Clinical trial NCT01623830: Targeting Reconsolidation to Prevent Return of Fear
Official title: Targeting Memory Reconsolidation to Prevent the Return of Fear in a Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Flying
Keywords: reconsolidation
fear of flying
virtual reality
virtual reality exposure therapy
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-06-20
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.)

Primary outcomes:
measure: Fear of Flying Inventory (FFI)
timeFrame: Post treatment (9 weeks)
measure: The Questionnaire on Attitudes Toward Flying (QAF)
timeFrame: post treatment (9 weeks)
Secondary outcomes:
measure: The Beck Depression Inventory (BDI)
timeFrame: post-treatment (9 weeks)
measure: State Trait Anxiety Inventory- State (STAI-State)
timeFrame: post-treatment (9 weeks)
measure: State Trait Anxiety Inventory- Trait (STAI-Trait)
timeFrame: post-treatment (9 weeks)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Barbara O Rothbaum, PhD
role: PRINCIPAL_INVESTIGATOR
References: