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Mindfulness-Based Therapy for Depression

N/A
Waitlist Available
Research Sponsored by Colorado State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adolescent: Age 12-17 years
At-risk for T2D: Overweight/obesity: BMI ≥85 percentile for age and sex
Must not have
Major medical problem: including T2D, assessed at baseline/screening as fasting glucose ≥126 mg/dL or 2-hour glucose ≥200 mg/dL, or any other significant medical condition reported during the medical history/physical examination
Regular medication use affecting mood, insulin, and/or weight: anti-anxiety medications, anti-depressants, anti-psychotics, insulin sensitizers, mood stabilizers, stimulants, and weight loss drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18-months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a mindfulness-based intervention (MBI) can help decrease depression and insulin resistance in adolescents at risk for type 2 diabetes (T2D). It is a multisite, pilot randomized controlled trial (RCT) comparing MBI to Cognitive Behavioral Therapy (CBT) and a didactic/health education (HealthEd) control group.

Who is the study for?
This trial is for adolescents aged 12-17 who are overweight or obese, at risk for type 2 diabetes with a family history of the disease, and experiencing depression. They must be in good general health without major psychiatric disorders, not on medications affecting mood or weight, and not receiving psychotherapy or structured weight loss treatment.
What is being tested?
The study tests a mindfulness-based intervention against cognitive-behavioral therapy and standard health education to see if it can reduce depression and insulin resistance in teens at risk for type 2 diabetes. It's a multisite pilot randomized controlled trial with participants followed up for one year.
What are the potential side effects?
Mindfulness interventions typically have minimal side effects but may include temporary increases in distress as individuals become more aware of their emotions. Cognitive-Behavioral Therapy could also cause some emotional discomfort due to confronting negative thoughts.

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 17 years old.
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My BMI is in the top 15% for my age and sex, putting me at risk for type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a major medical issue like diabetes with high blood sugar levels.
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I am taking medication for mood, diabetes, or weight management.
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I am currently in psychotherapy or a structured weight loss program.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intervention Fidelity
Recruitment Feasibility: Percentage of Eligible Adolescents who Enroll
Secondary study objectives
Assessment Feasibility: Percentage Accuracy of Protocols
Intervention Acceptability: Likeability/Credibility Ratings
Intervention Acceptability: Qualitative Themes
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based InterventionExperimental Treatment1 Intervention
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
Group II: Health EducationExperimental Treatment1 Intervention
6-week group program providing didactic information on adolescent health topics
Group III: Cognitive-Behavioral TherapyActive Control1 Intervention
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-Based Intervention
2021
N/A
~120
Health Education
2014
Completed Phase 3
~4410

Find a Location

Who is running the clinical trial?

Colorado State UniversityLead Sponsor
133 Previous Clinical Trials
38,348 Total Patients Enrolled
3 Trials studying Depression
535 Patients Enrolled for Depression
National Center for Complementary and Integrative Health (NCCIH)NIH
867 Previous Clinical Trials
674,851 Total Patients Enrolled
66 Trials studying Depression
33,450 Patients Enrolled for Depression
University of Colorado, DenverOTHER
1,810 Previous Clinical Trials
2,919,980 Total Patients Enrolled
13 Trials studying Depression
5,998 Patients Enrolled for Depression
Children's National Health SystemOTHER
9 Previous Clinical Trials
5,002,503 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
124 Previous Clinical Trials
90,556 Total Patients Enrolled
2 Trials studying Depression
278 Patients Enrolled for Depression

Media Library

Cognitive-Behavioral Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04992299 — N/A
Depression Research Study Groups: Cognitive-Behavioral Therapy, Mindfulness-Based Intervention, Health Education
Depression Clinical Trial 2023: Cognitive-Behavioral Therapy Highlights & Side Effects. Trial Name: NCT04992299 — N/A
Cognitive-Behavioral Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04992299 — N/A
~33 spots leftby Dec 2025
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