Physical Activity and Cognitive Behavioural Therapy in Panic Disorder and Agoraphobia

Panic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928810
• Other study ID #: 201015
• Status: Completed
• Phase: N/A
• First received: July 26, 2013
• Last updated: February 6, 2015
• Start date: March 2011
• Est. completion date: February 2014

Study information

• Verified date: February 2015
• 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) prior to in-vivo exposure supports the effect of cognitive behavioural therapy in patients with panic disorder and agoraphobia.

Description:

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Agoraphobia
• Panic Disorder

Intervention

Behavioral:
• Cognitive Behavioural Therapy
12 sessions of CBT including psychoeducation, interoceptive exposure and in-vivo 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
Primary	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)	No
Primary	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)	No
Secondary	Clinical Global Index (CIPS 1995)		Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)	No
Secondary	Beck Depression Inventory (CIPS 1995)		Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)	No
Secondary	Anxiety Sensitivity Index (Taylor 1998)		Baseline, every second session, 3 weeks, 7 weeks, 31 weeks (follow up)	No
Secondary	Body Sensations Questionnaire (Chambless 1984)		Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)	No
Secondary	Agoraphobic Cognitions Questionaire (Chambless 1984)		Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)	No
Secondary	Panic and Agoraphobia Scale	Severity scale for panic disorder	Change from baseline to 31 weeks (follow-up)	No

External Links

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