Clinical trial NCT05300061: 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
Overall status: COMPLETED
Phase: NA
Conditions: Specific Phobia
Keywords: Specific Phobia
Flying Phobia
Exposure Therapy
Values Interventions
Lead sponsor: University of Cyprus
Sponsor class: OTHER
Collaborators: name: Youth Board of Cyprus
First posted: 2022-03-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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:

1. 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.
2. 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:
3. 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.
4. 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.


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

Primary outcomes:
measure: Willingness
timeFrame: Day 1 (During experimental tasks)
measure: Virtual Reality Behavioural Approach Task (VR BAT)
timeFrame: Day 1 (During experimental tasks)
measure: Behavioural Willingness Assessment (BWA)
timeFrame: Day 1 (During experimental tasks)
measure: Follow up Flying Behaviour
timeFrame: One month follow up
Secondary outcomes:
measure: Avoidance Behaviours
timeFrame: Day 1 (During experimental tasks)
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: University of Cyprus
state: Non-US/Non-Canadian
Study officials:
affiliation: University of Cyprus
name: Maria Karekla, PhD
role: PRINCIPAL_INVESTIGATOR
References: