Effectiveness of Emotion-Focused Cognitive Behavioral Therapy for Treating Adolescents With Emotional Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00628888
First received: February 29, 2008
Last updated: April 2, 2009
Last verified: April 2009
  Purpose

This study will evaluate the effectiveness of an emotion-focused cognitive behavioral treatment program for adolescents with anxiety or unipolar depressive disorders.


Condition Intervention
Anxiety Disorders
Depression
Behavioral: Unified Treatment for Emotional Disorders in Youth (UP-Y)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Emotional Disorders in Adolescence

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Clinical Severity Rating (CSR) on the Anxiety Disorders Interview Schedule for DSM-IV, child and parent versions (ADIS-IV-C/P) [ Time Frame: Measured pre- and post-treatment, post-waitlist or 8 weeks into treatment and 3 and 6 months following treatment ] [ Designated as safety issue: No ]
  • Treatment gains and overall patient functioning measured by: Clinical Global Impression Scale(CGI) [ Time Frame: Measured at all post-treatment, waitlist and other follow-up points ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Emotion Regulation indices [ Time Frame: Measured pre- and post-treatment, post waitlist or 8 weeks into treatment and 3 months and 6 months after treatment ] [ Designated as safety issue: No ]
  • Changes in Anxiety and Depressive symptomology assessed by the CBCL and RCADS (parent and child version) [ Time Frame: Measured pre- and post-treatment, post waitlist or 8 weeks into treatment, 3 and 6 months following treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2006
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive the UP-Y, either immediately or after an 8 week wait list period.
Behavioral: Unified Treatment for Emotional Disorders in Youth (UP-Y)

All participants will receive between 8 and 21 weekly sessions of an emotion-focused cognitive behavioral treatment. These sessions will be delivered in a flexible manner, with skills such as psycho-education, motivational interviewing, emotion awareness, crisis management, parent emotion management, cognitive reappraisal/problem solving, emotion exposures, and relapse prevention.

Participants will be randomly assigned to either a wait list or immediate treatment condition. All participants, regardless of assignment will be offered the intervention. Participants assigned to the wait list condition will have an initial 8 week waiting period with minimal clinical contact (clinical check in every other week) before receiving active treatment.

Other Names:
  • Emotion Regulation
  • Cognitive Behavioral Therapy

Detailed Description:

Anxiety and depression are among the most prevalent psychiatric disorders in youth. Adolescents with anxiety or depression experience persistent emotional distress that can cause problems with school, family, and friends. In addition, anxiety and depressive disorders commonly co-exist, causing further distress for those affected. If left untreated, the difficulties associated with these disorders can persist into adulthood. Fortunately, anxiety and depression are highly treatable using a combination of medications and forms of psychotherapy, but many youth in community settings are unlikely to receive these treatments. An emotion-focused, cognitive behavioral treatment, specifically designed to meet a broad range of treatment needs of adolescents, may provide one way of translating effective treatment components to community settings. This study will evaluate the effectiveness of a transdiagnostic, emotion-focused, cognitive behavioral treatment program, called the Unified Protocol for the Treatment of Emotional Disorders in Youth (UP-Y), for adolescents with anxiety or unipolar depressive disorders.

Participants in this study will be assigned to receive either immediate or delayed UP-Y program sessions. Study participation will last up to 12 months after beginning treatment. Upon initiation of treatment, parent and child participants will undergo initial assessments that will include questionnaires about anxiety, worry, depression and emotion regulation; and an interview pertaining to the adolescent's anxiety and depression. Both parent and adolescent participants will then attend up to 21 weekly treatment sessions, lasting 60 minutes each. During sessions, participants will learn skills regarding acceptance of intense emotional states, how to actively cope with emotions, and act in healthy ways during anxiety- and depression-provoking situations. Throughout the course of treatment, parent and adolescent participants will be asked to keep records about the adolescent's emotions and functioning. Participants will also be given at-home assignments to practice skills learned in treatment sessions. During and after treatment, participants will complete questionnaires about their thoughts on the treatment sessions. Participants will repeat the initial assessment either following the waitlist delayed treatment condition or 8 weeks into treatment, immediately after the last treatment session as well as at months 3 and 6 of follow-up.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Principal diagnosis of major depressive disorder, social anxiety disorder, social phobia, panic disorder with or without agoraphobia, generalized anxiety disorder, obsessive compulsive disorder, agoraphobia, post-traumatic stress disorder, dysthymic disorder, anxiety disorder not-otherwise-specified, or depressive disorder not-otherwise-specified
  • At least one parent (or caregiver with whom the adolescent is living) available to accompany the adolescent to all assessment sessions and attend parent sessions as prescribed
  • For adolescents on medication, there must be a 1-month stabilization period (for benzodiazepines) or 3-month stabilization period (for selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, or tricyclics) before study entry
  • Able to maintain current medication regimen (or remain off psychopharmacologic treatment if not currently taking such medications) throughout the study, unless changes are medically necessary

Exclusion Criteria:

  • Co-occurring conditions, including positive diagnosis of schizophrenia, bipolar I or II disorder, pervasive developmental disorder, organic brain syndrome, mental retardation , or current suicidal/homicidal ideation
  • A prior course of cognitive behavioral treatment
  • Inability to speak, read, or understand English sufficiently well to complete study procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628888

Contacts
Contact: Jill T. Ehrenreich, PhD 305-284-9852 jehrenreich@psy.miami.edu

Locations
United States, Florida
Child and Adolescent Mood and Anxiety Treatment (CAMAT) Program Recruiting
Miami, Florida, United States, 33146
Contact: Emily Laird    305-284-9852    anxietylab@psy.miami.edu   
Principal Investigator: Jill T. Ehrenreich, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Jill T. Ehrenreich, PhD University of Miami
  More Information

Additional Information:
No publications provided

Responsible Party: Jill T. Ehrenreich, PhD, Assistant Professor of Psychology, University of Miami
ClinicalTrials.gov Identifier: NCT00628888     History of Changes
Other Study ID Numbers: K23 MH073946, DDTR BK-TKPD
Study First Received: February 29, 2008
Last Updated: April 2, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Unipolar Depression
Anxiety
Adolescent
Emotion
Cognitive Behavioral

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 31, 2014