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

NCT00576719 | Completed Phase 2 DMC

• 2 other identifiers: R01MH068277DSIR 84-CTS
• 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

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

• Panic Disorder Severity Scale-Child Version

  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)

1

EXPERIMENTAL

Participants will receive intensive cognitive behavioral therapy treatment without parent involvement

Behavioral: Intensive panic control treatment without parent involvement

2

EXPERIMENTAL

Participants will receive intensive cognitive behavioral therapy treatment with parent involvement

Behavioral: Intensive panic control treatment with parent involvement

3

PLACEBO COMPARATOR

Waitlist control group

Other: Waitlist control

Interventions

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.

1

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.

2

Waitlist control OTHER

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

3

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

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

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: phase 2
• 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: February 20, 2014

Record last verified: 2014-02

Locations

US (1)