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Values Interventions for Increasing Engagement With What is Feared in Individuals With Specific Phobias

Primary Purpose

Specific Phobia

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Personal Values Intervention
Prosocial Values Intervention
Sponsored by
University of Cyprus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Specific Phobia focused on measuring Specific Phobia, Flying Phobia, Exposure Therapy, Values Interventions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Cyprus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Personal Values Intervention

Prosocial Values Intervention

Control

Arm Description

Brief personal values intervention

Brief prosocial values intervention

No intervention control

Outcomes

Primary Outcome Measures

Willingness
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).
Virtual Reality Behavioural Approach Task (VR BAT)
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.
Behavioural Willingness Assessment (BWA)
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.
Follow up Flying Behaviour
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.

Secondary Outcome Measures

Avoidance Behaviours
Total number of avoidance behaviours employed by the participants during the virtual reality behavioural approach task were tallied by the experimenter.

Full Information

First Posted
November 24, 2021
Last Updated
March 17, 2022
Sponsor
University of Cyprus
Collaborators
Youth Board of Cyprus
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1. Study Identification

Unique Protocol Identification Number
NCT05300061
Brief Title
Values Interventions for Increasing Engagement With What is Feared in Individuals With Specific Phobias
Official Title
Evaluating the Use of Brief Values Interventions in Increasing Willingness to Approach and Approach Behaviour Towards Phobic Stimuli in Specific Phobias
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
May 14, 2021 (Actual)
Study Completion Date
May 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cyprus
Collaborators
Youth Board of Cyprus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Phobia
Keywords
Specific Phobia, Flying Phobia, Exposure Therapy, Values Interventions

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three-arm randomised control trial including two values interventions: (a) a personal one, b) a prosocial one, and (c) a no-instructions control. Each participant is allocated to one of the three arms.
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personal Values Intervention
Arm Type
Experimental
Arm Description
Brief personal values intervention
Arm Title
Prosocial Values Intervention
Arm Type
Experimental
Arm Description
Brief prosocial values intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention control
Intervention Type
Behavioral
Intervention Name(s)
Personal Values Intervention
Intervention Description
A 15 minute personal values intervention. Aim is to help participants clarify their own values around flying and promote committed action towards airplanes.
Intervention Type
Behavioral
Intervention Name(s)
Prosocial Values Intervention
Intervention Description
A 15 minute prosocial values intervention. Aim is to help participants clarify their prosocial values around flying and promote committed action towards airplanes.
Primary Outcome Measure Information:
Title
Willingness
Description
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).
Time Frame
Day 1 (During experimental tasks)
Title
Virtual Reality Behavioural Approach Task (VR BAT)
Description
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.
Time Frame
Day 1 (During experimental tasks)
Title
Behavioural Willingness Assessment (BWA)
Description
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.
Time Frame
Day 1 (During experimental tasks)
Title
Follow up Flying Behaviour
Description
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.
Time Frame
One month follow up
Secondary Outcome Measure Information:
Title
Avoidance Behaviours
Description
Total number of avoidance behaviours employed by the participants during the virtual reality behavioural approach task were tallied by the experimenter.
Time Frame
Day 1 (During experimental tasks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Karekla, PhD
Organizational Affiliation
University of Cyprus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cyprus
City
Nicosia
State/Province
Non-US/Non-Canadian
ZIP/Postal Code
1678
Country
Cyprus

12. IPD Sharing Statement

Plan to Share IPD
No

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Values Interventions for Increasing Engagement With What is Feared in Individuals With Specific Phobias

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