Transdiagnostic Individual Behavioral Activation and Exposure Therapy

NCT03412227 | Unknown

• 1 other identifier: Pro20170001171
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Anxiety; Depression; Children; Adolescents; CBT

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Global Impression Severity (CGIS) Scale: Independent Evaluator

  The CGI-S score provides a global rating of baseline severity ranging from 1 (not at all ill) to 7 (extremely ill), while the CGI-I provides a global rating of clinical improvement ranging from 1 (Very Much Improved) to 7 (Very Much Worse). The IE will provide a baseline CGI ratings for each patient at pretreatment and posttreatment. Subjects receiving a CGI-I rating of 1 (Very Much Improved) or 2 (Much Improved) by the IE at the end of posttreatment will be considered responders of treatment.

  Change from pre-treatment to post-treatment (baseline to 14-weeks)

Secondary Outcomes (2)

• Change in Behavioral Activation

  Change from pre-treatment to post-treatment (baseline to 14-weeks)

• Child Automatic Thoughts Scale-Negative/Positive

  Change from pre-treatment to post-treatment (baseline to 14-weeks)

Study Arms (2)

Principal Anxiety Disorder

OTHER

Youth with a principal anxiety disorder

Behavioral: Individual Behavioral Activation Therapy (IBAT); Behavioral: The Coping Cat Program for Youth Anxiety Disorders; Other: 14-week waitlist (WL) condition

Principal Depressive Disorder

OTHER

Youth with a principal unipolar depressive disorder

Behavioral: Individual Behavioral Activation Therapy (IBAT); Behavioral: The PASCET Program for Youth Depressive Disorders; Other: 14-week waitlist (WL) condition

Interventions

Individual Behavioral Activation Therapy (IBAT) BEHAVIORAL

IBAT is a manual-based, individual behavioral activation plus exposure therapy aimed at treating youth with anxiety, depression, and anger. The program consists of 10-14 weekly 60 minute sessions. It uses behavioral activation (BA) strategies to target avoidance by helping youth identify stuck points in their lives through functional assessment of numerous life domains, including family and peer interactions, school, extracurricular activities, and health and self-care.

Principal Anxiety Disorder; Principal Depressive Disorder

The PASCET Program for Youth Depressive Disorders BEHAVIORAL

The Primary and Secondary Control Enhancement Therapy (PASCET; Weisz, Southam-Gerow, Gordis, \& Connor-Smith, 2003; Weisz, Southam-Gerow et al., 2009; Weisz, Thurber, Sweeney, Proffitt, \& LeGagnoux, 1997) is a brief (usually 11-15 sessions) CBT program for depressed youths typically aged 8-15. Sessions and practice assignments are built on findings concerning cognitive and behavioral features of, and beneficial treatments for, youth depression (e.g., Lewinsohn et al., 1990; Stark et al., 1987), and on the two-process model of perceived control and coping (Rothbaum, Weisz, \& Snyder, 1982; Weisz et al., 1984a,b).

Principal Depressive Disorder

The Coping Cat Program for Youth Anxiety Disorders BEHAVIORAL

The "Coping Cat" program (Kendall \& Hedtke, 2006; Kendall, Choudhury, Hudson, \& Webb, 2002) has received substantial empirical support for its efficacy in both children (9-13 years old) and teens (12 - 17 years old) (Kendall, 1994; Kendall et al., 1997; Kendall et al., 2008) and involves (1) teaching children to identify their own anxious feelings and physiological signs of anxiety, (2) teaching children to identify their own anxiety-provoking cognitions, (3) developing a plan to guide coping - a plan that involves changing the child's thoughts (into positive self-talk) and actions (into self-initiated exposures), and (4) self-evaluation and self-reward.

Principal Anxiety Disorder

14-week waitlist (WL) condition OTHER

Youth assigned to the 14-week WL will receive no specific therapeutic services from study therapists during the 14-week WL period. However, participants will be assigned a WL Liaison whom families can contact in the event of clinical deterioration. The Liaison will also be responsible for sending links to, and monitor completion of, weekly and mid-WL online surveys (Qualtrics). Independent Evaluators will conduct post-WL diagnostic interviews at the completion of the 14-week WL. WL participants will receive compensation for completion of assessments. After completion of the WL, participants will be invited to continue in the study and be randomly assigned to one of the three behavioral treatments (IBAT, PASCET, or Coping Cat).

Principal Anxiety Disorder; Principal Depressive Disorder

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers University: lead

Study Sites (1)

Youth Anxiety and Depression Clinic

Piscataway, New Jersey, 08854, United States

RECRUITING

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MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Brian C Chu, Ph.D.

  Rutgers University (Youth Anxiety and Depression Clinic)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian C Chu, Ph.D.

CONTACT

848-445-3905; yadc@gsapp.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators will be masked to the treatment conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Clinical Trial, stratified by principal youth diagnosis (anxiety or depression).

Study Record Dates

• First Submitted: October 15, 2017
• First Posted: January 26, 2018
• Study Start: February 1, 2018
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)