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.: PACTR202110602061985 Date of Approval: 06/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of Clinical Bibliotherapy on Self esteem, Hope and Depressive Symptoms among Adolescents living with Sickle cell disorder in Ibadan
Official scientific title The Effect of Clinical Bibliotherapy on Self esteem, Hope and Depressive Symptoms among Adolescents living with Sickle cell disorder in Ibadan
Brief summary describing the background and objectives of the trial Persons living with chronic illnesses often have co-morbid mental and behavioural disorders. Studies show that persons who are able to cope well with the illness often have good self-esteem, hope, good social support, and employ active coping skills. Interventions available which incorporate some of these components like Cognitive behavioural disorder and Behavioural activation therapy are not readily accessible in Nigeria because of dwindling numbers of mental health professional. This study seeks to see if a guided online group reading of a memoir can improve the self esteem and hope ratings of adolescents living with sickle cell disorder and consequently reduce depressive symptoms.
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 Psychosocial
Anticipated trial start date 14/09/2021
Actual trial start date 14/09/2021
Anticipated date of last follow up 02/11/2021
Actual Last follow-up date 02/11/2021
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 32
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
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Clinical Bibliotherapy A memoir will be used. 2 chapters will be read and discussed online once a week. 5 weeks A guided group reading of a memoir of a person living with sickle cell disorder will be read and discussed online once a week for 5 weeks and post assessment will be done in the seventh week. 16
Control Group Clinical Bibliotherapy None 5 weeks No intervention will be given to this group until the results of the experimental group shows that it is effective 16 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adolescents and young adults with sickle cell disorder who are between thirteen to twenty five years Adolescents and young adults who can read and who consent to participate in the study. Adolescents and young adults with sickle cell disorder who have intellectual disorder as ascertained from school records. Adolescents and young adults with sickle cell disorder who are currently experiencing acute medical symptoms such as pain Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 13 Year(s) 25 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 31/08/2021 Oyo State Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Department of Planning, Research and Statistics Division, Oyo State Ministry of Health, Oyo state Secretariat, Ibadan Ibadan 5207 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Increase in self esteem and Hope as measured by Rosenberg Self esteem scale and Children's Hope Scale During recruitment and 2 weeks post intervention
Secondary Outcome Reduction in Depressive Symptoms as measured by Short Mood and Feelings Questionnaire During recruitment and 2 weeks post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ring Road State Hospital Ring Road State Hospital, Adeoyo, Ibadan Ibadan Nigeria
Ibadan Sickle Cell Foundation Ibadan Sickle Cell Foundation, Henry Tee Junction, Ring road, Ibadan Ibadan Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Falola Oluwabukola No 26, Joseph Falola Street, Olose Community, Apata, Ibadan Ibadan Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Falola Oluwabukola No 26, Joseph Falola Street, Olose Community, Apata, Ibadan Ibadan Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oluwabukola Falola oluwabukolaagnesfalola@gmail.com +2348155083783 No 26, Joseph Falola Street, Olose Community, Apata, Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Student of University of Ibadan
Role Name Email Phone Street address
Scientific Enquiries Cornelius Ani c.ani@imperial.ac.uk 07752161522 2nd Floor, Commonwealth Building, Imperial College, London
City Postal code Country Position/Affiliation
London United Kingdom Honorary Clinical Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Kunle Omojola uiccamh@gmail.com +2348109854936 Center for Child and Adolescent Mental Health, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Admin Officer for Center for Child and Adolescent Mental Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (texts, tables, figures, and appendices) Analytic Code,Statistical Analysis Plan,Study Protocol Beginning three months and ending 5 years following article publication Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information