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Targeting Reconsolidation to Prevent Return of Fear

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Barbara O. Rothbaum, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT01623830
First received: June 12, 2012
Last updated: December 9, 2016
Last verified: December 2016
  Purpose
The overall aim of this project is to determine if using a cue to trigger (and reactivate) the fear memory 10 minutes prior to exposure treatment sessions leads to less anxiety in patients with a fear of flying. The long term goals are to establish if targeting the reconsolidation of fear with a reminder of the fear is effective for human clinical populations in reducing relapse (return of fear). In this investigation, the investigators propose to treat 64 patients diagnosed with a fear of flying (FOF) using virtual reality exposure therapy (VRE). All patients in the study will receive exactly the same exposure treatment using a virtual airplane.

Condition Intervention
Fear of Flying Behavioral: Virtual Reality Exposure Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeting Memory Reconsolidation to Prevent the Return of Fear in a Pilot Randomized Clinical Trial

Further study details as provided by Barbara O. Rothbaum, PhD, Emory University:

Primary Outcome Measures:
  • Fear of Flying Inventory (FFI) [ Time Frame: Post treatment (9 weeks) ]
    a 33-item scale measuring intensity of FOF. Items are rated on a 9-point scale ranging from 0 ( not at all) to 8 ( very severely disturbing). The possible range of scores is 0-264 with higher total scores indicating greater fear of flying intensity.Test-retest reliability for 15 WL patients was .92, and it has been sensitive to change with treatment.

  • The Questionnaire on Attitudes Toward Flying (QAF) [ Time Frame: post treatment (9 weeks) ]
    assesses history of FOF, previous treatment, and attitudes toward flying. It includes a 36-item questionnaire rating the level of fear on an 11-point scale ranging from 0 to10 in different flying situations. The possible range of scores is 0 to 360 with higher scores indicating greater fear associated with flying. Test-retest reliability was .92, and split-half reliability was .99.


Secondary Outcome Measures:
  • The Beck Depression Inventory (BDI) [ Time Frame: post-treatment (9 weeks) ]
    a 21-item measure of cognitive and vegetative symptoms of depression is widely used in a variety of populations, including trauma victims and is sensitive to treatment effects on depression. The possible range for scores is 0-63 with higher scores suggesting more severe symptoms of depression.

  • State Trait Anxiety Inventory- State (STAI-State) [ Time Frame: post-treatment (9 weeks) ]
    The STAI-State is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). The possible range of scores is from 20-80, and higher scores indicate greater levels of anxiety.Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation.

  • State Trait Anxiety Inventory- Trait (STAI-Trait) [ Time Frame: post-treatment (9 weeks) ]
    The STAI-Trait is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). The possible range of scores is from 20-80, and higher scores indicate greater levels of anxiety. Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation.


Enrollment: 89
Study Start Date: July 2012
Study Completion Date: June 2016
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reactivation + VRE
Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions
Behavioral: Virtual Reality Exposure Therapy
Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment.
Other Names:
  • exposure therapy
  • fear of flying treatment
Active Comparator: Neutral Cue + VRE
VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
Behavioral: Virtual Reality Exposure Therapy
Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment.
Other Names:
  • exposure therapy
  • fear of flying treatment

Detailed Description:
Prior to each VRE session, the investigators will test a brief, easy-to-implement manipulation that triggers the fear memory and presumably allows it to be changed in a way that prevents the fear from returning later (i.e., prevents relapse). The investigators propose to randomly assign eligible participants to 1 of 2 conditions: 1) VRE therapy preceded by a reminder of the feared stimulus (a VR clip of a virtual airplane taxiing and taking off) presented 10 minutes prior to all VRE therapy sessions, or 2) VRE therapy preceded by a neutral cue (a VR clip of a virtual living room) presented 10 minutes prior to all VRE therapy sessions. Participants will be evaluated pre- and post-treatment and at a 3 month and 6 month follow-up visit to assess long-term effects.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adult participants, male and female, ages 18-70;
  2. Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for specific phobia, situational type or panic disorder with agoraphobia, in which flying is the primary feared stimulus, or agoraphobia without a history of panic disorder, in which flying is a feared stimulus; Participants may have comorbid depression or anxiety disorders to increase generalizability of sample, but fear of flying must be the primary complaint;
  3. Participants must have flown at least once before;
  4. Participants on psychoactive medications must be stabilized on that dose and medication for at least three months, and must agree to remain on that dose throughout the project. All assessments will include a form inquiring about any medication changes, and participants on medications will be monitored by their prescribing physician; and
  5. Participants must be literate in English.

Exclusion Criteria:

  1. Patients with current or history of mania, schizophrenia, or other psychoses;
  2. Patients with current (past 3 months) prominent suicidal ideation;
  3. Patients with current alcohol or drug abuse/dependence; and
  4. Patients unable to wear the virtual reality head mounted display for any reason (i.e. due to panic disorder, head discomfort, etc.)
  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: NCT01623830

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30306
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Barbara O Rothbaum, PhD Emory University
  More Information

Responsible Party: Barbara O. Rothbaum, PhD, Professor in Psychiatry and Associate Vice Chair of Clinical Research, Emory University
ClinicalTrials.gov Identifier: NCT01623830     History of Changes
Other Study ID Numbers: IRB00056442
Reconsolidation_NIMH_2012 ( Other Identifier: Other )
Study First Received: June 12, 2012
Results First Received: October 14, 2016
Last Updated: December 9, 2016

Keywords provided by Barbara O. Rothbaum, PhD, Emory University:
reconsolidation
fear of flying
virtual reality
virtual reality exposure therapy

ClinicalTrials.gov processed this record on July 26, 2017