Physical Activity and Cognitive Behavioural Therapy in Panic Disorder

Study Overview
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Brief Summary
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Physical activity (treadmill) supports the effect of cognitive behavioural therapy in patients with panic disorder with/without agoraphobia

Detailed Description
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Patients undergo cognitive behavioural therapy consisting of 8 group sessions within 1 month. All patients additionally complete a training of physical activity, which starts simultaneously to therapy and runs for 8 weeks (3 times/week, 30 minutes each). Half of the patients complete training on a treadmill while the other half completes a training programme of low intensity physical activity without cardiovascular activation. Flanking EEG (electroencephalogram) recordings shall help clarify biological processes underlying the therapeutical process.

Official Title
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The Influence of Physical Activity on the Effect of Cognitive Behavioural Therapy, Neurobiological Parameters and Information Processing in Patients With Panic Disorder With/Without Agoraphobia

Conditions
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Panic Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavioural Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject familiarized with experimental procedure and had given written informed consent Diagnosis of panic disorder with or without agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Sufficiently able to communicate with investigator, answer questions and fill in questionnaires Reachability of patient for treatment and follow-up Exclusion Criteria: Other psychiatric illnesses like schizophrenia, substance abuse or severe depressive episode Acute suicidal tendency Epilepsy or other illness of the central nervous system (e.g. brain tumor, encephalitis) Existence of contraindication against physical exercise Pregnancy or breastfeeding Changes of psychopharmacological treatment within the last 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training<br>Cognitive Behavioural Therapy (CBT) + Exercise training 3 times/week, 30 minutes on a treadmill, 70% maximal oxygen uptake (VO2max), 8 weeks | Behavioral: Cognitive Behavioural Therapy (CBT)<br>* 9 sessions of CBT including psychoeducation and interoceptive exposure<br>|
| Active Comparator: Movements<br>Cognitive Behavioural Therapy (CBT) + Low intensity physical activity without cardiovascular activation, 3 times/week, 30 minutes, 8 weeks | Behavioral: Cognitive Behavioural Therapy (CBT)<br>* 9 sessions of CBT including psychoeducation and interoceptive exposure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Anxiety (CIPS 1995) | Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder | up to 28 weeks (follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Panic and Agoraphobia Scale (Bandelow et al. 1995) |  | Baseline, 4 weeks, 8 weeks and 28 weeks (follow up) | 
| Beck Anxiety Inventory (CIPS 1995) |  | Baseline, 4 weeks, 8 weeks and 28 weeks (follow up) | 
| Clinical Global Index (CIPS 1995) |  | Baseline, 4 weeks, 8 weeks and 28 weeks (follow up) | 
| Beck Depression Inventory (CIPS 1995) |  | Baseline, 4 weeks, 8 weeks and 28 weeks (follow up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Panic disorder, Physical activity