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A Waitlist-Controlled Trial of the Unified Protocol for the Treatment of Emotional Disorders in Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jill May Ehrenreich, University of Miami
ClinicalTrials.gov Identifier:
NCT00628888
First received: February 29, 2008
Last updated: December 18, 2014
Last verified: December 2014

February 29, 2008
December 18, 2014
July 2006
September 2012   (final data collection date for primary outcome measure)
  • 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 ]
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 ]
Complete list of historical versions of study NCT00628888 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS) [ Time Frame: Measured before and after treatment and at Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
  • Family Environment Scale (FES) [ Time Frame: Measured before and after treatment and at Months 3 and 6 of follow-up ] [ 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 ]
Not Provided
Not Provided
 
A Waitlist-Controlled Trial of the Unified Protocol for the Treatment of Emotional Disorders in Adolescents
Treatment of Emotional Disorders in Adolescence

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

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 Adolescents (UP-A), for youth with anxiety or unipolar depressive disorders.

Participants in this study will be assigned to receive either immediate or delayed UP-A 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Anxiety Disorders
  • Depression
Behavioral: Unified Protocol for Adolescents (UP-A)
All participants will be offered the UP-A intervention, inclusive of 8 and 21 weekly sessions of an emotion-focused treatment with cognitive-behavioral elements, either immediately following randomization or after an 8-week delayed treatment waitlist. The UP-A sessions are delivered in a flexible manner. Several of the UP-A's treatment elements are fixed and received by all participants (psychoeducation about emotions and emotional behavior, awareness and mindfulness skills, antecedent cognitive reappraisal/problem-solving skills, emotion exposure strategies, and relapse prevention skills), although applied for varying numbers of sessions depending on clinical need. Other strategies (motivational enhancement, parenting strategies and crisis management strategies) are applied on an as-needed basis based on client needs.
Other Names:
  • Emotion Regulation
  • Evidence Based Treatment
  • Experimental: Unified Protocol for Adolescents (UP-A)
    Participants receive the UP-A intervention for 8-21 weeks immediately following randomization.
    Intervention: Behavioral: Unified Protocol for Adolescents (UP-A)
  • Experimental: Delayed Treatment/Waitlist
    Participants receive an 8-week waitlist condition with some attentional-control via monitoring for clinical deterioration. After a post-waitlist assessment, participants in this condition are offered the UP-A treatment for 8-21 weeks.
    Intervention: Behavioral: Unified Protocol for Adolescents (UP-A)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00628888
K23 MH073946, K23MH073946, DDTR BK-TKPD
No
Jill May Ehrenreich, University of Miami
University of Miami
National Institute of Mental Health (NIMH)
Principal Investigator: Jill Ehrenreich-May, PhD University of Miami
University of Miami
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP