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

NCT00628888 | Completed

• 2 other identifiers: K23MH073946DDTR BK-TKPD
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety Disorders; Depression

Keywords

Unipolar Depression; Anxiety; Adolescent; Emotion; Cognitive Behavioral

Outcome Measures

Primary Outcomes (2)

• Clinical Severity Rating (CSR) on the Anxiety Disorders Interview Schedule for DSM-IV, child and parent versions (ADIS-IV-C/P)

  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)

  Measured at all post-treatment, waitlist and other follow-up points

Secondary Outcomes (2)

• Emotion Regulation indices

  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)

  Measured pre- and post-treatment, post waitlist or 8 weeks into treatment, 3 and 6 months following treatment

Study Arms (2)

Unified Protocol for Adolescents (UP-A)

EXPERIMENTAL

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

Behavioral: Unified Protocol for Adolescents (UP-A)

Delayed Treatment/Waitlist

EXPERIMENTAL

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)

Interventions

Unified Protocol for Adolescents (UP-A) BEHAVIORAL

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.

Also known as: Emotion Regulation, Evidence Based Treatment

Delayed Treatment/Waitlist; Unified Protocol for Adolescents (UP-A)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Child and Adolescent Mood and Anxiety Treatment (CAMAT) Program

Miami, Florida, 33146, United States

Location

Related Publications (3)

• 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.

  PMID: 22642525 BACKGROUND

• 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.

  PMID: 24635001 BACKGROUND

• 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.

  PMID: 24960439 RESULT

Related Links

• Click here for more information on Dr. Ehnrenreich at the University of Miami Web site
• 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

MeSH Terms

Conditions

Anxiety Disorders; Depression; Depressive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Mood Disorders

Study Officials

• Jill Ehrenreich-May, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 5, 2008
• Study Start: July 1, 2006
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

US (1)