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Effectiveness of Intensive Cognitive Behavioral Therapy in Treating Adolescent Panic Disorder and Agoraphobia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT00576719
First received: December 17, 2007
Last updated: February 19, 2014
Last verified: February 2014

December 17, 2007
February 19, 2014
March 2005
March 2011   (final data collection date for primary outcome measure)
  • Anxiety Disorders Interview Schedule-Child and Parent Versions: Clinical Severity Rating, Agoraphobia Ratings, Panic Attack Frequency Scores, and Internal Sensation Anxiety Ratings [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Panic Disorder Severity Scale-Child Version [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00576719 on ClinicalTrials.gov Archive Site
  • Multidimensional Anxiety Scale for Children [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Childhood Anxiety Sensitivity Index [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Fear and Avoidance Hierarchy [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Children's Depression Inventory [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • The Panic Attack Record [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Subjective Symptoms Scale [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Panic and Phobia Questionnaire [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Participant Global Impression of Improvement (PGI) [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Perceptions of Treatment Questionnaire: Adolescent and Parent Versions [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Children's Perception Scale (Locus of Control Scale) [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Child Behavior Checklist (CBCL) [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Stress Index for Parents of Adolescents [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Parenting Locus of Control Scale [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Therapy Attitude Inventory [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Family Assessment Measure (FAM) [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Depression Anxiety and Stress Scale (DASS) [ Time Frame: Measured at Months 3, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Intensive Cognitive Behavioral Therapy in Treating Adolescent Panic Disorder and Agoraphobia
Intensive Treatment of Adolescent Panic and Agoraphobia

This study will evaluate the effectiveness of intensive cognitive behavioral therapy in treating adolescents with panic disorder with agoraphobia.

Panic disorder (PD) in adolescents is a prevalent and chronic anxiety disorder. People with PD experience unexpected attacks of fear, along with elevated heart rate, dizziness, faintness, weakness, and increased sweating. During these panic attacks, people may feel numbness in their hands, flushed or chilled, nauseous, or pain in the chest, and they may lose touch with reality. PD can lead to substantial social impairment for adolescents, including avoidance of school, independent activities, and peer involvement. When PD progresses so far that a person avoids public places where a panic attack might occur, the person is said to have a condition known as agoraphobia. Weekly sessions of cognitive behavioral therapy (CBT) appear to be effective in treating panic disorder with agoraphobia (PDA). However, many adolescents with PDA and their families report the need for a more immediate relief from the disorder. This study will evaluate the effectiveness of intensive CBT in treating adolescents with PDA.

Participants in this single blind study will be randomly assigned to one of three conditions: intensive CBT treatment including family members, intensive CBT treatment without family members, or a waitlist control group. All participants in the intensive CBT treatment groups will undergo 8 days of intensive CBT, for a total of 6 sessions. On Days 1 through 3 of treatment, participants will attend daily, 2-hour CBT sessions. The CBT sessions will include psychoeducation about anxiety, tactics to restructure anxiety-provoking thoughts, and exposure to bodily sensations that trigger panic. On Days 4 and 5, participants will meet with a therapist to learn ways to approach previously feared situations. On Days 6 and 7, participants will continue working independently or with family members to solidify skills. On Day 8, participants will attend a final 2-hour session to consolidate skills, review the independent weekend activities, and discuss ways to apply skills to the home environment. Parents of participants in the parental involvement group will attend the last 30 minutes of sessions, complete homework assignments, learn ways to coach their children through episodes, and participate in selected exposures. After 6 weeks of waitlist, participants in the waitlist control group will receive active treatment following the same procedures as the initial active treatment. All participants will be assessed at Months 3, 6, and 12 post-treatment.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Panic Disorder
  • Agoraphobia
  • Behavioral: Intensive panic control treatment without parent involvement
    Intensive panic control treatment without parent involvement is an 8-day, intensive form of cognitive behavioral therapy (CBT) with exposure, including 15-20 hours of direct therapist contact. The basic treatment components are psychoeducation about anxiety, restructuring anxiety-provoking thoughts, exposure to bodily sensations that trigger panic, and in vivo exposures.
  • Behavioral: Intensive panic control treatment with parent involvement
    Intensive panic control treatment with parent involvement involves the same form of intensive CBT, but with direct parent involvement. Parents will attend the last 30 minutes of didactic sessions, complete homework assignments, learn ways to coach their children, and participate in selected exposures.
  • Other: Waitlist control
    Waitlist control participants will receive active treatment (treatment with or without family involvement) after 6 weeks of waitlist.
  • Experimental: 1
    Participants will receive intensive cognitive behavioral therapy treatment without parent involvement
    Intervention: Behavioral: Intensive panic control treatment without parent involvement
  • Experimental: 2
    Participants will receive intensive cognitive behavioral therapy treatment with parent involvement
    Intervention: Behavioral: Intensive panic control treatment with parent involvement
  • Placebo Comparator: 3
    Waitlist control group
    Intervention: Other: Waitlist control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meets DSM-IV criteria for principal diagnosis of PD or PDA prior to treatment
  • Adolescent must be accompanied by at least one parent or caregiver
  • If on medication, there must be a 1-month stabilization period for benzodiazepines or 3-month stabilization period for SSRIs or tricyclics prior to study entry

Exclusion Criteria:

  • Positive diagnosis of schizophrenia, pervasive developmental disorder, organic brain syndrome, mental retardation, or current suicidal ideation
  • Unavailability of at least one parent or caregiver
  • Refusal of parent to accept random assignment to treatment condition
  • Refusal of parent or adolescent to accept stabilization of medication
  • Adolescent with parent who has any condition that would limit ability to understand treatment
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00576719
R01 MH068277, R01MH068277, DSIR 84-CTS
Yes
Boston University
Boston University
National Institute of Mental Health (NIMH)
Principal Investigator: Donna Pincus, PhD Boston University
Boston University
February 2014

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