Noradrenergic Manipulation and Virtual Reality Exposure Therapy in Phobic Participants

NCT02007694 | Completed Phase 2

• 1 other identifier: 2012-KP-2464
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Recent advances in animal research have identified pharmacological agents that appear to both accelerate and consolidate extinction learning. One cognitive enhancers is Yohimbine hydrochloride (YOH). A finding in animal literature is that the administration of YOH during extinction trials accelerates fear reduction and may convert ineffective exposures in to successful ones. It is thought that the mechanism of enhanced emotional memory is through elevated norepinephrine. However, recent findings demonstrate mixed results. In a randomized controlled trial claustrophobic participants underwent exposure in combination with YOH or placebo. The YOH group showed significantly better results on anxiety improvement than the placebo group. In a more recent study with participants with fear of flying no additional benefits of YOH were demonstrated. Therefore, we intend to replicate and extend these studies by enhancing the dose of YOH in combination with VRET and by extending our experimental design with another group which receives propranolol in combination with VRET. Propranolol is β-adrenergic receptor antagonist, which has proven to disrupt reconsolidation in healthy humans. In this randomized controlled trial a between groups design is chosen to further characterize the differential within and between trial extinction and to enhance possible between groups effects. Sixty participants with fear of flying or fear of heights will be randomly assigned to one of the following three conditions 1) VRET plus YOH, 2) VRET plus Propranolol, or 3) VRET plus placebo. Participants in all conditions will be offered three sessions of VRET over a period of two weeks.

Conditions

Phobic Disorders

Keywords

Phobic Disorders (Fear of Flying and acrophobia); Virtual Reality Exposure Therapy; Fear extinction; propranolol; Yohimbine

Outcome Measures

Primary Outcomes (3)

• FAS (Flight Anxiety Situations Questionnaire)

  The FAS is 32-item, self-report inventory designed to measure anxiety related to flying experienced in different situations. The FAS is divided into three subscales: the Anticipation scale, which represents situations before the actual flight, the In-flight scale, which refers to situations during a flight and the Generalized flight scale.

  Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)

• AQ (Acrophobia Questionnaire)

  The AQ (Cohen, 1977) is a 40-item self-report measure to assess anxiety in height situations. The AQ measures anxiety and avoidance behavior relative to height situations. Subject can express their fear on a scale ranging from 0-6, whereby 0 stands for "no fear at all" and 6 for "almost panic" (ranging from 0-120).

  Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)

• WAQ (Weekly Anxiety Questionnaire)

  The WAQ is an author-constructed transdiagnostic anxiety questionnaire to rate severity of experienced general anxiety. The WAQ is a 10-item self-report measure on which participants can rate their experienced anxieties. Ratings can be scored on a five-point Likert scale ranging from "not at all" to "permanently".

  In session 1, 2 and 3 and Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)

Secondary Outcomes (6)

• FAM (Flight Anxiety Modalities Questionnaire)

  Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)

• ATHQ (Attitude towards heights questionnaire)

  Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)

• DASS (Depression Anxiety Stress Scale)

  Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)

• PIT (Prospective Imagery Task)

  Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)

• ASI (Anxiety Sensitivity Inventory)

  Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)

Other Outcomes (9)

• QMI (Questionnaire upon Mental Imagery)

  Pre-assessment (baseline); first treatment session will follow within 3 weeks

• IPQ (Igroup Presence Questionnaire)

  Post session 1, 2 and 3 (all within 2 weeks, maximum 3 weeks)

• SSQ (Simulator Sickness Questionnaire)

  Post session 1, 2 and 3 (all within 2 weeks with a maximum of 3 weeks)

Study Arms (3)

VRET plus Yohimbine

ACTIVE COMPARATOR

Virtual Reality Exposure Therapy combined with the administration of yohimbine.

Behavioral: Virtual Reality Exposure Therapy (VRET)

VRET plus propranolol

ACTIVE COMPARATOR

Virtual Reality Exposure Therapy combined with the administration of propranolol

Behavioral: Virtual Reality Exposure Therapy (VRET)

VRET plus placebo

PLACEBO COMPARATOR

Virtual Reality Exposure Therapy combined with the administration of a non-active placebo pill

Behavioral: Virtual Reality Exposure Therapy (VRET)

Interventions

Virtual Reality Exposure Therapy (VRET) BEHAVIORAL

Graded exposure to feared specific stimulus by computer-generated 3D virtual environments.

VRET plus Yohimbine; VRET plus placebo; VRET plus propranolol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Marked fear of flying or acrophobia, indicated by a subjective fear rating of moderate or higher on anxiety specific measures.
• Being older than 18 years and younger than 75 years.

Sponsors & Collaborators

• VU University of Amsterdam: lead

Study Sites (1)

University of Amsterdam

Amsterdam, North Holland, 1018XA, Netherlands

Location

MeSH Terms

Conditions

Phobic Disorders; Aerophobia; Acrophobia

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Paul Emmelkamp, PhD

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: December 11, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

NL (1)