Cognitive Behavioral Therapy for Mental Health Issues in Youth

Overseen By Danielle Ibarra, PsyD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special therapy called the Unified Protocol, designed to help children and teens manage emotional issues like anxiety or depression. Researchers aim to assess the therapy's effectiveness through interviews and questionnaires. The trial divides participants into two groups: one for kids and one for teens, with both groups involving parents to help manage strong emotions. It suits kids and teens, ages 7-17, living in Miami-Dade County, who experience anxiety, depression, trauma, or similar emotional challenges. As an unphased trial, it offers participants a unique opportunity to contribute to the development of innovative therapies for emotional challenges.

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 prior data suggests that these cognitive-behavioral therapies are safe for youth?

Research shows that both the Unified Protocol for Adolescents (UP-A) and the Unified Protocol for Children (UP-C) are well-tolerated treatments. For teenagers, several studies, including those with random assignments, have found that the UP-A helps manage emotional issues without causing major side effects. This indicates the treatment is safe for teens, with no serious safety problems reported.

Similarly, the UP-C, designed for children, has been used in various places, such as Japan, and has shown promise as a type of Cognitive Behavioral Therapy (CBT) applicable to different issues. It focuses on group sessions with both children and their caregivers. No major reports of harm have emerged, indicating it is well-tolerated.

Both treatments use strategies to help manage emotions, which are key to the therapy. The evidence so far supports the safety of these protocols, making them a reliable option for treating emotional disorders in young people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because the Unified Protocols (UP-A and UP-C) offer a flexible, one-size-fits-all approach to treating a range of emotional disorders in young people, unlike traditional therapies that tend to target specific disorders individually. These protocols focus on teaching adolescents and children, along with their parents, strategies to handle intense emotions, which can be beneficial across various mental health challenges. Moreover, the group format of the UP-C also fosters social support, which can enhance treatment outcomes for children. This transdiagnostic method is gaining attention as it could streamline therapy processes and make emotional care more accessible and comprehensive for youth.

What evidence suggests that these treatments could be effective for emotional disorders in youth?

Research has shown that the Unified Protocol for Adolescents (UP-A), which participants in this trial may receive, effectively helps young people with emotional issues. Studies have found that it significantly reduces symptoms of anxiety and depression. Similarly, the Unified Protocol for Children (UP-C), another treatment option in this trial, has successfully eased anxiety and depression in children, yielding strong results. Both children's self-reports and their parents' reports indicate significant improvement in anxiety symptoms. Overall, these treatments help children and adolescents manage strong emotions better. ^{1 2 6 7 8}

Who Is on the Research Team?

Jill Ehrenreich-May, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 (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) 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11815469/

Efficacy of unified protocol for transdiagnostic treatment ... This study is a two-armed, randomised controlled trial on the efficacy of 12 week UP-A on adolescents with emotional disorders along with their parents.

2. advancesinpsychiatryandbehavioralhealth.com advancesinpsychiatryandbehavioralhealth.com/article/S2667-3827(25)00008-0/abstract

Unified Protocols for Transdiagnostic Treatment of Emotional ... Unified protocol for the transdiagnostic treatment of emotional disorders: protocol development and initial outcome data. Cogn Behav Pract ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666915325001003

The efficacy of the unified protocol for emotional disorders ... Overall, our findings suggest that the UP-C/A is effective in treating internalizing symptoms in children and adolescents that can be offered in different ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34064898/

Unified Protocol for the Transdiagnostic Treatment of ... The aim of this systematic review is to know the current (research studies) and future research interest (study protocols) in using the UP for ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0005789424000662

Feasibility, Acceptability, and Preliminary Efficacy of the ... The effectiveness of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A; Ehrenreich-May et al., 2018) ...

6. amazon.com amazon.com/Transdiagnostic-Treatment-Emotional-Disorders-Adolescents/dp/0190855533

Unified Protocol for Transdiagnostic Treatment of ... A comprehensive CBT-based workbook offering strategies to help adolescents manage various emotional disorders through emotion-focused education, awareness ...

7. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2021.731819/full

The Unified Protocol for Transdiagnostic Treatment of ... We introduced the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in Japan and adapted it to the Japanese context.

8. researchprotocols.org researchprotocols.org/2025/1/e74080

An Iteratively Adapted Transdiagnostic Prevention Program ... The UP-A has been found to effectively treat adolescent emotional disorders in multiple studies, including randomized controlled trials (RCTs) [ ...