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Physical Activity and Cognitive Behavioural Therapy in Panic Disorder

Primary Purpose

Panic Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy (CBT)
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring Panic disorder, Physical activity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Exercise training

    Movements

    Arm Description

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

    Cognitive Behavioural Therapy (CBT) + Low intensity physical activity without cardiovascular activation, 3 times/week, 30 minutes, 8 weeks

    Outcomes

    Primary Outcome Measures

    Hamilton Rating Scale for Anxiety (CIPS 1995)
    Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder

    Secondary Outcome Measures

    Panic and Agoraphobia Scale (Bandelow et al. 1995)
    Beck Anxiety Inventory (CIPS 1995)
    Clinical Global Index (CIPS 1995)
    Beck Depression Inventory (CIPS 1995)

    Full Information

    First Posted
    February 4, 2013
    Last Updated
    May 15, 2013
    Sponsor
    Charite University, Berlin, Germany
    Collaborators
    German Federal Ministry of Education and Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01788800
    Brief Title
    Physical Activity and Cognitive Behavioural Therapy in Panic Disorder
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Charite University, Berlin, Germany
    Collaborators
    German Federal Ministry of Education and Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Physical activity (treadmill) supports the effect of cognitive behavioural therapy in patients with panic disorder with/without agoraphobia
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Panic Disorder
    Keywords
    Panic disorder, Physical activity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise training
    Arm Type
    Experimental
    Arm Description
    Cognitive Behavioural Therapy (CBT) + Exercise training 3 times/week, 30 minutes on a treadmill, 70% maximal oxygen uptake (VO2max), 8 weeks
    Arm Title
    Movements
    Arm Type
    Active Comparator
    Arm Description
    Cognitive Behavioural Therapy (CBT) + Low intensity physical activity without cardiovascular activation, 3 times/week, 30 minutes, 8 weeks
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Behavioural Therapy (CBT)
    Intervention Description
    9 sessions of CBT including psychoeducation and interoceptive exposure
    Primary Outcome Measure Information:
    Title
    Hamilton Rating Scale for Anxiety (CIPS 1995)
    Description
    Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder
    Time Frame
    up to 28 weeks (follow up)
    Secondary Outcome Measure Information:
    Title
    Panic and Agoraphobia Scale (Bandelow et al. 1995)
    Time Frame
    Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
    Title
    Beck Anxiety Inventory (CIPS 1995)
    Time Frame
    Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
    Title
    Clinical Global Index (CIPS 1995)
    Time Frame
    Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
    Title
    Beck Depression Inventory (CIPS 1995)
    Time Frame
    Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
    Other Pre-specified Outcome Measures:
    Title
    EEG and endocrinology
    Description
    EEG (Mismatch Negativity, Loudness dependency, P50/P300) and diurnal profile of Cortisol and alpha-Amylase
    Time Frame
    Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject familiarized with experimental procedure and had given written informed consent Diagnosis of panic disorder with or without agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Sufficiently able to communicate with investigator, answer questions and fill in questionnaires Reachability of patient for treatment and follow-up Exclusion Criteria: Other psychiatric illnesses like schizophrenia, substance abuse or severe depressive episode Acute suicidal tendency Epilepsy or other illness of the central nervous system (e.g. brain tumor, encephalitis) Existence of contraindication against physical exercise Pregnancy or breastfeeding Changes of psychopharmacological treatment within the last 4 weeks
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andreas Ströhle, Prof. Dr.
    Organizational Affiliation
    Department of Psychiatry and Psychotherapy, CCM, Charité - Universitätsmedizin Berlin
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.angstambulanz-charite.de
    Description
    Related Info

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