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Completed

NCT Number: NCT01788800

Physical Activity and Cognitive Behavioural Therapy in Panic Disorder

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

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Key information

Conditions

Panic Disorder Anxiety Disorders Behavior Mental Disorders Motor Activity

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

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 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

Treatment and study plan

Cognitive Behavioural Therapy (CBT)

Behavioral

9 sessions of CBT including psychoeducation and interoceptive exposure

Primary outcomes

  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 outcomes

  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 outcomes

  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

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 on the Effect of Cognitive Behavioural Therapy, Neurobiological Parameters and Information Processing in Patients With Panic Disorder With/Without Agoraphobia

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 11, 2013
Registry last updated
May 16, 2013

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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