Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202209591337370 Date of Approval: 02/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intervention for depression among undergraduate religious education students: a randomized controlled trial
Official scientific title Intervention for depression among undergraduate religious education students: a randomized controlled trial
Brief summary describing the background and objectives of the trial Depression is a common mental health concern among Nigerian university students. Several studies have looked at how psychological interventions can help to manage depression among Nigerian students in other fields of learning, but not among undergraduate religious education students. Therefore, the aim of this randomized controlled trial (RCT) was to investigate the management of depression among undergraduate religious education students by employing religious rational emotive behaviour therapy (RREBT) and to identify the research implications for school-based religious intervention in Nigeria. The study hypothesis is that, compared to the students in the control condition, the management of depression using RREBT will be significantly realistic among undergraduate religious education students in the treatment condition.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/02/2019
Actual trial start date 01/03/2019
Anticipated date of last follow up 13/09/2019
Actual Last follow-up date 31/05/2019
Anticipated target sample size (number of participants) 350
Actual target sample size (number of participants) 67
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Waitlisted 0 12 weeks + 2weeks The students in the control condition were waitlisted to commence their treatment sessions a week after the study follow-up evaluation. 33 Dose Comparison
Experimental Group RREBT once per week 12 weeks + 2weeks follow-up The RREBT is a faith-based mental health intervention created following the principles and practice of REBT, a therapy, started by Ellis. In RREBT it is assumed that emotionally healthy behaviour can be actualized by harnessing an individual's absolutistic religious philosophies. Therefore, the incorporation of scriptural contents and other religious resources relevant to an individual’s religious traditions and orientations into the treatment process for resolving the emotional and/or behavioural problems of the individual is a common feature of RREBT. The treatment process involved a 12-week application of religious rational emotive behaviour therapy (RREBT). The RREBT techniques in addition to general REBT techniques for treatment of depression were used in the current intervention to render therapeutic assistance to undergraduate religious education students. One session held per week lasted for two hours. 34
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Undergraduate religious education students with moderate to severe depression were considered eligible for the study. Other eligibility criteria were being a first-year undergraduate religious education student, submission of a consent form, non-involvement in other depression treatment programs. Students were excluded if they failed to meet the inclusion criteria set out Adult: 19 Year-44 Year 18 Year(s) 20 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 29/01/2019 Faculty of Education Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room 209, Harden Building, Faculty of Education, University of Nigeria Nsukka. P.M.B. 410001, Enugu State, Nigeria. Nsukka 41001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Depression 1,2, 3
Secondary Outcome Student demographic variable 1
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Room 2 Ed. Ext. Nsukka 410001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Investigators Ed Ext. University of Nigeriia Nsukka 410001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Otusum Consult Shop A Bethany Plaza Nsukka Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chiedu Eseadi chiedu.eseadi@unn.edu.ng +23490699979311 Ed Ext Faculty of Educ. University of Nigeria
City Postal code Country Position/Affiliation
Nsukka Nigeria University of Nigeria
Role Name Email Phone Street address
Public Enquiries Amos Amedu amos.amedu@unn.edu.ng +2348068113635 Ed Ext. Faculty of Education, University of Nigeria
City Postal code Country Position/Affiliation
Nsukka Nigeria University of Nigeria
Role Name Email Phone Street address
Scientific Enquiries Vera Victor Aigbodion vera.victor@unn.edu.ng +2348034124850 Ed Ext., Faculty of Education University of Nigeria
City Postal code Country Position/Affiliation
Nsukka Nigeria University of Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The students' mean age in the treatment condition was 18.35±.08 years while the mean age for students in the control condition was 19.06±2.15 years. Information with respect to gender of participants showed that in RREBT group, 28.4% were males while 22.4% were females. Also, in the control group, 32.3% were males while 14.9% were females. Furthermore, based on ethnicity, in RREBT 35.8% were Igbo, 1.5% were Yoruba, and 13.4% were other ethnic groups. Likewise, in the control group, 38.8% were Igbo, 3.0% were Yoruba while 6.0% were other ethnic groups. Clinical Study Report 12months Interested users can request for data from the principal investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 02/09/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 02/09/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information