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Cognitive Behavioral Therapy for Depression and Insulin Sensitivity in Adolescents
Study Summary
This trial will compare the effects of a cognitive-behavioral therapy group to a health education control group in adolescent girls at-risk for type 2 diabetes with moderate depressive symptoms. The goal is to see if the cognitive-behavioral therapy group can improve insulin sensitivity and prevent worsening of insulin secretion over a one-year follow-up.
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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- I have not had thoughts or actions of harming myself.You have a serious mental health condition that could make it hard for you to follow the study rules and may need more treatment. This includes conditions like depression, bipolar disorder, PTSD, panic disorder, OCD, schizophrenia, conduct disorder, alcohol or drug abuse, and anorexia or bulimia.I am female.I am between 12 and 17 years old.Your depression score is higher than 20 on the CES-D scale.My BMI is in the top 15% for my age and sex.I am not taking medication that affects mood, weight, cortisol, or insulin sensitivity.I have a close family member with type 2 diabetes or related conditions.I have type 2 diabetes based on my blood sugar or HbA1c levels.I am in good health overall.I am currently in psychotherapy or a structured weight loss program.
- Group 1: Cognitive-behavioral therapy group
- Group 2: Health education group
- 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
Does the research demand for individuals of a certain age, or is it open to all adults?
"This trial is focused on participants aged between 12 and 17 years old."
What is the total sample size for this investigation?
"Affirmative. Clinicaltrials.gov corroborates that this experiment is actively enrolling participants, with a first posting date of October 1st 2017 and the most recent edit on July 21st 2022. 200 patients need to be enrolled from only one trial site."
What criteria must potential participants meet to qualify for this research project?
"To be eligible for acceptance into this study, individuals afflicted with depression must fall between the age range of 12 to 17. This research project is enlisting a total of 200 participants."
Are there any empty slots remaining in this medical trial?
"As reported on clinicaltrials.gov, this medical trial has been actively recruiting since October 1st 2017 and was last updated on July 21 2022."
What is the desired outcome of this medical experiment?
"The prime purpose of this investigation, which will span around 12 months, is to assess the alleviation of depressive symptoms. Additionally, Cortisol diurnal rhythm (Salivary cortisol by home collection throughout the day), Sleep duration as measured via actigraphy and Disinhibited eating using an Emotional Eating Scale adapted for Children depression scale are being studied as secondary objectives."
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