NCT01788800

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 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

January 1, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 16, 2013

Status Verified

May 1, 2013

Enrollment Period

4 years

First QC Date

February 4, 2013

Last Update Submit

May 15, 2013

Conditions

Panic Disorder

Keywords

Panic disorderPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for Anxiety (CIPS 1995)

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

    up to 28 weeks (follow up)

Secondary Outcomes (4)

  • Panic and Agoraphobia Scale (Bandelow et al. 1995)

    Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)

  • Beck Anxiety Inventory (CIPS 1995)

    Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)

  • Clinical Global Index (CIPS 1995)

    Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)

  • Beck Depression Inventory (CIPS 1995)

    Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)

Other Outcomes (1)

  • EEG and endocrinology

    Baseline, 4 weeks, 8 weeks and 28 weeks (follow up)

Study Arms (2)

Exercise training

EXPERIMENTAL

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)

Movements

ACTIVE COMPARATOR

Cognitive Behavioural Therapy (CBT) \+ Low intensity physical activity without cardiovascular activation, 3 times/week, 30 minutes, 8 weeks

Behavioral: Cognitive Behavioural Therapy (CBT)

Interventions

Cognitive Behavioural Therapy (CBT)BEHAVIORAL

9 sessions of CBT including psychoeducation and interoceptive exposure

Exercise trainingMovements

Eligibility Criteria

Age18 Years - 75 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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Panic DisorderMotor Activity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Andreas Ströhle, Prof. Dr.

    Department of Psychiatry and Psychotherapy, CCM, Charité - Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 4, 2013

First Posted

February 11, 2013

Study Start

January 1, 2009

Primary Completion

January 1, 2013

Study Completion

May 1, 2013

Last Updated

May 16, 2013

Record last verified: 2013-05