Cognitive Behavioral Therapy for Mental Health Issues in Youth

Overseen By Niza Tonarely-Busto, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Psychiatric hospitalization, Eating disorder, Substance-use, others

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

Compensation: Varies

Number of Visits: 15

Duration: 24 weeks

1500 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to administer the Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) and Adolescents (UP-A) to youth and participants' parents and to examine the efficacy and outcomes of the treatment using standardized measures, questionnaires, interviews. The UP-C and the UP-A are cognitive-behavioral therapies to treat emotional disorders.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems likely that you can continue your current medications, but it's best to confirm with the trial organizers.

What data supports the effectiveness of the treatment The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents?

Research shows that the Unified Protocol (UP) is effective for treating various emotional disorders, such as anxiety and depression, in both individual and group settings. It has been shown to reduce symptoms like depression and improve quality of life, making it a promising option for adolescents with mental health issues. ^{1 2 3 4 5}

Is the Unified Protocol for treating emotional disorders safe for young people?

The Unified Protocol, a type of cognitive behavioral therapy, has been studied in various formats and settings, including online and group formats, and has shown to be effective without any reported safety concerns in the available research. ^{1 2 3 4 6}

How is the Unified Protocol treatment different from other treatments for mental health issues in youth?

The Unified Protocol is unique because it is a flexible, transdiagnostic therapy that targets core issues common to multiple emotional disorders, like anxiety and depression, rather than focusing on a single disorder. This approach can simplify treatment by reducing the need for multiple specific treatment manuals. ^{1 4 5 6 7}

Research Team

Jill Ehrenreich-May, PhD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for children aged 7-17 with anxiety, depression, or similar emotional disorders who live in Miami-Dade County. They must speak English/Spanish and have a parent to participate in all sessions. Excluded are those prioritizing other issues like eating disorders or substance abuse, or who've had psychiatric hospitalization recently.

Inclusion Criteria

At least one parent or caregiver with whom the child is living with that can accompany the child and participate in all visits (assessment and treatment)

My child and I can speak and understand English or Spanish well enough for study procedures.

Children with conditions like tic/Tourette's disorder, eating disorders, or disruptive behavior disorders will not be automatically excluded from the study. If their main concern is related to emotional disorders and the treatment offered in this study is considered the best option for them, they may still participate.

Exclusion Criteria

I have not been hospitalized for psychiatric reasons in the last 6 months.

My family cannot wait for group therapy, declined a therapist, or missed 3+ sessions.

If you have other major issues that need immediate attention, like eating disorders, substance abuse, or serious mental health symptoms, you may not be eligible for this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) and Adolescents (UP-A) for up to 24 weeks

24 weeks

15 sessions (group format for children), individual format for adolescents

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents
• The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children

Trial Overview The study tests the Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) and Adolescents (UP-A). These cognitive-behavioral therapies aim to treat various emotional disorders through standardized measures and interviews.

Participant Groups

Group I: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children Experimental Treatment 1 Intervention

The participants in this group will receive the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in up to 15 sessions through a group format, attended over up to 24 weeks. Sessions will include parent and child strategies to manage strong emotions.

Group II: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents Experimental Treatment 1 Intervention

The participants in this group will receive the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) in an individual format for up to 24 weeks.

The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents is already approved in United States for the following indications:

Approved in United States as Unified Protocol for Adolescents for:

• Anxiety disorders
• Depressive disorders
• Obsessive-compulsive disorder
• Other emotional disorders

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

The Children's Trust, Miami FL

Collaborator

Trials

8

Recruited

8,600+

The Children's Trust

Collaborator

Trials

5

Recruited

2,500+

Findings from Research

The Unified Protocol (UP) for treating emotional disorders was found to be as effective as established single disorder protocols (SDPs) in reducing symptoms of co-occurring emotional disorders among 179 adults, with significant improvements observed from baseline to post-treatment and at 12-month follow-up.

Both treatment approaches led to large reductions in symptoms of generalized anxiety, social anxiety, and depression, indicating that the UP is a viable and potentially more cost-effective option for treating multiple emotional disorders simultaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Unified Protocol for transdiagnostic treatment of comorbid psychopathology accompanying emotional disorders compared to treatments targeting single disorders. Steele, SJ., Farchione, TJ., Cassiello-Robbins, C., et al.[2019]

The Unified Protocol (UP) for treating emotional disorders has shown promising results in a virtual group format, with significant improvements in depression, emotional regulation, and quality of life in a previous pilot study of 7 subjects.

After three months, the positive effects of the UP were maintained, indicating its potential for long-term efficacy in teletherapy settings, although more extensive research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unified Protocol for the transdiagnostic treatment of emotional disorders in virtual and group format in Argentina: three months follow-up of a pilot study Celleri, M., Cremades, CF., Rojas, L., et al.[2023]

The Unified Protocol (UP) is an emotion-focused cognitive-behavioral treatment that is being tested in an ongoing randomized controlled trial, showcasing its potential as a transdiagnostic approach for various emotional disorders.

The case example demonstrates how the UP's modular structure allows for tailored treatment, applying specific principles to address the individual needs of the patient, which may enhance its effectiveness across different diagnoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: A Case Study. Boisseau, CL., Farchione, TJ., Fairholme, CP., et al.[2022]

A brief online version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders was tested with 19 young adults, showing that 72% attended at least four out of five sessions, indicating good feasibility for this format.

Participants reported that key concepts from the therapy, like understanding emotions and mindfulness, were useful in their daily lives, and there was a significant reduction in anxiety-related life impairment at the 12-week follow-up compared to baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a brief, online transdiagnostic psychotherapy for young adults. Dimitropoulos, G., Lindenbach, D., Rowbotham, M., et al.[2023]

The Unified Protocol for the Treatment of Emotional Disorders in Adolescents (UP-A) is a flexible and principle-based treatment model that effectively addresses both depressive and anxiety disorders in adolescents.

Research supports the UP-A's positive outcomes, suggesting it simplifies treatment by reducing the number of different evidence-based manuals needed, although further investigation into clinical processes is recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using flexible clinical processes in the Unified Protocol for the Treatment of Emotional Disorders in Adolescence. Girio-Herrera, E., Ehrenreich-May, J.[2018]

The study is the first to evaluate the efficacy of the Spanish version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) as a universal preventive intervention in a school setting, involving 152 adolescents across five classes.

The researchers expect that the UP-A will significantly reduce symptoms of anxiety and depression in the experimental group compared to a waitlist control group, with additional benefits observed in various secondary outcomes such as self-esteem and school adjustment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Spanish Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: Study Protocol for a Cluster Randomized Controlled Trial. García-Escalera, J., Valiente, RM., Chorot, P., et al.[2020]

A study involving 31 adolescents with emotional disorders found that combining the unified protocol for treating emotional disorders with mindfulness significantly improved treatment outcomes compared to the unified protocol alone.

Both treatment methods effectively reduced emotional problems, but the mindfulness-enhanced approach showed greater improvements, particularly in non-phobic anxiety and depression, indicating that mindfulness can enhance the efficacy of existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the effectiveness of the unified protocol in combination with an additional mindfulness treatment to the unified protocol alone as treatment for adolescents diagnosed with emotional disorders. Maleki, M., Khorramnia, S., Foroughi, A., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of the Unified Protocol for transdiagnostic treatment of comorbid psychopathology accompanying emotional disorders compared to treatments targeting single disorders. [2019]

2. Argentina pubmed.ncbi.nlm.nih.gov

Unified Protocol for the transdiagnostic treatment of emotional disorders in virtual and group format in Argentina: three months follow-up of a pilot study [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The Development of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: A Case Study. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a brief, online transdiagnostic psychotherapy for young adults. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Using flexible clinical processes in the Unified Protocol for the Treatment of Emotional Disorders in Adolescence. [2018]

6. Canada pubmed.ncbi.nlm.nih.gov

The Spanish Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: Study Protocol for a Cluster Randomized Controlled Trial. [2020]

7. Brazil pubmed.ncbi.nlm.nih.gov

Comparing the effectiveness of the unified protocol in combination with an additional mindfulness treatment to the unified protocol alone as treatment for adolescents diagnosed with emotional disorders. [2021]