Physical Activity and Cognitive Behavioural Therapy in Panic Disorder and Agoraphobia

Study Overview
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Brief Summary
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Physical activity (treadmill) prior to in-vivo exposure supports the effect of cognitive behavioural therapy in patients with panic disorder and agoraphobia.

Detailed Description
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Patients receive a 12-session manualized cognitive behavioural therapy, implemented over 7 weeks and followed by two booster sessions. Five sessions consist of in-vivo exposures. Prior to these sessions patients undergo a training of physical activity. Half of the patients complete training on a treadmill at 70% of their maximal oxygen uptake while the other half complete training at 30%.

Official Title
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The Influence of Physical Activity (Prior to In-vivo Exposure) on the Effect of Cognitive Behavioural Therapy in Patients With Panic Disorder and Agoraphobia

Conditions
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Panic Disorder, Agoraphobia

Intervention / Treatment
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* Behavioral: Cognitive Behavioural Therapy


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 agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Score >= 18 in Hamilton Rating Scale for Anxiety Score >= 4 in Clinical Global Index Reachability of patient for treatment and follow-up Exclusion Criteria: DSM-IV Axis I diagnoses of any psychotic disorder, bipolar disorder, current alcohol or drug dependence and Axis II borderline personality disorder Change in pharmacological treatment in the last 4 weeks Acute suicidality Medical contraindications for mild to moderate exercise training or exposure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: 70% VO2max<br>Cognitive Behavioural Therapy (CBT) + aerobic exercise (30 minutes, 70% VO2max) prior to 5 in-vivo exposure sessions | Behavioral: Cognitive Behavioural Therapy<br>* 12 sessions of CBT including psychoeducation, interoceptive exposure and in-vivo exposure<br>* Other names: CBT;|
| Active Comparator: 30% VO2max<br>Cognitive Behavioural Therapy (CBT) + placebo exercise (30 minutes, 30% VO2max) prior to 5 in-vivo exposure sessions | Behavioral: Cognitive Behavioural Therapy<br>* 12 sessions of CBT including psychoeducation, interoceptive exposure and in-vivo exposure<br>* Other names: CBT;|

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 | Change from Baseline to 31 weeks (follow-up) | 
| Mobility Inventory (Chambless 1984) | A 27-item inventory for the measurement of self-reported agoraphobic avoidance behavior | Change from Baseline to 31 weeks (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Index (CIPS 1995) |  | Baseline, 3 weeks, 7 weeks, 31 weeks (follow up) | 
| Beck Depression Inventory (CIPS 1995) |  | Baseline, 3 weeks, 7 weeks, 31 weeks (follow up) | 
| Anxiety Sensitivity Index (Taylor 1998) |  | Baseline, every second session, 3 weeks, 7 weeks, 31 weeks (follow up) | 
| Body Sensations Questionnaire (Chambless 1984) |  | Baseline, 3 weeks, 7 weeks, 31 weeks (follow up) | 
| Agoraphobic Cognitions Questionaire (Chambless 1984) |  | Baseline, 3 weeks, 7 weeks, 31 weeks (follow up) | 
| Panic and Agoraphobia Scale | Severity scale for panic disorder | Change from baseline to 31 weeks (follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Panic Disorder, Agoraphobia, Physical Activity