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Completed

NCT Number: NCT00628888

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

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

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child and Adolescent Mood and Anxiety Treatment (CAMAT) Program

Miami, Florida, 33146, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Emotion Regulation, Evidence Based Treatment

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Treatment of Emotional Disorders in Adolescence

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Mar 5, 2008
Registry last updated
Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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