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Mindfulness-Based Therapy for Depression
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am at risk for type 2 diabetes and am the parent or guardian of a qualifying participant.I have a family history of Type 2 diabetes in close relatives.I am between 12 and 17 years old.I have a major medical issue like diabetes with high blood sugar levels.I am taking medication for mood, diabetes, or weight management.You have a high score on a depression test called the Center for Epidemiological Studies - Depression Scale (CES-D).My BMI is in the top 15% for my age and sex, putting me at risk for type 2 diabetes.You have been diagnosed with certain serious mental health conditions like anorexia, bipolar disorder, or major depression.You are currently having thoughts about hurting yourself or others.You have severe symptoms of depression, as measured by a specific test.I am currently in psychotherapy or a structured weight loss program.You are at risk of developing type 2 diabetes.
- Group 1: Cognitive-Behavioral Therapy
- Group 2: Mindfulness-Based Intervention
- Group 3: Health Education
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Children's National Health System: < 24 hours
Average response time
- < 1 Day
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