Specific PhobiaNCT05300061
Values Interventions for Increasing Engagement With What is Feared in Individuals With Specific Phobias
A study testing Personal Values Intervention and Prosocial Values Intervention in people with Specific Phobia, run by University of Cyprus at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Specific Phobia
- What is being tested?
- Personal Values Intervention and Prosocial Values Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Sep 2020to 14 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Severe heart disease
- High blood pressure
- Photosensitive epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Specific Phobia
- Being tested
- Personal Values Intervention, Prosocial Values Intervention
- Keywords
- Specific Phobia, Flying Phobia, Exposure Therapy, Values Interventions
- Medical subject headings
- Phobia, Specific, Aerophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Values InterventionBehavioural
A 15 minute personal values intervention. Aim is to help participants clarify their own values around flying and promote committed action towards airplanes.
Prosocial Values InterventionBehavioural
A 15 minute prosocial values intervention. Aim is to help participants clarify their prosocial values around flying and promote committed action towards airplanes.
| Study group | Role | What they receive |
|---|---|---|
| Personal Values Intervention | Experimental | Brief personal values intervention Receives: Behavioral: Personal Values Intervention |
| Prosocial Values Intervention | Experimental | Brief prosocial values intervention Receives: Behavioral: Prosocial Values Intervention |
| Control | No intervention | No intervention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1 (During experimental tasks)
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.
Measured: Day 1 (During experimental tasks)
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.
Measured: Day 1 (During experimental tasks)
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.
Measured: One month follow up
Secondary outcomes (1)
Avoidance Behaviours
Total number of avoidance behaviours employed by the participants during the virtual reality behavioural approach task were tallied by the experimenter.
Measured: Day 1 (During experimental tasks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Sep 2020
- Primary completion14 May 2021
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific PhobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cyprus
- Sponsor type
- University, hospital or other
- Collaborators
- Youth Board of Cyprus
- Responsible party
- Principal investigator, Maria Karekla, University of Cyprus
- Investigators
- Maria Karekla, PhD, Principal investigator, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300061
- Sponsor's protocol ID
- K3_K1_3
- Status last verified
- Mar 2022
- First submitted
- 24 Nov 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Brief Values Interventions in Increasing Willingness to Approach and Approach Behaviour Towards Phobic Stimuli in Specific Phobias
- ClinicalTrials.gov ID
- NCT05300061
- Acronym / sponsor ID
- K3_K1_3
- Conditions
- Specific Phobia
- Keywords
- Specific Phobia, Flying Phobia, Exposure Therapy, Values Interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of CyprusUniversity, hospital or other
- Collaborators
- Youth Board of Cyprus
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Personal Values Intervention | Experimental | Behavioral: Personal Values InterventionBrief personal values intervention |
| Prosocial Values Intervention | Experimental | Behavioral: Prosocial Values InterventionBrief prosocial values intervention |
| Control | No intervention | –No intervention control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Severe heart disease
- High blood pressure
- Photosensitive epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal Values InterventionA 15 minute personal values intervention. Aim is to help participants clarify their own values around flying and promote committed action towards airplanes. | Behavioural | Personal Values Intervention |
| Prosocial Values InterventionA 15 minute prosocial values intervention. Aim is to help participants clarify their prosocial values around flying and promote committed action towards airplanes. | Behavioural | Prosocial Values Intervention |
Primary outcome
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).
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.
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.
Follow up Flying Behaviour
Time frame: One month follow up
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.
1 secondary outcome
Avoidance Behaviours
Time frame: Day 1 (During experimental tasks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Karekla, PhD principal investigator
University of Cyprus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal Values Intervention and Prosocial Values Intervention in people with Specific Phobia, run by University of Cyprus at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness (time frame: Day 1 (During experimental tasks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.