NCT01928810

Brief Summary

Physical activity (treadmill) prior to in-vivo exposure supports the effect of cognitive behavioural therapy in patients with panic disorder and agoraphobia.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 27, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 9, 2015

Status Verified

February 1, 2015

Enrollment Period

2.9 years

First QC Date

July 26, 2013

Last Update Submit

February 6, 2015

Conditions

Panic DisorderAgoraphobia

Keywords

Panic DisorderAgoraphobiaPhysical Activity

Outcome Measures

Primary Outcomes (2)

  • Hamilton Rating Scale for Anxiety (CIPS 1995)

    Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder

    Change from Baseline to 31 weeks (follow-up)

  • Mobility Inventory (Chambless 1984)

    A 27-item inventory for the measurement of self-reported agoraphobic avoidance behavior

    Change from Baseline to 31 weeks (follow-up)

Secondary Outcomes (6)

  • 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)

  • 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)

  • Agoraphobic Cognitions Questionaire (Chambless 1984)

    Baseline, 3 weeks, 7 weeks, 31 weeks (follow up)

  • +1 more secondary outcomes

Study Arms (2)

70% VO2max

EXPERIMENTAL

Cognitive Behavioural Therapy (CBT) \+ aerobic exercise (30 minutes, 70% VO2max) prior to 5 in-vivo exposure sessions

Behavioral: Cognitive Behavioural Therapy

30% VO2max

ACTIVE COMPARATOR

Cognitive Behavioural Therapy (CBT) \+ placebo exercise (30 minutes, 30% VO2max) prior to 5 in-vivo exposure sessions

Behavioral: Cognitive Behavioural Therapy

Interventions

Cognitive Behavioural TherapyBEHAVIORAL

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

Also known as: CBT
30% VO2max70% VO2max

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Panic DisorderAgoraphobiaMotor Activity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersPhobic DisordersBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sophie Bischoff, Dipl.-Psych.

    Charite

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 26, 2013

First Posted

August 27, 2013

Study Start

March 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 9, 2015

Record last verified: 2015-02