Mindfulness and Psychological Inflexibility

Mindfulness Clinical Trial

Official title:

Mindfulness Skills Training and Psychological Inflexibility: a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05487872
• Other study ID #: BAU/EK-2022/02
• Status: Completed
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: June 24, 2022

Study information

• Verified date: August 2022
• Source: Bahcesehir Cyprus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 24, 2022
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mindfulness

Intervention

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

Locations

Country	Name	City	State
Cyprus	Bahçesehir Cyprus University	Nicosia

Sponsors (1)

Lead Sponsor	Collaborator
Bahcesehir Cyprus University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in anxiety	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.	at two time points (pre-intervention and immediately after the intervention)