MindfulnessNCT05487872
Mindfulness and Psychological Inflexibility
A study testing Mindfulness skills training to reduce experiential avoidance and anxiety symptoms in people with Mindfulness, run by Bahcesehir Cyprus University at 1 site in Cyprus.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness
- What is being tested?
- Mindfulness skills training to reduce experiential avoidance and anxiety symptoms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCyprus
- Study dates
- 2 May 2022to 24 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age of 18 and above,
- ability to read, and/or understand English
Who cannot join
- Participants who regularly practice mindfulness exercise were excluded form the analyses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mindfulness
- Being tested
- Mindfulness skills training to reduce experiential avoidance and anxiety symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness skills training to reduce experiential avoidance and anxiety symptomsBehavioural
The intervention aimed to increase participants' mindfulness skills which may be critical in decreasing general experiential avoidance and anxiety symptoms
| Study group | Role | What they receive |
|---|---|---|
| Audio-guided mindfulness skills training | Other | Participants in this group listened to a 15 mins audio track to practice mindfulness exercises Receives: 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 Receives: Behavioral: Mindfulness skills training to reduce experiential avoidance and anxiety symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at two time points (pre-intervention and immediately after the intervention)
Secondary outcomes (1)
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.
Measured: at two time points (pre-intervention and immediately after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start2 May 2022
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahcesehir Cyprus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buse Keskindag, Bahcesehir Cyprus University
- Investigators
- Buse Keskindag, Principal investigator, Bahcesehir Cyprus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487872
- Sponsor's protocol ID
- BAU/EK-2022/02
- Status last verified
- Aug 2022
- First submitted
- 30 Jul 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Skills Training and Psychological Inflexibility: a Randomized Trial
- ClinicalTrials.gov ID
- NCT05487872
- Acronym / sponsor ID
- BAU/EK-2022/02
- Conditions
- Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bahcesehir Cyprus UniversityUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audio-guided mindfulness skills training | Other | Behavioral: Mindfulness skills training to reduce experiential avoidance and anxiety symptomsParticipants in this group listened to a 15 mins audio track to practice mindfulness exercises |
| Virtual reality (VR) -based mindfulness skills training | Experimental | Behavioral: Mindfulness skills training to reduce experiential avoidance and anxiety symptomsParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age of 18 and above,
- ability to read, and/or understand English
Key exclusion criteria (1 listed)
- Participants who regularly practice mindfulness exercise were excluded form the analyses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness skills training to reduce experiential avoidance and anxiety symptomsThe intervention aimed to increase participants' mindfulness skills which may be critical in decreasing general experiential avoidance and anxiety symptoms | Behavioural | Audio-guided mindfulness skills training, Virtual reality (VR) -based mindfulness skills training |
Primary outcome
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)
1 secondary outcome
Change in anxiety
Time frame: at two time points (pre-intervention and immediately after the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buse Keskindag principal investigator
Bahcesehir Cyprus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness skills training to reduce experiential avoidance and anxiety symptoms in people with Mindfulness, run by Bahcesehir Cyprus University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in experiential avoidance (time frame: at two time points (pre-intervention and immediately after the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.