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.: PACTR202206574814636 Date of Approval: 19/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title DoBAt Pilot Trial
Official scientific title Digital delivery of Behavioural Activation Therapy to overcome depression and facilitate socioeconomic transitions of adolescents in South Africa
Brief summary describing the background and objectives of the trial Adolescent depression is a key public health concern, with high prevalence rates reported amongst rural and low resource communities in South Africa. Depression impacts young people’s ability to make decisions and manage stressful situations in life. It has also been linked to poor social, economic and health outcomes including early pregnancy, HIV, lower educational attainment and poverty in adulthood. Evidence is urgently needed for cost-effective and scalable interventions targeting adolescent depression. Behavioural activation (BA) is a psychological therapy which has been shown to be effective in treating adolescent depression, and can be adapted to diverse sociocultural contexts. In addition to improving depressive symptoms, studies suggest that BA targets cognitive functions involved in depression, including executive function and social cognition. These functions develop substantially during adolescence and are associated with a range of future socioeconomic outcomes. Further, BA has been successfully delivered online and through trained peer mentors with limited specialist intervention, offering a scalable solution to overcome the lack of access to psychological therapies. The proposed trial will be a pilot randomised controlled trial to evaluate digital delivery of Behavioural Activation therapy for adolescents with depression in rural South Africa (DoBAt Pilot Trial). Central to the study is an iterative process to co-design the DoBAt therapy app through extensive formative work with adolescents from the study site. We will assess the feasibility, acceptability and determine the preliminary effectiveness of the intervention (primary objective). As a secondary objective, we will locally adapt and pilot outcome measures of mental health, cognition, risky behaviours, socioeconomic measures, and collect descriptive data to inform the development of a further larger trial.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DoBAt Pilot Trial
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 01/04/2021
Actual trial start date 17/01/2022
Anticipated date of last follow up 31/01/2023
Actual Last follow-up date 31/01/2023
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 195
Recruitment status Completed
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 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
Control Group Control Intervention 6 sessions of an attention control will be self-administered over 10 weeks. Each episode will take approximately 20 minutes to complete. The control intervention will not be supported by weekly phone calls from a trained Peer Mentor. The control intervention will be delivered over 10 weeks. The control intervention consists of 6 sessions of an attention control in the form of a digital cellphone application (app) containing video excerpts from nature documentaries, that will be self-administered over 10 weeks. Each episode will last for approximately 20 minutes. The control intervention will not be supported by weekly phone calls from a trained Peer Mentor. 100 Active-Treatment of Control Group
Experimental Group DoBAt Intervention 6 sessions of Behavioural Activation therapy delivered by a digital application (app) and self-administered over 10 weeks. Each session/ episode will take approximately 20 minutes. In addition the app will be supported by 20 minute weekly phone calls from a trained Peer Mentor. The intervention will be self-administered over 10 weeks. The DoBAt Intervention consists of 6 sessions of Behavioural Activation therapy integrated into a narrative game design and delivered by a digital application (app) on a cell phone. At the end of each session the adolescent is encouraged to complete "Bonus Tasks" to integrate the principles of Behavioral Activation into their daily lives. Each session/ episode will take approximately 20 minutes and is self-administered over 10 weeks. In addition the app will be supported by 20 minute weekly phone calls from a trained Peer Mentor. 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
● Adolescent males or females aged between 15 and 19 years in grades 9 to 11 at the beginning of the study ● Mild to moderately severe depression indicated by a score between 5 and 19 on the PHQ-A. Those with mild depression (PHQA score 5-9) will only be included if both screening and baseline PHQA scores are more than/ equal to 5 ● Able to read sufficiently in Xitsonga to use the app ● Participant (and their parent/ guardian if <18) is willing and able to give informed consent and/or assent for participation in the trial ● Participant is intending to continue to live in the study area for 12 weeks after baseline ● Hospitalisation for at least five days for severe psychiatric illness (specifically bipolar disorder, schizophrenia and other psychoses), or a life-threatening or other serious physical illness ● History of bipolar disorder, schizophrenia and other psychoses ● Severe depression as indicated by score >19 on the PHQ-A and assessed by Trial Psychologist as too severe to participate ● Current suicidal ideation/thoughts with specific plans and means identified ● Currently receiving a psychological treatment for a mental health problem(s) ● Lacks capacity to consent to treatment or research participation ● Lacks capacity to utilise the app whether recruited to control or treatment group ● Any other reason that the staff feel would jeopardize the health or well-being of the participant or staff or would prevent proper conduct of the study ● Adolescents who do not speak Xitsonga Adolescent: 13 Year-18 Year 15 Year(s) 19 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 08/10/2020 M200532
Ethics Committee Address
Street address City Postal code Country
University of the Witwatersrand Human Research Ethics Committee Medical Johannesburg 2000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Feasibility and acceptability of the digitally delivered Behavioural Activation (BA) therapy intervention to overcome depression. We will assess the number of participants: recruited, assessed at baseline, randomised, completing the course of treatment, completing follow up measures. We will assess the acceptability of the recruitment method (including acceptability of randomisation), intervention and study design through a series of in-depth interviews and an Acceptability Questionnaire with participants. 0, 5, 11, 24 weeks
Secondary Outcome To pilot locally adapted outcome measures of mental health to inform the development of a further larger trial. - Generalised Anxiety Disorder (GAD-7) - Conor-Davidson Resilience Scale 10-item (CD-RISC) - Brief Rumination Response Scale 5-item (RRS) - Behavioural Activation for Depression Scale 25-item (BADS) - Emotional wellbeing (WEMWBS) 0,5, 11, 24 weeks
Secondary Outcome To pilot locally adapted outcome measures of cognition and collect descriptive data to inform the development of a further larger trial. Cognition tasks: - Affective set-shifting task - Affective go/no-go task - Affective backwards digit span - Balloon Analogue Risk Task (BART) - Matrix Reasoning Item Bank (MaRs-IB) - Emotion recognition task 0, 11 weeks
Secondary Outcome To pilot locally adapted outcome measures of risky behaviours and collect descriptive data to inform the development of a further larger trial. Risky Behaviours - School attendance - Substance use - Sexual behaviour Peer Influence scales 0, 11, 24 weeks
Secondary Outcome To pilot locally adapted socioeconomic measures and collect descriptive data to inform the development of a further larger trial. Socio-economic measures: - Employment and earnings - Consumption and finances - Aspirations and expectations - Time preference, risk preference, and loss aversion task 0, 11, 24 weeks
Primary Outcome Initial efficacy of the intervention on depressive symptoms amongst adolescents with depression compared to control. Depression symptoms will be assessed on the 9-item Patient Health Questionnaire Adolescent version 9-item (PHQ-A) 0, 5, 11, 24 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MRCWitsAgincourt Tintswalo Hospital, Main Road, Acornhoek, Mpumalanga Acornhoek 1360 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
SA and UK MRC Francie van Zijl Drive, Parowvallei, Tygerberg Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wits Health Consortium 31 Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Oxford University Department of Psychiatry, University of Oxford, Warneford Hospital Oxford Oxford OX1 2JD United Kingdom
Cambridge University Department of Psychology, University of Cambridge, Downing Street Cambridge CB2 3EB United Kingdom
Exeter University Department of Psychology, University of Exeter ,Washington Singer Building, Perry Road Exeter EX4 4QG United Kingdom
University of California Los Angeles 10889 Wilshire Blvd, Suite 700 Los Angeles CA 1406 United States Minor Outlying Islands
University of Limpopo C/O R71 Tzaneen Road and University Street Polokwane 0727 South Africa
University of Cape Town 46 Sawkins Road, Rondebosch Cape Town 7700 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kathleen Kahn kathleen.kahn@wits.ac.za +27824177373 School of Public Health, University of the Witwatersrand
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Professor of Public Health
Role Name Email Phone Street address
Principal Investigator Alan Stein Alan.stein@psych.ox.ac.uk +447947864283 Department of Child and Adolescent Psychiatry, University of Oxford
City Postal code Country Position/Affiliation
Oxford OX3 7JX United Kingdom Professor of Child and Adolescent Psychiatry
Role Name Email Phone Street address
Scientific Enquiries Alan Stein alan.stein@psych.ox.ac.uk +447947864283 Department of Psychiatry, Warneford Hospital
City Postal code Country Position/Affiliation
Oxford OX3 7JX United Kingdom Professor of Child and Adolescent Psychiatry
Role Name Email Phone Street address
Public Enquiries Kathleen Kahn kathleen.kahn@wits.ac.za +27824177373 School of Public Health, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Professor of Public Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Patient Data (IPD) Sharing Statement DoBAt Pilot Trial: Digital delivery of Behavioural Activation therapy to overcome depression and facilitate socioeconomic transitions amongst adolescents in South Africa Individual participant data for the above named pilot trial will be available in accordance with the information as follows: Individual participant quantitative data that underlie the results reported in each publication arising from the trial will be made available after deidentification. Any video, audio or qualitative data will not be available. Data will be available beginning 9 months and ending 36 months following main article publication to researchers who provide a methodologically sound proposal that purposes to achieve aims in the approved proposal and /or for individual participant data meta-analysis. Data is documented and stored on the MRC/Wits-Agincourt Data Repository with a digital object identifier (doi) and can be accessed with permission and in line with with MRC/Wits-Agincourt policies and procedures. Data requestors will need to sign a data access agreement before any data can be shared. In addition, Study Protocol and Statistical Analysis Plan documents will be available. Proposals requesting data access should be directed to Kathleen.kahn@wits.ac.za Statistical Analysis Plan,Study Protocol Beginning 9 months and ending 36 months following main article publication Data will be available beginning 9 months and ending 36 months following main article publication to researchers who provide a methodologically sound proposal that purposes to achieve aims in the approved proposal and /or for individual participant data meta-analysis.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://data.agincourt.co.za/index.php/home 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 23/09/2022 PACTR admin change 25 Nov 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 13/11/2024 Delays due to COVID-19 affecting school attendance. Additionally, a small pre-pilot study was conducted between November 2021 and January 2022. 25 Nov 2021 17 Jan 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 23/09/2022 PACTR admin change 01 Sep 2021 31 Jan 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 13/11/2024 n/a 31 Jan 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 13/11/2024 Reached approximate target sample size 195
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 23/09/2022 PACTR admin change Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 13/11/2024 Recruitment was completed in August 2022 Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 03/11/2022 GAD-7 was erroneously left out of the mental health scales when the trial was registered Secondary Outcome, To pilot locally adapted outcome measures of mental health to inform the development of a further larger trial. Mental health scales: - Conor-Davidson Resilience Scale 10-item (CD-RISC) - Brief Rumination Response Scale 5-item (RRS) - Behavioural Activation for Depression Scale 25-item (BADS) - Emotional wellbeing (WEMWBS) , 0,5, 11, 24 weeks Secondary Outcome, To pilot locally adapted outcome measures of mental health to inform the development of a further larger trial. - Generalised Anxiety Disorder (GAD-7) - Conor-Davidson Resilience Scale 10-item (CD-RISC) - Brief Rumination Response Scale 5-item (RRS) - Behavioural Activation for Depression Scale 25-item (BADS) - Emotional wellbeing (WEMWBS) , 0,5, 11, 24 weeks