Condition category
Mental and Behavioural Disorders
Date applied
19/06/2017
Date assigned
21/06/2017
Last edited
21/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The prevalence of diagnosable mental illnesses is increasing on North American university campuses. The Canadian health care system faces serious service challenges that result in long wait-times for mental health care. This is of particular concern for youth entering post-secondary education and affected by immediate and long term financial stressors and insecure futures. These stressors are often worse for youth from vulnerable socioeconomic and ethnic minority communities. Mindfulness-based programmes have been found to positively impact psychological and physical health with multiple meta-analyses demonstrating positive impacts in clinical and non-clinical populations. At York University, the mindfulness-based Healthy Student Initiative (HSI) programme has evolved over five years, offering group-based mindfulness meditation training to students throughout the school year. Despite assessed benefits, the ongoing question has been how to scale-up the HSI program to reach more students. This led to combining mindfulness-based self-help modules with an online community platform. The Mindfulness Virtual Community for students includes the three core elements: mindfulness-based self-help modules, online group meetings moderated by a psychologist (synchronous) and peer-to-peer discussion boards moderated by a psychologist (asynchronous). The aim of this study is to help students adopt mental health-promoting behaviours that may reduce their needs to access counselling services.

Who can participate?
Students aged 18 and older who are currently enrolled at York University (Canada).

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive an online programme to complete which includes mental health education, discussion boards, video conferences/messaging with counselling psychologists, and email reminders. Those in the second group are placed on the wait list where they have access to the programme at the end of the study. Participants are followed up at the end of the study to compare their anxiety levels, stress and overall health to prior to the programme.

What are the possible benefits and risks of participating?
Participants may benefit from the materials on common mental health challenges and practices of mindfulness, which can improve their overall quality of life, satisfaction and can enhance academic performance. There are no notable risks however, participants are provided with a resource list with available services in the community and on campus.

Where is the study run from?
York University (Canada)

When is the study starting and how long is it expected to run for?
June 2015 to December 2018

Who is funding the study?
Canadian Institutes of Health Research (Canada)

Who is the main contact?
1. Professor Christo El Morr (Scientific)
elmorr@yorku.ca
2. Professor Farah Ahmad (Scientific)
farahmad@yorku.ca
3. Professor Paul Ritvo (Scientific)
pritvo@yorku.ca

Trial website

www.studentsmentalhealth.com

Contact information

Type

Scientific

Primary contact

Prof Christo El Morr

ORCID ID

http://orcid.org/0000-0001-6287-3438

Contact details

York University
4700 Keele Street
HNE #412
Toronto
M3J 1P3
Canada
+1 416 736 2100 ext. 22053
elmorr@yorku.ca

Type

Scientific

Additional contact

Prof Farah Ahmad

ORCID ID

http://orcid.org/0000-0001-9747-1148

Contact details

York University
4700 Keele Street
Toronto
M3J 1P3
Canada
+1 416 736 2100 ext. 33898
farahmad@yorku.ca

Type

Scientific

Additional contact

Prof Paul Ritvo

ORCID ID

Contact details

York University
4700 Keele Street
Toronto
ON
M3J 1P3
Canada
+1 416 736 2100 ext. 22396
pritvo@yorku.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

York University REB Certificate #: e2017 - 181

Study information

Scientific title

Mindfulness Virtual approaches for students’ wellbeing on Campus: A randomised controlled trial

Acronym

MVC

Study hypothesis

Primary hypotheses:
1. Symptom scores for stress, depression and anxiety at T2 will be significantly better in the
2. Mindfulness virtual community (MVC) intervention group when compared with wait-list control group
3. Quality of life scores and program satisfaction at T2 will be significantly better for the MVC intervention group when compared with the wait-list control group
4. Rates of classroom absenteeism and self-reported disability days at T2 will be significantly lower for the MVC intervention group when compared with the wait-list control group

Secondary hypotheses:
1. Symptom scores for stress, depression and anxiety at T2 compared to T1 will be significantly reduced for MVC intervention group when compared with the wait-list control group
2. Level of mindfulness will be significantly higher at T2 compared to T1 for the MVC intervention group when compared with the wait-list control group
3. Quality of life scores at T2 compared to T1 will be significantly higher in the MVC intervention group when compared with the wait-list control group
4. Student engagement and experience will overall be significantly better for the MVC intervention group when compared to the wait-list control group
5. Rates of classroom absenteeism and self-reported disability days at T2 compared to T1 will be significantly lower for the MVC when compared to the wait-list control group

Ethics approval

York University Office of Research Ethics, Human Participants Review Sub-Committee (HPRC), 02/06/2017, ref: #e2017- 181

Study design

Double blind single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format; please use contact details to request a Participant Information Sheet and Consent Form.

Condition

Mental health including stress, anxiety and depression

Intervention

Participants complete an informed consent form and are randomly assigned to one of two study arms. Allocation is done by opening a sequentially numbered envelope containing a randomly-generated allocation by an off-site biostatistician.

Study arm 1 Wait List: This is a control arm for the study. Participants randomised to this arm are asked to complete two assessments over the period of the study (8 weeks). These assessments include a baseline and follow-up assessments (at baseline and week 8). Participants will be offered a list of available resources to support mental health. After 8 weeks, participants in this arm have an opportunity to access the mindfulness videos and exercises.

Study arm 2 Mindfulness Virtual Community (MVC) online intervention: Participants allocated to this arm complete baseline and follow-up (baseline and week 8) assessments, receive the list of resources, and also participate in a series of interactive, online activities. These activities include:
1. Mental health education (general and youth-specific) and mindfulness meditation practice, drawing from CBT principles, delivered as 12 audio-video recorded modules that will be released gradually at about 1-2 modules per week that participants may watch on their computers, tablets or phones at their own convenience
2. Anonymous, asynchronous peer-to-peer discussion boards (moderated by a counselling psychologist) pertaining to mental health and mindfulness practice
3. Anonymous, 20- minute synchronous video conferences (group-based) led by a counselling psychologist, scheduled 1-2 days a week, to engage participants on topics covered in the 12 modules
4. Direct messaging with the counselling psychologist
5. Email reminders from project staff when new modules and video conference sessions become available.

Participants are followed up at the end of the study with online surveys to be assessed for their anxiety levels, stress and health.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Depression level is measured using Patient Health Questionnaire (PHQ-9) using a self-administered online survey at baseline and week eight
2. Anxiety level is measured using Beck Anxiety Inventory (BAI) using a self-administered online survey at baseline and week eight
3. Stress level is measured using Perceived Stress Scale (PSS) using a self-administered online survey at baseline and week eight

Secondary outcome measures

1. Quality of Life is measured using Quality of Life Scale (QOLS) using a self-administered online survey at baseline and week eight
2. Student Satisfaction is measured using Brief Multi-Dimensional Students’ Life Satisfaction Scale (BMSLSS) using a self-administered online survey at baseline and week eight
3. Mindfulness level measured using Brief Five Facet Mindfulness Questionnaire (BFFMQ) using a self-administered online survey at baseline and week eight

Overall trial start date

03/06/2015

Overall trial end date

30/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 18 years of age or older
2. Currently enrolled as an undergraduate student at York University (Toronto, Keele campus) and planning to remain so for the coming semester
3. Reading, writing and conversing in English
4. Willing to be randomised into an intervention which may require up to 2 hours per week of their time

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

The total sample of RCT 480 students (240 in each arm) and will be recruited in three waves of 80 participants per arm for semesters: Fall 2017, Winter 2018, Fall 2018.

Participant exclusion criteria

1. Cannot meet the time commitments of the trial
2. Not comfortable in reading, writing and speaking English
3. Self-reported symptoms of psychosis (e.g. hallucinations, hearing voices) in last 30 days
4. Self-report dependencies on alcohol, illicit drugs, or prescription drugs used for non-medical reasons in last 30 days

Recruitment start date

23/06/2017

Recruitment end date

20/12/2018

Locations

Countries of recruitment

Canada

Trial participating centre

York University
4700 Keele Street
Toronto
M3J 1P3
Canada

Sponsor information

Organisation

York University

Sponsor details

4700 Keele Street
Toronto
M3J 1P3
Canada
+1 416 736 2100 ext 21069
muellerm@yorku.ca

Sponsor type

University/education

Website

http://research.info.yorku.ca/

Funders

Funder type

Government

Funder name

Canadian Institutes of Health Research

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study is not expected to be made available due to the data set containing sensitive mental health participant data and, hence, not available publicly. All dataset will be held by the Nominated Principal Applicant (PI), Dr. El Morr at York University. On receiving a request for release of data, the three PIs will make a joint decision.

Intention to publish date

30/12/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes