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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00576719 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Intensive Treatment of Adolescent Panic and Agoraphobia |
| Estimated Enrollment: | 90 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
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2: Experimental
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.
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3: No Intervention
Waitlist control group
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Other: Waitlist control
Waitlist control participants will receive active treatment (treatment with or without family involvement) after 6 weeks of waitlist.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sarah Whitton, PhD | 617-353-9610 | panic@bu.edu |
| United States, Massachusetts | |
| Boston University | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Donna Pincus, PhD | Boston University |
More Information
| Responsible Party: | Boston University ( Donna Pincus, PhD ) |
| Study ID Numbers: | R01 MH068277, DSIR 84-CTS |
| Study First Received: | December 17, 2007 |
| Last Updated: | March 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00576719 History of Changes |
| Health Authority: | United States: Federal Government |
|
Panic Disorder Anxiety Disorders Mental Disorders Agoraphobia |
|
Panic Disorder Pathologic Processes Disease |
Anxiety Disorders Mental Disorders Agoraphobia |