Condition category
Mental and Behavioural Disorders
Date applied
23/04/2014
Date assigned
22/05/2014
Last edited
22/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Nursing students are prone to high levels of stress. This can lead to poor physical and psychological health and result in low self-esteem and poorer academic performance. Students that are able to reduce their stress levels will be healthier, more productive and will be more successful in their academic and clinical studies. This, in turn, is likely to improve the quality of nursing care. The mindfulness-based stress reduction (MBSR) program is an eight-week workshop that teaches people a number of mindfulness techniques. It is known to significantly reduce stress levels, anxiety and depression. There have been several studies on MBSR that has been used to reduce stress levels in student nurses, but only with small groups of people, with no control group or tailored program. This study will assess how effective the program is at reducing stress and depression in Thai nursing students and whether it improves their self-esteem and mindfulness.

Who can participate?
Male and female nursing students, aged 18-20 years studying in the first and the second years of the Bachelor of nursing at the University of Phayao, Thailand.

What does the study involve?
127 participants are randomly assigned into one of two study groups. One group is split into three groups, all of which attend the MBSR program. The other group is the control. They do not take part in the MBSR program but have access to the mental health services from the Mental Health Counselling Centre at the university. All participants are asked to complete a baseline demographic questionnaire, collecting information on age, gender, year of study, educational background, religion, family status, financial status and any previous experiences of mindfulness practice. We also ask them to complete a series of questionnaires assessing stress, depression, self-esteem, mindfulness and use of health and counselling services. These questionnaires are collected at the beginning of the study and then at 8-weeks, 16-weeks and 32-weeks afterwards. We will also look at the participantsÂ’ academic grades, to investigate the impact of stress and stress management on their academic performance. Control participants will be offered the opportunity to receive a two-day intensive mindfulness workshop once the study is completed.

What are the possible benefits and risks of participants?
Benefits: Participants in the MBSR program are likely to benefit by learning to use mindfulness techniques to more effectively manage stress.
Risks: Some participants in the MBSR might experience discomfort including pain, numbness, cramping in the legs, and drowsiness.

Where is the study run from?
School of Nursing and Midwifery, Faculty of Health and Medicine, the University of Newcastle, Australia

When is the study starting and how long is it expected to run for?
From August 2013 to July 2014.

Who is funding the study?
The study is being conducted as PhD research within the School of Nursing and Midwifery, Faculty of Health and Medicine, The University of Newcastle, Australia.

Who is the main contact?
Professor Michael Hazelton
Michael.Hazelton@newcastle.edu.au

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Hazelton

ORCID ID

Contact details

School of Nursing and Midwifery
Faculty of Health and Medicine
The University of Newcastle
University Drive
Callaghan
2308
Australia
+61 2 4921 5695
Michael.Hazelton@newcastle.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of mindfulness-based stress reduction (MBSR) on stress, depression, self-esteem and mindfulness in Thai nursing students: A randomised controlled trial

Acronym

Study hypothesis

An eight week program of mindfulness-based stress reduction (MBSR) will reduce stress and depression and increase self-esteem and mindfulness in nursing students in Thailand.

Ethics approval

The study has joint ethics approval from the following ethics committees:
1. Human Research Ethics Committee, The University of Newcastle (Australia), 24/04/2013; Ref. H-2012-0347
2. Ethical Committee on Human Rights Related to Research Involving Human Subjects, University of Phayao (Thailand), 08/08/2013; Ref. 56-02-04-0008

Study design

Randomised double blinded parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Stress and Depression

Intervention

The intervention group received the MBSR program, whereas the control group were able to access existing mental health services on an as-needed basis. The MBSR program comprised of 8 weekly 2.5 hour group sessions and one full day (8 hours) silent practice, held in the 6th week of the program. The weekly sessions included a series of activities designed to develop mindfulness skills and practice. The MBSR intervention was delivered by a research team member trained in this form of psychosocial intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

A series of questionnaires assessing stress, depression, self-esteem, mindfulness were administered at baseline, 8 weeks, 16 weeks and 32 weeks.
1. Stress was measured using the Perceived Stress Scale (PSS); scores ranged from 0 (never) to 4 (very often)
2. Depression was measured using the Centre for Epidemiology Studies-Depression Scale (CES-D); scores ranged from 0 (rarely or none) to 3 (most or all)
3. Self-esteem was measured using the Rosenberg Self-Esteem Scale (RSES), scores ranged from 1 (strongly disagree) to 4 (strongly agree)
4. Mindfulness was measured using the Mindful Attention Awareness Scale (MAAS), scores ranged from 0 (almost always) to 6 (almost never)

Secondary outcome measures

1. The utilisation of health and counselling services were measured using a specially designed Health and Counselling Service Utilisation Questionnaire, at baseline, 8 weeks, 16 weeks and 32 weeks
2. Difference in intervention and control group participantsÂ’ academic grades in the undergraduate nursing program was measured by accessing participants' academic records at the end of the academic period (semester) in which the research was conducted

Overall trial start date

15/08/2013

Overall trial end date

13/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Female and male nursing students, aged 18-20 years and studying in the first and the second years of the Bachelor of Nursing at the University of Phayao, Thailand

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

127 participants

Participant exclusion criteria

Nursing students in the third and fourth years of the Bachelor of Nursing at the University of Phayao, Thailand

Recruitment start date

15/08/2013

Recruitment end date

13/07/2014

Locations

Countries of recruitment

Thailand

Trial participating centre

School of Nursing and Midwifery
Callaghan
2308
Australia

Sponsor information

Organisation

The University of Newcastle (Australia)

Sponsor details

c/o Professor Michael Hazelton
School of Nursing and Midwifery
Faculty of Health and Medicine
University Drive
Callaghan
2308
Australia
+61 2 4921 5695

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

The University of Newcastle Australia (Australia) - School of Nursing and Midwifery, the Faculty of Health and Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes