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

Panic Disorder Clinical Trial

Official title:

Intensive Treatment of Adolescent Panic and Agoraphobia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576719
• Other study ID #: R01MH068277
• Secondary ID: R01MH068277DSIR
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2007
• Last updated: February 19, 2014
• Start date: March 2005
• Est. completion date: March 2011

Study information

• Verified date: February 2014
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Agoraphobia
• Panic Disorder

Intervention

Behavioral:
• Intensive 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.
• Intensive 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.

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

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Disorders Interview Schedule-Child and Parent Versions: Clinical Severity Rating, Agoraphobia Ratings, Panic Attack Frequency Scores, and Internal Sensation Anxiety Ratings		Measured at Months 3, 6, and 12 post-treatment	No
Primary	Panic Disorder Severity Scale-Child Version		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Multidimensional Anxiety Scale for Children		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Childhood Anxiety Sensitivity Index		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Fear and Avoidance Hierarchy		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Children's Depression Inventory		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	The Panic Attack Record		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Subjective Symptoms Scale		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Panic and Phobia Questionnaire		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Participant Global Impression of Improvement (PGI)		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Perceptions of Treatment Questionnaire: Adolescent and Parent Versions		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Children's Perception Scale (Locus of Control Scale)		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Child Behavior Checklist (CBCL)		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Stress Index for Parents of Adolescents		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Parenting Locus of Control Scale		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Therapy Attitude Inventory		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Family Assessment Measure (FAM)		Measured at Months 3, 6, and 12 post-treatment	No
Secondary	Depression Anxiety and Stress Scale (DASS)		Measured at Months 3, 6, and 12 post-treatment	No