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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43MD020009-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) Coping Skills Training | Behavioral | 12 Week CBT Coping Skills Training Modules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| User Feedback Sentiment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PVAMU | Prairie View | Texas | 77446 | United States |
For confidentiality purposes.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Participants who engaged for all 12 weeks. | Posted | Number | Engagement completers | 12 weeks |
|
From enrollment until completion of the study, up to 12 weeks
Adverse events were monitored across all enrolled participants. Due to the low frequency of adverse events and the small sample size, adverse events were not analyzed or reported separately by treatment arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All enrolled participants | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Lippert | Prairie View A&M University | 5058009144 | amlippert@pvamu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jan 31, 2025 | Nov 19, 2025 | Prot_ICF_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2025 | Nov 19, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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 |
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.
| 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. | 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. | Week 12 |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| PHQ-9 total score at baseline | The Patient Health Questionnaire-9 (PHQ-9) assesses depressive symptom severity. Scores range from 0 to 27, with higher scores indicating greater depressive symptoms. | Mean | Standard Deviation | points |
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| GAD-7 total score at baseline | The Generalized Anxiety Disorder 7 (GAD-7) assesses anxiety symptom severity. Scores range from 0 to 21, with higher scores indicating greater anxiety symptoms. | Mean | Standard Deviation | Points |
|
| 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). |
|
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| Primary | 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. | The analysis population includes participants who completed the engagement measure at the specified assessment timepoint. | Posted | Mean | Standard Error | Mean engagement score | Week 4 |
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| Primary | 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. | The analysis population includes participants who completed the engagement measure at the specified assessment timepoint. | Posted | Mean | Standard Error | Mean engagement score | Week 8 |
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| Primary | 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. | The analysis population includes participants who completed the engagement measure at the specified assessment timepoint. | Posted | Mean | Standard Error | Mean engagement score | Week 12 |
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| Primary | 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. | The analysis population includes participants who completed the GAD-7 measure at the specified assessment timepoint. | Posted | Mean | Standard Error | GAD-7 total score | Week 12 |
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| Primary | 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. | The analysis population includes participants who completed the GAD-7 measure at the specified assessment timepoint. | Posted | Mean | Standard Error | GAD-7 total score | Week 8 |
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| Secondary | 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. | 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. | Posted | Median | Inter-Quartile Range | scores on a scale | Week 4 |
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| Secondary | 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. | 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. | Posted | Median | Inter-Quartile Range | scores on a scale | Week 8 |
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| Secondary | 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. | 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. | Posted | Median | Inter-Quartile Range | scores on a scale | Week 12 |
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| Primary | 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. | The analysis population includes participants who completed the GAD-7 measure at the specified assessment timepoint. | Posted | Mean | Standard Error | GAD-7 total score | Week 4 |
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| Primary | 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. | The analysis population includes participants who completed the GAD-7 measure at the specified assessment timepoint. | Posted | Mean | Standard Error | GAD-7 total score | Baseline |
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| Primary | 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. | The analysis population includes participants who completed the PHQ-9 measure at baseline. | Posted | Mean | Standard Error | PHQ-9 total score | Baseline |
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| Primary | 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. | The analysis population includes participants who completed the PHQ-9 measure at the specified time point | Posted | Mean | Standard Error | PHQ-9 total score | Week 4 |
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| Primary | 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. | The analysis population includes participants who completed the PHQ-9 measure at the specified time point | Posted | Mean | Standard Error | PHQ-9 total score | Week 8 |
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| Primary | 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. | The analysis population includes participants who completed the PHQ-9 measure at the specified time point | Posted | Mean | Standard Error | PHQ-9 total score | Week 8 |
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| 40 |
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| 40 |
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| 40 |
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