Development of a College Student-Delivered Cognitive-Behavioral Therapy (CBT) Intervention for Rural High School Students

NCT07240792 | Recruiting

• 1 other identifier: 27316
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depression; Anxiety; Stress

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  Through study completion, an average of 2 years

• Retention Rate

  The investigators will determine the percent of participants consented who completed all study measures.

  Through study completion, an average of 2 years

Secondary Outcomes (3)

• Participant Engagement

  Through study completion, an average of 2 years

• Credibility/Expectancy Questionnaire (CEQ)

  Week 6, Week 12

• Intervention Fidelity

  Through study completion, an average of 2 years

Study Arms (1)

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.

Behavioral: Student Delivered Cognitive Behavioral Therapy Intervention

Interventions

Student Delivered Cognitive Behavioral Therapy Intervention BEHAVIORAL

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.

Student Delivered Cognitive Behavioral Therapy (CBT) Intervention

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• High school students ages 13-18 years.
• Attending a participating rural high school in Schuylkill County, 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:
• i. 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Jamal H Essayli, PhD

CONTACT

(717) 531-0003; jessayli@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 21, 2025
• Study Start: February 25, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)