Recruiting

Cognitive-Behavioral Therapy

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT07240792

Conditions

Depression

Anxiety

Stress

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

Student Delivered Cognitive Behavioral Therapy Intervention

Study Details

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

Study ID

NCT07240792

Start date

Feb 25, 2026

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Student Delivered Cognitive Behavioral Therapy (CBT) Intervention

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.

Interventions

Student Delivered Cognitive Behavioral Therapy Intervention

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.

Primary outcome measure

  • Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item Emotional Distress-Depression [ Time Frame: Baseline, Week 6, Week 12 ]
  • PROMIS 8-item Emotional Distress-Anxiety [ Time Frame: Baseline, Week 6, Week 12 ]
  • PROMIS 8-item Psychological Stress Experiences [ Time Frame: Baseline, Week 6, Week 12 ]
  • Recruitment Rate [ Time Frame: Through study completion, an average of 2 years ]
  • Retention Rate [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Jamal H Essayli, PhD

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

Locations

Penn State College of Medicine

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Jamal H Essayli, PhD

717-531-0003jessayli@pennstatehealth.psu.edu

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-04-15.