Fear of Flying
Conditions
Keywords
reconsolidation, fear of flying, virtual reality, virtual reality exposure therapy
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.
Interventions
BEHAVIORALVirtual 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.
Sponsors
National Institute of Mental Health (NIMH)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| 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. | 44 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Exclusion from Study | 1 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 7 |
Baseline characteristics
| Characteristic | Reactivation + VRE | Neutral Cue + VRE | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 44 Participants | 89 Participants |
| Gender Female | 37 Participants | 34 Participants | 71 Participants |
| Gender Male | 8 Participants | 10 Participants | 18 Participants |
| Region of Enrollment United States | 45 participants | 44 participants | 89 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 44 |
| serious Total, serious adverse events | 0 / 45 | 0 / 44 |
Outcome results
Primary
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.
Time frame: Post treatment (9 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reactivation + VRE | Fear of Flying Inventory (FFI) | 65.55 units on a scale | Standard Deviation 49.88 |
| Neutral Cue + VRE | Fear of Flying Inventory (FFI) | 76.57 units on a scale | Standard Deviation 47.46 |
Primary
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.
Time frame: post treatment (9 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reactivation + VRE | The Questionnaire on Attitudes Toward Flying (QAF) | 126.29 units on a scale | Standard Deviation 85.32 |
| Neutral Cue + VRE | The Questionnaire on Attitudes Toward Flying (QAF) | 123.46 units on a scale | Standard Deviation 66.87 |
Secondary
State Trait Anxiety Inventory- State (STAI-State)
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.
Time frame: post-treatment (9 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reactivation + VRE | State Trait Anxiety Inventory- State (STAI-State) | 45.97 units on a scale | Standard Deviation 5.05 |
| Neutral Cue + VRE | State Trait Anxiety Inventory- State (STAI-State) | 46.29 units on a scale | Standard Deviation 5.4 |
Secondary
State Trait Anxiety Inventory- Trait (STAI-Trait)
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.
Time frame: post-treatment (9 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reactivation + VRE | State Trait Anxiety Inventory- Trait (STAI-Trait) | 44.83 units on a scale | Standard Deviation 4.36 |
| Neutral Cue + VRE | State Trait Anxiety Inventory- Trait (STAI-Trait) | 45.81 units on a scale | Standard Deviation 4.18 |
Secondary
The Beck Depression Inventory (BDI)
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.
Time frame: post-treatment (9 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reactivation + VRE | The Beck Depression Inventory (BDI) | 4.26 units on a scale | Standard Deviation 5.39 |
| Neutral Cue + VRE | The Beck Depression Inventory (BDI) | 3.6 units on a scale | Standard Deviation 3.74 |