Trial Outcomes & Findings for Targeting Reconsolidation to Prevent Return of Fear (NCT NCT01623830)
NCT ID: NCT01623830
Last Updated: 2017-02-02
Results Overview
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.
COMPLETED
NA
89 participants
Post treatment (9 weeks)
2017-02-02
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
44
|
|
Overall Study
COMPLETED
|
38
|
35
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
|
Overall Study
Exclusion from Study
|
1
|
2
|
Baseline Characteristics
Targeting Reconsolidation to Prevent Return of Fear
Baseline characteristics by cohort
| Measure |
Reactivation + VRE
n=45 Participants
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.
|
Neutral Cue + VRE
n=44 Participants
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.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=39 Participants
|
44 Participants
n=41 Participants
|
89 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Gender
Female
|
37 Participants
n=39 Participants
|
34 Participants
n=41 Participants
|
71 Participants
n=35 Participants
|
|
Gender
Male
|
8 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=39 Participants
|
44 participants
n=41 Participants
|
89 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Reactivation + VRE
n=38 Participants
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.
|
Neutral Cue + VRE
n=35 Participants
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.
|
|---|---|---|
|
Fear of Flying Inventory (FFI)
|
65.55 units on a scale
Standard Deviation 49.88
|
76.57 units on a scale
Standard Deviation 47.46
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Reactivation + VRE
n=38 Participants
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.
|
Neutral Cue + VRE
n=35 Participants
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.
|
|---|---|---|
|
The Questionnaire on Attitudes Toward Flying (QAF)
|
126.29 units on a scale
Standard Deviation 85.32
|
123.46 units on a scale
Standard Deviation 66.87
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Reactivation + VRE
n=38 Participants
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.
|
Neutral Cue + VRE
n=35 Participants
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.
|
|---|---|---|
|
The Beck Depression Inventory (BDI)
|
4.26 units on a scale
Standard Deviation 5.39
|
3.6 units on a scale
Standard Deviation 3.74
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Reactivation + VRE
n=38 Participants
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.
|
Neutral Cue + VRE
n=35 Participants
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.
|
|---|---|---|
|
State Trait Anxiety Inventory- State (STAI-State)
|
45.97 units on a scale
Standard Deviation 5.05
|
46.29 units on a scale
Standard Deviation 5.40
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Reactivation + VRE
n=38 Participants
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.
|
Neutral Cue + VRE
n=35 Participants
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.
|
|---|---|---|
|
State Trait Anxiety Inventory- Trait (STAI-Trait)
|
44.83 units on a scale
Standard Deviation 4.36
|
45.81 units on a scale
Standard Deviation 4.18
|
Adverse Events
Reactivation + VRE
Neutral Cue + VRE
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place