Comparison of Psychotherapy Programs to Treat Panic Disorder

Study Overview
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Brief Summary
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This study will determine the relative effectiveness of three psychotherapies in treating people with a panic disorder.

Detailed Description
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Panic disorder (PD) is a debilitating anxiety disorder. It is characterized by unexpected and repeated episodes of intense fear, accompanied by serious physical symptoms, such as chest pain, heart palpitations, shortness of breath, dizziness, or abdominal stress. Available treatments for PD include medication therapy and cognitive behavioral therapy (CBT), a type of psychotherapy that teaches people how to view panic attacks differently and how to reduce anxiety. Approximately 30% of patients refuse medication, however, and nearly 50% do not achieve remission with CBT alone. Therefore, there is a pressing need for additional non-pharmacologic treatment methods. Panic-focused psychodynamic psychotherapy (PFPP) and applied relaxation training (ART) are among some of the other available treatments for PD. During ART, individuals are taught to relax their muscles while being exposed to increasingly frightening situations. PFPP combines elements of CBT with other, more extensive approaches aimed at determining the anxiety's origin and at finding ways to reduce it. This study will compare the effectiveness of PFPP, CBT, and ART in treating PD. Participants in this single blind study will be randomly assigned to receive PFPP, CBT, or ART for 12 weeks. All participants will attend between 19 and 24 treatment sessions over the course of the study. Upon completing the study, participants will attend monthly follow-up visits for an additional 12 months. Participants assigned to ART who have not responded by the end of treatment may opt to receive PFPP or CBT. Outcomes will be assessed using a variety of scales to determine depression and anxiety symptoms.

Official Title
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Dynamic Treatment vs. CBT for Panic Disorder

Conditions
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Anxiety Disorders, Panic Disorder, Agoraphobia

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy
* Behavioral: Applied relaxation training (ART)
* Behavioral: Panic focused psychodynamic psychotherapy (PFPP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets DSM-IV diagnosis criteria for primary PD with or without agoraphobia History of at least one spontaneous panic attack per week within the month prior to study entry Exclusion Criteria: Active substance dependence within 6 months prior to study entry Lifetime history of any psychotic disorder, including bipolar disorder Acutely suicidal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive panic focused psychodynamic psychotherapy for 12 weeks | Behavioral: Panic focused psychodynamic psychotherapy (PFPP)<br>* PFPP will include 19 to 24 sessions over 12 weeks.<br>|
| Active Comparator: 2<br>Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks | Behavioral: Cognitive behavioral therapy<br>* CBT for panic disorder will include 19 to 24 sessions over 12 weeks.<br>* Other names: Panic control treatment;|
| Active Comparator: 3<br>Participants will receive applied relaxation training for 12 weeks | Behavioral: Applied relaxation training (ART)<br>* ART with exposure protocol will include 19 to 24 sessions over 12 weeks.<br>* Other names: ART;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Panic Disorder Severity Scale | A composite score of panic severity. High value = 28, lowest value =0. Higher=worse | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sheehan Disability Scale | Level of psychosocial functional impairment. highest value=30, lowest value =0, higher numbers indicate greater dysfunction | 12 weeks | 
| Clinical Global Impressions Scale | Clinical assessment of severity of impairment. Minimum value=1, maximum value =6; high scores worse | 12 weeks | 
| Hamilton Depression Rating Scale | Level of state depression. scale 0-81, 0 symptom free, 81 worst severity | 12 weeks | 
| Hamilton Anxiety Rating Scale | level of state anxiety. 0=symptom free, 56 most severe | 12 weeks | 
| Anxiety Disorder Sensitivity Index | Anxiety disorder sensitivity index measures Sensitivity to physical symptoms of anxiety (scores range from 0-64). 0= no anxiety, 64 =maximum anxiety | 12 weeks | 
| Brief Body Sensitivity Interpretation Questionnaire (BBSIQ) | The BBSIQ measures how physically sensitive the person is to physical symptoms of anxiety; (scores range 0-63) 0= no anxiety; 63= highest levels of physical anxiety | 12 weeks | 
| Panic-Specific Reflective Function | Ability to reflect on the emotional meaning of panic symptoms. scored -1 to 9, high numbers better | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD, CBT, PFPP