Transdiagnostic Individual Behavioral Activation and Exposure Therapy
The Overall Aim of the this project is to compare treatment outcomes and change in putative treatment mediators in Individual Behavioral Activation Therapy (IBAT) against two active psychological interventions (Coping Cat, PASCET) and a wait-list control. Participants will be 200 youth (ages 9-17) diagnosed with a principal anxiety or depression disorder and their caregivers.
Conditions:
🦠 Anxiety Disorders 🦠 Depression
🗓️ Study Start (Actual) 1 February 2018
🗓️ Primary Completion (Estimated) 31 August 2024
✅ Study Completion (Estimated) 31 August 2025
👥 Enrollment (Estimated) 200
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Piscataway, New Jersey, United States

📋 Eligibility Criteria

Description

  • 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.
Ages Eligible for Study: 9 Years to 17 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 October 2017
  • First Submitted that Met QC Criteria 21 January 2018
  • First Posted 26 January 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 November 2023
  • Last Update Posted 18 November 2023
  • Last Verified November 2023