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

NCT05300061 | Completed DMC

• 1 other identifier: K3_K1_3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 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. 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.
3. 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. 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.

Conditions

Specific Phobia

Keywords

Specific Phobia; Flying Phobia; Exposure Therapy; Values Interventions

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  One month follow up

Secondary Outcomes (1)

• Avoidance Behaviours

  Day 1 (During experimental tasks)

Study Arms (3)

Personal Values Intervention

EXPERIMENTAL

Brief personal values intervention

Behavioral: Personal Values Intervention

Prosocial Values Intervention

EXPERIMENTAL

Brief prosocial values intervention

Behavioral: Prosocial Values Intervention

Control

NO INTERVENTION

No intervention control

Interventions

Personal Values Intervention BEHAVIORAL

A 15 minute personal values intervention. Aim is to help participants clarify their own values around flying and promote committed action towards airplanes.

Personal Values Intervention

Prosocial Values Intervention BEHAVIORAL

A 15 minute prosocial values intervention. Aim is to help participants clarify their prosocial values around flying and promote committed action towards airplanes.

Prosocial Values Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Severe heart disease
• High blood pressure
• Photosensitive epilepsy

Sponsors & Collaborators

• University of Cyprus: lead
• Youth Board of Cyprus: collaborator

Study Sites (1)

University of Cyprus

Nicosia, Non-US/Non-Canadian, 1678, Cyprus

Location

MeSH Terms

Conditions

Phobia, Specific; Aerophobia

Study Officials

• Maria Karekla, PhD

  University of Cyprus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: March 29, 2022
• Study Start: September 1, 2020
• Primary Completion: May 14, 2021
• Study Completion: May 14, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)