Mindfulness in University Students. ATENEU Program (ATENEU)

November 30, 2023 updated by: ALICIA SANCHEZ PEREZ, Universidad Miguel Hernandez de Elche

Effects of a Mindfulness Program on the Occupational Balance and Mental Health of University Students. Protocol for a Randomized Controlled Trial Study. ATENEU Program (Mindfulness in University Students)

The study aims to examine the effects of a mindfulness-based intervention and a mindfulness-based intervention with virtual reality on occupational balance and on the reduction of psychological distress in university students (i.e. stress, anxiety and depression). The specific objectives will be to examine the effects of the intervention on other variables related to mental health, psychological functioning and occupations, and their maintenance at three months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The college student population is considered at high risk for developing mental health problems with the prevalence of depression being 34%, anxiety 32%, and sleep disorders 33% post-pandemic. This psychological distress affects students worldwide and is linked to poor academic performance and the presence of health risk behaviors such as substance use or suicide. Addressing student mental health is an urgent research priority. As such, a growing number of universities are offering interventions aimed at students, including MBI or mindfulness which is defined as the ability to pay attention to present moment experience with interest, curiosity, and acceptance MBI has been shown to have beneficial effects in students but the level of adherence to the program is low. One of the possible solutions could be the incorporation of virtual reality (VR) due to the high affinity of this population with new technologies and the increase in its frequency of use in neurorehabilitation and clinical psychology.

Objectives:

The study aims to examine the effects of a mindfulness-based intervention and a mindfulness-based intervention with virtual reality on occupational balance and on the reduction of psychological distress in university students (i.e. stress, anxiety and depression). The specific objectives will be to examine the effects of the intervention on other variables related to mental health, psychological functioning and occupations, and their maintenance at three months.

Methodology:

Single-blind, 3-arm randomized clinical trial (RCT): traditional MBI, MBI with VR, passive control group (waiting list), with 4 evaluation moments: pre-intervention, inter-session, post-intervention and follow-up. Participants will be undergraduate, master and doctoral students of the Miguel Hernández University of Elche, Alicante.

Intervention: Mindfulness-Based Intervention, Mindfulness-Based Intervention with virtual reality and Control group.

Variables and instruments:

This study will be carried out with mixed methodology. The quantitative part will be carried out by means of ad hoc questionnaires and measurement instruments adapted and validated in Spain, and by means of EMA (Ecological Momentary Assessment).

The qualitative part will be conducted through Focus Groups.

Study Type

Interventional

Enrollment (Estimated)

174

Phase

  • 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 Contact

Study Locations

  • Spain
    • Alicante
      • San Juan De Alicante, Alicante, Spain, 03550
        • Recruiting
        • Alicia Sánchez Pérez
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • being 18 years old or older
  • being a degree, master or doctorate student at Miguel Hernández University
  • speaking fluent Spanish
  • signing the informed consent form
  • having attended at least 4 of the 6 sessions (66% of the program)
  • internet access from a computer or smartphone to complete the online assessments and formal practices during the program.

Exclusion Criteria:

  • miss more than 2 out of 6 sessions (33% of the program)
  • present a severe mental disorder in active phase diagnosed by a health professional (e.g., schizophrenia, bipolar disorder)
  • are under the influence of alcohol or other drugs during sessions and/or assessments (determined by the program instructor)
  • participate in another standardized meditation program during the study period
  • withdrew before starting the intervention.
  • Additionally, should any participants require psychological or psychiatric treatment during the study, they will be excluded and referred to specialized care services.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-Based Health Care Program (MBHC).
Mindfulness skills will take over a 6-week period. Mindfulness skills will deliver in a weekly group format. Participants will be instructed to follow mindfulness practice at home. The program is focused on cultivating mindfulness of present-moment, cultivating a nonreactive, nonjudgmental attitude toward the experience, and includes specific formal and informal practices aimed at cultivating healthy habits and lifestyle (e.g., activities of daily living such as feeding, bathing, or showering and other occupations such as communication management, health management, etc.; and prosocial components (e.g., kindness and compassion).
Behavioral: Mindfulness program
Six weeks mindfulness program. The program is explained in arm descriptions.
Experimental: Mindfulness-Based Health Care program with virtual reality (MBHC-VR).
This program combines mindfulness practice with immersion in a virtual environment. The content and objectives of MBHC-VR program are the same that MBHC, with the main difference being that all formal practices of each session will be performed using VR.
Behavioral: Mindfulness program with Virtual Reality
Six weeks mindfulness program. The program is explained in arm descriptions.
No Intervention: Waiting list control group (WL).
Participants in the WL control group will not receive any intervention during the study. However, for ethical reasons, at the end of the 3-month follow-up assessment, participants of this WL control group will be invited to participate in the MBHC program free of charge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Occupational Balance
Time Frame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Occupational Balance Questionnaire (OBQ) is a brief 13-item tool scored on a 6-point Likert-type response scale, ranging from 0 (strongly disagree) to 5 (strongly agree), with a total score ranging from 0 to 65, where a higher score indicates greater occupational balance. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Anxiety, Depression and Stress
Time Frame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Anxiety, Depression and Stress Scale (DASS 21) consists of 21 items, 7 items for each subscale: DASS-D (depression), DASS-A (anxiety) and DASS-S (stress). Participants are asked to rate the degree to which this statement has happened to them in the past week on a scale from 0 (has not happened to me) to 3 (has happened to me a lot or most of the time). A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Academic stress
Time Frame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
SISCO Inventory which consists of 31 items distributed into: 1 filter item (yes-no), 1 item on a Likert-type scale from 1 (a little) to 5 (a lot), 8 items on a Likert-type scale from 1 (never) to 5 (always) that allow identifying stressful stimuli, 15 items on a Likert-type scale from 1 (never) to 5 (always) allowing to identify stressful stimuli divided into physical, psychological and behavioural reactions and 6 items on a Likert-type scale from 1 (never) to 5 (always) allowing to identify the frequency of use of coping strategies. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Burnout
Time Frame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Maslach Burnout Inventory-Student Survey Questionnaire (MBI-SS). The MBI-SS contains 15 items grouped into 3 subscales: Emotional Exhaustion (5 items), Cynicism (4 items), and Academic Efficacy (6 items). These items are scored on a scale from 0 (never/never) to 6 (always/every day). High scores on burnout and cynicism and low scores on academic efficacy are indicative of burnout. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Emotional dysregulation
Time Frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Difficulties in Emotional Regulation Scale (DERS) contains 28 items grouped into 5 subscales: Attention-Inattention, Clarity-Confusion, Acceptance-Rejection, Functioning-Interference, and Regulation-Discontrol. These items are scored on a Likert-type scale from 1 (almost never) to 5 (almost always). Higher scores indicate greater difficulties in emotion regulation.
Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Psychological flexibility
Time Frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Acceptance and Action Questionnaire II (AAQ-II) consists of 7 items to which participants respond on a 7-point Likert-type scale from 1 (never true) to 7 (always true). Scores range from 7 to 49. Higher scores indicate a tendency to act on the need to control or avoid aversive thoughts, memories, or feelings.
Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Mindfulness
Time Frame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Five Facets of Mindfulness Questionnaire Short-Form (FFMQ-SF) contains 24 items that assess the five facets of mindfulness: observing, describing, acting with awareness, non-judgement of inner experience, and non-reactivity to inner experience. It is scored on a Likert-type scale from 1 (never or very rarely true) to 5 (very often or always true). Higher scores indicate a greater capacity for mindfulness. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Self-compassion
Time Frame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Self-Compassion Scale short form (SCS-SF) consists of 12 items assessing 6 factors: Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, and Over-identification. Each item can be rated on a Likert-type scale from 1 (almost never) to 5 (almost always). Higher scores indicate greater self-compassion. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Life Satisfaction
Time Frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Satisfaction with Life Scale (SLS) is composed of 5 items with a 7-point Likert-type scale (from 1, strongly disagree; to 7, strongly agree). The score ranges from 5 to 35, with higher scores indicating greater satisfaction.
Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Adherence to the Mediterranean Diet
Time Frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Mediterranean Diet Adherence Test is a brief dietary assessment instrument consisting of a set of 14 short questions whose evaluation is intended to provide information on adherence to the Mediterranean Diet pattern. This questionnaire scores one point per question, with a score of <9 meaning low adherence and a score of >=9 meaning good adherence.
Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Sleep
Time Frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Insomnia Severity Index (ISI) is a 5-item self-report instrument that assesses the severity of the sleep problem, the degree of dissatisfaction and the impact on quality of life. Scores range from 0 (best score) to 28 (worst score).
Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Physical Activity
Time Frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
International Physical Activity Questionnaire (IPAQ-SF) is a self-administered questionnaire consisting of 7 items that assesses the time spent being physically active in the last 7 days.
Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Mental representations
Time Frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Plymouth Sensory Imagery Questionnaire (Psi-Q) consists of 21 items measuring 7 sensory modalities: vision, sound, smell, taste, touch, bodily sensation and emotions. The questionnaire has a Likert-type scale between 1 (no imagery) and 7 (perfectly clear and as vivid as the actual experience).
Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).

Collaborators and Investigators

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

Sponsor

Universidad Miguel Hernandez de Elche

Collaborators

Universidad Complutense de Madrid

Investigators

  • Principal Investigator: Alicia Sánchez Pérez, Ph.D, Universidad Miguel Hernández- Facultad de Medicina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 2, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

June 26, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mind02UMH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Three members of the research group will be in charge of data collection under the supervision of the principal investigator of this research project. All digital data, including evaluation questionnaires and consent forms, will be stored as a data package on an encrypted hard drive, strictly following the data management guidelines of the Research Ethics And Integrity Committee from Miguel Hernández Univesity. Identifiable personal data will be stored separately from anonymous data to avoid identification of personal data during handling. The confidentiality of the participants will be protected following the ethical guidelines of the Research Ethics And Integrity Committee from Miguel Hernández Univesity.

Once all phases of data collection have been completed, the data will be analyzed by 2 members of the group. Data will be available upon request to the corresponding author once the study is completed.

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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