Mindfulness-Based Therapy for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how mindfulness-based therapy can reduce depression and improve insulin resistance in teens at risk for type 2 diabetes (T2D). Participants will receive one of three treatments: mindfulness training, cognitive-behavioral therapy (a type of talk therapy), or health education. The researchers aim to determine which method best helps teens manage stress and potentially prevent T2D. Teens who are overweight, have a family history of diabetes, and experience symptoms of depression might be suitable for this trial. As an unphased trial, this study provides a unique opportunity for teens to explore innovative therapies that may enhance their mental and physical health.
Will I have to stop taking my current medications?
Yes, if you are regularly using medications that affect mood, insulin, or weight, such as anti-anxiety medications, anti-depressants, anti-psychotics, insulin sensitizers, mood stabilizers, stimulants, and weight loss drugs, you will not be eligible to participate in the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Past studies have shown that mindfulness-based interventions (MBIs) are safe and effective for reducing anxiety and depression symptoms. Research indicates that these therapies are generally well-tolerated and can improve emotional health without major side effects. Specifically, a shorter version of mindfulness-based cognitive therapy proved safe and helpful for easing depression and anxiety.
Cognitive-behavioral therapy (CBT), the other treatment in the trial, also has a strong record of safety and effectiveness. Studies indicate that CBT is widely used to treat depression and other mental health issues and is generally well-received by patients. While some people might experience uncomfortable emotions during therapy, no major risks are linked to CBT.
Both mindfulness-based therapies and CBT are supported by evidence showing they are safe options for managing mental health, making them good choices for those considering participation in the trial.12345Why are researchers excited about this trial?
Researchers are excited about the treatments being explored for depression because they offer unique approaches compared to traditional methods like medication and standard cognitive-behavioral therapy (CBT). The Mindfulness-Based Intervention, known as "Learning to BREATHE," introduces a fresh angle by focusing on mindfulness techniques, which help adolescents manage stress and emotional responses in a new way. Meanwhile, the "Blues Program" integrates cognitive-behavioral strategies tailored for group settings, which can enhance peer support and engagement among teens. These approaches emphasize personal awareness and community interaction, offering potentially quicker, more holistic benefits without the side effects associated with medication.
What evidence suggests that this trial's treatments could be effective for adolescents at risk for type 2 diabetes?
Research has shown that mindfulness-based interventions (MBIs), one of the treatments in this trial, effectively reduce symptoms of depression and anxiety in many people. MBIs teach individuals to stay present and calm, improving emotional regulation. Similarly, cognitive-behavioral therapy (CBT), another treatment option in this trial, has significantly lowered depression and anxiety symptoms. CBT matches medications in short-term effectiveness and surpasses them over time. Both MBIs and CBT are promising methods for addressing depression, which is linked to worsening insulin resistance in teenagers at risk for type 2 diabetes.56789
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 6-week group intervention, randomized to Mindfulness-Based Intervention, Cognitive-Behavioral Therapy, or Health Education
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-ups at 6 weeks and 1 year
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive-Behavioral Therapy
- Health Education
- Mindfulness-Based Intervention
Trial Overview
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.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
6-week group intervention, Learning to BREATHE, an adolescent mindfulness-based intervention derived from mindfulness-based stress reduction
6-week group program providing didactic information on adolescent health topics
6-week group intervention, the Blues Program, a cognitive-behavioral intervention for adolescents with elevated symptoms of depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
Colorado State University
Lead Sponsor
Children's National Research Institute
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
University of Colorado, Denver
Collaborator
Children's National Health System
Collaborator
Uniformed Services University of the Health Sciences
Collaborator
Citations
Cognitive behavioral therapy for depressive disorders
Participants with moderate to severe depression who participated in CBT reported a significant decrease in depression and anxiety symptoms at ...
Effect of Computer-Assisted Cognitive Behavior Therapy vs ...
In this randomized clinical trial of 175 adults, CCBT reduced depression, as measured by the Patient Health Questionnaire–9, to a significantly greater extent ...
A systematic review of digital and face-to-face cognitive ...
Since its emergence nearly fifty years ago, a large number of studies has underlined the effectiveness of CBT in improving depressive symptoms, ...
Cognitive behavior therapy vs. control conditions, other ...
CBT appears to be as effective as pharmacotherapies at the short term, but more effective at the longer term. Keywords: Depression, cognitive ...
The Efficacy of Cognitive Behavioral Therapy: A Review ...
CBT for depression was more effective than control conditions such as waiting list or no treatment, with a medium effect size (van Straten, Geraedts, Verdonck- ...
Cognitive–behavioral therapy for management of mental ...
Cognitive–behavioral therapy (CBT) helps individuals to eliminate avoidant and safety-seeking behaviors that prevent self-correction of faulty beliefs.
Cognitive Behavioral Therapy for Depression - PMC
A meta-analysis of 115 studies has shown that CBT is an effective treatment strategy for depression and combined treatment with pharmacotherapy is ...
Cognitive behavioral therapy
Risks. In general, there's little risk in getting cognitive behavioral therapy. But you may feel emotions that aren't comfortable at times. ...
Cognitive behavioral therapies are evidence-based – ...
CBTs currently hold status as research-supported or evidence-based treatments for depressive disorders (APA, 2021; NICE, 2022) and are suggested as first-line ...
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