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.: PACTR201903612339479 Date of Approval: 28/03/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF BEHAVIORAL THERAPY ON DEPRESSION IN ADOLESCENTS WITH SICKLE CELL DISEASE IN LAGOS STATE UNIVERSITY TEACHING HOSPITAL IKEJA.
Official scientific title EFFECT OF BEHAVIORAL THERAPY ON DEPRESSION IN ADOLESCENTS WITH SICKLE CELL DISEASE IN LAGOS STATE UNIVERSITY TEACHING HOSPITAL IKEJA
Brief summary describing the background and objectives of the trial Sickle Cell Disease (SCD) are a global health problem with a global high disease burden and common among those from Sub-Saharan Africa, Mediterranean countries and Saudi Arabia with more than half of the cases in Africa. As a chronic condition, some persons with SCD can suffer several life threatening physical complications and at risk of psycho-social difficulties.Depression has been identified as one of the commonest problems in SCD with a reported high prevalence. In Africa which bears the largest burden of SCD , there is lack of expertise for psychological therapies, availability and affordability is a major problem. Behavioral Activation Therapy (BAT) which is a form of behavioral therapy is less complex than other forms of therapy. This research will focus on the following objective;To determine the effect of a behavioral based therapy program (5 sessions over 5 weeks) in reducing depression scores and improving health related quality of life among adolescents in treatment group compared with a control group. It is hypothesized that there is no difference in depression scores and health related quality of life between treatment and control group post intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EffBATD
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 02/01/2017
Actual trial start date 16/01/2017
Anticipated date of last follow up 02/06/2017
Actual Last follow-up date 25/06/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL none
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
Crossover: all participants receive all interventions in different sequence during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Behavioral Activation Therapy 5 sessions over 5 weeks, interventions were done once a week (saturdays) 5 weeks weekly sessions with each session period of one hour, participants were seen in groups of 5 30
Control Group behavioral activation therapy once weekly 5 weeks behavioral activation therapy done after intervention group 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adolescents with sickle cell disease of both sex Adolescents with sickle cell disease who have mild to moderate depression using BDI scores >18 Adolescents between ages 12-17 Provision of informed and assent consent Adolescentss with sickle cell disease above age 17 Adolescents who are on antidepresants Adolescents with severe depression scores using BDI scores >29 Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 12 Year(s) 17 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 13/12/2016 Lagos State University Teaching Hospital Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi Road Ikeja Ikeja 100001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Depression scores using BDI-II Pre intervention and 5 weeks at end of intervention
Secondary Outcome Quality of Life scores using Paediatric quality of life scores Pre intervention and 5 weeks at end of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LAGOS STATE UNIVERSITY TEACHING HOSPITAL IKEJA LAGOS 1-5 OBA AKINJOBI WAY, G.R.A IKEJA LAGOS LAGOS 100001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
TAIWO TOLULOPE 1-5 0BA AKINJOBI WAY G.R.A IKEJA 100001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Lagos State University Teaching Hospital Ikeja 1-5 Oba Akinjobi way G.R.A Ikeja Ikeja 100001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
BOLANLE OLA 1-5 OBA AKINJOBI WAY IKEJA 100001 Nigeria
OLAYINKA ATILOLA 1-5 OBA AKINJOBI WAY G.R.A IKEJA 100001 Nigeria
CORNELIUS ANI 7th Floor Commonwealth Building Du Cane Road LONDON United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator TOLULOPE TAIWO teecubed20022002@yahoo.com +2348128817202 Dept of Psychiatry, Lagos State University Teaching Hospital, Ikeja
City Postal code Country Position/Affiliation
Ikeja 100001 Nigeria Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries Bolanle Ola wobola@yahoo.com +234703429007 Lagos State University Teaching Hospital, Ikeja
City Postal code Country Position/Affiliation
Ikeja 100001 Nigeria Associate Proffessor
Role Name Email Phone Street address
Public Enquiries Olayinka Atilola draromedics@yahoo.com +2348063867269 Dept of Psychiatry, Lagos State University Teaching Hospital, Ikeja
City Postal code Country Position/Affiliation
ikeja 100001 Nigeria consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be shared upon publication of results in open access peer review journals Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months after completion of the trial. Data sharing will be available on request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
nil 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