Physical Activity and Cognitive Behavioural Therapy in Panic Disorder

Panic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788800
• Other study ID #: 221012
• Status: Completed
• Phase: N/A
• First received: February 4, 2013
• Last updated: May 15, 2013
• Start date: January 2009
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Behavioral:
• Cognitive Behavioural Therapy (CBT)
9 sessions of CBT including psychoeducation and interoceptive exposure

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Federal Ministry of Education and Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EEG and endocrinology	EEG (Mismatch Negativity, Loudness dependency, P50/P300) and diurnal profile of Cortisol and alpha-Amylase	Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)	No
Primary	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)	No
Secondary	Panic and Agoraphobia Scale (Bandelow et al. 1995)		Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)	No
Secondary	Beck Anxiety Inventory (CIPS 1995)		Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)	No
Secondary	Clinical Global Index (CIPS 1995)		Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)	No
Secondary	Beck Depression Inventory (CIPS 1995)		Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)	No

External Links

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