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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Change in Anxiety, Depression and Stress
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Members of the research team who are not involved in the assessments and implementation of the intervention will be responsible for the random sequence and data analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Mindfulness program (Behavioral)
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.
干预措施: Mindfulness program with Virtual Reality (Behavioral)
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.
结局指标
主要结局
Change in Anxiety, Depression and Stress
时间窗: 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.
Change in Burnout
时间窗: 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.
Change in Occupational Balance
时间窗: 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.
Change in Academic stress
时间窗: 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.
次要结局
- Change in Emotional dysregulation(Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).)
- Change in Mindfulness(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 Sleep(Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).)
- Change in Psychological flexibility(Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).)
- Change in Self-compassion(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(Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).)
- Change in Adherence to the Mediterranean Diet(Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).)
- Change in Physical Activity(Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).)
- Change in Mental representations(Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).)
研究者
ALICIA SANCHEZ PEREZ
Associate Professor of Occupational Therapy
Universidad Miguel Hernandez de Elche