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.: PACTR202001710494962 Date of Approval: 29/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Cognitive Behavioural Therapy for Insomnia on Sleep Problems and Mental Health Among In-school Adolescents in Bayelsa State
Official scientific title Effectiveness of Cognitive Behavioural Therapy for Insomnia on Sleep Problems and Mental Health Among In-school Adolescents in Bayelsa State
Brief summary describing the background and objectives of the trial Adolescents ages 12 – 17 have been identified by various studies as the most sleep deprived population across all lifespan. The presence of an underlying sleep problem in almost every psychiatric disorder makes it of high priority to tackle sleep problems especially insomnia in adolescents. The purpose of this study is to assess the prevalence and correlates of insomnia among in-school adolescents in Bayelsa State Nigeria and to determine the effectiveness of cognitive behavioural therapy for insomnia on sleep problems and mental health outcomes.
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 Education /Training
Anticipated trial start date 13/01/2020
Actual trial start date 05/02/2020
Anticipated date of last follow up 03/04/2020
Actual Last follow-up date 26/03/2020
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 37
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
BSHRECVol.11910 Bayelsa State Health 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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cognitive behavioural therapy for insomnia A 45 - 60 minutes of group CBT-I one day a week 5 weeks The sleep intervention programme will consist of five sessions offered one day of each week for five weeks in the intervention schools. Each session will last 45-60 minutes. The mode of delivery will be through interactive lectures, role plays, video demonstrations and small group discussions. The first session will be a general introductory session. The participants will take turns introducing themselves to the group. This will be followed by setting ground rules and a discussion on the benefits of sleep. The second session will be spent exploring physiology of sleep. The objective of this session covers how sleep occurs, the roles of melatonin and adenosine, the impact of light on melatonin secretion, and the implication for sleep routine. The third session will focus on sleep hygiene education; the importance of building a lifestyle that fosters good sleep and how to have a routine sleep schedule. By the fourth session participants will be taught a relaxation technique. The focus will be on deep breathing exercises, muscle relaxation and creative imagery. The fifth session will be a revision of all the sessions and techniques taught in the course of the programme. It will also touch on relapse prevention and then a formal closing of the intervention. All sessions will begin with a recap of the topic learned the previous week. Participants will also be allowed to share their personal experiences and how they practiced their skills individually or collectively as a group. At the end of each session, there will also be a recap of what has been learnt. 25
Control Group Waiting list control groups Nil 5 weeks The waiting list controls would have no intervention during the 5 week period the intervention groups would receive group Cognitive Behavioural Therapy for Insomnia 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Students between the ages thirteen to seventeen (13– 17) years; 2. Students whose parents provide consent and 3. Students who provide assent will be included in the study. 1. Students identified as having learning difficulties by their teachers. 2. Students who have been treated for a psychiatric disorder in the past as ascertained from the socio-demographic questionnaire. 3. Students who are currently on any regular medication as ascertained from the socio-demographic questionnaire. Adolescent: 13 Year-18 Year 13 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 17/12/2019 Bayelsa State Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
State Secretariate complex Yenagoa 600000 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction of the insomnia severity scores 1 week after the intervention
Secondary Outcome 1. Improved bedtime routine as shown by a reduction in behavioural factors associated with insomnia. 2. Improved sleep latency – improved time from time in bed to sleep onset 3. Improved duration of night time sleep. 4. Improved daytime wakefulness. 5. Reduced depression scores. 6. Reduced emotional difficulties score. 7. Improved Family Function scores. 8. Improved knowledge of the benefits of adequate sleep. 1 week after the CBT-I sessions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Central Epie Secondary School Opolo Epie Yenagoa Nigeria
Community Secondary School Swali Swali, Yenagoa Yenagoa Nigeria
New Total Child Academy Bay bridge road, Yenezuegene Yenagoa Nigeria
Ebidou Comprehensive Academy Tinacious road, Tombia Yenagoa Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Diseyei Ruth Egbegi 4b Olayinka Atiku Street Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Diseyei Egbegi Block 6 flat 2 market estate Bayelsa Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Cornelius Ani 7th floor Commonwealth building Du Cane Road London United Kingdom
Diseyei Ruth Egbegi 4b Olayinka Atiku Street Lagos Nigeria
Dr. Tolulope Bella Awusah University College Hospital, Ibadan Ibadan Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Diseyei Egbegi ruthegbegi7@gmail.com +2348038091827 Block 6 Flat 2 Market Estate
City Postal code Country Position/Affiliation
Bayelsa Nigeria MSc Student University of Ibadan
Role Name Email Phone Street address
Public Enquiries Olakunle Omojola uiccamh@gmail.com +2348109854936 University college hospital, Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Programme Officer Centre for Child and Adolescent Mental Health University of Ibadan
Role Name Email Phone Street address
Scientific Enquiries Cornelius Ani c.ani@imperial.ac.uk +442083834161 7th floor commonwealth building, Du cane Road
City Postal code Country Position/Affiliation
London United Kingdom Project Supervisor Imperial College London
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes socio-demographic, WHO-QOL Bref, insomnia severity index, behavioural sleep questionnaire, emotional subscale of the strengths and difficulties questionnaire, short mood and feelings questionnaire, self rated health, family assessment device, knowledge questionnaire and client satisfaction questionnaire Statistical Analysis Plan,Study Protocol August 2020 Controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 08/04/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 08/04/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information