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Cognitive Behavioral Therapy

Cognitive Behavioral Therapy for Adolescent Depression (LEADS Trial)

N/A

Recruiting

Led By Rachel A Vaughn-Coaxum, Ph.D.

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages 12 years 0 months through 15 years 11 months at study enrollment

Have clinically elevated depression symptom severity based a cut-off score of ≥ 7 on the Patient Health Questionnaire-9, verified by clinician ratings on the Depression Rating Scale.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-intervention up to 6-months follow-up

Awards & highlights

LEADS Trial Summary

This trial is looking at how well a cognitive behavioral therapy skill is learned and retained by young adolescents who have experienced different levels of adversity.

Who is the study for?

This trial is for young adolescents aged 12-15 with symptoms of depression and a history of adverse childhood experiences. They must have a certain level of depression based on specific questionnaires but can't join if they have psychotic disorders, autism, substance abuse issues, ADHD, neurological conditions or are currently using stimulants.Check my eligibility

What is being tested?

The study tests how well these adolescents can learn and retain 'cognitive restructuring' skills from Cognitive Behavioral Therapy (CBT) over six months. It looks at how past adversity affects their ability to control thoughts during learning and the impact on acquiring this skill.See study design

What are the potential side effects?

Since the intervention involves non-pharmacological therapy (CBT), typical medication side effects are not expected. However, participants may experience emotional discomfort when discussing personal issues during therapy sessions.

LEADS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 15 years old.

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I have been diagnosed with severe depression.

LEADS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-intervention up to 6-months follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-intervention up to 6-months follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention up to 6-months follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Biobehavioral sympathetic recovery

Cognitive Restructuring Knowledge Test

Cognitive Restructuring Skill Acquisition

+1 more

Secondary outcome measures

Biobehavioral parasympathetic regulation

Other outcome measures

Self-reported depression symptom severity

LEADS Trial Design

1Treatment groups

Experimental Treatment

Group I: FIRST: Repairing ThoughtsExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,721 Previous Clinical Trials

16,343,126 Total Patients Enrolled

119 Trials studying Depression

34,005 Patients Enrolled for Depression

National Institute of Mental Health (NIMH)NIH

2,784 Previous Clinical Trials

2,689,185 Total Patients Enrolled

666 Trials studying Depression

251,494 Patients Enrolled for Depression

Rachel A Vaughn-Coaxum, Ph.D.Principal InvestigatorUniversity of Pittsburgh

1 Previous Clinical Trials

42 Total Patients Enrolled

1 Trials studying Depression

42 Patients Enrolled for Depression

Media Library

FIRST: Repairing Thoughts (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04719897 — N/A

Depression Research Study Groups: FIRST: Repairing Thoughts

Depression Clinical Trial 2023: FIRST: Repairing Thoughts Highlights & Side Effects. Trial Name: NCT04719897 — N/A

FIRST: Repairing Thoughts (Cognitive Behavioral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04719897 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction in place for participants of this clinical research?

"This trial is set to enroll patients aged 12-15. There are 197 distinct clinical trials for minors and 965 studies that focus on individuals who have surpassed the age of retirement."

Answered by AI

Am I eligible to partake in this clinical research?

"To be accepted into this clinical trial, applicants must have endured adverse childhood experiences and lie between the ages of 12-15. This research is taking a total of 90 participants."

Answered by AI

Are there any remaining vacancies for participants in this clinical trial?

"According to clinicaltrials.gov, this study is currently recruiting participants and was originally posted on May 19th of 2021 with the latest update occurring on June 20th of 2022."

Answered by AI

How many participants are enrolling in the trial?

"Affirmative. Clinicaltrials.gov archives demonstrate that this experiment, which was initially publicized on May 19th 2021, is actively recruiting participants. Approximately 90 patients need to be enlisted from 1 distinct medical facility."

Answered by AI