96 Participants NeededMy employer runs this trial

Yoga-Based Intervention + CBT for Teenage Depression

Recruiting at 1 trial location
BO
JD
Overseen ByJulie Desaulniers
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Butler Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments—yoga-based intervention and group cognitive-behavioral therapy (CBT)—to determine their effectiveness in helping teens with depression. The goal is to identify which approach is more effective and acceptable for teens experiencing frequent sadness or loss of interest in activities. Teens aged 12–18 who often feel down and can join group sessions may be eligible to participate. The trial will take place in Columbus, OH, and Boston, MA, and aims to assess how well these treatments integrate into a teen's routine. As an unphased trial, this study offers teens a unique opportunity to contribute to understanding effective mental health treatments.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have had significant changes in psychiatric treatment, like starting a new depression medication in the past 4 weeks, you may not be eligible for Set A.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that yoga is generally safe and well-tolerated by teenagers. Many studies have found that yoga can improve mental health by reducing anxiety and depression. For example, a yoga program in schools proved popular with students and enhanced their mental well-being. Teens also reported that yoga was a good and socially acceptable way to manage stress and improve their mood.

These studies have not commonly reported any serious side effects. Most teens find the yoga programs easy to follow and are willing to continue with them. This suggests that yoga is a safe option for teenagers dealing with mental health issues.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for teenage depression because they explore new ways of addressing mental health. Traditional treatments often include medications like SSRIs or individual therapy. However, the yoga-based intervention offers a holistic approach, incorporating physical movement and mindfulness, which can help reduce stress and improve mood. Group CBT, on the other hand, provides peer support and shared learning experiences, which can enhance the therapeutic process. Both treatments aim to provide teenagers with tools to manage their depression in a supportive and engaging environment.

What evidence suggests that this trial's treatments could be effective for teenage depression?

This trial will compare a Yoga-Based Intervention with Group Cognitive-Behavioral Therapy (CBT) for treating teenage depression. Research has shown that yoga can help reduce depression symptoms in teenagers. A recent study review found that yoga had a noticeable positive effect on lowering depression. Other research has also demonstrated that teens who participate in yoga programs experience better mental health and well-being.

Similarly, group CBT is a well-known and effective treatment for depression in teens. Studies consistently show that CBT helps reduce depression symptoms, making it a common first treatment choice. It also works well when combined with other treatments. Both yoga and CBT have strong evidence supporting their use for treating depression in adolescents. Participants in this trial will be assigned to either the Yoga-Based Intervention arm or the Group CBT arm to evaluate their effectiveness.678910

Who Is on the Research Team?

LU

Lisa Uebelacker, PhD

Principal Investigator

Butler Hospital

SY

Shirley Yen, PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for teens aged 12-18 who have symptoms of depression, can read and write in English, are medically cleared to participate in physical activity, can give consent/assent, and have access to a private space once a week for sessions.

Inclusion Criteria

4. Be able to read and write in English;
I am able to give consent or assent for this study.
1. Have elevated depressive symptoms, defined by: a) a score of 1 or greater on the PHQ-2 and 5 or greater on the PHQ-8 at screening; and b) a score of 10 or higher on the Quick Inventory of Depression-Adolescent Version-Clinician Rating (QIDS-A-CR), including either sad mood or anhedonia;
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a yoga-based intervention or group cognitive-behavioral therapy for 3 months

12 weeks
Weekly sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Group CBT
  • Yoga-Based Intervention

Trial Overview

The study compares two group treatments for teen depression: a yoga-based program versus group cognitive-behavioral therapy (CBT). Participants are randomly assigned to one of the groups at sites in Columbus, OH and Boston, MA.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Yoga armExperimental Treatment1 Intervention
Group II: gCBT armActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials
133
Recruited
16,700+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials
872
Recruited
12,930,000+

Nationwide Children's Hospital

Collaborator

Trials
354
Recruited
5,228,000+

Citations

1.

samhsa.gov

samhsa.gov/

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