Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Effectiveness of Emotion-Focused Cognitive Behavioral Therapy for Treating Adolescents With Emotional Disorders
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), October 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00628888
  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: Adolescent Emotional Disorders Treatment Protocol

MedlinePlus related topics: Anxiety Depression
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title: Treatment of Emotional Disorders in Adolescence

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 before and after treatment and at Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive and Negative Affect Scale (PANAS) [ Time Frame: Measured before and after treatment and at Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
  • Life Interference Measure (LIM) [ Time Frame: Measured before and after treatment and at all other assessment points ] [ Designated as safety issue: No ]
  • Child Anxiety Sensitivity Index (CASI) [ Time Frame: Measured before and after treatment and at all other assessment points ] [ Designated as safety issue: No ]
  • Depression Symptom Inventory-Suicidality Subscale (DSI-SS) [ Time Frame: Measured before, during, and after treatment and at Months 3 and 6 of follow-up ] [ Designated as safety issue: Yes ]
  • Child Behavior Checklist (CBCL) [ Time Frame: Measured before and after treatment and at Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
  • Emotion Regulation Questionnaire (ERQ-CA & ERQ-2) [ Time Frame: Measured before and after treatment and at all other assessment points ] [ Designated as safety issue: No ]
  • Multidimensional Adolescent Satisfaction Scale (MASS-21) [ Time Frame: Measured before and after treatment and at all other assessment points ] [ Designated as safety issue: No ]
  • Children's Automatic Thoughts Scale (CATS) [ Time Frame: Measured before and after treatment and at all other assessment points ] [ Designated as safety issue: No ]
  • University of Rhode Island Change Assessment Scale (URICA) [ Time Frame: Measured before and after treatment and at all other assessment points ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive immediate emotion-focused cognitive behavioral treatment.
Behavioral: Adolescent Emotional Disorders Treatment Protocol
Participants will receive 16 weekly sessions of emotion-focused cognitive behavioral treatment. These sessions will be delivered in a modular-based treatment approach, which will include psychoeducation, motivational interviewing, emotion awareness/mindfulness, crisis management, parent participation, cognitive reappraisal/problem solving, emotion exposures, and relapse prevention.
2: Experimental
Participants will receive delayed emotion-focused cognitive behavioral treatment.
Behavioral: Adolescent Emotional Disorders Treatment Protocol
Participants will receive 16 weekly sessions of emotion-focused cognitive behavioral treatment. These sessions will be delivered in a modular-based treatment approach, which will include psychoeducation, motivational interviewing, emotion awareness/mindfulness, crisis management, parent participation, cognitive reappraisal/problem solving, emotion exposures, and relapse prevention.

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 emotional and developmental needs of adolescents, may provide a better way of translating effective treatment components to community settings. This study will evaluate the effectiveness of an emotion-focused cognitive behavioral treatment program, called the Adolescent Emotional Disorders Treatment Protocol, for adolescents with anxiety or unipolar depressive disorders.

Participants in this study will be assigned to receive either immediate or delayed emotion-focused cognitive behavioral treatment program sessions. Study participation will last 12 months after beginning treatment. Upon initiation of treatment, parent and child participants will undergo initial assessments that will include questionnaires about anxiety, worry, and depression; an interview pertaining to the child participant's anxiety and depression; and a discussion task. Both parent and child participants will then attend up to 24 weekly treatment sessions, lasting 60 minutes each. During sessions, child participants will learn skills to think differently about situations causing anxiety, cope with emotions, and act in healthy ways in anxiety- and depression-provoking situations. Throughout the course of treatment, parent and child participants will be asked to keep records of the child's anxiety and depression. Child 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 assessments immediately after the last treatment session and 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 severe learning disorder that may prevent basic comprehension of questionnaire or treatment materials), or current suicidal/homicidal ideation
  • Receipt of a prior course of cognitive behavioral treatment
  • Unable to speak, read, or understand English sufficiently well to complete study procedures
  Contacts and Locations
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

Faculty Website  This link exits the ClinicalTrials.gov site
Child Anxiety Website  This link exits the ClinicalTrials.gov site

Responsible Party: University of Miami ( Jill Ehrenreich Assistant Professor of Psychology )
Study ID Numbers: K23 MH073946, DDTR BK-TKPD
Study First Received: February 29, 2008
Last Updated: October 28, 2008
ClinicalTrials.gov Identifier: NCT00628888  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Depression
Anxiety Disorders
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009