- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05300061
Values Interventions for Increasing Engagement With What is Feared in Individuals With Specific Phobias
Evaluating the Use of Brief Values Interventions in Increasing Willingness to Approach and Approach Behaviour Towards Phobic Stimuli in Specific Phobias
Exposure is considered the therapy of choice for specific phobias (SPs). Nevertheless, therapy engagement is extremely limited. SPs are maintained through avoidance of feared stimuli and as such willingness to approach what is feared constitutes a key factor that could explain limited treatment engagement. Values interventions, a key element of acceptance and commitment therapy (ACT), might be one way to increase engagement, yet to this date limited research exists in this area. For the purposes of the current study, two brief values interventions were developed: (a) a personal and (b) a prosocial one. These will be compared to (c) a no-instructions control in increasing willingness to approach and approach behaviour towards phobic stimuli. Ninety participants with flying phobia will be randomly allocated to one of the three groups. To measure willingness to engage with feared stimuli and approach behaviour two behavioural approach tasks using novel technologies (virtual reality), which aimed to expose participants to situations analogous to real life, were developed. Willingness and behavioural approach towards airplanes at a one month follow up will also be assessed.
Therefore, it is hypothesised that:
- Participants in either of the two values intervention groups will have greater willingness to engage and approach behaviour towards feared stimuli compared to those in control, during the study tasks.
Participants in either of the two values intervention groups will have greater willingness to engage and approach behaviour towards feared stimuli compared to those in control at follow up.
Additionally, as prosocial values provide an evolutionary advantage, the second study aim was to identify if they lead to greater engagement with phobic stimuli compared to personal ones. Therefore, it was also hypothesised that:
- Participants in the prosocial values group will have greater willingness to engage and approach behaviour towards feared stimuli compared to those in personal values group, both during the study tasks and at follow up.
- Participants in the prosocial values group will have greater willingness to engage and approach behaviour towards feared stimuli compared to those in personal values group at follow up.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Non-US/Non-Canadian
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Nicosia, Non-US/Non-Canadian, Cyprus, 1678
- University of Cyprus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 or older
- Meeting the Diagnostic and Statistical Manual for Mental Disorders 5
- Good knowledge of the Greek language (adequate comprehension level, reading level, and verbal communication)
Exclusion Criteria:
- Severe heart disease
- High blood pressure
- Photosensitive epilepsy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Personal Values Intervention
Brief personal values intervention
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A 15 minute personal values intervention.
Aim is to help participants clarify their own values around flying and promote committed action towards airplanes.
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Experimental: Prosocial Values Intervention
Brief prosocial values intervention
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A 15 minute prosocial values intervention.
Aim is to help participants clarify their prosocial values around flying and promote committed action towards airplanes.
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No Intervention: Control
No intervention control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Willingness
Time Frame: Day 1 (During experimental tasks)
|
In order to capture willingness to engage with feared stimuli three questions were employed, one question for each study task and one for follow up.
For example to capture willingness to engage with the virtual reality behavioural approach task, participants were asked: "How willing are you to participate in a virtual reality task involving airplanes?".
Answers for all three questions were rated on a scale from 1 (Not willing at all) to 10 (Extremely willing), with higher scores indicating greater willingness levels (i.e., total score: 1 - 10).
This approach for developing willingness questions was based on other studies similarly aiming to capture willingness as part of their outcomes using a brief measure (e.g., Fink-Lamotte et al., 2020).
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Day 1 (During experimental tasks)
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Virtual Reality Behavioural Approach Task (VR BAT)
Time Frame: Day 1 (During experimental tasks)
|
The virtual reality (VR) behavioural approach task was developed for the current study to capture approach behaviour towards airplanes in VR.
In total the task included seven steps.
Each step depicted a different aspect of flying with associated VR visuals and sounds: 1) airplane stopped engine off, 2) airplane stopped engine running, 3) taxiing, 4) take off, 5) cruising, 6) turbulence and 7) landing, each lasting between 51 and 129 seconds.
Approach behaviour was calculated by adding the number of steps participants completed in the VR BAT with total approach behaviour score ranging from 0 to 7.
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Day 1 (During experimental tasks)
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Behavioural Willingness Assessment (BWA)
Time Frame: Day 1 (During experimental tasks)
|
For this task, participants were presented with the option to book a short complementary flight.
This was a categorical response variable: Participants could either book a flight or decline to participate.
Booking a flight indicated approach behaviour towards airplanes.
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Day 1 (During experimental tasks)
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Follow up Flying Behaviour
Time Frame: One month follow up
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To measure approach behaviour towards airplanes outside the laboratory setting at a one month follow up, one question was employed ("In the past month, have you come in contact with airplanes in any way, such as taking a flight, or booking flight tickets or hotels abroad?") with a "yes" or "no" response (categorical response variable).
An affirmative response indicated approach behaviour towards airplanes.
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One month follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Avoidance Behaviours
Time Frame: Day 1 (During experimental tasks)
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Total number of avoidance behaviours employed by the participants during the virtual reality behavioural approach task were tallied by the experimenter.
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Day 1 (During experimental tasks)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maria Karekla, PhD, University of Cyprus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K3_K1_3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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