Physical Activity and Cognitive Behavioural Therapy in Panic Disorder

May 15, 2013 updated by: Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 28 weeks (follow up)

Secondary Outcome Measures

Outcome Measure
Time Frame
Panic and Agoraphobia Scale (Bandelow et al. 1995)
Time Frame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Beck Anxiety Inventory (CIPS 1995)
Time Frame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Clinical Global Index (CIPS 1995)
Time Frame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Beck Depression Inventory (CIPS 1995)
Time Frame: Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)
Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Andreas Ströhle, Prof. Dr., Department of Psychiatry and Psychotherapy, CCM, Charité - Universitätsmedizin Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 8, 2013

First Posted (ESTIMATE)

February 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 16, 2013

Last Update Submitted That Met QC Criteria

May 15, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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