Physical Activity and Cognitive Behavioural Therapy in Panic Disorder

Not Applicable

Completed

• Conditions: Panic Disorder
• Interventions: Behavioral: Cognitive Behavioural Therapy (CBT)

• Registration Number: NCT01788800
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2013-01
• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-11
• Status Verified: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-15
• Last Update Posted: 2013-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Subject familiarized with experimental procedure and had given written informed consent
2. Diagnosis of panic disorder with or without agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
3. Sufficiently able to communicate with investigator, answer questions and fill in questionnaires
4. Reachability of patient for treatment and follow-up

Exclusion Criteria

1. Other psychiatric illnesses like schizophrenia, substance abuse or severe depressive episode
2. Acute suicidal tendency
3. Epilepsy or other illness of the central nervous system (e.g. brain tumor, encephalitis)
4. Existence of contraindication against physical exercise
5. Pregnancy or breastfeeding
6. Changes of psychopharmacological treatment within the last 4 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Movements	Cognitive Behavioural Therapy (CBT)	Cognitive Behavioural Therapy (CBT) + Low intensity physical activity without cardiovascular activation, 3 times/week, 30 minutes, 8 weeks
Exercise training	Cognitive Behavioural Therapy (CBT)	Cognitive Behavioural Therapy (CBT) + Exercise training 3 times/week, 30 minutes on a treadmill, 70% maximal oxygen uptake (VO2max), 8 weeks

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Anxiety (CIPS 1995)	up to 28 weeks (follow up)	Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder

Secondary Outcome Measures

Name	Time	Method
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)