Panic DisorderNCT00576719
Effectiveness of Intensive Cognitive Behavioral Therapy in Treating Adolescent Panic Disorder and Agoraphobia
A study of Panic Disorder and Agoraphobia, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of intensive cognitive behavioral therapy in treating adolescents with panic disorder with agoraphobia. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Panic Disorder, Agoraphobia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensive Treatment of Adolescent Panic and Agoraphobia
This study will evaluate the effectiveness of intensive cognitive behavioral therapy in treating adolescents with panic disorder with agoraphobia.
Read the 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.
- Conditions
- Panic Disorder, Agoraphobia
- Being tested
- Intensive panic control treatment without parent involvement, Intensive panic control treatment with parent involvement, Waitlist control
- Medical subject headings
- Panic Disorder, Agoraphobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive panic control treatment without parent involvementBehavioural
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 involvementBehavioural
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 controlOther
Waitlist control participants will receive active treatment (treatment with or without family involvement) after 6 weeks of waitlist.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Cognitive Behavioral Therapy without Parent Involvement | Experimental | Participants will receive intensive cognitive behavioral therapy treatment without parent involvement Receives: Behavioral: Intensive panic control treatment without parent involvement |
| Intensive Cognitive Behavioral Therapy with Parent Involvement | Experimental | Participants will receive intensive cognitive behavioral therapy treatment with parent involvement Receives: Behavioral: Intensive panic control treatment with parent involvement |
| Waitlist Control Group | Placebo comparator | Waitlist control group Receives: Other: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Disorders Interview Schedule-Child and Parent Versions: Clinical Severity Rating, Agoraphobia Ratings, Panic Attack Frequency Scores, and Internal Sensation Anxiety Ratings
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.
Measured: Measured at Months 3, 6, and 12 post-treatment
Panic Disorder Severity Scale-Child Version
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.
Measured: Measured at Months 3, 6, and 12 post-treatment
Secondary outcomes (16)
Multidimensional Anxiety Scale for Children
Measured: Measured at Months 3, 6, and 12 post-treatment
Childhood Anxiety Sensitivity Index
Measured: Measured at Months 3, 6, and 12 post-treatment
Fear and Avoidance Hierarchy
Measured: Measured at Months 3, 6, and 12 post-treatment
Children's Depression Inventory
Measured: Measured at Months 3, 6, and 12 post-treatment
The Panic Attack Record
Measured: Measured at Months 3, 6, and 12 post-treatment
Subjective Symptoms Scale
Measured: Measured at Months 3, 6, and 12 post-treatment
Panic and Phobia Questionnaire
Measured: Measured at Months 3, 6, and 12 post-treatment
Participant Global Impression of Improvement (PGI)
Measured: Measured at Months 3, 6, and 12 post-treatment
Perceptions of Treatment Questionnaire: Adolescent and Parent Versions
Measured: Measured at Months 3, 6, and 12 post-treatment
Children's Perception Scale (Locus of Control Scale)
Measured: Measured at Months 3, 6, and 12 post-treatment
Child Behavior Checklist (CBCL)
Measured: Measured at Months 3, 6, and 12 post-treatment
Stress Index for Parents of Adolescents
Measured: Measured at Months 3, 6, and 12 post-treatment
Parenting Locus of Control Scale
Measured: Measured at Months 3, 6, and 12 post-treatment
Therapy Attitude Inventory
Measured: Measured at Months 3, 6, and 12 post-treatment
Family Assessment Measure (FAM)
Measured: Measured at Months 3, 6, and 12 post-treatment
Depression Anxiety and Stress Scale (DASS)
Measured: Measured at Months 3, 6, and 12 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startMar 2005
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Donna Pincus, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576719
- Sponsor's protocol ID
- R01MH068277
- Other IDs
- R01MH068277
- Status last verified
- Feb 2014
- First submitted
- 17 Dec 2007
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Treatment of Adolescent Panic and Agoraphobia
- ClinicalTrials.gov ID
- NCT00576719
- Acronym / sponsor ID
- R01MH068277
- Conditions
- Panic Disorder, Agoraphobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2005
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensive Cognitive Behavioral Therapy without Parent Involvement | Experimental | Behavioral: Intensive panic control treatment without parent involvementParticipants will receive intensive cognitive behavioral therapy treatment without parent involvement |
| Intensive Cognitive Behavioral Therapy with Parent Involvement | Experimental | Behavioral: Intensive panic control treatment with parent involvementParticipants will receive intensive cognitive behavioral therapy treatment with parent involvement |
| Waitlist Control Group | Placebo comparator | Other: Waitlist controlWaitlist control group |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive panic control treatment without parent involvementIntensive 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. | Behavioural | Intensive Cognitive Behavioral Therapy without Parent Involvement |
| Intensive panic control treatment with parent involvementIntensive 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. | Behavioural | Intensive Cognitive Behavioral Therapy with Parent Involvement |
| Waitlist controlWaitlist control participants will receive active treatment (treatment with or without family involvement) after 6 weeks of waitlist. | Other | Waitlist Control Group |
Primary outcome
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.
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.
16 secondary outcomes
Multidimensional Anxiety Scale for Children
Time frame: Measured at Months 3, 6, and 12 post-treatment
Childhood Anxiety Sensitivity Index
Time frame: Measured at Months 3, 6, and 12 post-treatment
Fear and Avoidance Hierarchy
Time frame: Measured at Months 3, 6, and 12 post-treatment
Children's Depression Inventory
Time frame: Measured at Months 3, 6, and 12 post-treatment
The Panic Attack Record
Time frame: Measured at Months 3, 6, and 12 post-treatment
Subjective Symptoms Scale
Time frame: Measured at Months 3, 6, and 12 post-treatment
Panic and Phobia Questionnaire
Time frame: Measured at Months 3, 6, and 12 post-treatment
Participant Global Impression of Improvement (PGI)
Time frame: Measured at Months 3, 6, and 12 post-treatment
Perceptions of Treatment Questionnaire: Adolescent and Parent Versions
Time frame: Measured at Months 3, 6, and 12 post-treatment
Children's Perception Scale (Locus of Control Scale)
Time frame: Measured at Months 3, 6, and 12 post-treatment
Child Behavior Checklist (CBCL)
Time frame: Measured at Months 3, 6, and 12 post-treatment
Stress Index for Parents of Adolescents
Time frame: Measured at Months 3, 6, and 12 post-treatment
Parenting Locus of Control Scale
Time frame: Measured at Months 3, 6, and 12 post-treatment
Therapy Attitude Inventory
Time frame: Measured at Months 3, 6, and 12 post-treatment
Family Assessment Measure (FAM)
Time frame: Measured at Months 3, 6, and 12 post-treatment
Depression Anxiety and Stress Scale (DASS)
Time frame: Measured at Months 3, 6, and 12 post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Pincus, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Panic Disorder and Agoraphobia, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.