To determine (1) the clinical effects of 0phobia to reduce anxiety symptoms and (2) the feasibility of the intervention and 3) effects on depression, general anxiety and mastery. Ultimately, the goal is to investigate the user-friendliness of 0-…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter will be the Acrophobia Questionnaire (AQ, Cohen; 1977)
subscale anxiety, a 20-item self-report questionnaire to measure fear of
heights (fear and avoidance). The 20-item anxiety subscale has a 7-point Likert
scale (*not anxious* to *extremely anxious*), total score 0-120. The
questionnaire is widely-used and has good psychometric properties (Cohen,
1977). This measure will be given at baseline, post-test and follow-up and
takes 5 minutes to complete. To be considered for inclusion, individuals have
to score at least a 45.45 on the AQ-Anxiety (one standard deviation below the
mean of a previous acrophobic sample; Cohen, 1972; Steinman and Teachman, 2011)
Secondary outcome
Secondary parameters are:
* The Attitudes Towards Heights Questionnaire (ATHQ; originally Abelson &
Curtis, 1989, with minor modifications to the wording reported in Coehlo,
Santos, Silvério, & Silva, 2006) is a 6-item measure in which individuals read
pairs of dichotomous adjectives describing ways people may feel about heights
(e.g., *Good/Bad,* *Safe/Dangerous*), and rate how they feel about elevated
places on a scale of 0 (which corresponds with the first adjective) to 10
(which corresponds with the second adjective). The ATHQ has been used in
several height fear treatment studies and is sensitive to treatment effects
(Coehlo et al., 2006; Emmelkamp, Bruynzeel, Drost, & van der Mast, 2001).
Reliability is good (Steinman & Teachman, 2014).
* Beck Anxiety Inventory (BAI; Beck et al., 1988) is a 21-item self-report
questionnaire assessing symptoms of anxiety. Patients record how much they have
been bothered by each symptom during the past week, including the day the
questionnaire is administered. Each item is rated on a 4-point Likert scale
ranging from 0 = not at all to 3 = severely: I could barely stand it. The total
score ranges from 0 to 63. The following guidelines are recommended for the
interpretation of scores: 0*9, normal or no anxiety; 10*18, mild to moderate
anxiety; 19*29, moderate to severe anxiety; and 30*63, severe anxiety. Internal
consistency is high (0.90-0.94) and convergent validity is good (Brown et al.,
1997).
* Igroup Presence Questionnaire (IPQ; Schubert, Friedmann and Regenbrecht
2001), a 14-item questionnaire which assess realism and *presence* in the VR
environment. Each of the items has five response categories from fully disagree
(1) to fully agree (5). Chronbach`s alpha is good (* = .73). This
questionnaire will be completed at post-test.
* System Usability Scale (SUS; Bangor et al., 2008): 10 items about user
friendliness of the online intervention. The SUS is composed of 10 statements
that are scored on a 5-point scale of strength of agreement. Final scores for
the SUS can range from 0 to 100, where higher scores indicate better usability.
This means that products that are at least passable have SUS scores above 70,
with better products scoring in the high 70s to upper 80s. Truly superior
products score better than 90. Products with scores less than 70 should be
considered candidates for increased scrutiny and continued improvement and
should be judged to be marginal at best. Reliability is good (Bangor et al.
2008). This questionnaire will be completed at post-test.
* Mastery (Pearlin Mastery Scale; Pearlin and Schooler, 1978), 7 items to
measure self-experienced control over a situation. Each of the 7 items has five
response categories from 1 (totally disagree) to 5 (totally agree). The
questionnaire has good psychometric properties. (Pearlin & Schooler, 1978).
This questionnaire will be completed at baseline, post-test and follow-up.
* The nine-item mood module of the Patient Health Questionnaire (PHQ-9 ;
Kroenke et al, 2007) is used to screen and to diagnose patients with depressive
disorders. The 9 items are each scored 0*3, total score range is 0*27. In a
review of Wittkampf et al. (Wittkampf et al., 2007), a sensitivity of 0.77
(0.71*0.84) and a specificity of 0.94 (0.90*0.97) was found for the PHQ-9.This
questionnaire will be completed at baseline, post-test and follow-up.
* Assessment of current anxiety level directly before and after exposure.
* The GAD-7 (Spitzer et al., 2006 ) is a 7-item self-report questionnaire to
asses generalized anxiety symptoms. Each of its 7 questions is rated 0 - 3
(*not at all* to *nearly every day*), and the total score range is 0 - 21.
Psychometric properties are good (Donker et al., 2011; Spitzer et al.,
2006).This questionnaire will be completed at baseline, post-test and
follow-up.
Background summary
Specific phobias, such as intense fear of flying, heights, or spiders, are the
most common form of mental health disorder worldwide. Specific phobias have a
lengthy history of clinical research and very effective exposure treatment
exists (Wolitzky-Taylor et al., 2008).However, due to high costs, stigma, and
long waiting lists, access to evidence-based therapy is currently limited.
Meta-analyses on treatment effectiveness for people suffering from specific
phobias have shown that Virtual Reality Exposure Therapy (VRET) is as effective
as traditional forms of exposure therapy (Marino et al., 2015; Parsons and
Rizzo 2008; Powers and Emmelkamp 2008; Opris et al., 2012). VRET, however,
involves relatively high costs and limited accessibility which make it
prohibitive for the larger part of the population. This project capitalizes on
novel technology and recent scientific advances to develop an affordable
treatment modality that is available for anybody, anywhere. Specifically,
0-phobia, a self-help virtual reality (VR) exposure therapy for fear of
heights, that is delivered through a smartphone application (app) in
combination with rudimentary cardboard VR goggles will be developed and tested.
We hypothesize that 0-phobia is feasible and effective in reducing anxiety
symptoms and is feasible to use.
Study objective
To determine (1) the clinical effects of 0phobia to reduce anxiety symptoms and
(2) the feasibility of the intervention and 3) effects on depression, general
anxiety and mastery. Ultimately, the goal is to investigate the
user-friendliness of 0-phobia for commercial purpose. Results from this study
will provide insight to create a business model and marketing strategy.
Study design
This study will be a randomized controlled trial with two arms: the
intervention condition (0-phobia) and a waitlist condition.
Intervention
The intervention 0-phobia is 3-week self-help virtual reality (VR) exposure
therapy for fear of heights, that is delivered through a smartphone application
(app) in combination with rudimentary cardboard VR goggles. 0phobia includes
modules of psychoeducation, case examples, exposure through VR, cognitive
techniques, monitoring of symptoms, and a relapse prevention module.
Participants in the waitlist condition will be offered the intervention after
post-test.
Study burden and risks
The burden of participation consists of completing online baseline
questionnaires (15 minutes) and performing the intervention (3 weeks x 5-20
minutes and daily exposure practice during 2 weeks of 10 minutes). In addition,
participants will be asked to complete an online post-intervention assessment
immediately after completion of the last module of 0-phobia (less than 5
minutes), the intervention (20 minutes) and a follow up after 3 months (20
minutes). There is minimal risk involved and the burden to participants is
limited.Participants may feel stress and anxiety, may experience motion
sickness or in the unlikely event, may fall during VR exposure.
Note that this study recruits healthy participants who have symptoms of fear of
heights. There is minimal risk and burden on participants is limited.
Participants may feel stress and anxiety, but in order for the intervention to
be effective, participants need to experience anxiety during VR exposure (this
is only 1 module out of 6 modules). Participants will practice with a
hierarchy of fear situations using gradual exposure (from low fear situations
to high fear situations) in which participants learn to manage their anxiety so
their anxiety levels will be tolerable. The probability of cyber sickness is
minimized by the optimization of the frame rate. In addition, there is no use
of fast-moving objects and subjects can not move very quickly through the VR
environment. Chances are minimized by safety instructions: they are instructed
to hold on to a solid object and removing sharp objects in their immediate
environment. Elderly (> 65 years) are more vulnerable when they are to be
excluded from the study. Participants are instructed to remover their
cardboards in case they experience cyber sickness, high distress or if they
feel out of balance. By removing them, levels of high distress, cyber sickness
or out of balance are immediately reduced. Should there nevertheless occur
undesirable effects, than the subject can approach the research team by email
or phone for the necessary support. . Severely depressed and suicidal
individuals will be excluded from the study. In the unlikely case that a
participant shows suicidal ideation at post-test, he or she will be contacted
by the research assistant and asked to give permission to contact his or her
GP, who may refer the participant for specific mental health treatment.
van der boechorststraat 1
Amsterdam 1081 BT
NL
van der boechorststraat 1
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
-scoring above 45.45 on the AQ-Anxiety
-are between 18-64 years old
-have access to a smart phone (Android) and internet
-willing to participate in the research study and providing informed consent
-willing to fill in questionnaires (4 times)
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-present with symptoms of severe depression or suicidality respectively as measured with the PHQ-9; total score > 19 or a score 3 on the suicidal ideation question of the WSQ (Donker et al. 2009)
-have insufficient knowledge of the Dutch language
-are under current treatment for specific phobia or psychotropic medication (unless on stable dosage for the previous 3 months and no changes planned during the study period)
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL59777.029.16 |