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

NCT00576719 | Completed DMC

• 1 other identifier: R01MH068277
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Panic Disorder; Agoraphobia

Outcome Measures

Primary Outcomes (2)

• Anxiety Disorders Interview Schedule-Child and Parent Versions: Clinical Severity Rating, Agoraphobia Ratings, Panic Attack Frequency Scores, and Internal Sensation Anxiety Ratings

  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.

  Measured at Months 3, 6, and 12 post-treatment

• Panic Disorder Severity Scale-Child Version

  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.

  Measured at Months 3, 6, and 12 post-treatment

Secondary Outcomes (16)

• Multidimensional Anxiety Scale for Children

  Measured at Months 3, 6, and 12 post-treatment

• Childhood Anxiety Sensitivity Index

  Measured at Months 3, 6, and 12 post-treatment

• Fear and Avoidance Hierarchy

  Measured at Months 3, 6, and 12 post-treatment

• Children's Depression Inventory

  Measured at Months 3, 6, and 12 post-treatment

• The Panic Attack Record

  Measured at Months 3, 6, and 12 post-treatment

Study Arms (3)

Intensive Cognitive Behavioral Therapy without Parent Involvement

EXPERIMENTAL

Participants will receive intensive cognitive behavioral therapy treatment without parent involvement

Behavioral: Intensive panic control treatment without parent involvement

Intensive Cognitive Behavioral Therapy with Parent Involvement

EXPERIMENTAL

Participants will receive intensive cognitive behavioral therapy treatment with parent involvement

Behavioral: Intensive panic control treatment with parent involvement

Waitlist Control Group

PLACEBO COMPARATOR

Waitlist control group

Other: Waitlist control

Interventions

Intensive panic control treatment with parent involvement BEHAVIORAL

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.

Intensive Cognitive Behavioral Therapy with Parent Involvement

Waitlist control OTHER

Waitlist control participants will receive active treatment (treatment with or without family involvement) after 6 weeks of waitlist.

Waitlist Control Group

Intensive panic control treatment without parent involvement BEHAVIORAL

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 Cognitive Behavioral Therapy without Parent Involvement

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Boston University Charles River Campus: lead

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Panic Disorder; Agoraphobia

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Phobic Disorders

Study Officials

• Donna Pincus, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 19, 2007
• Study Start: March 1, 2005
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 21, 2026

Record last verified: 2014-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)