Behavioral therapy for anxiety and depression in youth

Randomized Clinical Trial of Transdiagnostic Behavioral Activation and Exposure Therapy for Youth: A Comparison of Effects and Mediators

This study is testing a new therapy for kids and teens with anxiety and depression to see if it works better than two other common treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 9 Years to 17 Years
• Sex: All
• Sponsor: Rutgers, The State University of New Jersey (Academic / other)
• Locations: 1 site (Piscataway, New Jersey)
• Trial ID: NCT03412227 on ClinicalTrials.gov

What this trial studies

This project aims to compare the effectiveness of Individual Behavioral Activation Therapy (IBAT) against two established psychological interventions, Coping Cat and PASCET, as well as a wait-list control. The study will involve 200 youth aged 9-17 who are diagnosed with anxiety or depression, along with their caregivers. By utilizing a transdiagnostic approach, the study seeks to address both anxiety and depression simultaneously, potentially improving treatment outcomes. Participants will be assessed through a semi-structured interview to confirm their diagnoses.

Who should consider this trial

Good fit: Ideal candidates are youth aged 9-17 with a principal diagnosis of anxiety or unipolar depression.

Not a fit: Patients without a principal diagnosis of anxiety or depression, or those with other unrelated mental health issues, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective treatment options for youth suffering from anxiety and depression.

How similar studies have performed: While transdiagnostic interventions have shown promise in adult populations, their application in children and adolescents is less explored, making this approach somewhat novel.

Eligibility criteria

We expect 200 youth (ages 9-17 years) with either a principle anxiety (n=100) or a unipolar depression disorder (n=100) and their parents/caregivers to serve as participants.

Inclusion Criteria:

To participate, a youth must meet criteria for a primary DSM-5 (American Psychiatric Association, 2003) diagnosis of any of the following:

* Generalized Anxiety Disorder (GAD)
* Separation Anxiety Disorder (SEP)
* Social Anxiety Disorder (SAD)
* Specific Phobia (SP)
* Panic Disorder (PD)
* Agoraphobia
* Major Depression Disorder (MDD)
* Depression Disorder - Insufficient Symptoms (DD-Insufficient)
* Persistent Depressive Disorder (PDD)

Comorbid (non-principal) disorders are acceptable, including the presence of disorders not listed above. Diagnosis will be based on both youth and parent report during an Independent Evaluator (IE) semi-structured interview. Youth may also participate with a subclinical diagnosis for any of these disorders if: (a) the youth demonstrates sufficient symptoms but does not yet reach clinical levels of impairment OR (b) the youth demonstrates only several symptoms related to the above disorders but demonstrates clinical impairment, AND (c) the consenting parent agrees that anxiety or mood problems would be appropriate as a clinical focus for treatment. Allowing youth with subclinical diagnoses will allow the study to investigate the effectiveness of the therapies across a range of clinical severity. This design models usual community care where a larger range of severity is witnessed and many youth may not meet all criteria for formal diagnosis. After receiving an initial diagnostic assessment at T1, the parent must consent and the youth must assent to continued participation in the study, including randomization to treatment condition, and must be willing to receive psychological therapy at the Youth Anxiety and Depression Clinic (YAD-C), a specialty program within the outpatient clinic of the Rutgers University Graduate School of Applied and Professional Psychology (GSAPP).

Exclusion Criteria:

Youth who have a principal DSM-5 disorder other than one of the above listed anxiety or depression disorders (e.g., anorexia nervosa, Post-traumatic Stress Disorder, Attention Deficit-Hyperactivity Disorder), or who have received any diagnosis of:

* Intellectual Disability
* Autism Spectrum Disorder
* schizophrenia
* bipolar disorder.

Youth who demonstrate suicidal ideation or intent (by child or parent report) severe enough to require current hospitalization, or youth who have attempted suicide in the past 3 months, will also be excluded. These clinical problems require specialized treatment that YAD-C is not prepared to offer. Youth will not be excluded on the basis of gender or racial/ethnic origin. However, youth and at least one parent will be required to speak English sufficiently enough to complete study procedures and surveys in English. Participants will be asked not to engage in any other outpatient psychological treatment during their time in the study; this is important to enhance internal validity of the study and conforms with best clinical practices to avoid conflicting treatment recommendations. However, current use of antidepressant or anxiolytic medications will NOT be an exclusion. Participants will be asked to arrive at a stable dosage and schedule for their medication, in consultation with their presiding physician or psychiatrist, prior to study initiation. Use of medications and any other treatment modalities will be assessed during study participation and compared across treatment and WL conditions.

Where this trial is running

Piscataway, New Jersey

• Youth Anxiety and Depression Clinic — Piscataway, New Jersey, United States (Recruiting)

Study contacts

• Principal investigator: Brian C Chu, Ph.D. — Rutgers University (Youth Anxiety and Depression Clinic)
• Study coordinator: Brian C Chu, Ph.D.

Conditions Anxiety Disorders; Depression; Anxiety; Children; Adolescents; CBT