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

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Boston University

Status and phase

Completed
Phase 2

Conditions

Panic Disorder
Agoraphobia

Treatments

Behavioral: Intensive panic control treatment without parent involvement
Behavioral: Intensive panic control treatment with parent involvement
Other: Waitlist control

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00576719
DSIR 84-CTS
R01MH068277 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

63 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

63 participants in 3 patient groups, including a placebo group

1
Experimental group
Description:
Participants will receive intensive cognitive behavioral therapy treatment without parent involvement
Treatment:
Behavioral: Intensive panic control treatment without parent involvement
2
Experimental group
Description:
Participants will receive intensive cognitive behavioral therapy treatment with parent involvement
Treatment:
Behavioral: Intensive panic control treatment with parent involvement
3
Placebo Comparator group
Description:
Waitlist control group
Treatment:
Other: Waitlist control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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