Guided Group Telehealth to Deliver Evidence-based Therapeutic Care to Black College Students
Phase: NA
Conditions: Anxiety Depression
Sponsor: Dr. Veronica Tetterton

Study Protocol and Informed Consent Form 
Official Study Title: Guided group telehealth to deliver evidence-based therapeutic care to Black college 
students 
NCT Number:  
Date of Document: 01/31/2025 

 
 
Office of Research, Innovation & Sponsored Programs 
P.O. Box 519, Mail Stop 2800   Prairie View, Texas 77446 
Phone (936) 261-1553    Fax (936) 261-3529 
 
To: 
Anne Lippert, Ph.D., Principal Investigator 
 
From: 
Dennis Daniels, Ph.D. 
IRB Chair 
 
Date:  
January 31, 2025 
 
Re: 
 
IRB Protocol #2024-044 
Guided Group Telehealth to Deliver Evidence-Based Therapeutic Care to Black 
College Students 
 
The amendment to your IRB Protocol submitted on January 16, 2025 has been approved. Please 
continue to only use the consent tools with the “PVAMU Approved” stamp. 
 
Any future correspondence regarding this study should reference the Protocol Title and Number. 
 
 
 
 
Dennis Daniels, Ph.D. 
IRB Chair 
Email: dedaniels@pvamu.edu 
 
PLEASE NOTE: As the principal investigator of this study, you assume the following 
responsibilities: 
 Record Retention: Records must be retained for at least 3 years after study completion. 
 Amendments: Changes to research study activities may not be initiated without IRB 
approval. 
 Unanticipated Problems/Adverse events: Any unanticipated problems/adverse events 
must be reported to the IRB immediately. 
 Informed Consent/Assent: If applicable, all subjects must be given a copy of the 
consent/assent document approved by the IRB (see attached). 
 Completion: Once the study is complete, you must complete the IRB-Completion-
Report-Form.pdf (pvamu.edu) and submit it to the Office of Research Compliance at 
researchcompliance@pvamu.edu. 
Docusign Envelope ID: 49B8E73D-0D1D-4244-8EC6-B0A18738A599

January 16th, 2025  
To: Institutional Review Board (IRB) Committee  
From: Dr. Anne Lippert  
Subject: Request for Amendment to Approved Study – Additional Question   
Study Title: Guided group telehealth to deliver evidence-based therapeutic 
care to Black college students  
IRB Protocol Number: 2024-044  
Dear Members of the IRB Committee,  
We are writing to request an amendment to our approved study protocol to 
add an additional question to assess suicidality. If students are suicidal, we 
want to eliminate them from the study, provide access to resources for them, 
and alert student counseling services. We have attached 1. Our approved IRB 
protocol with a revised procedure on pg 8 of the protocol itself, indicating the 
suicidal risk assessment question, and the suicide risk assessment question 
itself on the bottom of page 18. 2. The sections we changed as individual 
documents so you do not need to search for the changes in the IRB protocol 
itself. We appreciate your time and effort in reviewing this amendment and 
are happy to provide any additional information or clarification as needed.  
Anne M. Lippert 
Assistant Professor,  
Department of Psychology 
Prairie View A&M University 
Received 1/16/2025

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Participants will access the study via an online link provided by email or via word of mouth. 
After providing basic demographic and their email address (to receive payment), they will then 
answer a question to assess their suicide risk. If they have not had suicidal thoughts in the 
previous three weeks, they will continue on to the study. If they indicate they have had such 
thoughts in the prior three weeks, they will be disqualified from the study and a screen will 
appear with contact  information regarding mental health resources (see attached survey 
measures). Dr. Lippert will then explain the situation to Student Counseling Services and 
provide the student's contact information (email address) to them. Student Counseling Services 
will then make contact with the student and carry out protocols they have in place to help 
suicidal students. For those students who continue with the study, they will take the PHQ‐9 and 
the GAD‐7 to measure their depression and anxiety levels. If they score 5 or above on either 
test they will be invited to participate in the therapy part of the study. In this part of the study 
the participant will be assigned to either receive individual teletherapy or group teletherapy for 
12 weeks. This therapy takes place via text. Participants may be asked to read 
psychoeducational materials and complete homework assignments. Participants assigned to 
the individual therapy, will receive support in the form of direct asynchronous communication 
with the therapist. Participants assigned to the group therapy will receive support in the form 
of direct asynchronous communication with the therapist and asynchronous communication 
with peers struggling with similar issues. Throughout the at week 4, 8 and12 of therapy, 
participants will take the GAD‐7, PHQ‐9, and self‐report questionnaires to measure their 
engagement and experience. 
 
 

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Office of Research, Innovation & Sponsored Programs 
P.O. Box 519, Mail Stop 6000   Prairie View, Texas 77446 
Phone (936) 261-1553    Fax (936) 261-3529
To: 
Anne Lippert, Ph.D., Principal Investigator 
From: 
Dennis Daniels, Ph.D. 
IRB Chair 
Date: 
October 28, 2024 
Re: 
IRB Protocol #2024-044 
The IRB protocol application submitted by you titled “Guided Group Telehealth to Deliver 
Evidence-Based Therapeutic Care to Black college students” has been deemed expedited and 
approved on October 28, 2024. 
Any future correspondence regarding this study should reference the Protocol Title and Number. 
Please also make sure to use the consent forms with the “PVAMU Approved” Stamp.  
Dennis Daniels, Ph.D. 
IRB Chair 
Office: 936-261-3070 
PLEASE NOTE: As the principal investigator of this study, you assume the following 
responsibilities: 

Record Retention: Records must be retained for at least 3 years after study completion.

Amendments: Changes to research study activities may not be initiated without IRB
approval.

Unanticipated Problems/Adverse events: Any unanticipated problems/adverse events
must be reported to the IRB immediately.

Informed Consent/Assent: If applicable, all subjects must be given a copy of the stamped
consent/assent document approved by the IRB (see attached).

Completion: Once the study is complete, you must complete the IRB-Completion-
Report-Form.pdf (pvamu.edu) and submit it to the Office of Research Compliance at
researchcompliance@pvamu.edu.
Docusign Envelope ID: A3BBBFFD-F3F8-4757-803A-2019643C27F7

Page 1 of 13 
DO NOT BEGIN RESEARCH WITH HUMAN SUBJECTS UNTIL IRB APPROVAL IS RECEIVED 
IRB FORM-01 
Revised 07/2018 
Prairie View A&M University 
IRB Protocol Application 
INSTRUCTIONS 
1. Complete Training
PI, Co-Investigator and anyone interacting with potential participants must complete necessary training.
Refresher training must be completed every three years. More details can be found at: http://www.pvamu.edu/research/office- 
of-research-compliance/207-revision-v1/irb-training/
2. Complete Form
Form must be typed and free of typographical/grammatical errors.
3. Attach Documents to Application
Recruitment materials as applicable: flyers, letters, scripts, e-mail, etc. 
Consent documentation as applicable: consent protocol, consent form or assent form 
Survey and/or Interview Questions 
Funding Proposals (as applicable) 
Any other documents referenced in this application as applicable 
4. Submit Application
Submit the complete IRB protocol (application and required documentation) to the Office of Research and Compliance,
Wilhelmina Delco Building, Room #163 in person or by email at research@pvamu.edu.
Review of proposal will not begin until the complete protocol is received.
Warning: The following is considered protocol non-compliance: 
a.) personnel beginning research with human subjects before being added to the approved IRB protocol; 
b.) proceeding with the protocol before obtaining final IRB approval; 
c.) failing to follow the established criteria or procedures that were approved by the IRB; 
d.) adding, removing or modifying a research instrument (or adding to an existing instrument) in a survey study without prior IRB 
approval unless the changes are within a range of anticipated potential changes specified as acceptable within the IRB 
approval; and 
e.) implementing any change in the protocol without IRB approval is considered protocol non-compliance. 
Non-compliance may result in a report being made to the funding agency listed on this protocol and/or the Office of Human Research 
Protections (OHRP).  PVAMU's Federalwide Assurance (FWA) with OHRP is restricted to research funded by the Department of Health 
and Human Services.  However, the same process for conducting investigations and taking actions by the IRB will apply to all research 
regardless of funding source. PVAMU reserves the right to voluntarily report any event that is not associated with federal funding to OHRP. 
If you have any questions or need assistance completing this application, please call 
Crysta Mendes (936) 261-1553, or e-mail research@pvamu.edu 
IRB USE ONLY 
Last Name  
IRB# 
✔
✔
✔
✔
✔
Lippert 
2024-044
Received 7/8/2024

Page 2 of 13 
DO NOT BEGIN RESEARCH WITH HUMAN SUBJECTS UNTIL IRB APPROVAL IS RECEIVED 
 
  
INVESTIGATOR INFORMATION  
 
Principal Investigator Name: 
 
 
Faculty 
Staff 
Graduate Student* 
Undergraduate Student* 
Department: 
 
 
College:   
 
 
Mailing Address (if not PVAMU): 
Phone: 
 
 
Fax: 
 
 
E-mail:    
 
 
Co - Investigator Name:    
 
 
 
 
 
 
 
Faculty 
Staff  
 
Graduate Student* 
Undergraduate Student* 
Department: 
College: 
Mailing Address (if not PVAMU): 
Phone: 
 
Fax: 
 
E-mail:    
 
Please list additional investigators (if applicable):     
 
 
 
 
 
*For Students: Answer the following and list your faculty advisor 
Is this study part of your Thesis or Dissertation? 
 
If Yes, do you have approval from your Thesis/Dissertation Committee? 
Yes 
Yes 
No 
No 
 
Graduate Committee Chair/Faculty Advisor Name:    
 
 
Department: 
 
 
College: 
 
Mailing Address (if not PVAMU): 
 
 
 
Phone: 
 
Fax: 
 
E-mail: 
Project Title: 
 
 
 
Anticipated Start and End Dates: 
 
 
Funding Status: 
Externally Funded* 
Grant Application* 
Internally Funded* 
Not Funded 
 
Other    
 
Funding Agency (if applicable):    
 
*Must include a draft of the grant application. Once grant is completed/submitted, a final draft must be submitted to the IRB. 
 
 
Does this protocol require approval from multiple IRBs? 
Yes, please state below 
No, only from PVAMU IRB 
 
 
Anne Lippert
✔
Psychology
Arts and Sciences
(936) 261-5267
amlippert@pvamu.edu
8/2024-8/2028
✔
NIH
✔
Guided group telehealth to deliver evidence-based therapeutic care to 
Black college students

Page 3 of 13 
DO NOT BEGIN RESEARCH WITH HUMAN SUBJECTS UNTIL IRB APPROVAL IS RECEIVED 
 
  
PURPOSE OF STUDY  
 
Provide a brief statement, in lay terminology, outlining the purposes of this study. The following issues must be addressed: 
a. 
Why are you doing this research project and what do you propose to learn? 
b. 
What is the justification for doing the study? Include, as appropriate, preliminary data and/or references to previous 
research, or gaps in our knowledge. 
If you need more space, put "see attached" in the box and attach your complete purpose of study statement. Please title the attachment. 
 
 
 
  
RISKS AND BENEFITS  
 
 
Describe any potential risks or discomforts to the participant (including physical, psychological and/or social): 
Risks to subjects are rated as “Low”, “Medium”, “High”. Do not say “none”. 
 
 
Describe any potential benefits to the research participant or society: 
 
Describe alternatives to participation/opportunity to withdraw: 
 
 
  
SUBJECT RECRUITMENT  
 
 
Number of participants (target population): 
 
Ages of Participants:    
 
 
Gender of subjects: 
Male 
Female 
 
Maximum anticipated sample size: 
What are the selection criteria for participation (i.e. include target population and maximum anticipated sample size)? 
For clarification on target population and maximum anticipated sample size, please refer to FAQ #35 on the PVAMU IRB website. 
 
 
The current mental health crisis across college campuses particularly impacts students at Historically 
Black Colleges and Universities (HBCUs), who, compared to their Predominantly White Institution 
(PWI) counterparts, have fewer resources and less funding to support student psychological health 
[1]. While online therapy offers benefits, it does not solve the issue that the number of available 
therapists is insufficient to treat the number of students seeking help [2]. A promising solution is to 
increase opportunities for group therapy, which is equivalent to individual therapy in terms of 
outcomes [3]. As such, the purpose of our study is to assess the impact of an online, group text based
 therapy (one mental health counselor to many students) against a one-to-one (one mental health 
counselor to one student) therapy among HBCU students. Specifically, we will compare a HIPPA 
compliant, guided group telehealth (GGT) therapy (group therapy) called TheraGroup against a 
HIPPA compliant individual telehealth (IT) therapy (individual therapy) on measures of engagement, 
user experience, and mental health outcomes. If outcome measures in the GGT group are in line with 
outcome measures in the IT group, the feasibility study will serve as a precursor to testing the effects 
f GGT i
Th
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participants may be at risk of psychological harm. As the survey measures and therapy intervention 
ask participants to explore their mental health, specifically difficulties they may be having and traumatic
 events they have previously experienced, this process may exacerbate pre-existing mental health 
Participants in this study will benefit from receiving mental health treatment from qualified 
professionals. Identifying effective group telehealth therapies to increase the access to mental health 
interventions contributes not only to the expansion of scientific knowledge within the field of mental 
health, but also to practical applications. Based on the findings of this study, interventions, trainings, 
and supports can be developed to treat mental illness in Black college students. This has potential 
b
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Participants may withdraw at any time
8000
18 years or older
✔
Participants must be Black college students attending Prairie View A&M University (PVAMU) who are 
at least 18 years of age, and who qualify for psychological clinical intervention based on their current 
levels of depression and anxiety. 
200
✔

Page 4 of 13 
DO NOT BEGIN RESEARCH WITH HUMAN SUBJECTS UNTIL IRB APPROVAL IS RECEIVED 
 
Do the criteria for selection exclude individuals based on gender, culture, language, economic status or ethnicity? 
 
Yes 
No 
 
If yes, please justify exclusion: 
 
 
Are there any special physical or psychological conditions of subjects? (If so, please describe.) 
 
 
Source of participants: 
 
PVAMU students (provide explanation below) 
Community (provide explanation below) 
Schools* (provide explanation below) 
Other (provide explanation below) 
 
 
 
 
For studies involving schools: 
Does the study involve a school district? 
Yes 
No 
 
If Yes, which school district(s)?:   
 
 
*Note: If the study involves a school district, approval must be obtained from the school district. 
 
 
 
 
Vulnerable Populations: 
 
Not applicable 
Children 
Pregnant women 
Prisoners 
Adults who lack ability to consent 
Employees 
Other, describe:   
 
If vulnerable populations will be used, please describe additional safeguards to protect their rights and welfare: 
✔
✔
We are excluding non-Black individuals. The telehealth program we are testing is tailored for the 
Black population and thus we would like to test it on a matching sample.
Participants who score a 5 or more on the GAD-7 (anxiety) or the PHQ-9 (depression) will qualify for 
the therapeutic intervention aspect of the study. These scores represent at least a minimal level of 
anxiety and depression.
✔
Participants will be Black college students attending PVAMU
✔
✔
N/A

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DO NOT BEGIN RESEARCH WITH HUMAN SUBJECTS UNTIL IRB APPROVAL IS RECEIVED 
 
Recruitment Method (all flyers, advertisements, etc. are subject to IRB review): 
 
Telephone solicitation (attach script) 
Radio (attach script) 
Television (attach script) 
 
Newspaper advertising (attach ad copy) 
Posted notices (attach copy) 
Letter (attach copy) 
 
E-mail (attach copy of text to be sent for recruitment) 
 
Direct person-to-person contact, describe:   
 
Other, describe: 
 
 
 
 
How will initial contact be made with potential participants? (be specific) 
 
 
 
Other than as an Investigator, do you have any other relationship with participants? (i.e. doctor-patient, teacher-student, 
counselor-student, etc.) 
Yes 
No 
 
If Yes, explain the relationship and describe how you will avoid any type of coercion: 
 
 
✔
✔
We will inform the student counseling center about the study and provide referral information
Participants will initially be made aware via an email sent to all PVAMU students. For students 
attending the mental health services at PVAMU, a mental health professional may tell them about the 
study.
✔
It is possible the PI may be a professor of some of the participants. However, no direct contact 
regarding the study will be made in this relationship capacity and she will not be recruiting 
participants directly through her courses.

Page 6 of 13 
DO NOT BEGIN RESEARCH WITH HUMAN SUBJECTS UNTIL IRB APPROVAL IS RECEIVED 
 
  
CONSENT  
 
LOCATION 
Describe the setting where the consent process will take place (i.e. classroom, office, park, personal computer, etc.): 
 
 
 
PERSONNEL 
Name individuals or group of individuals who will be speaking directly to potential participants during the consent process: 
 
 
 
CONSENT TOOLS 
Please check all that apply and attach to the application: 
Cover Letter 
Adult Consent Form 
Information Sheet 
Minor Assent Form 
Telephone Script 
Parental Consent Form 
Location where consent forms will be filed: 
(Consent forms must be kept on file for 3 years after completion of the study and data analysis) 
 
 
 
WAIVER 
Request for waiver of informed consent or waiver of documentation of informed consent: 
Yes 
No 
 
If Yes, explain below: 
 
 
If the consent is in person, this will take place in Dr. Lippert's office, rm 219 Don Clark Hall, where Dr. Lippert will provide 
a paper version of the consent form that students will sign with a pen. If the consent will take place online via an electronic 
device such as a phone or computer, participants will receive the consent form via docusign. Through docusign they can 
sign electronically to indicate their consent. 
Dr. Lippert will be available to participants to answer any questions as they read through the consent 
form. Her contact information is available on the consent form.
✔
All data and forms including consent forms will be kept on a password protected computer in Dr. 
Lipperts office in Don Clark Hall, rm 219
✔

Page 7 of 13 
DO NOT BEGIN RESEARCH WITH HUMAN SUBJECTS UNTIL IRB APPROVAL IS RECEIVED 
 
  
COMPENSATION / COURSE CREDIT  
 
 
Will monetary compensation be given to the participant? 
Yes 
No 
 
If Yes, explain below and attach a detailed compensation of payment including amount and schedule of payments to 
participant: 
 
 
 
Will course credit be given to the participant as compensation? 
Yes 
No 
 
If Yes, provide details below and alternate assignment to obtain equal credit: 
 
 
 
  
SUBJECT MATTER  
 
 
Check the appropriate box(es) concerning the subject matter of the research: 
No sensitive matters 
Learning disability 
Abortion 
Physical disability 
AIDS/HIV 
Psychological inventory 
Alcohol 
Review of criminal records 
Body composition 
Review of educational records 
Criminal activity 
Sexual Activity 
Depression 
Suicide 
Drugs 
Other, specify:   
 
 
  
DECEPTION OR COERCION  
 
Will deception or coercion be used? 
Yes 
No 
 
If Yes, attach debriefing form and briefly describe deception: 
 
 
✔
Participants will receive payment in the form of Amazon gift cards. Our study has 4 time points in 
which participants may be compensated for their time. These time points are listed below along with 
the amount participants receive for taking part in each time point.
Time               Compensation 
Time 1: before therapy started   $5
Time 2: 4 weeks after therapy has started  $50
Time 3: 8 weeks after therapy has started  $100
✔
✔
✔
general mental health issues
✔

Page 8 of 13 
DO NOT BEGIN RESEARCH WITH HUMAN SUBJECTS UNTIL IRB APPROVAL IS RECEIVED 
 
  
PROCEDURES  
 
What will participants be asked to do? (Describe the study in detail from recruitment to completion) 
If you need additional space, put "see attached" in the box below and attach complete description of procedures. 
 
 
 
Describe the location where research activities will take place: 
 
 
How long will the participants be engaged in research? (length of time, i.e. 15 minutes on day 1, etc.): 
 
 
During data collection, describe what steps will be taken to ensure participant privacy: 
 
 
Is the research anonymous or confidential? (Cannot be both) 
Anonymous: The identity of the participant cannot be readily determined by the investigator AND the identity of the 
participant is not connected to information gathered. 
Confidential: Research participants can be identified; however, information gathered will be protected. 
 
Provisions for anonymity/confidentiality: 
Secure storage (required) 
 
Replies coded 
 
What specific steps will be followed to ensure anonymity or confidentiality of participants' responses? 
 
 
Participants will access the study via an online link provided by email or via word of mouth. Next, they
will take the PHQ-9 and the GAD-7 to measure their depression and anxiety levels. If they score 5 or
above on either test they will be invited to participate in the therapy part of the study. In this part of
the study the participant will be assigned to either receive individual teletherapy or group teletherapy
for 12 weeks. This therapy takes place via text. Participants may be asked to read
psychoeducational materials and complete homework assignments. Participants assigned to the
individual therapy, will receive support in the form of direct asynchronous communication with the
therapist. Participants assigned to the group therapy will receive support in the form of direct
asynchronous communication with the therapist and asynchronous communication with peers
struggling with similar issues. Throughout the at week 4, 8 and12 of therapy, participants will take the
GAD-7, PHQ-9, and self-report questionnaires to measure their engagement and experience.
The research will take place on participants personal electronic devices by logging on to the 
web-based TheraGroup platform.TheraGroup is aproprietary real-time virtual based platform that 
provides text based group therapy. It is is a cloud software that offers HIPAA compliant asynchronous 
text chat.
up to 12 weeks
Due to the longitudinal design of this project, collecting identifiable data is necessary.
Specifically, participants’ names and contact information are needed to match participant information 
at different time points and to contact participants about distributing their gift card compensation. In 
order to preserve participant confidentiality and minimize the potential harm of participant information 
being identified, participants’ will be prompted to create an identification number comprised of the first 
two letters of their last name combined with the last four digits of their phone number (e.g., Jane 
D
’
ti i
t ID
b
ld b
DO1234) Thi ID
b
ill
ll
h
t
t h
✔
✔
The participant ID and identifying information (name-code-index) as described above will be stored on a password 
protected spreadsheet. Only Dr. Lippert and her team will have the ability to de-identify participants. Disclosure of data via 
research dissemination methods such as presentations at conferences and in study related publications will not contain 
identifying information. In addition, for the group therapy, participants use a name they make up for the purpose of the 
group only to ensure they remain anonymous. The therapy contains no face to face modalities. It all occurs via text based 
communication.

Page 9 of 13 
DO NOT BEGIN RESEARCH WITH HUMAN SUBJECTS UNTIL IRB APPROVAL IS RECEIVED 
 
  
DATA COLLECTION  
 
Research Type: 
Qualitative 
Quantitative 
Both 
Will any new data or documents be collected? (i.e. public records, survey instruments, evaluation tools, etc.) 
Yes 
No 
 
If Yes, describe what data or documents will be used and how they will be obtained: 
 
 
Will recordings be made? 
Yes 
No 
 
If Yes:  
Video Taping 
Audio Taping 
Mandatory Recording 
Voluntary Recording 
Is the use of recordings detailed in the consent form? 
Yes 
No 
 
Will recordings be retained? 
Yes 
No 
 
If Yes, how long will records be retained before they are destroyed/erased? 
 
 
 
Will any new specimens be collected? (i.e. blood tissue, etc.) 
Yes 
No 
 
If Yes, describe what specimens will be used and how they will be obtained: 
 
Does the experiment involve the use of human fluid, tissue and/or blood? 
Yes 
No 
✔
✔
 Data will include the following: 1. Behavioral data (events that occur in the system due to students interacting with the system; e.g., time spent logged on)
2. Self-report data (measures of engagement, user experience surveys, the PHQ and GAD7 scores). Participant data will be
collected via the TheraGroup systems backend in the form of log data (Behavioral Data) or through Qualtrics (Depression and Anxiety scores, measures 
of engagement, user experience surveys).
✔
✔
✔

Page 10 of 13 
DO NOT BEGIN RESEARCH WITH HUMAN SUBJECTS UNTIL IRB APPROVAL IS RECEIVED 
 
Will any invasive or sensitive procedures be done? 
Yes 
No 
 
If Yes, check all that apply: 
Blood Samples 
Physical Measurements (electrodes, etc) 
rDNA 
Stress Exercise 
Urine Samples 
Other, specify:  
 
 
 
 
  
DOCUMENT RETENTION  
 
Federal regulations require that human research documents be retained for a minimum of three years 
AFTER the completion of the study AND data analysis. Some disciplines or granting agencies require 
longer retention times. 
 
Length of time retained after completion of study and data analysis: 
 
 
 
Person responsible for data retention (If you are a student, please list faculty mentor) & data storage location: 
 
 
 
 
  
OTHER COMPLIANCE ISSUES  
 
 
If the study involves the use of animals, infectious biohazards (e.g. blood), and/or recombinant DNA, it is required that 
approval be granted for the use of such through the appropriate compliance committee. 
✔
At least three years
All data will be kept on a password protected computer in Dr. Lippert's office in Rm 219 in Don Clark 
Hall.

Page 11 of 13
DO NOT BEGIN RESEARCH WITH HUMAN SUBJECTS UNTIL IRB APPROVAL IS RECEIVED
SIGNATURE ASSURANCES
PRINCIPAL INVESTIGATOR
I understand Prairie View A&M University's procedures concerning research involving human subjects and by initialing
below, I certify:
I have read The Belmont Report “Ethical Principles and Guidelines for the Protection of Human Subjects of
Research” and subscribe to the principles it contains.
I accept responsibility for the scientific and ethical conduct of this research study.
I will obtain prior approval from the Institutional Review Board (IRB) before amending or altering the research
protocol or implementing changes in the approved consent form and/or information sheet.
I will immediately report to the IRB any unanticipated effects on subjects which may occur as a result of this study.
I will retain the consent forms and other research documents in a locked/secure manner for a minimum of three
years. Students must turn over all documents to the primary faculty advisor upon completion of the study in most
cases.
I will complete, on request by the IRB, the Continuation/Final Review forms.
I do not have a personal/financial conflict of interest and I have submitted my Financial Conflict of Interest Disclosure
Statement in Maestro (if applicable).
(If you have a conflict of interest, you must specify - as an attachment - the conflict of interest and describe
what safeguards are in place to ensure that the conflict of interest does not affect the experimental results.)
I have reviewed all forms and documents being submitted.
Principal Investigator Signature:
Typed Name:
Date:
FACULTY / RESEARCH ADVISOR
I certify that I have read and agree with this proposal, that the Principal Investigator has received adequate training to
perform this research, and will receive adequate supervision while performing this research:
By initialing, I certify that I do not have a personal/financial conflict of interest and I have submitted my Financial
Conflict of Interest Disclosure Statement in Maestro (if applicable).
(If you have a conflict of interest, you must specify - as an attachment - the conflict of interest and describe
what safeguards are in place to ensure that the conflict of interest does not affect the experimental results.)
Faculty/Research Advisor Signature:
Typed Name:
Date:
below, I ce
I h
R
I a
I w
pr
I w
I
c
I
I
S
wh
I ha
Anne Lippert
6/26/2024

Page 12 of 13 
DO NOT BEGIN RESEARCH WITH HUMAN SUBJECTS UNTIL IRB APPROVAL IS RECEIVED 
 
CO-INVESTIGATOR or PERSONNEL 
(If needed, print additional copies for studies with more than one Co-Investigator or Personnel) 
 
I understand Prairie View A&M University's procedures concerning research involving human subjects and by initialing 
below, I certify: 
 
  
I  have  read  The  Belmont  Report  “Ethical  Principles  and  Guidelines  for  the  Protection  of  Human  Subjects  of 
Research” and subscribe to the principles it contains. 
 
I accept responsibility for the scientific and ethical conduct of this research study. 
 
I will obtain prior approval from the Institutional Review Board (IRB) before amending or altering the research 
protocol or implementing changes in the approved consent form and/or information sheet. 
 
I will immediately report to the IRB any unanticipated effects on subjects which may occur as a result of this study. 
 
 
  
I will retain the consent forms and other research documents in a locked/secure manner for a minimum of three 
years. Students must turn over all documents to the primary faculty advisor upon completion of the study in most 
cases. 
 
  
I will complete, on request by the IRB, the Continuation/Final Review forms. 
 
  
I do not have a personal/financial conflict of interest and I have submitted my Financial Conflict of Interest Disclosure 
Statement in Maestro (if applicable). 
(If you have a conflict of interest, you must specify - as an attachment - the conflict of interest and describe 
what safeguards are in place to ensure that the conflict of interest does not affect the experimental results.) 
 
  
I have reviewed all forms and documents being submitted. 
 
 
Co-Investigator or Personnel Signature: 
 
 
Typed Name: 
Date: 
 
 
 
 
 
 
FACULTY / RESEARCH ADVISOR 
 
I certify that I have read and agree with this proposal, that the Principal Investigator has received adequate training to 
perform this research, and will receive adequate supervision while performing this research: 
 
  
By initialing, I certify that I do not have a personal/financial conflict of interest and I have submitted my Financial 
Conflict of Interest Disclosure Statement in Maestro (if applicable). 
(If you have a conflict of interest, you must specify  - as an attachment  - the conflict of interest and describe 
what safeguards are in place to ensure that the conflict of interest does not affect the experimental results.) 
 
Faculty/Research Advisor Signature: 
 
 
 
Typed Name: 
Date: 
 
 
 

Page 13 of 13 
DO NOT BEGIN RESEARCH WITH HUMAN SUBJECTS UNTIL IRB APPROVAL IS RECEIVED 
TRAINING 
(for office use only) 
PRINCIPAL INVESTIGATOR 
IRB Member: 
Social/Behavioral Research Course: 
YES 
YES 
NO 
NO 
Date: 
Date: 
IRB accepts Alternative Training: 
YES 
NO 
Date: 
YES 
NO 
Date: 
CO-INVESTIGATOR or PERSONNEL (if more than one Co-Investigator or Personnel, please write training completion 
dates on a separate page) 
IRB Member: 
YES
NO
Date: 
Social/Behavioral Research Course: 
YES
NO
Date: 
IRB accepts Alternative Training: 
YES
NO
Date: 
YES
NO
Date: 
Training Reviewer: 
Date: 
PROTOCOL APPROVAL 
(for office use only) 
EXEMPT 
Declared by: 
Date: 
EXPEDITED 
Approved - Reviewer 1: 
Date: 
Approved - Reviewer 2: 
Date: 
FULL REVIEW 
Referred for Full Review: 
Date: 
Approved: 
Date: 
Date of Full Review (attach minutes):     
X
X
Lippert
Expires: 10/28/2024 
Synthea Horton
7/9/2024
X
Dennis Daniels, Ph.D.
10/28/2024

 
PRAIRIE VIEW A&M UNIVERSITY  
OFFICE OF RESEARCH COMPLIANCE  
CONSENT FORM 
 
 
 
 
THIS PROJECT HAS BEEN REVIEWED BY THE 
PRAIRIE VIEW A&M UNIVERSITY INSTITUTIONAL REVIEW BOARD  
FOR THE PROTECTION OF HUMAN SUBJECTS.   
Phone:  (936) 261-1553, Office of Research & Innovation 
 
1 of 3 
 
TITLE OF STUDY: Guided group telehealth to deliver evidence-based therapeutic care to Black 
college students 
 
PROTOCOL NUMBER: 
 
DEAR STUDY PARTICIPANT: 
 
You are invited to participate in a research study about the effectiveness of virtual group therapy in 
Black college students. You were selected as a possible participant because you are  
We ask that you read this form and ask any questions you may have before agreeing to be in the 
study. 
 
This study is being conducted by: Dr. Anne Lippert, Department of Psychology, Prairie View A&M 
University 
 
Background Information 
 
The purpose of this study is to investigate the impact of virtual group therapy on mental health in 
Black college students 
 
Procedures: 
 
If you agree to participate in this study, we will ask you to do the following things: 
First you will access  the  study  via an  online link. Next,  you will complete two mental health 
assessments. At this point you may be asked to continue on in the study. If you decide to do so you 
will receive either individual  teletherapy or  group  teletherapy for 12  weeks.   This  therapy  may 
take  place  via video,  audio  or  text. You  may  be asked  to  read psychoeducational  materials  
and  complete  homework   assignments as part of the therapy. Throughout the 12 weeks you will be 
asked to report on your experiences and take mental health assessments. 
 
Risks and Benefits of participating in the Study 
 
By participating in this study, you  may be  at risk of psychological harm. As the study asks you to 
explore your  mental  health,  specifically   difficulties  you  may  be having  and  traumatic events  
you  have previously   experienced,   this process   may exacerbate   pre-existing   mental health 
issues. However, we believe these risks are low to medium and no greater than those encountered in 
everyday life. In addition, you are free to withdraw from the study at any time. 
 
Participants in this study will benefit from receiving mental health treatment from qualified mental  
health professionals. In addition,  based  on the  findings  of this  study,  interventions,   trainings,  

 
PRAIRIE VIEW A&M UNIVERSITY  
OFFICE OF RESEARCH COMPLIANCE  
CONSENT FORM 
 
 
 
 
THIS PROJECT HAS BEEN REVIEWED BY THE 
PRAIRIE VIEW A&M UNIVERSITY INSTITUTIONAL REVIEW BOARD  
FOR THE PROTECTION OF HUMAN SUBJECTS.   
Phone:  (936) 261-1553, Office of Research & Innovation 
 
2 of 3 
 
and supports can be  developed  to  treat  mental  illness  in Black  college  students.  This  has  
potential benefits  for  stakeholders, including  college  campuses   and the  communities   they 
serve,  by  increasing the psychological alternatives and improving the health and well-being of 
students. 
 
 
Compensation: 
 
You will receive payment in the form of Amazon gift cards. There are four time points in our study 
during which you may receive payment: Prior to therapy ($5.00), then four weeks after therapy has 
begun ($50.00), eight weeks after therapy has begun ($100.00), and 12 weeks after therapy has 
begun ($150.00). The  amazon  gift cards  will  be sent  to the  email  address you provided no later  
than two weeks after the corresponding time period.  
 
Confidentiality: 
 
The records of this study will be kept private. In all reports resulting from this study, we will not 
include any information that will make it possible to identify you as a participant.  Research records 
will be stored securely and only researchers will have access to the records.  
 
Voluntary Nature of the Study: 
 
Participation in this study is voluntary. Your decision whether or not to participate will not affect 
your current or future relations with Prairie View A&M University. If you decide to participate, you 
are free to not answer any question or withdraw at any time without affecting those relationships.  
 
Contacts and Questions: 
The researchers conducting this study are: Dr. Anne Lippert.  
You may ask any questions you have now. If you have questions later, you are encouraged to 
contact the Principal Investigator at 219 Don Clark Hall, 936.261.5267, amlippert@pvamu.edu.  
 
If you have any questions or concerns regarding this study and would like to talk to someone other 
than the researcher(s), you are encouraged to contact the Office of Research Compliance at 
(researchcompliance@pvamu.edu)  in the Office for Research and Innovation, P.O. Box 519; MS 
2800   Prairie View, Texas 77446 Phone 936.261.1553.   
 
You will be given a copy of this information to keep for your records. 
 
 
 

PRAIRIE VIEW A&M UNIVERSITY  
OFFICE OF RESEARCH COMPLIANCE 
CONSENT FORM 
THIS PROJECT HAS BEEN REVIEWED BY THE 
PRAIRIE VIEW A&M UNIVERSITY INSTITUTIONAL REVIEW BOARD 
FOR THE PROTECTION OF HUMAN SUBJECTS.   
Phone:  (936) 261-1553, Office of Research & Innovation 
3 of 3 
Statement of Consent: 
I have read the above information. I have asked questions and have received answers. I consent to 
participate in the study. 
Signature:____________________________________________ Date: __________________ 
Signature of Investigator:________________________________ Date: _________________ 

Subject: Opportunity to Participate in a Research Project 
Dear PVAMU students, 
My name is Dr. Anne Lippert and I am an Assistant Professor in the Psychology Department at 
PV. I am emailing you to invite you to be part of a research project about virtual group mental 
health therapy for Black college students. The purpose of the research is to determine how group 
telehealth therapy compares to individual telehealth therapy.  
If you participate in this project, you will be asked to first complete two mental health 
assessments. You may then be asked to continue the study and take part in a 12-week virtual 
therapy program. During this 12-week period you will be asked to complete activities related to 
the therapy, take mental health assessments, and provide feedback on your experience.  
If you participate in this study, you may be eligible to earn up to $305.00 in the form of an 
Amazon gift card over approximately 12 weeks of your time. Participation is voluntary, but I 
hope you will choose to be part of this project. To participate in the study you must be a Black 
PVAMU college student of 18 years or older. 
For more information, or to sign up, go to [enter study website here] or contact me at 
amlippert@pvamu.edu. 
Thanks,  
Anne Lippert, PhD 

PHQ-9 
 
Over the last 2 weeks, how often have you been bothered by any of the following problems?  
 
Scale: 0 = not at all; 1 = several days; 2 = more than half the days;  3 = nearly every day 
 
1.Little interest or pleasure in doing things  
2. Feeling down, depressed, or hopeless  
3. Trouble falling or staying asleep, or sleeping too much  
4. Feeling tired or having little energy  
5. Poor appetite or overeating  
6. Feeling bad about yourself or that you are a failure or have let yourself or your family down  
7. Trouble concentrating on things, such as reading the newspaper or watching television  
8. Moving or speaking so slowly that other people could have noticed. Or the opposite being so 
fidgety or restless that you have been moving around a lot more than usual  
9. Thoughts that you would be better off dead, or of hurting yourself 
 
GAD-7 
 
Over the last two weeks, how often have you been bothered by the following problems?   
Scale: 0 = not at all; 1 = several days; 2 = more than half the days;  3 = nearly every day 
 
 
1. Feeling nervous, anxious, or on edge 
2. Not being able to stop or control worrying 
3. Worrying too much about different things  
4. Trouble relaxing    
5. Being so restless that it is hard to sit still  
6. Becoming easily annoyed or irritable    
7. Feeling afraid, as if something awful might happen 
 
 
 
Engagement  
 
On a scale from 1 to 5 with 1 being not at all to 5 being completely, rate how much the following 
statement applies to your experience with the telehealth therapy program: 
 
 
 
1. I was interested in the therapy 
2. I was intrigued when i used the telehealth therapy services 
3. I was focused when I used the telehealth therapy services 
4. I enjoyed using the telehealth therapy services 

5. It was boring to use the telehealth therapy services 
6. I felt frustrated using the telehealth therapy services 
7. I found the telehealth services confusing 
8. I felt unmotivated to use the telehealth services 
 
User Feedback Experience 
 
1. What, if anything, did you enjoy about your experience in using the guided telehealth 
therapy? 
 
2. What, if anything, could be improved about your experience in using the guided telehealth 
therapy? 
 
3. Did you feel the psychoeducational content was culturally relevant to you as a Black 
individual? Please explain