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Completed

NCT Number: NCT01928810

Physical Activity and Cognitive Behavioural Therapy in 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.

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Key information

Conditions

Panic Disorder Agoraphobia Anxiety Disorders Behavior Mental Disorders Motor Activity Phobic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioural Therapy

Behavioral

12 sessions of CBT including psychoeducation, interoceptive exposure and in-vivo exposure

Other names: CBT

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 27, 2013
Registry last updated
Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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