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Physical Activity and Cognitive Behavioural Therapy in Panic Disorder and Agoraphobia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928810
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : February 9, 2015
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Prof. Dr. Andreas Ströhle, 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.

Condition or disease Intervention/treatment Phase
Panic Disorder Agoraphobia Behavioral: Cognitive Behavioural Therapy Not Applicable

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%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: 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 Name: CBT




Primary Outcome Measures :
  1. 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

  2. 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


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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928810


Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Investigators
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Principal Investigator: Sophie Bischoff, Dipl.-Psych. Charite
Additional Information:
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Responsible Party: Prof. Dr. Andreas Ströhle, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01928810    
Other Study ID Numbers: 201015
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: February 9, 2015
Last Verified: February 2015
Keywords provided by Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany:
Panic Disorder
Agoraphobia
Physical Activity
Additional relevant MeSH terms:
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Disease
Panic Disorder
Agoraphobia
Pathologic Processes
Anxiety Disorders
Mental Disorders