Boston University
Boston, Massachusetts, 02215, United States
NCT Number: NCT00576719
This study will evaluate the effectiveness of intensive cognitive behavioral therapy in treating adolescents with panic disorder with agoraphobia.
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Notify Me12 year–17 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Waitlist control participants will receive active treatment (treatment with or without family involvement) after 6 weeks of waitlist.
Time frame: Measured at Months 3, 6, and 12 post-treatment
Diagnostic Interview of anxiety disorders and related disorders in childhood and adolescence. The ADIS-IV-C/P was used as an independent evaluator measure. The ADIS-IV C/P results in a 0-8 clinical severity rating of the child's primary presenting problems. The ADIS will also be used for ratings of distress and functional interference caused by panic disorder and related disorders. We will also use data on the number of panic attacks during the preceding week.
Time frame: Measured at Months 3, 6, and 12 post-treatment
This measure assesses symptoms of panic disorder in adolescents. It is a 7-item self report measure that assesses 1) panic frequency 2) distress associated with panic attacks, 3) severity of anticipatory anxiety, 4) agoraphobia and avoidance, 5) fear associated with the physical symptoms that accompany panic attacks, 6) work and 7) social impairments related to panic. The sum of these seven items yields an overall PDA severity form. The PDSS uses a 5 point ordinal scale (0 to 4) yielding a total score between 0 and 28.
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Time frame: Measured at Months 3, 6, and 12 post-treatment
Boston University Charles River Campus
Other
Intensive Treatment of Adolescent Panic and Agoraphobia
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