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Physical Activity and Cognitive Behavioural Therapy in Panic Disorder and Agoraphobia

Primary Purpose

Panic Disorder, Agoraphobia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
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, Agoraphobia, Physical Activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    70% VO2max

    30% VO2max

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Hamilton Rating Scale for Anxiety (CIPS 1995)
    Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder
    Mobility Inventory (Chambless 1984)
    A 27-item inventory for the measurement of self-reported agoraphobic avoidance behavior

    Secondary Outcome Measures

    Clinical Global Index (CIPS 1995)
    Beck Depression Inventory (CIPS 1995)
    Anxiety Sensitivity Index (Taylor 1998)
    Body Sensations Questionnaire (Chambless 1984)
    Agoraphobic Cognitions Questionaire (Chambless 1984)
    Panic and Agoraphobia Scale
    Severity scale for panic disorder

    Full Information

    First Posted
    July 26, 2013
    Last Updated
    February 6, 2015
    Sponsor
    Charite University, Berlin, Germany
    Collaborators
    German Federal Ministry of Education and Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01928810
    Brief Title
    Physical Activity and Cognitive Behavioural Therapy in Panic Disorder and Agoraphobia
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    February 2014 (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) 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%.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    70% VO2max
    Arm Type
    Experimental
    Arm Description
    Cognitive Behavioural Therapy (CBT) + aerobic exercise (30 minutes, 70% VO2max) prior to 5 in-vivo exposure sessions
    Arm Title
    30% VO2max
    Arm Type
    Active Comparator
    Arm Description
    Cognitive Behavioural Therapy (CBT) + placebo exercise (30 minutes, 30% VO2max) prior to 5 in-vivo exposure sessions
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Behavioural Therapy
    Other Intervention Name(s)
    CBT
    Intervention Description
    12 sessions of CBT including psychoeducation, interoceptive exposure and in-vivo 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
    Change from Baseline to 31 weeks (follow-up)
    Title
    Mobility Inventory (Chambless 1984)
    Description
    A 27-item inventory for the measurement of self-reported agoraphobic avoidance behavior
    Time Frame
    Change from Baseline to 31 weeks (follow-up)
    Secondary Outcome Measure Information:
    Title
    Clinical Global Index (CIPS 1995)
    Time Frame
    Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
    Title
    Beck Depression Inventory (CIPS 1995)
    Time Frame
    Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
    Title
    Anxiety Sensitivity Index (Taylor 1998)
    Time Frame
    Baseline, every second session, 3 weeks, 7 weeks, 31 weeks (follow up)
    Title
    Body Sensations Questionnaire (Chambless 1984)
    Time Frame
    Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
    Title
    Agoraphobic Cognitions Questionaire (Chambless 1984)
    Time Frame
    Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
    Title
    Panic and Agoraphobia Scale
    Description
    Severity scale for panic disorder
    Time Frame
    Change from baseline to 31 weeks (follow-up)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 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 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sophie Bischoff, Dipl.-Psych.
    Organizational Affiliation
    Charite
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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