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.: PACTR202201684613316 Date of Approval: 10/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Tele-Psychotherapy for Youth using Mobile Phones during Covid-19 Pandemic
Official scientific title The Effect of Tele-Support Psychotherapy Delivered by Trained Lay Health Workers for Depression Treatment among Youth in Kampala District during the Covid-19 pandemic
Brief summary describing the background and objectives of the trial Common mental health problems such as depression and anxiety affect one in four people worldwide. Fortunately, the majority is of mild to moderate severity which makes them amenable to first-line psychological treatments and many people do recover. The COVID-19 pandemic has resulted in lockdowns which have resulted in loss of income to procure basic needs. Financial losses, loneliness, excessive drug and alcohol use to cope with increased stress are bound to increase the likelihood of depression, anxiety and post-traumatic stress. It is against this background that we propose to develop a tele-psychotherapy service in Kampala district. In this study, we aim to conduct online and community-based participatory qualitative research to obtain information on the potential usefulness of individual tele-support psychotherapy in addressing depression and other psychosocial challenges that youth are facing during the Covid-19 pandemic. Thereafter, we aim to conduct a pilot randomized trial to provide evidence for preliminary effectiveness of a tele-support psychotherapy platform for depression among youth in Kampala district. We will compare the effectiveness of individual tele-support psychotherapy (TSP) delivered by trained lay counsellors in combination with standard mental health services (SMHS) for depression with use of SMHS alone. The proposed tele-psychotherapy platform will allow the youth with mobile phones access first-line psychotherapy through voice call, video and messaging platforms. This will allow for remote, fast, convenient, private and affordable assistance to learn practical skills that can resolve mental distress or learn coping skills for stressors that cannot be modified.
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 01/02/2022
Actual trial start date
Anticipated date of last follow up 30/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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 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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tele Support Psychotherapy 1 Session per week for eight weeks 8 Weeks Session 1 is to enable the client and counselor get to know each other and to initiate and promote the healing process. Session 2 is to increase knowledge of the client about how common mental health problems such as depression are related to the Covid-19 pandemic. Session 3 & 4 is to help the client continue to express their personal painful experiences. Session 5 is to teach positive coping skills that client can use to deal with difficult situations. Session 6 is to help clients learn how to cope with stigma and discrimination at personal, family, and community level. Session 7 is to help group members acquire basic livelihood skills that will enable them to identify income generating activities that will improve their livelihoods thus enabling them to take control of their lives and Session 8 is to help the client present their income generating activity and receive feedback. 150
Control Group Standard Mental Health Services 8 Weeks Young people identified with significant mental health symptoms will be referred to a counselor at the nearest health facility offering mental health services. Mental health problems identified will be managed accordingly using the usual standard mental health treatments. For our study setting, these will be Makerere University, Naguru, and Mulago hospitals. 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be eligible for the study, each participant must be 15-30 years old, diagnosed with significant depression symptoms assessed with the self reporting questionnaire, residing in Naguru Go-down and Kamwokya slums, or Makerere University campus. Participants will be excluded if they have severe untreated major mental illness (untreated psychosis or mania or high suicide risk) that would interfere with participation in psychotherapy. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 30 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 25/01/2022 Makerere University School of Health Science Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Makerere University School of Health Sciences Kampala 0256 Uganda
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 21/04/2022 Uganda National Council of Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda, P.O.BOX 6884, Kampala Kampala 0256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Indicators of Feasibility Indicators of Acceptability Depression Symptoms Anxiety Symptoms Baseline, 6 months and 12 months
Secondary Outcome Fidelity Contextual Influences Suicide Risk Social Support Stigma Cost-effectiveness Self-esteem Copying Skills Baseline, 6 months and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Naguru Go down Naguru li village road Kampala 0256 Uganda
Kamwokya Kamwokya Road Kampala 0256 Uganda
Makerere University Sir Apollo Kagwa Road Kampala 0256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
USAID 1300 Pennsylvania Avenue, NW, UA Washington DC Washington DC 1300 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor USAID 1300 Pennsylvania Avenue Washington DC 1300 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
The Medical Concierge Group TMCG Lugogo By-Pass Kampala 0256 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Etheldreda Nakimuli Mpungu ethelmpungu@yahoo.com +256788994050 Makerere University College of Health Sciences Department of Psychiatry
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries John Mark Bwanika johnmark@tmcg.co.ug +256782764739 Lugogo By-pass
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Researcher
Role Name Email Phone Street address
Public Enquiries Stella Imot healthsciences.irb@gmail.com +256774313924 Makerere University College of Health Sciences School of Medicine
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Member of Makerere University School of Health Sciences Research and Ethics Committee
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Demographics and clinical and psycho-social variables Focus Group Discussion scripts Data Sharing Statements We will make available individual participant data (including data dictionaries). For each published article, the individual participant data that underlies the results reported including text, tables, figures, and appendices) will be shared. Further, the study protocol, statistical Analysis Plan and analytic Code will be made available in open access peer reviewed journals. This data can be accessed by investigators whose proposed use of the data has been approved by an independent review committee beginning 12 months and ending 36 months following article publication. Proposals should be directed to etheldreda.nakimuli@mak.ac.ug To gain access, data requestors will need to sign a data sharing agreement. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years The de-identified data set and a data dictionary will be made available with publication of the trial after obtaining relevant Institutional Research Ethics Board approval of a proposal and signed data access agreement.
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