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

December 18, 2014 updated by: Jill May Ehrenreich, University of Miami

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33146
        • Child and Adolescent Mood and Anxiety Treatment (CAMAT) Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Unified Protocol for Adolescents (UP-A)
Participants receive the UP-A intervention for 8-21 weeks immediately following randomization.
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: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measured pre- and post-treatment, post-waitlist or 8 weeks into treatment and 3 and 6 months following treatment
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
Measured at all post-treatment, waitlist and other follow-up points

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Measured pre- and post-treatment, post waitlist or 8 weeks into treatment and 3 months and 6 months after treatment
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
Measured pre- and post-treatment, post waitlist or 8 weeks into treatment, 3 and 6 months following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

February 29, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (ESTIMATE)

March 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 19, 2014

Last Update Submitted That Met QC Criteria

December 18, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23MH073946 (NIH)
  • DDTR BK-TKPD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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