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
  Purpose

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


Condition Intervention Phase
Panic Disorder
Agoraphobia
Behavioral: Intensive panic control treatment without parent involvement
Behavioral: Intensive panic control treatment with parent involvement
Other: Waitlist control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intensive Treatment of Adolescent Panic and Agoraphobia

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 63
Study Start Date: March 2005
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive intensive cognitive behavioral therapy treatment without parent involvement
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.
Experimental: 2
Participants will receive intensive cognitive behavioral therapy treatment with parent involvement
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.
Placebo Comparator: 3
Waitlist control group
Other: Waitlist control
Waitlist control participants will receive active treatment (treatment with or without family involvement) after 6 weeks of waitlist.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576719

Locations
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Donna Pincus, PhD Boston University
  More Information

No publications provided

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT00576719     History of Changes
Other Study ID Numbers: R01 MH068277, R01MH068277, DSIR 84-CTS
Study First Received: December 17, 2007
Last Updated: February 19, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Agoraphobia
Panic Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014