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Clinical Trials/NCT01788800
NCT01788800
Completed
Not Applicable

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

Charite University, Berlin, Germany0 sites46 target enrollmentJanuary 2009
ConditionsPanic Disorder

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Panic Disorder
Sponsor
Charite University, Berlin, Germany
Enrollment
46
Primary Endpoint
Hamilton Rating Scale for Anxiety (CIPS 1995)
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
May 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Andreas Ströhle

Prof. Dr.

Charite University, Berlin, Germany

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hamilton Rating Scale for Anxiety (CIPS 1995)

Time Frame: up to 28 weeks (follow up)

Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder

Secondary Outcomes

  • 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))

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