Physical Exercise Versus Cognitive-behavioral Therapy (CBT) for Panic Disorders: A Randomised Controlled Trial

Study Overview
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Brief Summary
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The purpose of this study is to compare manualised physical exercise conducted in groups to manualised cognitive-behavioral therapy conducted in groups as treatment for panic disorder with or without agoraphobia.

Official Title
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Effects of Physical Exercise on Anxiety and Co-morbid Emotional Disturbances: A Clinical Trail in a Day Care Unit

Conditions
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Panic Disorder

Intervention / Treatment
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* Behavioral: Physical exercise
* Behavioral: Cognitive-behavioral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained Clinical diagnosis of panic disorder with and without agoraphobia according to The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR, 4th ed., text revision; American Psychiatric Association, 2000), established through administration of Structural Clinical Interview for DSM-IV axis I disorders (SCID I; First, Spitzer, Gibbon, & Williams, 1995). Exclusion Criteria: Brain-organic disorders according to DSM-IV-TR The presence of psychotic disorders according to DSM-IV-TR, established through administration of SCID I Present substance-abuse Medical condition that excludes participation in physical activity Major Depressive Disorder according to DSM-IV-TR established through administration of SCID I.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical exercise<br>Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks | Behavioral: Physical exercise<br>* Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks<br>|
| Active Comparator: Cognitive-behavioral therapy<br>Cognitive-behavioral therapy conducted in groups (5-8 participants per group). 1 session (á 2-2.25 hours depending on group size) per week for 12 consecutive weeks | Behavioral: Cognitive-behavioral therapy<br>* Cognitive-behavioral therapy conducted in groups (5-8 participants per group). 1 session (á 2-2.25 hours depending on group size) per week for 12 consecutive weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility Inventory (MI) - Alone & Accompanied |  | Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up | 
| Agoraphobic Cognitions Questionnaire (ACQ) |  | Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up | 
| Body Sensations Questionnaire |  | Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up | 
| Panic frequency - Self-report & Clinician-rating |  | Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up | 
| Panic distress/disability - Self-report & Clinician-rating |  | Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Anxiety Inventory (BAI) |  | Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up | 
| State-Trait Anxiety Inventory - State & Trait (STAI S/T) |  | Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up | 
| Beck Depression Inventory II (BDI-II) |  | Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up | 
| Quality of Life Inventory (QoLI) |  | Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Panic disorder, Physical exercise, Cognitive-behavioral therapy, Manualized