Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05929430

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)

Led by Universidad Miguel Hernandez de Elche · Updated on 2024-12-24

174

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

Universidad Miguel Hernandez de Elche

Lead Sponsor

U

Universidad Complutense de Madrid

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the effects of two types of mindfulness-based programs on occupational balance and psychological distress, including stress, anxiety, and depression, in university students. This study focuses on mental health challenges faced by students, particularly post-pandemic, where depression, anxiety, and sleep disorders have become common. The research aims to also explore how these interventions influence other mental health and psychological factors and whether benefits persist three months after the programs. The study is a single-blind, randomized clinical trial with three groups: a traditional mindfulness-based health care program (MBHC), an MBHC program combined with virtual reality (MBHC-VR), and a passive control group on a waiting list. Each program lasts six weeks with weekly group sessions and home practices. The MBHC-VR group completes formal mindfulness practices using virtual reality technology. Participants in the control group do not receive the intervention during the study but are offered the mindfulness program after a three-month follow-up. Participants will be undergraduate, master, or doctoral students who complete assessments before, during, immediately after, and three months following the intervention. Researchers will use questionnaires, ecological momentary assessment, and focus groups to measure changes in occupational balance, anxiety, depression, stress, academic stress, burnout, emotional regulation, psychological flexibility, mindfulness, self-compassion, life satisfaction, diet adherence, sleep, physical activity, and mental representations. The study includes monitoring attendance and internet access for completing assessments and practices.

CONDITIONS

Brief Title

Mindfulness in University Students. ATENEU Program

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Being 18 years old or older
  • Currently enrolled as a degree, master, or doctorate student at Miguel Hernández University
  • Fluent in Spanish
  • Signing the informed consent form
  • Attending at least 4 out of 6 mindfulness program sessions (66% attendance)
  • Having internet access via computer or smartphone to complete online assessments and formal practices
Not Eligible

You will not qualify if you...

  • Missing more than 2 out of 6 mindfulness sessions (over 33% absence)
  • Having a severe mental disorder in active phase diagnosed by a health professional (e.g., schizophrenia, bipolar disorder)
  • Being under the influence of alcohol or other drugs during sessions or assessments
  • Participating in another standardized meditation program during the study period
  • Withdrawing before starting the intervention
  • Requiring psychological or psychiatric treatment during the study (participants will be excluded and referred to specialized care)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or online) for eligibility assessment and consent

Mindfulness-Based Intervention

Duration - 6 weeks

Participants engage in a six-week mindfulness program, either traditional or combined with virtual reality. Sessions occur weekly in groups, with additional mindfulness practice at home to cultivate mindfulness, healthy habits, and prosocial behaviors.

Weekly group sessions plus daily home practice

Follow-up

Duration - 12 weeks

Participants' mental health, occupational balance, and other outcomes are assessed three months after the intervention to evaluate lasting effects.

1 follow-up assessment visit approximately 12 weeks post-intervention

Trial Site Locations

Total: 1 location

1

Alicia Sánchez Pérez

Sant Joan d'Alacant, Alicante, Spain, 03550

Actively Recruiting

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Research Team

A

Alicia Sánchez Pérez, Ph.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Published Research Related To This Trial

Prevalence and risk factors for mental health problems in university undergraduate students: A systematic review with meta-analysis.

Elena Sheldon, Melanie Simmonds-Buckley, Claire Bone...

https://pubmed.ncbi.nlm.nih.gov/33812241

Efficacy of a mindfulness-based programme with and without virtual reality support to reduce stress in university students: A randomized controlled trial.

Marta Modrego-Alarcón, Yolanda López-Del-Hoyo, Javier García-Campayo...

https://pubmed.ncbi.nlm.nih.gov/33957506

The Mindfulness Map: A Practical Classification Framework of Mindfulness Practices, Associated Intentions, and Experiential Understandings.

Nava Levit-Binnun, Keren Arbel, Dusana Dorjee

https://pubmed.ncbi.nlm.nih.gov/34712178

Mindfulness-Based Interventions for University Students: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

Anna F Dawson, William W Brown, Joanna Anderson...

https://pubmed.ncbi.nlm.nih.gov/31743957

The ATENción Plena en Enfermedad de Alzheimer (ATENEA-Mindfulness in Alzheimer's Disease) Program for Caregivers: Study Protocol for a Randomized Controlled Trial.

Alicia Sánchez-Pérez, Daniel Mendialdua-Canales, Miriam Hurtado-Pomares...

https://pubmed.ncbi.nlm.nih.gov/35327020

Effects of a mindfulness-based program on the occupational balance and mental health of university students. Protocol for a randomized controlled trial.

Carmen Lillo-Navarro, Paula Fernández-Pires, Gemma Benavides Gil...

https://pubmed.ncbi.nlm.nih.gov/38696406