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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01677429
First received: August 19, 2012
Last updated: September 30, 2012
Last verified: September 2012
  Purpose

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 Intervention
Panic Disorder
Proprioceptive Disorders
Device: VR movie + balance challenge
Device: still pictures from VR
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Change in Panic or anxiety levels [ Time Frame: weeks 1 (baseline) ,5 and 11 (end of trial) ] [ Designated as safety issue: No ]
    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:
  • Change in Balance impairment [ Time Frame: weeks 1 (baseline) ,5 and 11 (end of trial) ] [ Designated as safety issue: No ]
    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:
  • blood pressure (mmHg) [ Time Frame: weeks 1 (baseline) ,5 and 11 (end of trial) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677429

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

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01677429     History of Changes
Other Study ID Numbers: SHEBA-12-9520-AC-CTIL
Study First Received: August 19, 2012
Last Updated: September 30, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
panic disorder
balance impairment
virtual reality

Additional relevant MeSH terms:
Disease
Panic Disorder
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014