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RESEARCH ARTICLE
Asia Pac J Clin Trials Nerv Syst Dis 2018,  3:89

Mindfulness training programme for undergraduate and graduate students with depression, anxiety and stress symptoms: Study protocol for a randomized controlled trial


1 Department of Psychology, Federal University of Minas Gerais, Belo Horizonte, Brazil
2 Department of Psychology, State University of São Paulo, Ribeirão Preto, Brazil

Date of Web Publication27-Aug-2018

Correspondence Address:
Alessandra Almeida Assumpcao
Department of Psychology, Federal University of Minas Gerais, Belo Horizonte
Brazil
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Source of Support: The study was supported by Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)., Conflict of Interest: None


DOI: 10.4103/2542-3932.238434

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  Abstract 

Background and objectives: High prevalence rates of depression, anxiety and stress symptoms in undergraduate and graduate students have been pointed out as a growing concern in the literature. The high indexes of these psychopathological symptoms are considered a serious health problem, since they imply losses in the institutional, social and family spheres. Research on mindfulness interventions has demonstrated positive results in treating these symptoms. The study aims to evaluate the efficacy of mindfulness training programme in the treatment of depression, anxiety and stress symptoms in undergraduate and graduate students.
Design: This is a randomized parallel-design controlled trial.
Methods: Undergraduate and graduate students from the Federal University of Minas Gerais with depressive, anxiety and stress symptoms will be randomized into control and training group (n = 24/group). Mindfulness training will take place in a weekly meeting within 6 weeks and will be in a group format constituted by 8-12 participants. Each meeting will take 90 minutes. The control group will also receive the intervention after 6 weeks in the wait list condition.
Outcome measures: The primary outcomes are Beck Depression Inventory-II, Beck Anxiety Inventory, and Perceived Stress Scale scores. The secondary outcomes are Rosenberg Self-Esteem Scale, and 12-item Short-Form Health Survey scores.
Discussion: This trial will evaluate the efficacy of mindfulness training programme for undergraduate and graduate students with depressive, anxious and stress symptoms. This will help to improve mental health and the quality of life, as well as reducing psychological and social burdens for this population.
Ethics and dissemination: The study protocol was approved by the Ethics Committee of Federal University of Minas Gerais, in Belo Horizonte, Brazil on April 20th, 2017, approval number 2.025.573. The committee will audit the progression of the research. The investigation results will be disseminated on peer review scientific journals.
Trial registration: This trial was registered in the Brazilian Clinical Trial Registry (http://www.ensaiosclinicos.gov.br) (registration No. RBR-4mmvpc) on July 21st, 2017.

Keywords: depression; anxiety; stress; university students; college students; randomized controlled trial; mindfulness; quality of life


How to cite this article:
Assumpcao AA, Neufeld CB, Teodoro MM. Mindfulness training programme for undergraduate and graduate students with depression, anxiety and stress symptoms: Study protocol for a randomized controlled trial. Asia Pac J Clin Trials Nerv Syst Dis 2018;3:89-96

How to cite this URL:
Assumpcao AA, Neufeld CB, Teodoro MM. Mindfulness training programme for undergraduate and graduate students with depression, anxiety and stress symptoms: Study protocol for a randomized controlled trial. Asia Pac J Clin Trials Nerv Syst Dis [serial online] 2018 [cited 2018 Oct 23];3:89-96. Available from: http://www.actnjournal.com/text.asp?2018/3/3/89/238434


  Introduction Top


Background

High prevalence rates of depression, anxiety and stress symptoms in undergraduate and graduate students have been pointed out as a growing concern in the literature. The high indexes of these psychopathological symptoms are considered a serious health problem, since they imply losses in the institutional, family and social spheres.

Studies with mindfulness-based interventions (MBIs) have shown positive associations between mindfulness practices and psychological well-being for college students (Shapiro et al., 2008; Moses et al., 2016). Mindfulness Based Stress Reduction (MBSR) is the most researched MBI for this target population. MBSR aims to assist people with stress to develop better coping strategies to deal with stressful events. The original programme is 8 weeks long, but there are variations that range from seven to four sessions. In the sessions formal meditation and informal practices are taught and trained aiming to increase levels of mindfulness.

The meta-analysis by McConville et al. (2017) points out that mindfulness training contributes to the reduction of stress, anxiety and depression symptoms. The authors evaluated 19 studies that included 1815 participants and it was noticed that there was a significant improvement in humour, self-efficacy, empathy and dispositional mindfulness levels in university students of health areas (medicine, nursing, social work and psychology). The authors emphasized that in addition to the encouraging results found, mindfulness training (in its varied approaches) can be easily adapted and integrated into the curricula of health students, however, they caution that participation in training should be voluntary to provide positive effects.

Other researches have presented positive results from mindfulness training especially regarding general mental and physical health of college students (Irving et al., 2009; Bond et al., 2013), positive affect (Escuriex and Labbé, 2011) and positive self-statements (Bond et al., 2013). In addition, there is evidence of improvement in cognitive aspects such as concentration (Paul et al., 2007), selective and sustained attention, visual perception, work memory (Semple, 2010; Jensen et al., 2012) and knowledge retention (Ramsburg and Youmans, 2014). Previous clinical studies have evaluated the efficacy of MBIs for depression, anxiety and stress [Table 1].
Table 1: Clinical studies investigating the efficacy of Mindfulness-Based Interventions for depression, anxiety and stress symptoms in undergraduate and graduate students

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No studies with MBIs were found in Brazil for this specific population until this proposal was elaborated. We hypothesize that mindfulness training will decrease depressive, anxiety and stress symptoms in the target population and will also increase quality of life and self-esteem.

Objective

This trial study aims to evaluate the efficacy of mindfulness training for reducing depression, anxiety and stress symptoms in undergraduate and graduate students.


  Methods/Design Top


Study design

This randomized parallel-design controlled trial will be conducted in Federal University of Minas Gerais. Approximately 44 students will be recruited and randomized into one of two groups: training and control (wait list condition). The primary outcome measure will be Beck Depression Inventory-II, Beck Anxiety Inventory and Perceived Stress Scale score differences observed at baseline, after the treatment, and 3 months follow-up. The secondary outcome measures will be Rosenberg Self-Esteem and 12-Item Health Survey scores also at baseline, after the intervention and 3 months after the intervention. The flow chart of the trial is shown in [Figure 1].
Figure 1: Flow chart of the trial.

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Study setting

Faculdade de Filosofia e Ciências Humanas, Federal University of Minas Gerais, Brazil.

Study procedures

The study will consist of two phases: screening period and randomized controlled trial. The students will be informed of the nature of the research and its procedures. After providing informed consent, participants will be screened. The students who meet the inclusion criteria will be randomly assigned to receive training or to wait in line for 6 weeks, after this period, they will also receive training. The symptoms will be assessed at baseline, after the intervention and 3 months after the intervention.

Recruitment

The research will be advertised widely in the student community at the Federal University of Minas Gerais. Posters will be put up in the University buildings. Social Media and the institution website will be used. Researches and contributors will also circulate an e-mail presenting the study and inviting students to attend the research. Advertising will focus on letting students know about the study and directing them to a dedicated e-mail (atencaoplenaufmg@gmail.com) to information and scheduling of the screening interviews.



Population

The training will be performed in a group format composed of 8 to 12 patients with duration of 6 sessions of 90 minutes each. Six groups will be performed: three training groups (n = 27) and three control groups with the same number of patients.

Inclusion criteria

Patients will be required to meet all of the following conditions to be included in this trial:

  • Be regularly enrolled at the university
  • Men and women aged ≥ 17 years and ≤ 60 years
  • Depression symptoms (mild and moderate) measured by Beck Depression Inventory-II (BDI-II) (Beck et al., 1996) (scores ≥ 14, and ≤ 28)
  • Anxiety symptoms measured by Beck Anxiety Scale (BAI) (Beck and Steer, 1993) (scores > 0)
  • Stress symptoms measured by Perceived Stress Scale (PSS) (Cohen et al., 1983) (scores > 0)


Exclusion criteria

Patients presenting with any of the following conditions will be excluded from this trial:

  • No recent history (past 12 months) of severe psychopathology (psychosis, suicide attempt and risk, panic disorder and posttraumatic stress disorder)
  • Having epilepsy or some neurocognitive disorder
  • Be in psychological treatment (lasting 6 months)
  • Practicing mindfulness meditation frequently (lasting 6 months)


Withdrawal criteria

The students will be voluntarily withdrawn from the study if declining continued treatment.

Randomization

After evaluation and inclusion of 24 participants, they will be randomized into intervention and control groups. In order to eliminate the experimental allocation bias to the groups, the following procedures will be adopted [Table 2]: (1) initially, the “researcher 2” will forward the evaluation protocols to the “researcher 3”who will not be aware of the hypotheses of the study and will not participate in the screening, (2) “Researcher 3” will generate a random list from the SPSS-22 program and will inform the “Researcher 2” about the allocation by e-mail (which will be duly registered and archived), (3) the “researcher 2”, in turn, will document the allocation in the database that will be verified by the “researcher 3”.
Table 2: Researchers and their roles in each stage of the study

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Blinding

The nature of psychological intervention does not mask or blind patients and therapists. However, some procedures will be adopted to mask some stages of data collection and analysis: (1) the “Researcher 4” who will be involved in the initial statistical analysis will be blind to treatment allocation; (2) “Researcher 1” will be aware of the experimental and control groups only after the analyzes and descriptions of the data for the final report; (3) only “Researcher 2” will perform data collection, schedule evaluation sessions, and conduct telephone contact with participants; (4) the “Researcher 3” responsible for group randomization will be blind to the hypotheses of the study and will not have participation or contact with the participants.

Interventions

The present mindfulness training programme was based on the intervention created by Segal et al. (2002) called Mindfulness Based Cognitive Therapy (MBCT) and in the books: The Mindful Way Workbook (Teasdale et al., 2013) and Mindfulness: a practical guide finding peace in a frantic world (Williams and Penman, 2011). The programme was adapted, maintaining the main structure and components of MBCT. Among the alterations are: (1) decrease in time from 120 minutes to 90 minutes, (2) decrease from eight to six sessions, (3) exclusion of a full-day retreat, (4) decrease in proposed home practice time of 45 minutes to a progressive increase of the practice from 10 to 25 minutes and (5) the home practice frequency suggested five times instead of six times. These changes are based on the literature that points out that there is no data on optimal session time or home practice for MBIs (Creswell, 2017). All sessions will be conducted by a licensed psychotherapist with three years of mindfulness personal practice will also be supervised bi-weekly by a Mindfulness Certified Instructor (Oxford Mindfulness Centre).

The central training components are formal and informal mindfulness practices, activities on the theme proposed in each session, as well as the development of cognitive and behavioral skills to deal with depression, anxiety and stress symptoms. These two components, the cognitive and the experiential, compose the typical MBCT programme. The in-class sessions follow a standard format which begins by discussing the homework of the previous session (frequency of meditation, any obstacles to completion, and the meditation experience). Subsequently, a short exposition on the theme of the week is carried out accompanied by an activity to reinforce the content presented. Then one or two mindfulness practices are taught.

At the end of each meditation exercise, the therapist and participant discussed emotional, physiological, and cognitive experiences. After mindfulness training, the homework week practices are explained and the meeting ends. Weekly handouts are also given to illustrate concepts, and homework reflections are included. Homework includes individual sessions of meditation audio (downloaded files) corresponded to the theme of the weekly meeting, reinforcing techniques used in class.

Training group: Mindfulness training sessions will be conducted once a week within 6 weeks. Each session will last approximately 90 minutes. The protocol is as follows: First session: (1) introduction to mindfulness and autopilot, (2) body scan, and 3-minute meditation. Second session: (1) appreciation of here and now, (2) breathing, and 3-minute meditation, (3) learning about feelings and thoughts. Third session: (1) staying in the present moment, (2) working with the body and the breathing, and 3-minute meditation. Fourth session: (1) recognizing aversion, (2) sound and thought mediation. Fifth: (1) let it be, (2) exploring difficulties, (3) loving kindness meditation. Sixth session: (1) recalling training, (2) relapse prevention, (3) body scan and 3-minute meditation. Control group: will have mindfulness training after waiting for 6 weeks (the period of training group).

Participants who are using psychotropic drugs for depression and/or anxiety will be accepted in the study. This variable will be considered in the data analysis as a possible confounding variable. To do so, weekly, additions or suspension of psychotropic drugs will be noted both for participants who start the study using medication as well as participants who start using during the programme.

Outcome measures

Data will be assessed at baseline, after treatment and 3 months after treatment.

Primary outcome measures

  • The PSS is a self-report instrument that evaluates psychological stress based on the transactional model of an individual’s ability to cope with life events. It does not elicit the presence or absence of specific stressful life events (e.g., divorce, death in the family, etc.) but rather assess the individual’s pattern of reacting to events. It was developed by Cohen et al. (1983), and it was translated and validated by Luft et al. (2007), containing 14 items rated on a Likert-type scale (0 = never to 4 = always), with the final score ranging from 0 to 56. The overall mean presented by the population was 21.37 points in the study by Luft et al. (2007). The instrument obtained a reliability index of 0.82 in the Brazilian version.
  • BDI-II is a self-report measure of depression severity over the past 2 weeks and it is structured in 21 items rated on a 4-point Likert scale, referring to symptoms and activities. Sample items include degree of “sadness” and “loss of pleasure.” The interpretation of the data follows the following pattern: scores between 0 and 13 (minimum); scores from 14 to 19 (mild depression); scores from 20 to 28 (moderate depression); scores from 29 to 63 (severe depression). The internal consistency found was 0.93 for adults and the reliability was 0.65. In the Brazilian version, the cut-off point of 10/11 was the best threshold to detect depression, reaching sensitivity of 70% and specificity of 87% (Gomes-Oliveira et al., 2012).
  • The BAI is a self-report instrument structured in 21 items rated on a 4-point Likert scale referring to cognitive and somatic symptoms of anxiety, with higher scores indicating increased anxiety. The interpretation of the data follows the following pattern: scores between 0 to 10 (minimal anxiety); scores from 11 to 19 (mild anxiety); scores of 20 to 30 (moderate anxiety); scores from 31 to 63 (severe anxiety) (Cunha, 2001). The internal consistency found in the Brazilian version varied between 0.92-0.94 for adults and the reliability was 0.75.


Secondary outcome measures

  • The Rosenberg Self-Esteem Scale (RSES) is a self-report instrument that evaluates global self-esteem by measuring both positive and negative feelings about the self (Rosenberg, 1989). It is a 10-item scale, six of which refer to a positive view of oneself and four referring to a self-deprecating vision. For each statement there are four response options, Likert type (I totally agree = 4 to totally disagree = 1). The sum of the responses to the 10 items provides the scale score whose total score ranges from 10 to 40 and the achievement of a high score reflects a high self-esteem. The inverted items for the one-dimensional model are: 2, 5, 8, 9 and 10. For the Brazilian version (Hutz, 2000) Cronbach’s alpha value was 0.86.
  • The 12-item Short-Form Health Survey (SF-12) is a self-report instrument created by Ware et al. (1994), designed as an alternative to the 36-Item Health Survey (SF-36) previously developed by same authors. The SF-12 evaluates eight different dimensions of influence on quality of life, considering the individual’s perception regarding aspects of his health in the last four weeks. Each item has a group of responses distributed on a graded scale, Likert type, being evaluated the following dimensions: physical function, physical aspect, pain, general health, vitality, social function, emotional aspect and mental health. Through an algorithm of the instrument, two scores can be measured: Physical (Physical Component Summary or PCS) and mental (Mental Component Summary or MCS). In both, the score ranges from 0 to 100, with the highest scores being associated with better levels of Quality of Life. In Brazil, the SF-12 had its translated version validated by Camelier (2004). The mean PCS is 49.6 and MCS is 51.9, respectively. The Cronbach alpha coefficient found was equal to 0.83 (Silveira et al., 2013).


Participant timeline

The schedule of data collection, interventions, and outcome evaluations is shown in [Table 3].
Table 3: Timing of data collection, interventions, and outcome evaluations in the trial

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Data collection and management

Paper based case report forms will be used for documentation. Entries will be transferred into an electronic format using a double-data entry strategy by trained professional staff. For confidentiality, all data collected from participants will be assigned a study serial number in the database and de-identified. Electronic data will be preserved in a password-protected computer and managed by a professional.

The investigator and other staff involved in the study will perform their duties, strictly follow the clinical trial protocol, and adopt standard operating procedures to ensure the implementation of the quality control and quality assurance systems. During the clinical trial, all observations and findings will be verified, and quality control will have conducted at each stage of data processing to ensure that the data are complete, accurate, authentic, and reliable. Original documents and case report forms will be examined with a focus on compliance, integrity, and consistency.

Sample size

The sample calculation was performed in the G Power 3.1 software (Psychology Department, Universität Düsseldorf, Germany) (Faul et al., 2007) a priori type of power analysis and was based on repeated measures (within-between interaction) ANOVA 2 × 3, in which “2” represents number of groups (control and experimental) and the “3” are related to the repetitions (before the intervention, last session and 3-month follow-up). Effect size (f = 0.25), with a type I error of 5% (α = 0.05) and 90% power (β = 0.10), reached the minimum number of 36. But anticipating that a sample size of 48 subjects (24 required per group) will be needed when considering a 30% drop-out rate (van Bastelaar et al., 2008).

Statistical analysis

The data analysis will be guided by the “The Consolidated Standards of Reporting Trials (CONSORT, 2010)”, and intention-to-treat (ITT) analyzes will be conducted, with all participants who have completed the pre-test measures. The participants data who abandoned treatment will be considered and, in these cases, the total average of the depression (BDI-II), anxiety (BAI) and stress (PSS) scales’ scores will be considered. Differences between groups will be calculated with a 95% confidence interval after the programme and three months after intervention for primary and secondary measures. For the primary outcome variables, multivariate logistic regression analysis will be used and to calculate the difference between the continuous variables will be used the multivariate analysis to verify the repeated measures of each participant. For the remaining missing values, the value of the last observation carried forward will be used.

Protocol analyzes will also be performed to reveal patterns between subjective measures (self-report instruments) and t-tests for independent samples and chi-square (χ2) analyzes for possible demographic differences and differences between baseline dependent variables. The following confounding variables will be adjusted: age, sex, level of education, level of depression and number of sessions attended.

The series 2 (group) × 3 (time) of the mixed ANOVA models will be used to test the following hypotheses: a) After the intervention the participants will obtain clinical and statistically significant improvement in the reduction of depression, anxiety and stress symptoms; b) After the intervention the participants will obtain clinical and statistically significant improvement in quality of life and self-esteem scores; c) The clinical and statistically significant gains will be maintained three months after the intervention’s end.

To interpret the interactions between groups a series of t-tests and effect size (d Cohen) will be used to examine (1) possible differences between baseline and post-test; (2) between intervention and follow-up after three months and (3) between baseline and follow-up in which the effect sizes of 0.2, 0.5 and 0.8 are considered small, medium and large, respectively. The relationship between the presence in the sessions, the home practice and the outcome variables will be evaluated by means of linear regression analysis. The database will be made available to a statistician for analysis. The results of these statistical analyses (researcher 4) will be reported to researcher 1 and used to prepare the research report.

To evaluate clinical improvement parameters chi-square (χ2) analyses will be used to test the difference between groups. Clinical improvement will be evaluated by reducing the following parameters: a) Change from mild to moderate and from mild to minimum in BDI-II; b) Change from mild to moderate and from mild to minimal in BAI; c) Reduction in PSS score.

Data monitoring

Trial progression will be reported to the ethical committee every 12 months, and progress will be updated in the registered database (Brazilian Clinical Trial Registry) at the same time. The risks of this proposal are minimal. A possible risk to participants during screening is that they may feel uncomfortable answering questions, getting tired, or getting excited. Should this occur, “Researcher 2”, responsible for this stage, will follow all the necessary procedures to assist the participant in this situation. Regarding the intervention, it is believed that it will lead to the symptomatic improvement of the participant or it will be innocuous. During the intervention, all participants will be closely monitored by “Researchers 1 and 2” and all measures will be taken if participants’ symptoms worsen. If this happens, a measure adopted will be the referral for individual care in the psychological service at UFMG and, if necessary, referral for psychiatric treatment at UFMG.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of Federal University of Minas Gerais, in Belo Horizonte, Brazil on April 20th, 2017, approval number 2.025.573. The committee will audit the progression of the research. The investigation results will be disseminated on peer review scientific journals. The trial will be reported in line with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist (Additional file 1 [Additional file 1]).

Consent

Participants will provide written informed consent (Additional file 2 [Additional file 2]) prior to participation in the trial.

Confidentiality

All patient data will be kept confidential.


  Discussion Top


The present study aims to evaluate the efficacy of mindfulness training for reducing the depression, anxiety and stress symptoms’ levels in undergraduate and graduate students. The study will contribute to clinical practice by providing evidence that mindfulness training can contribute to decrease depression, anxiety and stress symptoms and will help students learn how to manage adverse emotional states after the training. Moreover, they can learn to apply these techniques in their professional future.

This intervention will also help increase levels in quality of life and reduce psychological and social burdens. MBIs in general are promising interventions supported by a growing body of evidence that should be considered as curricular adjuncts to this end. The study limitations are the small sample size and the short-term follow-up (3 months).


  Trial Status Top


Recruitment is ongoing at the time of submission.

Additional files

Additional file 1: SPIRIT checklist.

Additional file 2: Ethical approval document.

Acknowledgments

We are very grateful to the research team for the support.

Author contributions

AAA designed the study and will perform the mindfulness training programme. CBN and MMT co-designed the study, revised. All authors approved the final version of the manuscript.

Conflicts of interest

The authors declare no conflicts of interest.

Financial support

The study was supported by Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES).

Institutional review board statement

The study protocol was approved by the Ethics Committee of Federal University of Minas Gerais, in Belo Horizonte, Brazil on April 20th, 2017, approval number 2.025.573. The trial will be performed in accordance with the relevant laws and regulations of the Declaration of Helsinki and relevant hospital’s ethical principles. This trial was registered in the Brazilian Clinical Trial Registry (http://www.ensaiosclinicos.gov.br) (registration No. RBR-4mmvpc) on July 21st, 2017.

Declaration of patient consent

The authors certify that they will obtain all appropriate patient consent forms. In the form, the patients will give their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Reporting statement

The writing and editing of the article will be performed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidance for protocol reporting.

Biostatistics statement

The statistical methods of this study were reviewed by the biostatistician of Federal University of Minas Gerais, Brazil.

Copyright license agreement

The Copyright License Agreement has been signed by all authors before publication.

Data sharing statement

Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices) will be shared. Study protocol, informed consent form and clinical study report will be promulgated within 12 months after the completion of the trial. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal.

Plagiarism check

Checked twice by iThenticate.

Peer review

Externally peer reviewed.

Funding: The study was supported by Coordenação de Aperfeiçoamento de Pessoalde Nível Superior (CAPES). [33]

 
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    Figures

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    Tables

  [Table 1], [Table 2], [Table 3]



 

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