DepressionNCT07240792
Development of a College Student-Delivered Cognitive-Behavioral Therapy (CBT) Intervention for Rural High School Students
A study testing Student Delivered Cognitive Behavioral Therapy Intervention in people with Depression and Anxiety, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This research is being done to find out the effectiveness, feasibility, and acceptability of a college student-delivered cognitive-behavioral therapy (CBT) intervention in high schools in rural Schuylkill County, Pennsylvania to treat mental health problems (i.e. depression and anxiety) in adolescents. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Depression, Anxiety, Stress
- What is being tested?
- Student Delivered Cognitive Behavioral Therapy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- High school students ages 13-19 years.
- Attending a participating rural high school in rural county in Pennsylvania.
- Presenting with self-reported symptoms of depression, anxiety, or stress. Must have a t-score ≥ 55 on one or more of the following three measures:
- PROMIS Emotional Distress Depression short-form questionnaire ii. PROMIS Emotional Distress Anxiety short-form questionnaire iii. PROMIS Psychological Stress Experiences short-form questionnaire
- English-speaking (to ensure comprehension of CBT materials and assessments).
Who cannot join
- Diagnosis of a psychotic disorder, bipolar disorder, intellectual disability, or seizure disorder.
- Assessed to be at high risk for suicide or requiring immediate crisis intervention.
- Inability to participate in school-based sessions due to scheduling conflicts or behavioral concerns.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State College of Medicine
Hershey, Pennsylvania, 17033
Jamal H Essayli, PhD, 717-531-0003 ext. 320191, jessayli@pennstatehealth.psu.edu
About this study
Official title: Expanding Mental Health Access in Rural High Schools: Development and Testing of a College Student-Delivered Cognitive-Behavioral Therapy (CBT) Intervention
This research is being done to find out the effectiveness, feasibility, and acceptability of a college student-delivered cognitive-behavioral therapy (CBT) intervention in high schools in rural Schuylkill County, Pennsylvania to treat mental health problems (i.e. depression and anxiety) in adolescents. This project will respond to the need for evidence-based, acceptable, accessible, and low-cost adolescent cognitive-behavioral interventions that lead to long-term improvements in adolescents' mental health outcomes.
Read the detailed description
The overarching goal of this study is to iteratively adapt and test an innovative mental health delivery model that leverages college students to provide cognitive-behavioral therapy (CBT) to high school students in rural Schuylkill County, Pennsylvania. The investigators' preliminary data and established Community Advisory Board (CAB) support three key premises that drive this project. First, depression, anxiety, and stress are the most prevalent mental health challenges facing rural adolescents. Second, multiple barriers impede access to mental health care in rural communities, including provider shortages, mental health stigma, cost, insurance constraints, and limited parental knowledge or support. Third, these barriers can be addressed by enhancing school-based mental health services through a novel delivery model: licensed psychologists training undergraduate students to provide CBT interventions directly in high school settings.
Aim 1: Iteratively adapt and pilot CBT for high school students in rural Pennsylvania. The investigators will employ a systematic adaptation process guided by their preliminary data and the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) to develop a culturally responsive and contextually appropriate CBT intervention for rural high school settings. This iterative refinement process will integrate feedback from two complementary sources: (1) semi-structured interviews with high school student participants and college student interventionists; and (2) a CAB comprising high school students, parents/caregivers, school mental health providers, school administrators, and college student interventionists. By the end of the two-year project period, the investigators will have developed a CBT intervention specifically tailored for high school students in rural Pennsylvania, with clear documentation of adaptation decisions and their empirical basis.
Aim 2: Examine the effects of the adapted CBT intervention on mental health outcomes among rural high school students. The investigators will evaluate preliminary effectiveness using self-report measures of depression, anxiety, and stress in 24-40 high school students (6-10 students/CBT group) across four implementation periods. Outcomes will be measured at pre-treatment, mid-treatment, and post-treatment. The investigators hypothesize that the adapted CBT intervention will result in at least a 50% decrease in mental health symptoms.
Aim 3: Evaluate the feasibility, acceptability, engagement, and fidelity of the adapted CBT intervention. The investigators will employ a mixed-methods approach to comprehensively evaluate four key implementation outcomes. Feasibility will be assessed through recruitment and retention metrics, while acceptability will be measured via standardized instruments and stakeholder feedback. Engagement will be tracked through session attendance and participation rates, and fidelity will be monitored through systematic assessment of intervention delivery. The investigators hypothesize that the adapted CBT intervention will meet or exceed pre-determined benchmarks across all implementation outcomes.
- Conditions
- Depression, Anxiety, Stress
- Being tested
- Student Delivered Cognitive Behavioral Therapy Intervention
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Student Delivered Cognitive Behavioral Therapy InterventionBehavioural
Our study aims to evaluate whether a 12-week cognitive-behavioral therapy (CBT) program delivered in both group and individual formats by trained college students can effectively help adolescents with symptoms of depression, anxiety, and stress. We will assess the program's feasibility, acceptability, and effectiveness in a high school setting. Sessions will cover topics such as: understanding connections between thoughts, feelings, and behaviors, identifying and challenging unhelpful thought patterns, using exposure principles to face feared situations, building problem-solving skills, and engaging in positive activities.
| Study group | Role | What they receive |
|---|---|---|
| Student Delivered Cognitive Behavioral Therapy (CBT) Intervention | Experimental | The investigators will develop an intervention protocol drawing from evidence-based cognitive-behavioral therapy (CBT) components, including psychoeducation, behavioral activation, exposure therapy, cognitive restructuring, and problem solving, tailored to address the mental health needs in rural high school students and implemented by undergraduate college students. Receives: Behavioral: Student Delivered Cognitive Behavioral Therapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item Emotional Distress-Depression
The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression measure is an 8-item self-report questionnaire that examines depressive symptoms. Scores range from 8-40, with higher scores indicating higher levels of depression.
Measured: Baseline, Week 6, Week 12
PROMIS 8-item Emotional Distress-Anxiety
The PROMIS Emotional Distress-Anxiety measure is an 8-item self-report questionnaire that examines anxiety symptoms. Scores range from 8-40, with higher scores indicating higher levels of anxiety.
Measured: Baseline, Week 6, Week 12
PROMIS 8-item Psychological Stress Experiences
The PROMIS Psychological Stress Experiences measure is an 8-item self-report questionnaire that examines stress symptoms. Scores range from 8-40, with higher scores indicating higher levels of stress.
Measured: Baseline, Week 6, Week 12
Recruitment Rate
The investigators will determine the percent of participants recruited who consented to the study and attended the initial session.
Measured: Through study completion, an average of 2 years
Retention Rate
The investigators will determine the percent of participants consented who completed all study measures.
Measured: Through study completion, an average of 2 years
Secondary outcomes (3)
Participant Engagement
The investigators will measure engagement through session attendance rates and session participation tracking.
Measured: Through study completion, an average of 2 years
Credibility/Expectancy Questionnaire (CEQ)
The Credibility/Expectancy Questionnaire (CEQ) is a 6-item questionnaire that examines the participants' perceptions of treatment credibility and their expectations for improvement. Scores range from 4-36 for questions 1, 2, 3, and 5. Questions 4 and 6 use a 0-100% scale. Higher scores indicate a more positive perception of the treatment and lower scores indicate a more negative perception of the treatment.
Measured: Week 6, Week 12
Intervention Fidelity
The investigators will measure intervention fidelity via systematic fidelity monitoring through an adapted CBT checklist completed by interventionists after each session. A random sample of sessions (20%) will be audio-recorded and rated by independent evaluators to verify self-reported fidelity.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start25 Feb 2026
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamal Essayli, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240792
- Sponsor's protocol ID
- 27316
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Mental Health Access in Rural High Schools: Development and Testing of a College Student-Delivered Cognitive-Behavioral Therapy (CBT) Intervention
- ClinicalTrials.gov ID
- NCT07240792
- Acronym / sponsor ID
- 27316
- Conditions
- Depression, Anxiety, Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to find out the effectiveness, feasibility, and acceptability of a college student-delivered cognitive-behavioral therapy (CBT) intervention in high schools in rural Schuylkill County, Pennsylvania to treat mental health problems (i.e. depression and anxiety) in adolescents. This project will respond to the need for evidence-based, acceptable, accessible, and low-cost adolescent cognitive-behavioral interventions that lead to long-term improvements in adolescents' mental health outcomes.
Detailed description
The overarching goal of this study is to iteratively adapt and test an innovative mental health delivery model that leverages college students to provide cognitive-behavioral therapy (CBT) to high school students in rural Schuylkill County, Pennsylvania. The investigators' preliminary data and established Community Advisory Board (CAB) support three key premises that drive this project. First, depression, anxiety, and stress are the most prevalent mental health challenges facing rural adolescents. Second, multiple barriers impede access to mental health care in rural communities, including provider shortages, mental health stigma, cost, insurance constraints, and limited parental knowledge or support. Third, these barriers can be addressed by enhancing school-based mental health services through a novel delivery model: licensed psychologists training undergraduate students to provide CBT interventions directly in high school settings.
Aim 1: Iteratively adapt and pilot CBT for high school students in rural Pennsylvania. The investigators will employ a systematic adaptation process guided by their preliminary data and the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) to develop a culturally responsive and contextually appropriate CBT intervention for rural high school settings. This iterative refinement process will integrate feedback from two complementary sources: (1) semi-structured interviews with high school student participants and college student interventionists; and (2) a CAB comprising high school students, parents/caregivers, school mental health providers, school administrators, and college student interventionists. By the end of the two-year project period, the investigators will have developed a CBT intervention specifically tailored for high school students in rural Pennsylvania, with clear documentation of adaptation decisions and their empirical basis.
Aim 2: Examine the effects of the adapted CBT intervention on mental health outcomes among rural high school students. The investigators will evaluate preliminary effectiveness using self-report measures of depression, anxiety, and stress in 24-40 high school students (6-10 students/CBT group) across four implementation periods. Outcomes will be measured at pre-treatment, mid-treatment, and post-treatment. The investigators hypothesize that the adapted CBT intervention will result in at least a 50% decrease in mental health symptoms.
Aim 3: Evaluate the feasibility, acceptability, engagement, and fidelity of the adapted CBT intervention. The investigators will employ a mixed-methods approach to comprehensively evaluate four key implementation outcomes. Feasibility will be assessed through recruitment and retention metrics, while acceptability will be measured via standardized instruments and stakeholder feedback. Engagement will be tracked through session attendance and participation rates, and fidelity will be monitored through systematic assessment of intervention delivery. The investigators hypothesize that the adapted CBT intervention will meet or exceed pre-determined benchmarks across all implementation outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Student Delivered Cognitive Behavioral Therapy (CBT) Intervention | Experimental | Behavioral: Student Delivered Cognitive Behavioral Therapy InterventionThe investigators will develop an intervention protocol drawing from evidence-based cognitive-behavioral therapy (CBT) components, including psychoeducation, behavioral activation, exposure therapy, cognitive restructuring, and problem solving, tailored to address the mental health needs in rural high school students and implemented by undergraduate college students. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- High school students ages 13-19 years.
- Attending a participating rural high school in rural county in Pennsylvania.
- Presenting with self-reported symptoms of depression, anxiety, or stress. Must have a t-score ≥ 55 on one or more of the following three measures:
- English-speaking (to ensure comprehension of CBT materials and assessments).
Key exclusion criteria (3 listed)
- Diagnosis of a psychotic disorder, bipolar disorder, intellectual disability, or seizure disorder.
- Assessed to be at high risk for suicide or requiring immediate crisis intervention.
- Inability to participate in school-based sessions due to scheduling conflicts or behavioral concerns.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Student Delivered Cognitive Behavioral Therapy InterventionOur study aims to evaluate whether a 12-week cognitive-behavioral therapy (CBT) program delivered in both group and individual formats by trained college students can effectively help adolescents with symptoms of depression, anxiety, and stress. We will assess the program's feasibility, acceptability, and effectiveness in a high school setting. Sessions will cover topics such as: understanding connections between thoughts, feelings, and behaviors, identifying and challenging unhelpful thought patterns, using exposure principles to face feared situations, building problem-solving skills, and engaging in positive activities. | Behavioural | Student Delivered Cognitive Behavioral Therapy (CBT) Intervention |
Primary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item Emotional Distress-Depression
Time frame: Baseline, Week 6, Week 12
The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression measure is an 8-item self-report questionnaire that examines depressive symptoms. Scores range from 8-40, with higher scores indicating higher levels of depression.
PROMIS 8-item Emotional Distress-Anxiety
Time frame: Baseline, Week 6, Week 12
The PROMIS Emotional Distress-Anxiety measure is an 8-item self-report questionnaire that examines anxiety symptoms. Scores range from 8-40, with higher scores indicating higher levels of anxiety.
PROMIS 8-item Psychological Stress Experiences
Time frame: Baseline, Week 6, Week 12
The PROMIS Psychological Stress Experiences measure is an 8-item self-report questionnaire that examines stress symptoms. Scores range from 8-40, with higher scores indicating higher levels of stress.
Recruitment Rate
Time frame: Through study completion, an average of 2 years
The investigators will determine the percent of participants recruited who consented to the study and attended the initial session.
Retention Rate
Time frame: Through study completion, an average of 2 years
The investigators will determine the percent of participants consented who completed all study measures.
3 secondary outcomes
Participant Engagement
Time frame: Through study completion, an average of 2 years
Credibility/Expectancy Questionnaire (CEQ)
Time frame: Week 6, Week 12
Intervention Fidelity
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Student Delivered Cognitive Behavioral Therapy Intervention in people with Depression and Anxiety, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamal H Essayli, PhD ((717) 531-0003 ext. 320191, jessayli@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item Emotional Distress-Depression (time frame: Baseline, Week 6, Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.