Cognitive Behavioral Therapy for Depression and Anxiety

Overseen By Sherelle Harmon, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Seizure disorder, Psychosis, Organic brain syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 28 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Cognitive Behavioral Therapy (CBT) for children and teens with severe irritability, anxiety, or mood disorders. The researchers aim to understand the development of these conditions and identify effective treatments. Children diagnosed with an anxiety or mood disorder, or who exhibit significant irritability and disruptive behavior, might be suitable candidates. Both the child and a parent must speak English and participate in the therapy sessions. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatments for these conditions.

What prior data suggests that Cognitive Behavioral Therapy is safe for treating depression and anxiety in school-aged youth?

Research has shown that Cognitive Behavioral Therapy (CBT) is generally safe and well-tolerated. Studies have found that CBT can help reduce avoidance behaviors and manage incorrect beliefs, improving mental health conditions like depression and anxiety. Negative effects from CBT are rare. A review of studies checked for harm in some cases and found no major safety concerns. CBT is widely used and proven effective in treating various mental health issues, suggesting it is a safe option for most people considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy (CBT) for depression and anxiety because it offers a non-pharmacological approach that targets the root causes of these conditions. Unlike medications, which often focus on altering brain chemistry, CBT works by changing patterns of thinking and behavior that contribute to emotional distress. This therapy empowers individuals with coping strategies and skills to manage their symptoms more effectively over the long term. Additionally, CBT has been shown to have fewer side effects compared to many antidepressant and anti-anxiety medications, making it an appealing option for those who prefer a drug-free treatment.

What evidence suggests that Cognitive Behavioral Therapy might be an effective treatment for severe irritability in school-aged youth?

Studies have shown that Cognitive Behavioral Therapy (CBT), which participants in this trial will receive, effectively treats depression and anxiety. Research indicates that CBT can improve symptoms of depression, with about half of the patients experiencing positive results. In the short term, CBT matches medication in effectiveness and may surpass it in the long run. Many studies support its effectiveness, highlighting its role in managing mood disorders. Additionally, digital CBT tools have demonstrated promise for long-term benefits in treating depression. Overall, CBT is a well-established method for improving mental health conditions like depression and anxiety. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children aged 4-17 with anxiety or mood disorders, or those experiencing irritability and emotional dysregulation. At least one parent must participate in the study phases. Both child and parent need to understand English without a translator.

Inclusion Criteria

At least one parent must be available and willing to participant in both phases.

I am between 4 and 17 years old.

My child and I can complete consent forms and participate in English without needing a translator.

Exclusion Criteria

I have significant issues with my nervous system affecting my senses or movement.

History of seizure disorder, psychosis, or organic brain syndrome

Conditions requiring acute intervention, e.g., active suicidality

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Comprehensive, multimodal assessment including diagnostic interviews, behavioral ratings, and neurophysiological tasks

4-6 weeks

Multiple visits (in-person)

Treatment

Participants receive evidence-based treatment such as cognitive behavioral therapy

Up to 28 weeks

Regular sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy

Trial Overview

The study tests Cognitive Behavioral Therapy (CBT) as a treatment for severe irritability in youth with depression, anxiety, or both. It aims to identify how this therapy affects emotional and behavioral issues.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S0165032725012339

Cognitive behavioral therapies are evidence-based – ...

Fifty-nine studies (95 %) included a measure of depressive symptoms. Positive (74 %) and negative outcomes (65 %) were also frequently investigated. Harm and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9840507/

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 ...

3.

crowncounseling.com

crowncounseling.com/statistics/cbt-success-rate-statistics/

CBT Success Rate Statistics: Effectiveness of CBT in 2024

The overall response rate for CBT in treating depression is approximately 50%. CBT demonstrates an effect size of approximately g=0.75 for PTSD ...

4.

nature.com

nature.com/articles/s41746-022-00677-8

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, ...

5.

mdpi.com

mdpi.com/1648-9144/61/3/431

Next-Generation Cognitive-Behavioral Therapy for ...

Taking together, the current evidence strongly suggests that digital CBT tools hold significant promise for effective long-term treatment outcomes in depression ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8489050/

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.

7.

psychiatryonline.org

psychiatryonline.org/doi/full/10.1176/appi.focus.20200045

Cognitive-Behavioral Treatments for Anxiety and Stress- ...

I-CBT has been shown (17–19) to be superior to waitlist and placebo conditions in the treatment of adults with a range of anxiety and trauma ...

8.

mayoclinic.org

mayoclinic.org/tests-procedures/cognitive-behavioral-therapy/about/pac-20384610

Cognitive behavioral therapy

CBT can be a very helpful tool in treating many mental health conditions, such as depression, anxiety, post-traumatic stress disorder, also ...