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Effectiveness of Cognitive Behavioral Therapy With Panic Control Treatment for Adolescents With Panic Disorder

Primary Purpose

Panic Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy (CBT) with panic control treatment (PCT) for adolescents
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 panic disorder or panic disorder with agoraphobia prior to treatment
  • If on medication, must undergo a 1-month stabilization period for benzodiazepines or 3-month stabilization period for selective serotonin reuptake inhibitors or tricyclics before study entry

Exclusion Criteria:

  • Positive diagnosis of schizophrenia, pervasive developmental disorder, organic brain syndrome, or mental retardation
  • Current suicidal ideation
  • Refusal of parent to accept random assignment to treatment condition
  • Refusal of parent or adolescent to accept stabilization of medication

Sites / Locations

  • Boston University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive cognitive behavioral therapy with panic control treatment.

Participants will receive cognitive behavioral therapy with panic control treatment after a 12-week waitlist period.

Outcomes

Primary Outcome Measures

Anxiety Disorders Interview Schedule-Child and Parent Versions: Clinical Severity Rating, Agoraphobia Ratings, Weekly Panic Attack Frequency Scores, and Monthly Panic Attack Frequency Scores
Weekly Record of Anxiety and Depression (WRAD)
The Panic Attack Record (PAR)

Secondary Outcome Measures

The Childhood Anxiety Sensitivity Index (CASI)
Children's Depression Inventory (CDI)
The Fear Survey Schedule for Children - Revised
The Revised Children's Manifest Anxiety Scale
Behavioral Approach Test (BAT)

Full Information

First Posted
June 24, 2008
Last Updated
March 4, 2015
Sponsor
Boston University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00705380
Brief Title
Effectiveness of Cognitive Behavioral Therapy With Panic Control Treatment for Adolescents With Panic Disorder
Official Title
Cognitive-Behavioral Treatment of Panic in Adolescence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

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 cognitive behavioral therapy with a panic control treatment component in treating adolescents with panic disorder.
Detailed Description
More than 3 million people in the United States will experience a panic attack at some point in their lives. A panic attack occurs when a person experiences an intense feeling of sudden fear as well as physical sensations of breathlessness, rapid heart beat, and dizziness. Panic disorder, which is characterized by reoccurring panic attacks, often develops during childhood or adolescence and, if left untreated, can interfere with a child's normal development, relationships, school work, and psychological well-being. Cognitive behavioral therapy (CBT) with a panic control treatment (PCT) component is a type of psychotherapy that teaches new ways to control anxiety or panic attacks. It has been found to be effective in treating adults with panic disorder. However, more research is needed to determine if CBT with PCT, when adapted specifically for adolescents, is also effective in treating adolescents with panic disorder. This study will evaluate the effectiveness of CBT with a PCT component in treating adolescents with panic disorder. Participation in this study will last up to 18 months. All participants will first undergo baseline assessments that will include a behavioral/psychological assessment while wearing a heart-rate monitoring device; questionnaires relating to experiences of anxiety, fear, and depression; and parent and child clinical interviews. Participants will then be assigned randomly to receive either immediate CBT with PCT or delayed CBT with PCT, which will occur after a 12-week waitlist period. CBT with PCT for all participants will include 11 weekly individual sessions, lasting 60 minutes each. During sessions, participants will learn specifically designed ways for adolescents to reduce or overcome panic attacks. Throughout treatment, participants will keep daily records of their anxiety and will complete self-monitoring forms to monitor panic attacks. During the 12-week waitlist period, the waitlist group participants will complete the same daily records and self-monitoring forms. The waitlist group participants will also meet with a therapist once every other week to discuss the nature of any panic attacks or address any concerns. Once all 12 weeks have passed, they will begin CBT with PCT. All participants will repeat the baseline assessments at Months 3, 6, and 12 after treatment.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive cognitive behavioral therapy with panic control treatment.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive cognitive behavioral therapy with panic control treatment after a 12-week waitlist period.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT) with panic control treatment (PCT) for adolescents
Intervention Description
CBT with PCT treatment will consist of 11 weekly sessions that are designed to be developmentally appropriate for a younger population. The primary aim of this treatment will be to directly influence three aspects of panic attacks and general anxiety: the cognitive/misinterpretational aspect, the hyperventilatory response, and the conditioned reactions to physical sensations. Throughout treatment, participants will keep daily records of their anxiety and will complete self-monitoring forms to monitor panic attacks.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist control
Intervention Description
During the 12-week waitlist period, participants will keep daily records of their anxiety and will complete self-monitoring forms to monitor panic attacks. Participants will also meet with a therapist every other week to discuss the nature of any panic attacks or address any concerns.
Primary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule-Child and Parent Versions: Clinical Severity Rating, Agoraphobia Ratings, Weekly Panic Attack Frequency Scores, and Monthly Panic Attack Frequency Scores
Time Frame
Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up
Title
Weekly Record of Anxiety and Depression (WRAD)
Time Frame
Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up
Title
The Panic Attack Record (PAR)
Time Frame
Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up
Secondary Outcome Measure Information:
Title
The Childhood Anxiety Sensitivity Index (CASI)
Time Frame
Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up
Title
Children's Depression Inventory (CDI)
Time Frame
Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up
Title
The Fear Survey Schedule for Children - Revised
Time Frame
Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up
Title
The Revised Children's Manifest Anxiety Scale
Time Frame
Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up
Title
Behavioral Approach Test (BAT)
Time Frame
Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up

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 panic disorder or panic disorder with agoraphobia prior to treatment If on medication, must undergo a 1-month stabilization period for benzodiazepines or 3-month stabilization period for selective serotonin reuptake inhibitors or tricyclics before study entry Exclusion Criteria: Positive diagnosis of schizophrenia, pervasive developmental disorder, organic brain syndrome, or mental retardation Current suicidal ideation Refusal of parent to accept random assignment to treatment condition Refusal of parent or adolescent to accept stabilization of medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Mattis, 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 Cognitive Behavioral Therapy With Panic Control Treatment for Adolescents With Panic Disorder

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