The Assessment and Treatment of Balance Impairment Using Virtual Reality (VR) in Panic Disorder Patients

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Hypotheses

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.

Rationale

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	Phase
Panic Disorder; Proprioceptive Disorders	Device: VR movie + balance challenge; Device: still pictures from VR; Behavioral: Cognitive Behavioral Therapy	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:	Treatment
Study Start Date :	June 2015
Estimated Primary Completion Date :	June 2016
Estimated Study Completion Date :	September 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Other Outcome Measures:

1. 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.
2. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Stage 1

Patients

• Clinical diagnosis of panic disorder
• Stable on the same drug and dosage for at least one month

Healthy controls

• Determined as healthy upon completion of the MINI
• At the age of 18-45 years
• Matching patients by age, sex and BMI

Stage 2

Patients only

• The same patients, who have participated in Stage 1.

Exclusion Criteria:

Stage 1

Patients

• Co-morbidity with another psychiatric disorder (phobia is acceptable)
• Cognitive dysfunction or a neurological disorder
• Patients reacting with extreme anxiety to VR exposure at screening
• History of substance and/ or alcohol abuse

Healthy controls (in addition to the exclusion criteria above)

• Any psychiatric diagnosis

Stage 2

Patients only

The same patients from Stage 1, therefore they follow the same exclusion criteria mentioned in Stage 1.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Revital Amiaz, MD	972-3-5303774	amiazr@gmail.com
Contact: Efrat Czerniak, MSc	972-54-7711222	efrat30.3@gmail.com

Locations

Israel
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

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator:	Asaf Caspi, MD	Sheba Medical Center
Study Chair:	Matti Mintz, PhD	Tel Aviv University
Study Director:	Revital Amiaz, MD	Sheba Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT01677429 History of Changes
Other Study ID Numbers:	SHEBA-12-9520-AC-CTIL
First Posted:	September 3, 2012
Last Update Posted:	June 24, 2015
Last Verified:	June 2015

Keywords provided by Sheba Medical Center:

panic disorder; balance impairment; virtual reality

Additional relevant MeSH terms:

Disease; Panic Disorder; Somatosensory Disorders; Pathologic Processes; Anxiety Disorders	Mental Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms