NCT00705380

Brief Summary

This study will evaluate the effectiveness of cognitive behavioral therapy with a panic control treatment component in treating adolescents with panic disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 1998

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2008

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

6.3 years

First QC Date

June 24, 2008

Last Update Submit

March 4, 2015

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (3)

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

    Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up

  • Weekly Record of Anxiety and Depression (WRAD)

    Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up

  • The Panic Attack Record (PAR)

    Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up

Secondary Outcomes (5)

  • The Childhood Anxiety Sensitivity Index (CASI)

    Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up

  • Children's Depression Inventory (CDI)

    Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up

  • The Fear Survey Schedule for Children - Revised

    Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up

  • The Revised Children's Manifest Anxiety Scale

    Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up

  • Behavioral Approach Test (BAT)

    Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up

Study Arms (2)

1

EXPERIMENTAL

Participants will receive cognitive behavioral therapy with panic control treatment.

Behavioral: Cognitive behavioral therapy (CBT) with panic control treatment (PCT) for adolescents

2

ACTIVE COMPARATOR

Participants will receive cognitive behavioral therapy with panic control treatment after a 12-week waitlist period.

Behavioral: Cognitive behavioral therapy (CBT) with panic control treatment (PCT) for adolescentsBehavioral: Waitlist control

Interventions

Cognitive behavioral therapy (CBT) with panic control treatment (PCT) for adolescentsBEHAVIORAL

CBT with PCT treatment will consist of 11 weekly sessions that are designed to be developmentally appropriate for a younger population. The primary aim of this treatment will be to directly influence three aspects of panic attacks and general anxiety: the cognitive/misinterpretational aspect, the hyperventilatory response, and the conditioned reactions to physical sensations. Throughout treatment, participants will keep daily records of their anxiety and will complete self-monitoring forms to monitor panic attacks.

12
Waitlist controlBEHAVIORAL

During the 12-week waitlist period, participants will keep daily records of their anxiety and will complete self-monitoring forms to monitor panic attacks. Participants will also meet with a therapist every other week to discuss the nature of any panic attacks or address any concerns.

2

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Meets DSM-IV criteria for principal diagnosis of panic disorder or panic disorder with agoraphobia prior to treatment
  • If on medication, must undergo a 1-month stabilization period for benzodiazepines or 3-month stabilization period for selective serotonin reuptake inhibitors or tricyclics before study entry

You may not qualify if:

  • Positive diagnosis of schizophrenia, pervasive developmental disorder, organic brain syndrome, or mental retardation
  • Current suicidal ideation
  • Refusal of parent to accept random assignment to treatment condition
  • Refusal of parent or adolescent to accept stabilization of medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Panic Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sarah Mattis, 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

Study Record Dates

First Submitted

June 24, 2008

First Posted

June 26, 2008

Study Start

July 1, 1998

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

US(1)