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Physical Activity and Cognitive Behavioural Therapy in Panic Disorder

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ClinicalTrials.gov Identifier: NCT01788800
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : May 16, 2013
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) supports the effect of cognitive behavioural therapy in patients with panic disorder with/without agoraphobia

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

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise training

Cognitive Behavioural Therapy (CBT)

+ Exercise training 3 times/week, 30 minutes on a treadmill, 70% maximal oxygen uptake (VO2max), 8 weeks

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

Active Comparator: Movements

Cognitive Behavioural Therapy (CBT)

+ Low intensity physical activity without cardiovascular activation, 3 times/week, 30 minutes, 8 weeks

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




Primary Outcome Measures :
  1. Hamilton Rating Scale for Anxiety (CIPS 1995) [ Time Frame: up to 28 weeks (follow up) ]
    Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder


Secondary Outcome Measures :
  1. Panic and Agoraphobia Scale (Bandelow et al. 1995) [ Time Frame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up) ]
  2. Beck Anxiety Inventory (CIPS 1995) [ Time Frame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up) ]
  3. Clinical Global Index (CIPS 1995) [ Time Frame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up) ]
  4. Beck Depression Inventory (CIPS 1995) [ Time Frame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up) ]

Other Outcome Measures:
  1. EEG and endocrinology [ Time Frame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up) ]
    EEG (Mismatch Negativity, Loudness dependency, P50/P300) and diurnal profile of Cortisol and alpha-Amylase



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01788800


Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Investigators
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Principal Investigator: Andreas Ströhle, Prof. Dr. Department of Psychiatry and Psychotherapy, CCM, Charité - Universitätsmedizin Berlin
Additional Information:
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Responsible Party: Prof. Dr. Andreas Ströhle, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01788800    
Other Study ID Numbers: 221012
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: May 16, 2013
Last Verified: May 2013
Keywords provided by Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany:
Panic disorder
Physical activity
Additional relevant MeSH terms:
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Disease
Panic Disorder
Pathologic Processes
Anxiety Disorders
Mental Disorders