Mindfulness and Psychological Inflexibility

August 2, 2022 updated by: Buse Keskindag, Bahcesehir Cyprus University

Mindfulness Skills Training and Psychological Inflexibility: a Randomized Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Nicosia, Cyprus
        • Bahcesehir Cyprus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in experiential avoidance
Time Frame: 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)
at two time points (pre-intervention and immediately after the intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in anxiety
Time Frame: 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.
at two time points (pre-intervention and immediately after the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bahcesehir Cyprus University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Buse Keskindag, Bahcesehir Cyprus University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BAU/EK-2022/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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