Clinical trial NCT00576719: Effectiveness of Intensive Cognitive Behavioral Therapy in Treating Adolescent Panic Disorder and Agoraphobia
Official title: Intensive Treatment of Adolescent Panic and Agoraphobia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Panic Disorder
Agoraphobia
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-12-19
Enrollment: 63
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety Disorders Interview Schedule-Child and Parent Versions: Clinical Severity Rating, Agoraphobia Ratings, Panic Attack Frequency Scores, and Internal Sensation Anxiety Ratings
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Panic Disorder Severity Scale-Child Version
timeFrame: Measured at Months 3, 6, and 12 post-treatment
Secondary outcomes:
measure: Multidimensional Anxiety Scale for Children
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Childhood Anxiety Sensitivity Index
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Fear and Avoidance Hierarchy
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Children's Depression Inventory
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: The Panic Attack Record
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Subjective Symptoms Scale
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Panic and Phobia Questionnaire
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Participant Global Impression of Improvement (PGI)
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Perceptions of Treatment Questionnaire: Adolescent and Parent Versions
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Children's Perception Scale (Locus of Control Scale)
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Child Behavior Checklist (CBCL)
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Stress Index for Parents of Adolescents
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Parenting Locus of Control Scale
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Therapy Attitude Inventory
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Family Assessment Measure (FAM)
timeFrame: Measured at Months 3, 6, and 12 post-treatment
measure: Depression Anxiety and Stress Scale (DASS)
timeFrame: Measured at Months 3, 6, and 12 post-treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Donna Pincus, PhD
role: PRINCIPAL_INVESTIGATOR
References: