Clinical trial NCT01928810: 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
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder
Agoraphobia
Keywords: Panic Disorder
Agoraphobia
Physical Activity
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2013-08-27
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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

Primary outcomes:
measure: Hamilton Rating Scale for Anxiety (CIPS 1995)
timeFrame: Change from Baseline to 31 weeks (follow-up)
measure: Mobility Inventory (Chambless 1984)
timeFrame: Change from Baseline to 31 weeks (follow-up)
Secondary outcomes:
measure: Clinical Global Index (CIPS 1995)
timeFrame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
measure: Beck Depression Inventory (CIPS 1995)
timeFrame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
measure: Anxiety Sensitivity Index (Taylor 1998)
timeFrame: Baseline, every second session, 3 weeks, 7 weeks, 31 weeks (follow up)
measure: Body Sensations Questionnaire (Chambless 1984)
timeFrame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
measure: Agoraphobic Cognitions Questionaire (Chambless 1984)
timeFrame: Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)
measure: Panic and Agoraphobia Scale
timeFrame: Change from baseline to 31 weeks (follow-up)
Other outcomes:
Locations:
Study officials:
affiliation: Charite
name: Sophie Bischoff, Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
References: