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

NCT01677429 | Unknown

• 1 other identifier: SHEBA-12-9520-AC-CTIL
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Panic Disorder; Proprioceptive Disorders

Keywords

panic disorder; balance impairment; virtual reality

Outcome Measures

Primary Outcomes (1)

• Change in Panic or anxiety levels

  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.

  weeks 1 (baseline) ,5 and 11 (end of trial)

Secondary Outcomes (1)

• Change in Balance impairment

  weeks 1 (baseline) ,5 and 11 (end of trial)

Other Outcomes (2)

• blood pressure (mmHg)

  weeks 1 (baseline) ,5 and 11 (end of trial)

• heart rate (bpm)

  weeks 1 (baseline) ,5 and 11 (end of trial)

Study Arms (3)

VR movie + balance challenge

EXPERIMENTAL

VR-based balance training

Device: VR movie + balance challenge

still pictures from VR

SHAM COMPARATOR

Exposure to still pictures from the same VR scene but no balance challenge

Device: still pictures from VR

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

Standard CBT protocol for the treatment of panic disorder

Behavioral: Cognitive Behavioral Therapy

Interventions

VR movie + balance challenge DEVICE

Computer Assisted Rehabilitation Environment Integrated Reality System used for the challenge of balance control

Also known as: CAREN™ D-FLOW V 3.8.1 by MOTEK B.V

VR movie + balance challenge

still pictures from VR DEVICE

Monitoring only still pictures from the VR scene in a loop, no balance challenge

Also known as: CAREN D-FLOW V 3.8.1 by MOTEK B.V.

still pictures from VR

Cognitive Behavioral Therapy BEHAVIORAL

For the treatment of panic disorder

Also known as: CBT standard protocol

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Any psychiatric diagnosis
• Stage 2
• Patients only

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center, Sheba Rehabilitation Center for Advanced Technologies

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Panic Disorder; Somatosensory Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Asaf Caspi, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Matti Mintz, PhD

  Tel Aviv University

  STUDY CHAIR

• Revital Amiaz, MD

  Sheba Medical Center

  STUDY DIRECTOR

Central Study Contacts

Revital Amiaz, MD

CONTACT

972-3-5303774; amiazr@gmail.com

Efrat Czerniak, MSc

CONTACT

972-54-7711222; efrat30.3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2012
• First Posted: September 3, 2012
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

IL (1)