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Effectiveness of Cognitive Behavioral Therapy With Panic Control Treatment for Adolescents With Panic Disorder

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00705380
First received: June 24, 2008
Last updated: July 8, 2008
Last verified: July 2008
  Purpose

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


Condition Intervention Phase
Panic Disorder
Behavioral: Cognitive behavioral therapy (CBT) with panic control treatment (PCT) for adolescents
Behavioral: Waitlist control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Treatment of Panic in Adolescence

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Anxiety Disorders Interview Schedule-Child and Parent Versions: Clinical Severity Rating, Agoraphobia Ratings, Weekly Panic Attack Frequency Scores, and Monthly Panic Attack Frequency Scores [ Time Frame: Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ]
  • Weekly Record of Anxiety and Depression (WRAD) [ Time Frame: Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ]
  • The Panic Attack Record (PAR) [ Time Frame: Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Childhood Anxiety Sensitivity Index (CASI) [ Time Frame: Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ]
  • Children's Depression Inventory (CDI) [ Time Frame: Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ]
  • The Fear Survey Schedule for Children - Revised [ Time Frame: Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ]
  • The Revised Children's Manifest Anxiety Scale [ Time Frame: Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ]
  • Behavioral Approach Test (BAT) [ Time Frame: Measured at pretreatment; post-treatment; and Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: July 1998
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive cognitive behavioral therapy with panic control treatment.
Behavioral: Cognitive behavioral therapy (CBT) with panic control treatment (PCT) for adolescents
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.
Active Comparator: 2
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 adolescents
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.
Behavioral: Waitlist control
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.

Detailed Description:

More than 3 million people in the United States will experience a panic attack at some point in their lives. A panic attack occurs when a person experiences an intense feeling of sudden fear as well as physical sensations of breathlessness, rapid heart beat, and dizziness. Panic disorder, which is characterized by reoccurring panic attacks, often develops during childhood or adolescence and, if left untreated, can interfere with a child's normal development, relationships, school work, and psychological well-being. Cognitive behavioral therapy (CBT) with a panic control treatment (PCT) component is a type of psychotherapy that teaches new ways to control anxiety or panic attacks. It has been found to be effective in treating adults with panic disorder. However, more research is needed to determine if CBT with PCT, when adapted specifically for adolescents, is also effective in treating adolescents with panic disorder. This study will evaluate the effectiveness of CBT with a PCT component in treating adolescents with panic disorder.

Participation in this study will last up to 18 months. All participants will first undergo baseline assessments that will include a behavioral/psychological assessment while wearing a heart-rate monitoring device; questionnaires relating to experiences of anxiety, fear, and depression; and parent and child clinical interviews. Participants will then be assigned randomly to receive either immediate CBT with PCT or delayed CBT with PCT, which will occur after a 12-week waitlist period. CBT with PCT for all participants will include 11 weekly individual sessions, lasting 60 minutes each. During sessions, participants will learn specifically designed ways for adolescents to reduce or overcome panic attacks. Throughout treatment, participants will keep daily records of their anxiety and will complete self-monitoring forms to monitor panic attacks. During the 12-week waitlist period, the waitlist group participants will complete the same daily records and self-monitoring forms. The waitlist group participants will also meet with a therapist once every other week to discuss the nature of any panic attacks or address any concerns. Once all 12 weeks have passed, they will begin CBT with PCT. All participants will repeat the baseline assessments at Months 3, 6, and 12 after treatment.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705380

Locations
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Investigators
Principal Investigator: Sarah Mattis, PhD Boston University
  More Information

No publications provided

Responsible Party: Sara Mattis, PhD, Boston University
ClinicalTrials.gov Identifier: NCT00705380     History of Changes
Other Study ID Numbers: R29 MH58641, DSIR CT-S
Study First Received: June 24, 2008
Last Updated: July 8, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Disease
Panic Disorder
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014