ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Effectiveness of Intensive Cognitive Behavioral Therapy in Treating Adolescent Panic Disorder and Agoraphobia

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Effectiveness of Intensive Cognitive Behavioral Therapy in Treating Adolescent Panic Disorder and Agoraphobia
Official Title  Intensive Treatment of Adolescent Panic and Agoraphobia
Brief Summary

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

Detailed Description

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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
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 ]
Secondary Outcome Measure  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 ]
Condition  Panic Disorder
Agoraphobia
Intervention  Behavioral: Intensive panic control treatment without parent involvement
Behavioral: Intensive panic control treatment with parent involvement
Other: Waitlist control
MEDLINE PMIDs
Links Click here for more information on the Intensive Treatment of Adolescent Panic Disorder and Agoraphobia Program at Boston University This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  90
Start Date  February 2004
Completion Date February 2009
Eligibility Criteria 

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
Gender Both
Ages 12 Years to 17 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Sarah Whitton, PhD     617-353-9610     panic@bu.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00576719
Organization ID R01 MH068277
Secondary IDs †† DSIR 84-CTS
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Donna Pincus, PhD     Boston University    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date August 2008
First Received Date  December 17, 2007
Last Updated Date August 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers