Physical Activity and Cognitive Behavioural Therapy in Panic Disorder and Agoraphobia

Not Applicable

Completed

• Conditions: Agoraphobia; Panic Disorder
• Interventions: Behavioral: Cognitive Behavioural Therapy

• Registration Number: NCT01928810
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

Detailed 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%.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-07-26
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-27
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-06
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30% VO2max	Cognitive Behavioural Therapy	Cognitive Behavioural Therapy (CBT) + placebo exercise (30 minutes, 30% VO2max) prior to 5 in-vivo exposure sessions
70% VO2max	Cognitive Behavioural Therapy	Cognitive Behavioural Therapy (CBT) + aerobic exercise (30 minutes, 70% VO2max) prior to 5 in-vivo exposure sessions

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Anxiety (CIPS 1995)	Change from Baseline to 31 weeks (follow-up)	Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder
Mobility Inventory (Chambless 1984)	Change from Baseline to 31 weeks (follow-up)	A 27-item inventory for the measurement of self-reported agoraphobic avoidance behavior

Secondary Outcome Measures

Name	Time	Method
Agoraphobic Cognitions Questionaire (Chambless 1984)	Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Panic and Agoraphobia Scale	Change from baseline to 31 weeks (follow-up)	Severity scale for panic disorder
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)