Trial record 15 of 49 for:    Open Studies | "Phobic Disorders"

Noradrenergic Manipulation and Virtual Reality Exposure Therapy in Phobic Participants

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by VU University of Amsterdam
Sponsor:
Information provided by (Responsible Party):
Paul M.G.Emmelkamp, VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT02007694
First received: March 20, 2013
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Phobic Disorders
Behavioral: Virtual Reality Exposure Therapy (VRET)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Noradrenergic Manipulation and Virtual Reality Exposure Therapy in Phobic Participants

Resource links provided by NLM:


Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:
  • FAS (Flight Anxiety Situations Questionnaire) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.

  • AQ (Acrophobia Questionnaire) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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).

  • WAQ (Weekly Anxiety Questionnaire) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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".


Secondary Outcome Measures:
  • FAM (Flight Anxiety Modalities Questionnaire) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The FAM is 23-item, self-report inventory designed to measure how fear of flying can be expressed. On a five-point-likert scale the intensity of fear can be rated. The FAM is divided into two subscales: the Somatic Modality, which represents the physical symptoms and the Cognitive Modality, which measures distressing cognitions.

  • ATHQ (Attitude towards heights questionnaire) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The ATHQ contains six questions assessing the attitude towards heights (range 0-60).

  • DASS (Depression Anxiety Stress Scale) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The DASS is 42-item self-report measure that assesses level of depression, anxiety, and stress over the previous week. Each scale consists of 14 items, which are grouped into smaller subscales. The depression scale consists of the following subscales: dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia and inertia. The anxiety scale consists of: autonomic arousal, skeletal musculature effects, situational anxiety and subjective experience of anxious affect. The stress scale consists of: difficulty relaxing, nervous arousal, easily agitated, irritable/overreactive and impatient. The internal consistency of the DASs is good to excellent (Cronbach's alpha ranging from .88 to .96; Brown et al., 1997).

  • PIT (Prospective Imagery Task) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The PIT is based on MacLeod and Byrne, (1996) and Stöber, (2000) and will be used to measure imagery for 10 positive and 10 negative prospective events. As in Holmes, Lang, et al. (2008), subjects will be asked to rate the vividness of prospective positive events (e.g., "You will have lots of energy and enthusiasm") or negative events (e.g., "Someone close to you will reject you") on a 5-point scale (1 = no image at all; 5 = very vivid).

  • ASI (Anxiety Sensitivity Inventory) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The ASI is a 16-items self-report questionnaire, measuring fear of anxiety-related symptoms. Each item is rated on a five-point likert scale ranging from 0 (very little) to 4 (very much). The ASI is scored by summing all items; possible scores range from 0 to 64, with higher scores reflecting higher levels of anxiety sensitivity.

  • SUDs (Subjective Units of Discomfort) [ Time Frame: 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). ] [ Designated as safety issue: No ]
    Subjective Units of Discomfort (SUDs) will be taken every 3 minutes to monitor patients' subjective anxiety (Wolpe, 1990).


Other Outcome Measures:
  • QMI (Questionnaire upon Mental Imagery) [ Time Frame: Pre-assessment (baseline); first treatment session will follow within 3 weeks ] [ Designated as safety issue: No ]
    The QMI measures vividness of imagery typically experienced by participants across seven sensory modalities: visual, auditory, cutaneous, gustatory, kinaesthetic, olfactory, and organic. The QMI is a reliable instrument containing 35 items. The items rate the vividness on a seven point scale (1 = "I perceive it perfectly clearly, as if it were real"; 7 = "I think about it, but I cannot imagine it").

  • IPQ (Igroup Presence Questionnaire) [ Time Frame: Post session 1, 2 and 3 (all within 2 weeks, maximum 3 weeks) ] [ Designated as safety issue: No ]
    The IPQ is a 14-item, self-report inventory designed to measure to what degree participants experience the virtual environments as real.The IPQ consists of three underlying factors, which refer to respectively: 1) the spatial presence, meaning which is the sense of really being in a virtual environment, 2) involvement: the attention which is paid to the real world and to the virtual environments and 3) the realness of the virtual world, which refers to the reality jugdement of the virtual world. The subject can give an indication of how real the virtual world is on a scale ranging from -3 to +3, respectively "completely disagree" and "completely agree".

  • SSQ (Simulator Sickness Questionnaire) [ Time Frame: Post session 1, 2 and 3 (all within 2 weeks with a maximum of 3 weeks) ] [ Designated as safety issue: No ]
    The SSQ is a 27-item self-report questionnaire designed to measure whether subjects experienced any physiological symptoms during and after being in the virtual environments. Participants can give an indication whether and to what degree they experienced twenty-seven physiological symptoms: with underlying factors tiredness, anxiety or panic and traumatic memory.

  • EEQ (Exposure Experience Questionnaire) [ Time Frame: Post session 1, 2 and 3 (all within 2 weeks with a maximum of 3 weeks) ] [ Designated as safety issue: No ]
    The EEQ is a 7-item author-constructed self-report questionnaire we designed to measure the degree of anxiety and presence after virtual reality exposure therapy.

  • TGAQ (Treatment Gain and Attribution Questionnaire) [ Time Frame: Post-assessment (inmediately after the last treatment session) ] [ Designated as safety issue: No ]
    The TGAQ is based on the TGAQ from Powers and colleague's and (Powers et al., 2008) is a fourteen-item scale assesses participants' perceptions of their level of improvement and the extent to which the herbal supplement facilitated or interfered with their exposure treatment. The four dimensions are rated using 100-point visual analogue scales, including the following: (a) overall improvement (not at all improved to much improved), (b) medication interference (not at all detrimental to extremely detrimental), (c) medication facilitation (not at all helpful to extremely helpful), and (d) exposure facilitation (not at all helpful to extremely helpful).

  • Drug guess [ Time Frame: Post-assessment (inmediately after the last treatment session) ] [ Designated as safety issue: No ]
    A questionnaire consisting of 5 questions concerning the medication and its possible effects will be used to assess whether participants are aware in which drug condition they participate. Participants are asked whether they had received YOH/propranolol or placebo and rated on a scale ranging from 0 (not sure at all) to 100 (definite) how sure they were that their guess was right.

  • Self-efficacy questionnaire [ Time Frame: Pre- and post session 1, 2 and 3 (all within 2 weeks with a maximum of 3 weeks) ] [ Designated as safety issue: No ]
    The self-efficacy questionnaire is a self-report inventory designed to measure the degree of self-efficacy subjects experienced with respect to the phobic situation. The inventory consists of five items on self-efficacy in phobic situations. The items represent five different themes 1) the capability to reduce the experienced fear, 2) to think clearly, 3) to control for ones own actions, 4) to control anxious thoughts and feelings and 5) to stay in the situation while experiencing intense fear. The participant can give an indication by giving a percentage representing their evaluation of their own capability.

  • Cognitions Questionnaire [ Time Frame: Post session 1, 2 and 3 (all within 2 weeks with a maximum of 3 weeks) ] [ Designated as safety issue: No ]
    The cognition questionnaire is a self-report inventory designed to investigate the level of positive and negative cognitions subjects have about themselves. The questionnaire consists of 30 items for fear of flying which can be scored on a five-point Likert scale ranging from "not at all" to "permanently".

  • Expectancy [ Time Frame: Pre-assessment (baseline); first treatment session will follow within 3 weeks ] [ Designated as safety issue: No ]
    Participants expectancy about the outcome will be rated on a 5-item self-report scale based on the Borkovec and Nau (1972) expectancy of improvement scale (0%-100%).


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VRET plus Yohimbine
Virtual Reality Exposure Therapy combined with the administration of yohimbine.
Behavioral: Virtual Reality Exposure Therapy (VRET)
Graded exposure to feared specific stimulus by computer-generated 3D virtual environments.
Active Comparator: VRET plus propranolol
Virtual Reality Exposure Therapy combined with the administration of propranolol
Behavioral: Virtual Reality Exposure Therapy (VRET)
Graded exposure to feared specific stimulus by computer-generated 3D virtual environments.
Placebo Comparator: VRET plus placebo
Virtual Reality Exposure Therapy combined with the administration of a non-active placebo pill
Behavioral: Virtual Reality Exposure Therapy (VRET)
Graded exposure to feared specific stimulus by computer-generated 3D virtual environments.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007694

Contacts
Contact: Katharina Meyerbröker, PhD 003120525 ext 6812 K.Meyerbroker@uva.nl
Contact: Nexhmedin Morina, PhD N.Morina@uva.nl

Locations
Netherlands
University of Amsterdam Recruiting
Amsterdam, Nord Holland, Netherlands, 1018XA
Contact: Katharina Meyerbröker, PhD    003120525 ext 6812    K.Meyerbroker@uva.nl   
Contact: Nexhmedin Morina, PhD       N.Morina@uva.nl   
Sponsors and Collaborators
VU University of Amsterdam
Investigators
Principal Investigator: Paul Emmelkamp, PhD VU University of Amsterdam
  More Information

No publications provided

Responsible Party: Paul M.G.Emmelkamp, Prof. dr., VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT02007694     History of Changes
Other Study ID Numbers: 2012-KP-2464
Study First Received: March 20, 2013
Last Updated: December 6, 2013
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by VU University of Amsterdam:
Phobic Disorders (Fear of Flying and acrophobia)
Virtual Reality Exposure Therapy
Fear extinction
propranolol
Yohimbine

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders
Yohimbine
Propranolol
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on August 20, 2014