Targeting Reconsolidation to Prevent Return of Fear

NCT01623830 | Completed Results

• 2 other identifiers: IRB00056442Reconsolidation_NIMH_2012
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fear of Flying

Keywords

reconsolidation; fear of flying; virtual reality; virtual reality exposure therapy

Outcome Measures

Primary Outcomes (2)

• Fear of Flying Inventory (FFI)

  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.

  Post treatment (9 weeks)

• The Questionnaire on Attitudes Toward Flying (QAF)

  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.

  post treatment (9 weeks)

Secondary Outcomes (3)

• The Beck Depression Inventory (BDI)

  post-treatment (9 weeks)

• State Trait Anxiety Inventory- State (STAI-State)

  post-treatment (9 weeks)

• State Trait Anxiety Inventory- Trait (STAI-Trait)

  post-treatment (9 weeks)

Study Arms (2)

Reactivation + VRE

EXPERIMENTAL

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

Neutral Cue + VRE

ACTIVE COMPARATOR

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

Interventions

Virtual Reality Exposure Therapy BEHAVIORAL

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.

Also known as: exposure therapy, fear of flying treatment

Neutral Cue + VRE; Reactivation + VRE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants, male and female, ages 18-70;
• 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;
• Participants must have flown at least once before;
• 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
• Participants must be literate in English.

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30306, United States

Location

MeSH Terms

Conditions

Aerophobia

Interventions

Virtual Reality Exposure Therapy; Implosive Therapy

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Barbara Rothbaum
• Organization: Emory University

brothba@emory.edu

404-712-8866

Study Officials

• Barbara O Rothbaum, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Psychiatry and Associate Vice Chair of Clinical Research

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 20, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: February 2, 2017
• Results First Posted: February 2, 2017

Record last verified: 2016-12

Locations

US (1)