Targeting Reconsolidation to Prevent Return of Fear

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.)

Arm && Interventions

Group	Intervention	Description
Neutral Cue + VRE	Virtual Reality Exposure Therapy	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.
Reactivation + VRE	Virtual Reality Exposure Therapy	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

Primary Outcome Measures

Name	Time	Method
Fear of Flying Inventory (FFI)	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)	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

Name	Time	Method
The Beck Depression Inventory (BDI)	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)	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)	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.