Digital CBT for Teenage Depression

(CBT+ Trial)

LB
Overseen ByLauren B Shomaker, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Colorado State University
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 a new method to assist teenagers with depression and obesity by combining digitally enhanced cognitive-behavioral therapy (CBT) with a digital app. CBT changes thoughts and behaviors to improve mood, while the app supports these skills in daily life. Participants will join either a group using only CBT or one using both CBT and the app to determine which is more effective. This trial suits teens aged 12-17 who struggle with depression and are overweight. As an unphased trial, it provides a unique opportunity for teens to access innovative treatment methods early.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this digital CBT app is safe for adolescents?

Studies have shown that digital cognitive-behavioral therapy (CBT) is generally safe and well-tolerated by teenagers. Research indicates that digital CBT can effectively reduce depression symptoms in teens without major side effects. A review of various studies found digital CBT to be more effective than standard counseling in managing depression.

Another study on computerized CBT also supported its safety, demonstrating its effectiveness in treating anxiety and depression in teens. Although these studies did not focus specifically on safety, the absence of reported negative effects suggests that digital CBT is a safe option for most teens.

In summary, digital CBT, including app-based versions, appears to be a safe treatment for teen depression based on current evidence.12345

Why are researchers excited about this trial?

Researchers are excited about the Digital CBT for Teenage Depression because it combines traditional cognitive-behavioral therapy (CBT) with a digital enhancement that makes it more accessible and engaging. Unlike other treatments that rely solely on in-person therapy sessions, this approach includes a digital app that teens can use throughout their therapy program. This app provides additional support and resources outside of the virtual group sessions, potentially leading to better engagement and outcomes. By integrating technology, this method could make therapy more appealing and approachable for teenagers, encouraging more consistent participation and adherence.

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

Research has shown that cognitive-behavioral therapy (CBT) helps reduce depression in teens. In this trial, participants will receive either standard CBT or an enhanced version called CBT-Plus (CBT+), which includes access to a digital app. Studies suggest that digital CBT, which uses apps to assist therapy, can be even more effective than traditional methods. Digital CBT keeps teens more engaged in their treatment, leading to better mental health. One study found that digital CBT significantly reduced depression compared to regular counseling. Overall, using digital tools with CBT can make therapy more accessible while remaining effective in treating teen depression.34678

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-17 who are overweight or obese (BMI at or above the 85th percentile) and have significant symptoms of depression. Teens can't join if they are pregnant, breastfeeding, have active suicidal thoughts, recent major weight loss treatments, type 2 diabetes, or certain serious medical conditions.

Inclusion Criteria

Elevated depression symptoms, Center for Epidemiologic Studies-Depression Scale (CES-D) ≥21
I am between 12 and 17 years old.
My BMI is at or above the 85th percentile for my age and sex.

Exclusion Criteria

Pregnancy/breastfeeding (females)
Active suicidality or self-harm
I have had bariatric surgery, used weight loss medication, or lost over 3% body weight recently.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually; CBT focuses on changing thoughts and changing behaviors to improve mood

6 weeks
6 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
Follow-up assessments at 6 weeks and 3 months

App Optimization

Focus groups and iterative pilot testing with adolescents to optimize the app's integration with CBT-group virtual sessions

Ongoing during trial

What Are the Treatments Tested in This Trial?

Interventions

  • Digitally Enhanced Cognitive-Behavioral Therapy

Trial Overview

The study compares two approaches: one group gets cognitive-behavioral therapy (CBT) plus a digital app to help practice CBT skills between sessions; the other group receives only CBT in a group setting. Participants are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive-behavioral therapy-Plus (CBT+)Experimental Treatment2 Interventions
Group II: Cognitive-behavioral therapy (CBT)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials
138
Recruited
38,200+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Digitally Enhanced Cognitive-Behavioral Therapy (CBT+)

Our overarching study rationale is that enhancement of CBT-group with a digital app is likely to strengthen homework completion and translation ...

Next-Generation Cognitive-Behavioral Therapy for Depression

Results: Findings indicate that NG-CBT interventions improve treatment accessibility and engagement while maintaining clinical effectiveness. Personalized ...

Digitally Enhanced Cognitive-Behavioral Therapy (CBT+)

In adolescents with depression and obesity, evidence-based programs for depression, like cognitive-behavioral therapy (CBT), might improve ...

Preliminary Efficacy of a Digital Intervention for Adolescent ...

This study aims to examine the efficacy of a mobile app DTx versus an active control as an adjunct treatment for adolescent depression symptoms.

Effectiveness of Digital Cognitive Behavioral Therapy in ...

Conclusion: Digital CBT is a highly effective intervention for reducing depressive symptoms in adolescents, outperforming standard counseling in ...

Efficacy of internet-based cognitive-behavioral therapy for ...

This systematic review and meta-analysis aims to comprehensively assess the efficacy of ICBT in addressing depression among adolescents.

Next-Generation Cognitive-Behavioral Therapy for ...

This systematic review aims to present the latest developments in next-generation CBT interventions of digital support tools, teletherapies, and personalized ...

Cognitive-behavioral therapy for adolescent depression and ...

Overall, results have shown that CBT for depression in adolescents is effective in reducing suicidality. In general, these programs teach coping skills and ...