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Completed

NCT Number: NCT00576719

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

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

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Waitlist Control

Other

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

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

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

    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.

  2. Panic Disorder Severity Scale-Child Version

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

    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.

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

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Intensive Treatment of Adolescent Panic and Agoraphobia

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Dec 19, 2007
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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