Clinical trial NCT02007694: Noradrenergic Manipulation and Virtual Reality Exposure Therapy in Phobic Participants
Official title: Noradrenergic Manipulation and Virtual Reality Exposure Therapy in Phobic Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Phobic Disorders
Keywords: Phobic Disorders (Fear of Flying and acrophobia)
Virtual Reality Exposure Therapy
Fear extinction
propranolol
Yohimbine
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

-

Primary outcomes:
measure: FAS (Flight Anxiety Situations Questionnaire)
timeFrame: 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)
measure: AQ (Acrophobia Questionnaire)
timeFrame: 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)
measure: WAQ (Weekly Anxiety Questionnaire)
timeFrame: 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:
measure: FAM (Flight Anxiety Modalities Questionnaire)
timeFrame: 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)
measure: ATHQ (Attitude towards heights questionnaire)
timeFrame: 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)
measure: DASS (Depression Anxiety Stress Scale)
timeFrame: 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)
measure: PIT (Prospective Imagery Task)
timeFrame: 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)
measure: ASI (Anxiety Sensitivity Inventory)
timeFrame: 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)
measure: SUDs (Subjective Units of Discomfort)
timeFrame: Every 3 minutes during exposure (exposure will be done twicely 25 minutes every therapy session. Thus, starting at minute 1 every 3 minute a SUD will be asked. After a break of 10 minutes, exposure will start again (25 minutes).
Other outcomes:
measure: QMI (Questionnaire upon Mental Imagery)
timeFrame: Pre-assessment (baseline); first treatment session will follow within 3 weeks
measure: IPQ (Igroup Presence Questionnaire)
timeFrame: Post session 1, 2 and 3 (all within 2 weeks, maximum 3 weeks)
measure: SSQ (Simulator Sickness Questionnaire)
timeFrame: Post session 1, 2 and 3 (all within 2 weeks with a maximum of 3 weeks)
measure: EEQ (Exposure Experience Questionnaire)
timeFrame: Post session 1, 2 and 3 (all within 2 weeks with a maximum of 3 weeks)
measure: TGAQ (Treatment Gain and Attribution Questionnaire)
timeFrame: Post-assessment (inmediately after the last treatment session)
measure: Drug guess
timeFrame: Post-assessment (inmediately after the last treatment session)
measure: Self-efficacy questionnaire
timeFrame: Pre- and post session 1, 2 and 3 (all within 2 weeks with a maximum of 3 weeks)
measure: Cognitions Questionnaire
timeFrame: Post session 1, 2 and 3 (all within 2 weeks with a maximum of 3 weeks)
measure: Expectancy
timeFrame: Pre-assessment (baseline); first treatment session will follow within 3 weeks
Locations:
city: Amsterdam
country: Netherlands
facility: University of Amsterdam
state: Nord Holland
Study officials:
affiliation: University of Amsterdam
name: Paul Emmelkamp, PhD
role: PRINCIPAL_INVESTIGATOR
References: