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

Primary Purpose

Anxiety Disorders, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unified Protocol for Adolescents (UP-A)
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Unipolar Depression, Anxiety, Adolescent, Emotion, Cognitive Behavioral

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Child and Adolescent Mood and Anxiety Treatment (CAMAT) Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Unified Protocol for Adolescents (UP-A)

Delayed Treatment/Waitlist

Arm Description

Participants receive the UP-A intervention for 8-21 weeks immediately following randomization.

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.

Outcomes

Primary Outcome Measures

Clinical Severity Rating (CSR) on the Anxiety Disorders Interview Schedule for DSM-IV, child and parent versions (ADIS-IV-C/P)
Treatment gains and overall patient functioning measured by: Clinical Global Impression Scale(CGI)

Secondary Outcome Measures

Emotion Regulation indices
Changes in Anxiety and Depressive symptomology assessed by the CBCL and RCADS (parent and child version)

Full Information

First Posted
February 29, 2008
Last Updated
December 18, 2014
Sponsor
University of Miami
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00628888
Brief Title
A Waitlist-Controlled Trial of the Unified Protocol for the Treatment of Emotional Disorders in Adolescents
Official Title
Treatment of Emotional Disorders in Adolescence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depression
Keywords
Unipolar Depression, Anxiety, Adolescent, Emotion, Cognitive Behavioral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unified Protocol for Adolescents (UP-A)
Arm Type
Experimental
Arm Description
Participants receive the UP-A intervention for 8-21 weeks immediately following randomization.
Arm Title
Delayed Treatment/Waitlist
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Unified Protocol for Adolescents (UP-A)
Other Intervention Name(s)
Emotion Regulation, Evidence Based Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Ehrenreich-May, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and Adolescent Mood and Anxiety Treatment (CAMAT) Program
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22642525
Citation
Levin L, Henderson HA, Ehrenreich-May J. Interpersonal predictors of early therapeutic alliance in a transdiagnostic cognitive-behavioral treatment for adolescents with anxiety and depression. Psychotherapy (Chic). 2012 Jun;49(2):218-230. doi: 10.1037/a0028265.
Results Reference
background
PubMed Identifier
24635001
Citation
Girio-Herrera E, Ehrenreich-May J. Using flexible clinical processes in the Unified Protocol for the Treatment of Emotional Disorders in Adolescence. Psychotherapy (Chic). 2014 Mar;51(1):117-22. doi: 10.1037/a0032517.
Results Reference
background
PubMed Identifier
24960439
Citation
Queen AH, Barlow DH, Ehrenreich-May J. The trajectories of adolescent anxiety and depressive symptoms over the course of a transdiagnostic treatment. J Anxiety Disord. 2014 Aug;28(6):511-21. doi: 10.1016/j.janxdis.2014.05.007. Epub 2014 Jun 2.
Results Reference
result
Links:
URL
http://www.miami.edu/childanxiety
Description
Click here for more information on Dr. Ehnrenreich at the University of Miami Web site
URL
http://www.miami.edu/childanxiety
Description
Click here for more information on the Child and Adolescent Mood and Anxiety Treatment (CAMAT) program in the Department of Psychology at the University of Miami

Learn more about this trial

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

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