The Influence of Physical Activity (Prior to In-vivo Exposure) on the Effect of Cognitive Behavioural Therapy in Patients With Panic Disorder and Agoraphobia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 78
- Primary Endpoint
- Hamilton Rating Scale for Anxiety (CIPS 1995)
Study Overview
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%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
70% VO2max
Cognitive Behavioural Therapy (CBT)
- aerobic exercise (30 minutes, 70% VO2max) prior to 5 in-vivo exposure sessions
Intervention: Cognitive Behavioural Therapy (Behavioral)
30% VO2max
Cognitive Behavioural Therapy (CBT)
- placebo exercise (30 minutes, 30% VO2max) prior to 5 in-vivo exposure sessions
Intervention: Cognitive Behavioural Therapy (Behavioral)
Outcomes
Primary Outcomes
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
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
- Anxiety Sensitivity Index (Taylor 1998)(Baseline, every second session, 3 weeks, 7 weeks, 31 weeks (follow up))
- Body Sensations Questionnaire (Chambless 1984)(Baseline, 3 weeks, 7 weeks, 31 weeks (follow up))
- Clinical Global Index (CIPS 1995)(Baseline, 3 weeks, 7 weeks, 31 weeks (follow up))
- Beck Depression Inventory (CIPS 1995)(Baseline, 3 weeks, 7 weeks, 31 weeks (follow up))
- Agoraphobic Cognitions Questionaire (Chambless 1984)(Baseline, 3 weeks, 7 weeks, 31 weeks (follow up))
- Panic and Agoraphobia Scale(Change from baseline to 31 weeks (follow-up))
Investigators
Prof. Dr. Andreas Ströhle
Prof. Dr.
Charite University, Berlin, Germany