NCT05487872

Brief Summary

This study aimed to examine whether mindfulness skills training can help to reduce experiential avoidance and anxiety level. This study investigated whether the training delivery methods (audio-guided mindfulness exercise or virtual reality-based mindfulness exercise) differ in terms of changing general experiential avoidance and anxiety symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 30, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

July 30, 2022

Last Update Submit

August 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in experiential avoidance

    Experiential avoidance is an example of psychological inflexibility. Experiential avoidance was measured via Acceptance and Action Questionnaire-II. The scale includes 7 items that are rated on a seven-point scale (1 = never true - 7 = always true). The minimum and maximum scores on the scale range between 7 and 49 points. Higher scores on the scale indicate greater experiential avoidance (psychological inflexibility)

    at two time points (pre-intervention and immediately after the intervention)

Secondary Outcomes (1)

  • Change in anxiety

    at two time points (pre-intervention and immediately after the intervention)

Study Arms (2)

Audio-guided mindfulness skills training

OTHER

Participants in this group listened to a 15 mins audio track to practice mindfulness exercises

Behavioral: Mindfulness skills training to reduce experiential avoidance and anxiety symptoms

Virtual reality (VR) -based mindfulness skills training

EXPERIMENTAL

Participants in this group completed mindfulness exercises on the VR system. The system included the same 15 mins audio track and additionally a video that displayed a 360° spherical landscape view of the sea in the afternoon

Behavioral: Mindfulness skills training to reduce experiential avoidance and anxiety symptoms

Interventions

The intervention aimed to increase participants' mindfulness skills which may be critical in decreasing general experiential avoidance and anxiety symptoms

Audio-guided mindfulness skills trainingVirtual reality (VR) -based mindfulness skills training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age of 18 and above,
  • ability to read, and/or understand English

You may not qualify if:

  • Participants who regularly practice mindfulness exercise were excluded form the analyses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahçeşehir Cyprus University

Nicosia, Cyprus

Location

Study Officials

  • Buse Keskindag

    Bahcesehir Cyprus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2022

First Posted

August 4, 2022

Study Start

May 2, 2022

Primary Completion

June 24, 2022

Study Completion

June 24, 2022

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations