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

NCT ID: NCT00705380

Last Updated: 2015-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-07-31

Study Completion Date

2004-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Panic Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Participants will receive cognitive behavioral therapy with panic control treatment.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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.

2

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

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.

Waitlist control

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Boston University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sarah Mattis, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston University

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R29MH058641

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR CT-S

Identifier Type: -

Identifier Source: secondary_id

R29MH058641

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mechanisms of Panic Disorders Treatment
NCT01323556 UNKNOWN PHASE2/PHASE3
Psychodynamic Therapy for Treating Panic Disorder
NCT00128388 COMPLETED PHASE2/PHASE3