ClinicalTrials.gg
CompletedNCT00576719Updated Jul 21, 2026

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

An interventional study of Intensive panic control treatment without parent involvement and Intensive panic control treatment with parent involvement in Panic Disorder and Agoraphobia, sponsored by Boston University Charles River Campus. Completed at 1 site in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Panic Disorder
  • Agoraphobia
03

In context

Panic Disorder

270 studies on the registry are indexed under Panic Disorder; 37 are open to participants now.

This study's enrollment of 63 is below the median of 77 across 215 interventional studies indexed under Panic Disorder.

Browse Panic Disorder studies →

Lead sponsor

Boston University Charles River Campus is the lead sponsor of 159 studies on the registry; 33 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 9 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Meets 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Intensive Cognitive Behavioral Therapy without Parent Involvement

    Participants will receive intensive cognitive behavioral therapy treatment without parent involvement

    Behavioral: Intensive panic control treatment without parent involvement

  • Experimental
    Intensive Cognitive Behavioral Therapy with Parent Involvement

    Participants will receive intensive cognitive behavioral therapy treatment with parent involvement

    Behavioral: Intensive panic control treatment with parent involvement

  • Placebo comparator
    Waitlist Control Group

    Waitlist control group

    Other: Waitlist control

Interventions

  • BehavioralIntensive panic control treatment without parent involvement

    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.

  • BehavioralIntensive panic control treatment with parent involvement

    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.

  • OtherWaitlist control

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  2. 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.

    Time frame: Measured at Months 3, 6, and 12 post-treatment

Secondary outcomes

  1. Multidimensional Anxiety Scale for Children

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  2. Childhood Anxiety Sensitivity Index

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  3. Fear and Avoidance Hierarchy

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  4. Children's Depression Inventory

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  5. The Panic Attack Record

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  6. Subjective Symptoms Scale

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  7. Panic and Phobia Questionnaire

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  8. Participant Global Impression of Improvement (PGI)

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  9. Perceptions of Treatment Questionnaire: Adolescent and Parent Versions

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  10. Children's Perception Scale (Locus of Control Scale)

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  11. Child Behavior Checklist (CBCL)

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  12. Stress Index for Parents of Adolescents

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  13. Parenting Locus of Control Scale

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  14. Therapy Attitude Inventory

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  15. Family Assessment Measure (FAM)

    Time frame: Measured at Months 3, 6, and 12 post-treatment

  16. Depression Anxiety and Stress Scale (DASS)

    Time frame: Measured at Months 3, 6, and 12 post-treatment

07

Study locations

1 site
  • Boston University
    Boston, Massachusetts 02215, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00576719
Responsible party
Sponsor
First posted
Dec 19, 2007
Start date
Mar 2005
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Jul 21, 2026

Study contacts

Donna Pincus, PhD
principal investigator · Boston University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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