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.: PACTR202011691886690 Date of Approval: 11/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Online Wellness Activities for Kenyan Students
Official scientific title Digital Single-Session Interventions Work Best? A Comparative Effectiveness Randomized Controlled Trial with Kenyan Adolescents
Brief summary describing the background and objectives of the trial Common mental health problems—like symptoms of depression and anxiety—are the leading cause of disability for adolescents, contributing 45% to the overall burden of disease among young people. However, only a small fraction of those in need receive any treatment especially in low-and middle-income countries (LMICs), where access to treatment is especially low. Common barriers to services include high costs of treatment, a lack of trained mental health professionals, transportation and scheduling difficulties, and stigma associated with professional help-seeking. This challenge is commonly referred to as the treatment gap. One promising strategy to reduce the treatment gap involves the development and testing of brief, efficient, digital mental health interventions delivered in a single session. Guided by this logic, we are performing a randomized controlled trial (RCT) comparing two active single-session interventions against each other and against an active control group.Our trial has four aims: 1) test whether Shamiri-Digital can effectively reduce depressive and anxiety symptoms among Kenyan adolescents, 2) evaluate the efficacy of a single-session intervention based on CBT exercises, 3) compare the effects of Shamiri-Digital and Digital-CBT and 4) examine the acceptability and appropriateness of each intervention.
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 01/01/2021
Actual trial start date
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 926
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
U111112603055 World Health Organization
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 Central randomisation by phone/fax 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 Shamiri Digital Once 60 minutes The Shamiri-Digital will be adapted from a previous study with Kenyan youths. The intervention will consist of three modules: growth mindset, gratitude, and value affirmations. The growth mindset activities will teach participants about the brain’s ability to grow in response to difficulties/challenges in various domains (e.g., interpersonal relationships, personality traits and academic performance). Participants will read testimonials about a Kenyan peer who used growth to overcome a challenge. They will then write their own growth stories reflecting on a challenge that they have faced and how they overcame that challenge. In the gratitude exercises, participant will learn about gratitude and the importance of practicing and expressing gratitude. Through a “good things” exercise, participants will list three good things in their lives for which they are grateful. Finally, in the value affirmation exercises, participants will reflect on values that are important to them and brainstorm ways to apply these values in new ways. 309
Experimental Group Digital CBT Once 60 minutes The Digital CBT intervention will be adapted from previous work adapting exercises from cognitive behavioral therapy for digital single-session interventions. The intervention will consist of three modules: cognitive restructuring, problem solving, and behavioral activation. The cognitive restructuring activities will teach participants to identify and reframe negative thoughts. Participants will read testimonials about a Kenyan peer who is experiencing negative thoughts about a stressful situation. Participants will then identify negative beliefs that the student is facing and generate ways that the student could reframe those beliefs. Then, participants will apply the same cognitive restructuring technique to a situation in their own lives19. In the problem solving exercise, participants will learn an evidence-based approach to problem solving involving five steps: 1) identifying and defining a problem, 2) generating a list of possible solutions, 3) evaluating the strengths and weaknesses of the possible solutions, 4) selecting a solution, and 5) applying the solution, and determining whether an additional solution is needed. Participants will be instructed to think of a problem they are currently facing and then apply the aforementioned problem solving method. In the behavioral activation exercise, participants will identify pleasurable activities and mastery activities and reflect on why these activities are important to them. Then, they will complete a “positive activity plan” in which they identify an activity they want to perform more in the upcoming weeks, list when and how they will perform the activity, and brainstorm ways they can overcome potential obstacles. 309
Control Group Study skills control Once 60 minutes Content for the study-skills control will be adapted from a previous study-skills control intervention that has been used in a previous RCT of Shamiri-Digital. The structure of the study-skills activities will mirror the structure of the Shamiri-Digital and Digital-CBT and will require similar effort and time. It has four lessons: note-taking, effective study strategies, time management skills and the study cycle. In the first lesson, students learn effective note taking strategies called the 5Rs of note-taking and do a simple note-taking exercise, in lesson two students learn about effective study strategies, in lesson three students learn time managements skills and do a simple time-management exercise, and finally students learn about the study cycle that ties together all the other lessons that they learnt earlier. 308 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All students aged between 13 and 18 inclusive, will be eligible. No further exclusion criteria will be applied. Adolescent: 13 Year-18 Year 13 Year(s) 18 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 11/06/2020 University of Pennsylvania Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
3800 Spruce St., First Floor Suite 151, Philadelphia, PA 19104, United States of America Philadelphia 19104 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Depressive symptoms as assessed using the Patient Health Questionnaire-8 (PHQ-8). Participant will complete measures at baseline, 2 weeks, 4 weeks, and 12 weeks after study activities
Primary Outcome Anxiety symptoms as assessed using the Generalized Anxiety Disorder Screener (GAD-7). Participant will complete measures at baseline, 2 weeks, 4 weeks, and 12 weeks after study activities
Primary Outcome Subjective well-being as assessed using the Short Warwick-Edinburgh Mental Well-being Scale. Participant will complete measures at baseline, 2 weeks, 4 weeks, and 12 weeks after study activities.
Secondary Outcome Acceptability (i.e., the extent to which a given treatment is agreeable or satisfactory) as assessed using the Acceptability of Intervention Measure (AIM) Participants will complete this after completing the study activities.
Secondary Outcome Primary control (i.e., the extent to which individuals believe they can affect objective conditions in their lives, such as their grades or the actions of other people) as assessed using items from the perceived control scale for children (PCSC). Participant will complete measures at baseline, 2 weeks, 4 weeks, and 12 weeks after study activities.
Secondary Outcome . Secondary control (i.e., the extent to which individuals believe that they can manage the personal and psychological impact of objective events) as assessed using items from the Secondary Control Scale for Children (SCSC Participant will complete measures at baseline, 2 weeks, 4 weeks, and 12 weeks after study activities.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Thika High School Township, Off Kenyatta Road, Thika, Kenya Thika Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Templeton World Charity Foundation Bayside Executive Park, Bldg 2. West Bay Street and Blake Road Nassau N-7776 Bahamas
Shamiri Institute Inc 125 Western Avenue Allston United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tom Osborn 12a Elgeyo Marakwet Road Nairobi Kenya Individual
Primary Sponsor Shamiri Institute Inc 125 Western Avenue Allston United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr. Christine Wasanga P.O. Box 3678 Nairobi 00506 Kenya
Dr. John Weisz 33 Kirkland Street Cambridge United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Akash Wasil wasil@sas.upenn.edu 16317669466 Stephen A. Levin Building / 425 S
City Postal code Country Position/Affiliation
Philadeplphia 19104-601 United States of America Department of Psychology University of Pennsylvania
Role Name Email Phone Street address
Public Enquiries Tom Osborn osborn@shamiri.institute +1254702001307 12a Elgeyo Marakwet Road
City Postal code Country Position/Affiliation
Nairobi Kenya Shamiri Institute
Role Name Email Phone Street address
Scientific Enquiries Tom Osborn wasil@sas.upenn.edu 16317669466 Stephen A. Levin Building / 425 S. University Ave
City Postal code Country Position/Affiliation
Philadephia United States of America Department of Psychology University of Pennsylvannia
Role Name Email Phone Street address
Principal Investigator Robert DeRubeis derubeis@psych.upenn.edu 2155735804 Room 455, Levin Building, 425 S. University Ave.
City Postal code Country Position/Affiliation
Philadelphia United States of America Professor and Director of Clinical Training
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the article that results from this trial, after de-identification (text, tables, figures and appendices). Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 3 years following article publication Access to data will be open. Anyone who wishes to access the data for any purpose will be able to. Data will be made available indefinitely at a link to be posted upon trial completion
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