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Behavioral Intervention
Cognitive Behavioral Therapy for Adolescent Depression (PATHway Trial)
N/A
Recruiting
Led By Benjamin W Van Voorhees, MD, MPH
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adolescents ages 13 through 18 years
Adolescents ages 13 through 18 years,
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start to end of recruitment, 32 months
Awards & highlights
PATHway Trial Summary
This trial will test a "behavioral vaccine" to help prevent depression in adults. The vaccine will be tested in 4 health systems across the US.
Who is the study for?
This trial is for adolescents aged 13-18 with mild to moderate depression symptoms (PHQ-9 score of 5-18), who may have had past depressive episodes but are not currently in one. Participants must speak English, be willing to follow the study protocol, and not be on medication or in therapy for mood disorders.Check my eligibility
What is being tested?
The PATHway Study tests a 'behavioral vaccine' called CATCH-IT designed to prevent depression. It's based in primary care and uses Cognitive-Behavioral, Humanistic, and Interpersonal Training. The study will optimize this intervention across several health systems before wider implementation.See study design
What are the potential side effects?
As CATCH-IT is a non-medical intervention focusing on behavioral training, traditional side effects associated with medications are not expected. However, participants might experience discomfort discussing personal issues or temporary increases in distress.
PATHway Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 13 and 18 years old.
Select...
I am between 13 and 18 years old.
PATHway Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start to end of recruitment, 32 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start to end of recruitment, 32 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of Intervention
Anxiety Symptoms
Body Mass Index
+24 moreSecondary outcome measures
Moderation of COVID-19-related behaviors and consequences
Moderation of COVID-19-related social determinants of health
PATHway Trial Design
16Treatment groups
Experimental Treatment
Active Control
Group I: 9. Parent program modules onlyExperimental Treatment1 Intervention
Parent program modules
Group II: 8. Full Adolescent program onlyExperimental Treatment1 Intervention
Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules
Group III: 7. Adolescent cognitive-behavioral therapy modules + interpersonal therapy modulesExperimental Treatment1 Intervention
Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules
Group IV: 6. Adolescent behavioral activation modules + interpersonal therapy modulesExperimental Treatment1 Intervention
Adolescent behavioral activation modules Adolescent interpersonal therapy modules
Group V: 5. Adolescent behavioral activation modules + cognitive-behavioral therapy modulesExperimental Treatment1 Intervention
Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules
Group VI: 4. Adolescent interpersonal therapy modules onlyExperimental Treatment1 Intervention
Adolescent interpersonal therapy modules only
Group VII: 3. Adolescent cognitive-behavioral therapy modules onlyExperimental Treatment1 Intervention
Adolescent cognitive-behavioral therapy modules only
Group VIII: 2. Adolescent behavioral activation modules onlyExperimental Treatment1 Intervention
Adolescent behavioral activation modules only
Group IX: 15. Adolescent cognitive-behavioral therapy + interpersonal therapy + parent program modulesExperimental Treatment1 Intervention
Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules
Group X: 14. Adolescent behavioral activation + interpersonal therapy + parent program modulesExperimental Treatment1 Intervention
Adolescent behavioral activation modules Adolescent interpersonal therapy modules Parent program modules
Group XI: 13. Adolescent behavioral activation + cognitive-behavioral therapy + parent program modulesExperimental Treatment1 Intervention
Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Parent program modules
Group XII: 12. Adolescent interpersonal therapy modules + parent program modulesExperimental Treatment1 Intervention
Adolescent interpersonal therapy modules Parent Program
Group XIII: 11. Adolescent cognitive-behavioral therapy modules + parent program modulesExperimental Treatment1 Intervention
Adolescent cognitive-behavioral therapy modules Parent program modules
Group XIV: 10. Adolescent behavioral activation modules + parent program modulesExperimental Treatment1 Intervention
Adolescent behavioral activation modules Parent program modules
Group XV: 1. No adolescent modules + no parent modulesActive Control1 Intervention
No adolescent nor parent modules will be offered to the participant.
Group XVI: 16. All adolescent + parent program modulesActive Control1 Intervention
Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules
Find a Location
Who is running the clinical trial?
Ann & Robert H Lurie Children's Hospital of ChicagoOTHER
260 Previous Clinical Trials
5,188,838 Total Patients Enrolled
4 Trials studying Depression
1,091 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,796 Previous Clinical Trials
2,689,161 Total Patients Enrolled
670 Trials studying Depression
252,554 Patients Enrolled for Depression
NorthShore University HealthSystemOTHER
132 Previous Clinical Trials
737,262 Total Patients Enrolled
5 Trials studying Depression
3,318 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child's guardian has a cognitive or intellectual impairment.I have attempted suicide or self-harmed with moderate or greater severity.I am an adolescent who does not speak or read English.I am not interested in participating in the trial anymore.I am between 13 and 18 years old.I am currently in cognitive-behavioral therapy.I am currently on medication for depression, anxiety, or similar conditions.I am experiencing thoughts of harming myself.I have not had suicidal thoughts in the last 6 months.I am between the ages of 13 and 18.I am currently receiving treatment for a mood disorder.I am a teenager with mild to moderate depression.I have had depression in the past but am not currently experiencing it.I am not willing to follow the study rules.My parent or guardian does not speak English or Spanish.I am a teenager with mild to moderate depression.I am between 13 and 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: 1. No adolescent modules + no parent modules
- Group 2: 2. Adolescent behavioral activation modules only
- Group 3: 3. Adolescent cognitive-behavioral therapy modules only
- Group 4: 4. Adolescent interpersonal therapy modules only
- Group 5: 6. Adolescent behavioral activation modules + interpersonal therapy modules
- Group 6: 5. Adolescent behavioral activation modules + cognitive-behavioral therapy modules
- Group 7: 11. Adolescent cognitive-behavioral therapy modules + parent program modules
- Group 8: 16. All adolescent + parent program modules
- Group 9: 7. Adolescent cognitive-behavioral therapy modules + interpersonal therapy modules
- Group 10: 9. Parent program modules only
- Group 11: 10. Adolescent behavioral activation modules + parent program modules
- Group 12: 13. Adolescent behavioral activation + cognitive-behavioral therapy + parent program modules
- Group 13: 14. Adolescent behavioral activation + interpersonal therapy + parent program modules
- Group 14: 12. Adolescent interpersonal therapy modules + parent program modules
- Group 15: 15. Adolescent cognitive-behavioral therapy + interpersonal therapy + parent program modules
- Group 16: 8. Full Adolescent program only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare facilities are participating in this research trial?
"At present, the trial is available at 6 distinct medical centres situated in Chicago, Glenview and Park Ridge among several other cities. For your convenience, we recommend that you choose a clinic close to your residence to reduce any unecessary travel needs associated with participation."
Answered by AI
What sort of individuals does this clinical trial seek to recruit?
"In this trial, 400 adolescents aged 13 to 18 with a history of depressive episodes yet currently exhibiting elevated levels of depression (as indicated by PHQ-9 scores between 5 and 18) are desired."
Answered by AI
Are new participants being recruited for this medical experiment?
"Affirmative. Clinicaltrials.gov verifies that this experiment, which was first publicized on December 1st 2021, is actively seeking volunteers. Approximately 400 individuals are needed for the 6 available sites."
Answered by AI
How many recruits have been admitted to this experiment?
"Affirmative. Clinicaltrials.gov data reveals that the experiment, which was initially made accessible on December 1st 2021 is presently looking for participants in need of treatment. This trial requires 400 individuals to be sourced from 6 distinct sites."
Answered by AI
Are seniors over 60 being admitted into this research program?
"This experiment is searching for individuals aged 13 to 18 years old."
Answered by AI
Who else is applying?
What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
UT Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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