Targeting Reconsolidation to Prevent Return of Fear

Fear of Flying Clinical Trial

Official title:

Targeting Memory Reconsolidation to Prevent the Return of Fear in a Pilot RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623830
• Other study ID #: IRB00056442
• Secondary ID: Reconsolidation_
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: July 8, 2016
• Start date: July 2012
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Adult participants, male and female, ages 18-70;

2. Participants must meet 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.)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fear of Flying

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear of Flying Inventory	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). Test-retest reliability for 15 WL patients was .92, and it has been sensitive to change with treatment. Reports of the total number of anxiety symptoms the participant typically experienced when flying (Fear of Flying Interview) were significantly correlated with FFI score ( r = .45, p < .01).	Post treatment (9 weeks)	No
Primary	The Questionnaire on Attitudes Toward Flying	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. Test-retest reliability was .92, and split-half reliability was .99. The QAF Fear item is a subscale of this measure and asks the participant to rate, using a Likert-type scale ranging from 0 to 10, his or her present FOF.	post treatment (9 weeks)	No
Secondary	The Beck Depression Inventory	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.	post-treatment (9 weeks)	No
Secondary	State Trait Anxiety Inventory- State	The STAI-State is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation.	post-treatment (9 weeks)	No
Secondary	State Trait Anxiety Inventory- Trait	The STAI-Trait is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation.	post-treatment (9 weeks)	No