Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201803003177455 Date of Approval: 09/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Randomized Controlled Trial of Rational Emotive Behavior Therapy Program on Depressive Symptoms among University Students with Blindness in Nigeria
Official scientific title Effect of Rational Emotive Behavior Therapy Program on Depressive Symptoms among University Students with Blindness in Nigeria
Brief summary describing the background and objectives of the trial Depression is a major public health challenge among students in universities. Research outcomes show that blindness is a significant risk factor for depressive episodes.Beside attendant difficulties faced by university students with blindness, their situations are further heightened by economic stress, academic pressure (Steptoe, Tsuda, & Tanaka, 2007), difficulty adjusting to the school environment and planning for their future (Buchanan, 2012). Previous studies show that blind students experience denial, isolation, low self-esteem, anxiety, non acceptance by peers, pain, regret and bitterness due to loss of vision (e.g. Bhagotra, Sharma, & Raina, 2008). All these have adverse psychological effect that can lead to depression among students with blindness. Teaching university students with blindness a variety of rational emotive skills that would enable them to manage depression and depressive symptoms could be an important avenue to make them feel less depressed and become more energetic to successfully cope with their academic life. The objective of this study is to examine the efficacy of rational emotive behavior therapy (REBT) intervention on depressive symptoms among university students with blindness in Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Depression,Eye Diseases,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 15/02/2017
Actual trial start date 03/04/2017
Anticipated date of last follow up 20/10/2017
Actual Last follow-up date 21/10/2017
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 65
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
REC/EDF/17/00005 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 Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group REBT Group Twice per week 12weeks REBT Depression Manual 33
Control Group No intervention group 12weeks 32 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Having a depression score of at least 20 on the BDI-II. Being skilled in Braille reading and writing. Having no other forms of physical comorbidities. Willingness and readiness to be available during the period of the study. Having no history of previous/current intervention that aimed to reduce depressive symptoms. Students who did not meet the inclusionary criteria were excluded 24 Year(s) 26 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 15/03/2017 Departmental Research Ethics Committee, Department of Educational Foundations, University of Nigeria Nsukka
Ethics Committee Address
Street address City Postal code Country
Harden Building, University of Nigeria Nsukka Nsukka 410001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Beck Depression Inventory-II (BDI-II). Time 1 (Pretest) Time 2 (Post-treatment) Time 3 (Follow-up)
Secondary Outcome Demographic Questionnaire Time 1(Pretest)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Universities in South-East Nigeria South-East South East Nigeria
University of Nigeria Nsukka Room 213 Department of Educational Foundations 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
Primary Sponsor Liziana N. Onuigbo , Chiedu Eseadi, Samuel Ebifa, Uchenna Cosmas Ugwu, Charity N, Onyishi, Eke Kalu Oyeoku Education Extension, University of Nigeria Nsukka Nsukka 410001 Nigeria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Otusum Consult, Training & Services Abak Rd Uyo 520261 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Liziana Onuigbo liziana.onuigbo@unn.edu.ng 08066956428 Education Extension Block B, University of Nigeria Nsukka
City Postal code Country Position/Affiliation
Nsukka 410001 Nigeria Academic Staff, University of Nigeria Nsukka
Role Name Email Phone Street address
Public Enquiries Samuel Ebifa esemclassic@gmail.com 0803848028 PG Odili Hostel, University of Nigeria Nsukka
City Postal code Country Position/Affiliation
Nsukka 410001 Nigeria University of Nigeria Nsukka
Role Name Email Phone Street address
Scientific Enquiries Chiedu Eseadi chiedu.eseadi@unn.edu.ng 08137258914 DEPARTMENT OF EDUCATIONAL FOUNDATIONS, UNIVERSITY OF NIGERIA, NSUKKA
City Postal code Country Position/Affiliation
Enugu 410001 Nigeria Academic Staff, University of Nigeria Nsukka
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information