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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18-months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
2020
N/A
~80
Health Education
2014
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

Colorado State UniversityLead Sponsor
125 Previous Clinical Trials
38,239 Total Patients Enrolled
3 Trials studying Depression
535 Patients Enrolled for Depression
National Center for Complementary and Integrative Health (NCCIH)NIH
831 Previous Clinical Trials
668,813 Total Patients Enrolled
61 Trials studying Depression
32,790 Patients Enrolled for Depression
University of Colorado, DenverOTHER
1,732 Previous Clinical Trials
2,143,428 Total Patients Enrolled
11 Trials studying Depression
5,286 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

Frequently Asked Questions

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

Is participation in this exploration limited to those over sixty years of age?

"The age restrictions for this medical study are between 12 and 17, as specified by the inclusion criteria."

Answered by AI

What goals is this research seeking to accomplish?

"This trial's primary objective is to ascertain the number of eligible adolescents that sign up, and it will last for approximately one year. Secondary goals include assessing facilitator adherence and competence during mock sessions with a score of 8 or greater on MBI, CBT, and HealthEd rating scales (1=poor to 10=excellent), determining how many months are needed to reach recruitment goal via CONSORT flow analysis, as well as verifying that assessment protocols have an accuracy rate of 95% or higher."

Answered by AI

Could you provide an overview of the Canadian locations that are running this clinical experiment?

"Currently, this trial is taking place at four distinct locations: Fort Collins, Aurora, Washington and another site. It's recommended to select a nearby centre in order to reduce the strain of travelling for those who choose to participate."

Answered by AI

Is there room for more participants in this research endeavor?

"As shown on clinicaltrials.gov, this investigation is currently recruiting volunteers and has been since the 25th of January 2022. The trial was last updated on September 22nd 2022."

Answered by AI

Does this trial offer me the opportunity to partake?

"This clinical trial is looking for 120 adolescent patients aged between 12 and 17. Applicants must display symptoms of depression as indicated by a Center for Epidemiological Studies - Depression Scale (CES-D) score above 20, be overweight/obese with a BMI ≥85 percentile for age and sex, have a family history of type 2 diabetes in one or both biological parents, siblings, aunt(s), uncle(s), or grandparent(s). Lastly, applicants should exhibit good general health based on medical history/physical examination results. A parent/guardian must also accompany the qualifying participant to the clinic."

Answered by AI

How many test subjects are being monitored in this trial?

"This trial necessitates the enlistment of 120 participants who meet its requirements. Prospective patients can attend either Colorado State University in Fort Collins, or University of Colorado Denver/Children's Hospital Colorado in Aurora for participation."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Virginia
What site did they apply to?
Uniformed Services University
Children's National Health System
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Children's National Health System: < 24 hours
Average response time
  • < 1 Day
~18 spots leftby Aug 2024