Physical Activity and Cognitive Behavioural Therapy in Panic Disorder and Agoraphobia

February 6, 2015 updated by: Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 70% VO2max

Cognitive Behavioural Therapy (CBT)

+ aerobic exercise (30 minutes, 70% VO2max) prior to 5 in-vivo exposure sessions
Behavioral: Cognitive Behavioural Therapy
12 sessions of CBT including psychoeducation, interoceptive exposure and in-vivo exposure
Other Names:
  • CBT
Active Comparator: 30% VO2max

Cognitive Behavioural Therapy (CBT)

+ placebo exercise (30 minutes, 30% VO2max) prior to 5 in-vivo exposure sessions
Behavioral: Cognitive Behavioural Therapy
12 sessions of CBT including psychoeducation, interoceptive exposure and in-vivo exposure
Other Names:
  • CBT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Index (CIPS 1995)
Time Frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Beck Depression Inventory (CIPS 1995)
Time Frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Anxiety Sensitivity Index (Taylor 1998)
Time Frame: Baseline, every second session, 3 weeks, 7 weeks, 31 weeks (follow up)
Baseline, every second session, 3 weeks, 7 weeks, 31 weeks (follow up)
Body Sensations Questionnaire (Chambless 1984)
Time Frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Agoraphobic Cognitions Questionaire (Chambless 1984)
Time Frame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
Panic and Agoraphobia Scale
Time Frame: Change from baseline to 31 weeks (follow-up)
Severity scale for panic disorder
Change from baseline to 31 weeks (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Sophie Bischoff, Dipl.-Psych., Charité

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

August 26, 2013

First Posted (Estimate)

August 27, 2013

Study Record Updates

Last Update Posted (Estimate)

February 9, 2015

Last Update Submitted That Met QC Criteria

February 6, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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