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

Primary Purpose

Panic Disorder, Agoraphobia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intensive panic control treatment without parent involvement
Intensive panic control treatment with parent involvement
Waitlist control
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Participants will receive intensive cognitive behavioral therapy treatment without parent involvement

Participants will receive intensive cognitive behavioral therapy treatment with parent involvement

Waitlist control group

Outcomes

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
Panic Disorder Severity Scale-Child Version

Secondary Outcome Measures

Multidimensional Anxiety Scale for Children
Childhood Anxiety Sensitivity Index
Fear and Avoidance Hierarchy
Children's Depression Inventory
The Panic Attack Record
Subjective Symptoms Scale
Panic and Phobia Questionnaire
Participant Global Impression of Improvement (PGI)
Perceptions of Treatment Questionnaire: Adolescent and Parent Versions
Children's Perception Scale (Locus of Control Scale)
Child Behavior Checklist (CBCL)
Stress Index for Parents of Adolescents
Parenting Locus of Control Scale
Therapy Attitude Inventory
Family Assessment Measure (FAM)
Depression Anxiety and Stress Scale (DASS)

Full Information

First Posted
December 17, 2007
Last Updated
February 19, 2014
Sponsor
Boston University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00576719
Brief Title
Effectiveness of Intensive Cognitive Behavioral Therapy in Treating Adolescent Panic Disorder and Agoraphobia
Official Title
Intensive Treatment of Adolescent Panic and Agoraphobia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder, Agoraphobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive intensive cognitive behavioral therapy treatment without parent involvement
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive intensive cognitive behavioral therapy treatment with parent involvement
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Waitlist control group
Intervention Type
Behavioral
Intervention Name(s)
Intensive panic control treatment without parent involvement
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive panic control treatment with parent involvement
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waitlist control
Intervention Description
Waitlist control participants will receive active treatment (treatment with or without family involvement) after 6 weeks of waitlist.
Primary Outcome Measure Information:
Title
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
Title
Panic Disorder Severity Scale-Child Version
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Secondary Outcome Measure Information:
Title
Multidimensional Anxiety Scale for Children
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
Childhood Anxiety Sensitivity Index
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
Fear and Avoidance Hierarchy
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
Children's Depression Inventory
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
The Panic Attack Record
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
Subjective Symptoms Scale
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
Panic and Phobia Questionnaire
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
Participant Global Impression of Improvement (PGI)
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
Perceptions of Treatment Questionnaire: Adolescent and Parent Versions
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
Children's Perception Scale (Locus of Control Scale)
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
Child Behavior Checklist (CBCL)
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
Stress Index for Parents of Adolescents
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
Parenting Locus of Control Scale
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
Therapy Attitude Inventory
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
Family Assessment Measure (FAM)
Time Frame
Measured at Months 3, 6, and 12 post-treatment
Title
Depression Anxiety and Stress Scale (DASS)
Time Frame
Measured at Months 3, 6, and 12 post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Pincus, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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

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