Mindfulness and Psychological Inflexibility

• Sponsor: Bahcesehir Cyprus University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05487872
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.7
• Patients Per Site Per Month: 23

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mindfulness	Behavioral: Mindfulness skills training to reduce experiential avoidance and anxiety symptoms	N/A

Detailed Description

The experimental design (randomized trial) was used in this study. Data were collected through convenience sampling. After obtaining ethical approval fromEthics Committee of the Bahçeşehir Cyprus University, participants were invited to participate in the study via advertisements posted in the university building. Recruited participants were randomly assigned to the experimental group or control group. All participants will be provided with an informed consent form which provided information about participant's right and data management. Participants in the experimental group completed mindfulness exercise on Virtual Reality (VR) system where they listened to an audio track (guide for the exercise) and saw calming nature scenes (e.g., views on the beach) whereas those in the control group completed mindfulness exercise by listening to the (same) audio track only. Each mindfulness session took approximately 15 mins. In total, four sessions were completed in two weeks (2 sessions per week). After obtaining informed consent, the participants completed a survey pack that included valid and reliable measurement scales (mindfulness skills [The Cognitive and Affective Mindfulness Scale - Revised], experiential avoidance [Acceptance and Action Questionnaire-II], and anxiety symptoms [Generalized Anxiety Disorder Scale]) at two-time points (i.e., pre-test [before intervention], and post-test [after 4 sessions/when sessions were completed], At the end of the study, the participants were provided with a debrief form.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Mindfulness Skills Training and Psychological Inflexibility: a Randomized Trial
• Actual Study Start Date: May 2, 2022
• Actual Primary Completion Date: Jun 24, 2022
• Actual Study Completion Date: Jun 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Audio-guided mindfulness skills training 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; The intervention aimed to increase participants' mindfulness skills which may be critical in decreasing general experiential avoidance and anxiety symptoms
Experimental: Virtual reality (VR) -based mindfulness skills training 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; The intervention aimed to increase participants' mindfulness skills which may be critical in decreasing general experiential avoidance and anxiety symptoms

Outcome Measures

Primary Outcome Measures

1. Change in experiential avoidance [at two time points (pre-intervention and immediately after the intervention)]

   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)

Secondary Outcome Measures

1. Change in anxiety [at two time points (pre-intervention and immediately after the intervention)]

   Anxiety symptoms were measured via Generalized Anxiety Disorder Scale. The scale includes 7 items rated on 4 point scale (0 = Not at all, 1 = Several days, 2 = More than half of the days - 3 = Nearly every day). Scores 5, 10, 15 obtained from the test indicate mild, moderate, and severe anxiety, respectively.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• age of 18 and above,

• ability to read, and/or understand English

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bahçeşehir Cyprus University	Nicosia		Cyprus

Sponsors and Collaborators

• Bahcesehir Cyprus University

Investigators

• Principal Investigator: Buse Keskindag, Bahcesehir Cyprus University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Buse Keskindag, Principal Investigator, Bahcesehir Cyprus University
• ClinicalTrials.gov Identifier: NCT05487872
• Other Study ID Numbers: BAU/EK-2022/02
• First Posted: Aug 4, 2022
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 4, 2022