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.: PACTR202311762941157 Date of Approval: 06/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cognitive-Behavioral Therapy in Enhancing Quality of Sleep and Cognitive Functions in Elderly People in Machakos County, Kenya
Official scientific title Cognitive Behavioral Therapy in Enhancing Quality of Sleep and Cognitive Functions in Elderly People in Machakos County, Kenya
Brief summary describing the background and objectives of the trial Sleep duration and quality are equally important for optimal quality of life. Indeed, waking and sleeping are not at all independent from each other, and they cannot be separated. Sleep plays a fundamental role in the recovery process from fatigue, memory, and even other functions that can also be dependent on it, like repairing and restoring our brains and hormonal balances. The sleep structure depends on the age of the sleeper, and some large variations can appear in the progressive modifications that develop with the aging process. Research Objectives are: To evaluate the efficacy of CBT in enhancing sleep quality among elderly people. To evaluate the efficacy of CBT in improving cognitive function To evaluate the intermediary of CBT between sleep and cognitive functions.
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 02/10/2023
Actual trial start date 02/10/2023
Anticipated date of last follow up 01/01/2024
Actual Last follow-up date 01/03/2024
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 44
Recruitment status Completed
Publication URL N/A
Secondary Ids Issuing authority/Trial register
B0301092023 Institutional Scientific Ethics Review of the University of East Africa Baraton
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cognitive Behavioral Therapy 30 to 60 minutes once in a week for 12 weeks 12 weeks Train people with sleep disorders on cognitive interventions, behavioral interventions, psychological interventions, sleep hygiene, and breathing methods to manage sleep disorders. The detailed interventions are elaboratively provided in the teaching brochures. 35
Control Group Sleep Hygiene Education 30 to 60 minutes once every week for 12 weeks 12weeks Sleep hygiene education involves enhancing the sleeping routine and associating the bedroom with sleep. The research provides education on sleep environment, timing of sleep, relaxation rituals, regular schedules, and activities before and during sleep. 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Elderly people 65 years of age and older who can give and sign study-related informed consent forms Have sleep disorders. Available for the period of the study by being residents of Machakos County. Above 85 years old. Old people whose cognitive functions are severely impaired beyond comprehension of the study instructions Who needs specialized care that will affect follow-up? Aged: 65+ Year(s) 65 Year(s) 85 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 01/09/2023 University of Eastern Africa Baraton
Ethics Committee Address
Street address City Postal code Country
Baraton Eldoret 30100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cognitive function, Depression, anxiety At 0 weeks and 12 weeks
Secondary Outcome None NA
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Machakos Level Five Hospital Machakos Machakos 90100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Emmanuel Maveere Maonga Machakos Machakos 90100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Emmanuel Maonga Machakos Machakos 90100 Kenya Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel Maonga maongae1@gmail.com +254716409709 Machakos
City Postal code Country Position/Affiliation
Machakos 90100 Kenya Principal Investigator
Role Name Email Phone Street address
Public Enquiries Emmanuel Maonga maongae1@gmail.com +254716409709 Machakos
City Postal code Country Position/Affiliation
Machakos 90100 Kenya principal investigator
Role Name Email Phone Street address
Scientific Enquiries Zeng Hui zenghui@csu.edu.cn +8613786155688 Tongzipo Road
City Postal code Country Position/Affiliation
Changsha 410083 China Prof and Head of Gerontological Nursing at Xiangya School of Nursing Central South University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Immediately after the conclusion of this study, the results will be shared with the public after the de-identification of individual trial participants. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The results will be shared after the completion of data collection and publication for up to 5 years. The access to the results will be open to those who want to access them.
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