION 4.10 • n=58 Participants
|
9.43 Points
STANDARD_DEVIATION 4.10
|
9.43 Points
STANDARD_DEVIATION 4.10 • n=1 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: The analysis population includes participants who completed the engagement measure at the specified assessment timepoint.
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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=13 Participants
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.
|
Individual Teletherapy (IT)
n=17 Participants
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).
|
|---|---|---|
|
Engagement (8-item Scale)
|
3.90 Mean engagement score
Standard Error .12
|
4.62 Mean engagement score
Standard Error .12
|
PRIMARY outcome
Timeframe: Week 8Population: The analysis population includes participants who completed the engagement measure at the specified assessment timepoint.
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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=15 Participants
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.
|
Individual Teletherapy (IT)
n=17 Participants
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).
|
|---|---|---|
|
Engagement (8-item Scale)
|
4.11 Mean engagement score
Standard Error .12
|
4.70 Mean engagement score
Standard Error .12
|
PRIMARY outcome
Timeframe: Week 12Population: The analysis population includes participants who completed the engagement measure at the specified assessment timepoint.
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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=15 Participants
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.
|
Individual Teletherapy (IT)
n=17 Participants
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).
|
|---|---|---|
|
Engagement (8-item Scale)
|
3.74 Mean engagement score
Standard Error .12
|
4.79 Mean engagement score
Standard Error .12
|
PRIMARY outcome
Timeframe: Week 12Population: The analysis population includes participants who completed the GAD-7 measure at the specified assessment timepoint.
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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=15 Participants
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.
|
Individual Teletherapy (IT)
n=17 Participants
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).
|
|---|---|---|
|
Anxiety Symptoms (GAD-7)
|
14.91 GAD-7 total score
Standard Error 1.12
|
11.69 GAD-7 total score
Standard Error 1.19
|
PRIMARY outcome
Timeframe: Week 8Population: The analysis population includes participants who completed the GAD-7 measure at the specified assessment timepoint.
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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=15 Participants
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.
|
Individual Teletherapy (IT)
n=17 Participants
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).
|
|---|---|---|
|
Anxiety Symptoms (GAD-7)
|
13.79 GAD-7 total score
Standard Error 1.12
|
13.23 GAD-7 total score
Standard Error 1.19
|
PRIMARY outcome
Timeframe: Week 4Population: The analysis population includes participants who completed the GAD-7 measure at the specified assessment timepoint.
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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=13 Participants
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.
|
Individual Teletherapy (IT)
n=17 Participants
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).
|
|---|---|---|
|
Anxiety Symptoms (GAD-7)
|
13.09 GAD-7 total score
Standard Error 1.19
|
13.02 GAD-7 total score
Standard Error 1.19
|
PRIMARY outcome
Timeframe: BaselinePopulation: The analysis population includes participants who completed the GAD-7 measure at the specified assessment timepoint.
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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=20 Participants
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.
|
Individual Teletherapy (IT)
n=20 Participants
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).
|
|---|---|---|
|
Anxiety Symptoms (GAD-7)
|
10.01 GAD-7 total score
Standard Error 0.98
|
8.96 GAD-7 total score
Standard Error 1.05
|
PRIMARY outcome
Timeframe: BaselinePopulation: The analysis population includes participants who completed the PHQ-9 measure at 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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=20 Participants
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.
|
Individual Teletherapy (IT)
n=20 Participants
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).
|
|---|---|---|
|
Depressive Symptoms (PHQ-9)
|
10.62 PHQ-9 total score
Standard Error 0.99
|
9.90 PHQ-9 total score
Standard Error 1.08
|
PRIMARY outcome
Timeframe: Week 4Population: The analysis population includes participants who completed the PHQ-9 measure at the specified time point
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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=14 Participants
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.
|
Individual Teletherapy (IT)
n=17 Participants
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).
|
|---|---|---|
|
Depressive Symptoms (PHQ-9)
|
16.56 PHQ-9 total score
Standard Error 1.08
|
15.93 PHQ-9 total score
Standard Error 1.08
|
PRIMARY outcome
Timeframe: Week 8Population: The analysis population includes participants who completed the PHQ-9 measure at the specified time point
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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=15 Participants
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.
|
Individual Teletherapy (IT)
n=17 Participants
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).
|
|---|---|---|
|
Depressive Symptoms (PHQ-9)
|
16.02 PHQ-9 total score
Standard Error 0.99
|
15.30 PHQ-9 total score
Standard Error 1.08
|
PRIMARY outcome
Timeframe: Week 8Population: The analysis population includes participants who completed the PHQ-9 measure at the specified time point
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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=15 Participants
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.
|
Individual Teletherapy (IT)
n=17 Participants
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).
|
|---|---|---|
|
Depressive Symptoms (PHQ-9)
|
15.12 PHQ-9 total score
Standard Error 1.08
|
14.49 PHQ-9 total score
Standard Error 1.08
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants who engaged for all 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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=20 Participants
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.
|
Individual Teletherapy (IT)
n=20 Participants
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).
|
|---|---|---|
|
Completion Rate
|
15 Engagement completers
|
17 Engagement completers
|
SECONDARY outcome
Timeframe: Week 4Population: Participants who provided open-ended responses at Week 4 were included. Sentiment scores were summarized using medians and interquartile ranges due to non-normal distributions.
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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=7 Participants
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.
|
Individual Teletherapy (IT)
n=8 Participants
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).
|
|---|---|---|
|
User Feedback Sentiment
|
0.134 scores on a scale
Interval 0.044 to 0.17
|
0.217 scores on a scale
Interval 0.1 to 0.365
|
SECONDARY outcome
Timeframe: Week 8Population: Participants who provided open-ended responses at Week 8 were included. Sentiment scores were summarized using medians and interquartile ranges due to non-normal distributions.
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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=15 Participants
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.
|
Individual Teletherapy (IT)
n=17 Participants
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).
|
|---|---|---|
|
User Feedback Sentiment
|
0.38 scores on a scale
Interval 0.18 to 0.56
|
0.45 scores on a scale
Interval 0.26 to 0.63
|
SECONDARY outcome
Timeframe: Week 12Population: Participants who provided open-ended responses at Week 12 were included. Sentiment scores were summarized using medians and interquartile ranges due to non-normal distributions.
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.
Outcome measures
| Measure |
Guided Group Therapy (GGT) Via TheraGroup
n=15 Participants
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.
|
Individual Teletherapy (IT)
n=17 Participants
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).
|
|---|---|---|
|
User Feedback Sentiment
|
0.39 scores on a scale
Interval 0.281 to 0.476
|
0.393 scores on a scale
Interval 0.255 to 0.476
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place