The Assessment and Treatment of Balance Impairment Using Virtual Reality (VR) in Panic Disorder Patients
|ClinicalTrials.gov Identifier: NCT01677429|
Recruitment Status : Unknown
Verified June 2015 by Sheba Medical Center.
Recruitment status was: Not yet recruiting
First Posted : September 3, 2012
Last Update Posted : June 24, 2015
The investigators hypothesize that among individuals who suffer from panic disorder there is higher incidence of co-morbid balance impairment than in the healthy population.
The investigators hypothesize that the treatment of panic disorder, through the treatment of co-morbid balance impairment using virtual reality (VR) exposure therapy environment, is more effective than the exposure to still pictures from the same scene in VR without balance challenge or comparing to standard cognitive behavioral therapy (CBT) for the treatment of panic disorder.
This research relies on previous studies, which have shown mutuality between anxiety and balance impairment, even if only sub-clinical. The VR-based training environment enables multi-sensorial stimulus in a dynamic interactively changing setting. With the addition of a cognitive task (dual task distracting the fear), the investigators can add cognitive load and therefore challenge the control of balance even more. Individuals who suffer from balance impairment avoid their exposure to many balance-challenging situations - a fact that may increase their anxiety. The investigators assume that a considerable number of PD individuals also experience balance control impairments - mostly subclinical ones. Moreover, balance impairment accompanies other psychiatric disorders, though not enough literature exists on the subject.
|Condition or disease||Intervention/treatment|
|Panic Disorder Proprioceptive Disorders||Device: VR movie + balance challenge Device: still pictures from VR Behavioral: Cognitive Behavioral Therapy|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||September 2016|
Experimental: VR movie + balance challenge
VR-based balance training
Device: VR movie + balance challenge
Computer Assisted Rehabilitation Environment Integrated Reality System used for the challenge of balance control
Other Name: CAREN™ D-FLOW V 3.8.1 by MOTEK B.V
Sham Comparator: still pictures from VR
Exposure to still pictures from the same VR scene but no balance challenge
Device: still pictures from VR
Monitoring only still pictures from the VR scene in a loop, no balance challenge
Other Name: CAREN D-FLOW V 3.8.1 by MOTEK B.V.
Active Comparator: Cognitive Behavioral Therapy
Standard CBT protocol for the treatment of panic disorder
Behavioral: Cognitive Behavioral Therapy
For the treatment of panic disorder
Other Name: CBT standard protocol
- Change in Panic or anxiety levels [ Time Frame: weeks 1 (baseline) ,5 and 11 (end of trial) ]The investigators will evaluate panic and anxiety levels on week 1, and then examine whether there was a change in panic or anxiety levels on weeks 5 and 11.
- Change in Balance impairment [ Time Frame: weeks 1 (baseline) ,5 and 11 (end of trial) ]The investigators will evaluate balance impairment levels on week 1, and then examine whether there was a change in balance levels on weeks 5 and 11.
- blood pressure (mmHg) [ Time Frame: weeks 1 (baseline) ,5 and 11 (end of trial) ]The investigators will measure blood pressure on week 1 and then evaluate whether there was a change in blood pressure on weeks 5 and 11.
- heart rate (bpm) [ Time Frame: weeks 1 (baseline) ,5 and 11 (end of trial) ]The investigators will measure the heart rate on week 1 and then evaluate whether there was a change in heart rate on weeks 5 and 11.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677429
|Contact: Revital Amiaz, MDfirstname.lastname@example.org|
|Contact: Efrat Czerniak, MScemail@example.com|
|Sheba Medical Center, Sheba Rehabilitation Center for Advanced Technologies||Not yet recruiting|
|Ramat Gan, Israel, 52621|
|Principal Investigator: Asaf Caspi, MD|
|Sub-Investigator: Revital Amiaz, MD|
|Principal Investigator:||Asaf Caspi, MD||Sheba Medical Center|
|Study Chair:||Matti Mintz, PhD||Tel Aviv University|
|Study Director:||Revital Amiaz, MD||Sheba Medical Center|