Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201806003335323 Date of Approval: 20/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Rational Emotive Behavior Coaching on School-related Stress and Burnout Among Medical Students
Official scientific title Effect of Rational Emotive Behavior Coaching on School-related Stress and Burnout Among Medical Students
Brief summary describing the background and objectives of the trial Chronic stress affects students¿ health (Hamaideh, 2011). Burnout is a psychological reaction to chronic stress (Halbesleben & Buckley, 2004). Meanwhile, Chaló et al. (2017) observed that stress-related disorders are significant in university student population, and most campus health services have insufficient resources to tackle them. According to Hamaideh (2011), university students are affected by stressors because university life is transitional in nature. Chronic stress may undermine an individual¿s psychological, behavioral, and biological health outcomes (Schneiderman, Ironson & Siegel, 2005). Burnout affects the student population in several ways. Burnout can negatively affect students¿ effectiveness by reducing their desire to learn and perception of their academic efficacy (Nowack & Hanson, 2003). Burnout may cause depersonalization, misguided academic work expectations and emotional exhaustion in students (Man, Men, Sin, & Urn, 2015). Student burnout is still increasing following their high aspiration and cognitive investment of efforts towards learning (Newmann, Wehlage, & Lamborn, 1992; Ugwu, Onyishi, & Tyoyima, 2013). However, the development and application of evidence-based interventions to surmount burnout may be significantly useful to clinicians who wish to support public health policy decisions and improve people¿s health and wellbeing (Kourmousi et al, 2015). Such interventions are urgently needed given that burnout may result in dysfunctional feelings, health difficulties, withdrawal, and reduced performance (Byrne, 1999). Studies suggest that psychological interventions like the rational emotive behavior coaching (REBC) may be useful for managing student burnout. Therefore, the objective of this investigation is to examine the effectiveness of an REBC program on burnout among undergraduate students in south-east, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Chronic Stress, Burnout,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 15/01/2018
Actual trial start date 22/01/2018
Anticipated date of last follow up 24/05/2018
Actual Last follow-up date 24/05/2018
Anticipated target sample size (number of participants) 456
Actual target sample size (number of participants) 52
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
REC/EDF/18/00002 Departmental Research Ethics Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group REBC Group Twice per week 12weeks REBT program manual 26
Control Group No-intervention control group Twice per week 12weeks No-intervention 26 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria were that a participant must be an undergraduate student in a public university in South-east Nigeria, and must indicate burnout syndrome at the baseline assessment. Other criteria included that the participant must complete informed consent form and must be willing to focus on the program till the end without accepting any intervention program on student burnout during the program period. Not meeting inclusion criteria 18 Year(s) 30 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/01/2018 Departmental Research Ethics Committee, Department of Educational Foundations, University of Nigeria Nsukka
Ethics Committee Address
Street address City Postal code Country
Room 213, Harden Building, Department of Educational Foundations, University of Nigeria Nsukka Nsukka 410001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Oldenburg Burnout Inventory ¿ Student Version Time 1 Time 2 Time 3
Primary Outcome Perceived Stress Scale Time 1
Secondary Outcome Demographic questionnaire Time 1
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Counselling Unit, Nnamdi Azikiwe University Library, University of Nigeria Nsukka, South-East Nigeria Main Library, Opposite Students' Shuttle Park, UNN, Nsukka Nsukka 410001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal Funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Otusum Consult Training & Services Abak Rd uyo 520261 Nigeria Commercial Sector/Industry
Secondary Sponsor Otusum Consult Training & Services Abak Rd uyo 520261 Nigeria Commercial Sector/Industry
Secondary Sponsor Otusum Consult Training & Services Abak Rd uyo 520261 Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Ezenwaji Ifeyniwa Room 213, Harden Building, Department of Educational Foundations, University of Nigeria Nsukka Nsukka 410001 Nigeria
Eseadi Chiedu Room 213, Harden Building, Department of Educational Foundations, University of Nigeria Nsukka Nsukka 410001 Nigeria
Uchenna Cosma Ugwu Department of Human Kinetics and Health Education, University of Nigeria Nsukka Nsukka 410001 Nigeria
Kennedy Ololo Department of Sociology/Psychology/Criminology & Security Studies, Federal University Ndufu Alike Ikwo,Ebonyi State, Nigeria. Alike Ikwo 1010 Nigeria
Angie Oboegbulem Room 213, Harden Building, Department of Educational Foundations, University of Nigeria Nsukka Nsukka 410001 Nigeria
Charity Okide Department of Adult Education and Extra-Mural Studies, University of Nigeria Nsukka 410001 Nigeria
Bernedeth Ezegbe Department of Social Sciences Education Nsukka 410001 Nigeria
Anthonia Nwobi Department of Adult Education and Extra-Mural Studies, University of Nigeria Nsukka Nsukka 410001 Nigeria
Justina Ifeoma Ofuebe Department of Human Kinetics and Health Education, University of Nigeria Nsukka Nsukka 410001 Nigeria
Chinwe Okpoko Department of Human Kinetics and Health Education, University of Nigeria Nsukka Nsukka 410001 Nigeria
Dorothy Ifeyinwa Ugwu Department of Human Kinetics and Health Education, University of Nigeria Nsukka Nsukka 410001 Nigeria
Nkiru Christiana Ohia Institute of African Studies, University of Nigeria Nsukka Nsukka 410001 Nigeria
Samuel Ugwoke Room 213, Harden Building, Department of Educational Foundations, University of Nigeria Nsukka Nsukka 410001 Nigeria
Eucharia Nchedo Aye Room 213, Harden Building, Department of Educational Foundations, University of Nigeria Nsukka Nsukka 410001 Nigeria
Immaculata Akaneme Room 213, Harden Building, Department of Educational Foundations, University of Nigeria Nsukka Nsukka 410001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ezenwaji Ifeyinwa ifeyinwa.ezenwaji@unn.edu.ng 08033539703 Room 213, Harden Building, Department of Educational Foundations, University of Nigeria Nsukka
City Postal code Country Position/Affiliation
Nsukka 410001 Nigeria Academic Staff
Role Name Email Phone Street address
Public Enquiries Uchenna Cosmas Ugwu uchennacos.ugwu@unn.edu.ng 08037786068 Department of Human Kinetics and Health Education, University of Nigeria Nsukka,
City Postal code Country Position/Affiliation
Nsukka 410001 Nigeria Academic Staff
Role Name Email Phone Street address
Scientific Enquiries Chiedu Eseadi chiedu.eseadi@unn.edu.ng 08137258914 Room 213, Harden Building, Department of Educational Foundations, University of Nigeria Nsukka
City Postal code Country Position/Affiliation
Nsukka 410001 Nigeria Academic Staff
REPORTING
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