A Randomised Controlled Trial of Online Group CBT for Symptoms of Depression and Anxiety Among University Students in South Africa
Phase: NA
Conditions: Depression, Anxiety
Sponsor: University of Stellenbosch

A randomised controlled trial of online group CBT for symptoms of 
depression and anxiety among university students in South 
Africa 
 
 
Principal Investigator:  
Professor Jason Bantjes  
Institute for Life Course Health Research, Department of Global Health, Stellenbosch 
University 
 
Co-Investigators:  
Dr Elsie Breet  
Institute for Life Course Health Research, Department of Global Health, Stellenbosch 
University 
 
Dr Munita Dunn-Coetzee 
Director: Centre for Student Counselling and Development  
Student Affairs, Stellenbosch University 
 
Mr Charl Davids 
Deputy Director: Centre for Student Counselling and Development  
Student Affairs, Stellenbosch University 
 
Professor Ronald C. Kessler 
Department of Health Care Policy, Harvard Medical School, Boston, MA, United States 
 
Professor Robert Bossarte 
School of Public Health, University of West Verginia 
 
 
Document date: 03 August 2021 
 

 
 
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INTRODUCTION 
 
Depression and anxiety are common and debilitating disorders, both internationally 
(Eisenberg, Gollust, Golberstein, & Hefner, 2007; Hajduk, Heretik, Vaseckova, 
Forgacova, & Pecenak, 2019; Hasin, Goodwin, Stinson, & Grant, 2005; Hunt, Slade, 
& Andrews, 2004), and in South Africa (Herman et al., 2009). Among university 
students, symptoms of depression and anxiety  are also very common (Bantjes et al., 
2019) and are associated with significant problems including higher rates of academic 
failure and suicidal behaviours (Cranford, Eisenberg, & Serras, 2009; Eisenberg et al., 
2007; Hysenbegasi, Hass, & Rowland, 2005). Despite viable psychotherapeutic and 
pharmacological options, the majority of depressed or anxious university students, like 
others in the general population, do not pursue treatment (Tolin, 2010; Trivedi et al., 
2006; Wilson & Deane, 2010). Further, barriers to care, both those involving practical 
issues and psychological factors, lead to high attrition rates from treatment, resulting 
in modest effect sizes in effectiveness trials (Collins, Westra, Dozois, & Burns, 2004; 
Fergusson, Horwood, Ridder, & Beautrais, 2005). As a means of increasing 
accessibility and retention, effective psychological group interventions for symptoms of 
depression and anxiety have been developed and tested (Conley, Durlak, & Kirsch, 
2015). Identifying individuals with a high likelihood of responding to psychological 
group interventions would enable clinicians to target this inexpensive treatment only to 
the patients with a high probability of responding; allowing more intensive treatments 
to be reserved for patients who would not respond to group-based skills training. The 
development of a system to make this determination would represent a major advance 
and address an unmet need.  To date no attempts have been made to trial the use of 
psychological interventions for clinically significant symptoms of depression or anxiety 
among university students in South Africa.  It is within this context that we propose a 
randomized controlled trial on the use of online group interventions for symptoms of 
depression or anxiety among university students in South Africa. The research project 
is a collaboration between the Centre for Student Counselling and Development at 
Stellenbosch University (SUN), the Institute for Life Course Health Research, 
Department of Global Health at SUN, and experts from the University of West Virginia 
and Harvard University. 
 
METHODS 
 

 
 
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Study aims:  
 
The specific aims of the study are: 
1) Determine the proportion of university students who will utilize online psychological 
interventions for symptoms of depression and anxiety. 
2) Determine if a 10-week online group CBT (GCBT) intervention effectively reduces 
symptoms of depression and anxiety among university students when compared 
with three control group interventions (i.e., Mood Flow, SilverCloud guided, and 
SilverCloud unguided). 
 
This is a parallel group, unblinded randomized controlled trial (RCT), to assess 
the effectiveness of a novel 10-week online group CBT (GCBT) intervention that we 
have developed for university students reporting symptoms of depression or anxiety.  
Students will be recruited from Stellenbosch University to participate in this RCT. 
Students will be sent an email invitation in randomized batches of 400 students at a 
time. The email will explain that we are conducting research on the use of digital 
interventions to reduce symptoms of depression and anxiety. The email will also invite 
students to enrol in the study by completing an online baseline assessment. Students 
will be asked to complete an Informed Consent Form before participating in the 
baseline assessment or any of the interventions. The Online Informed Consent Form 
outlines the primary aims of the study, inclusion/exclusion criteria, and rights as a 
participant (e.g., skip any question, discontinue at any time, right to withdraw) as well 
as detail about the online psychological group interventions. Students who meet the 
inclusion criteria will be randomized in a 1:1 ratio to one of the four study arms: the 
experiment group (i.e., the 10-week online GCBT intervention) or one of the three 
control groups (i.e., Mood Flow, SilverCloud guided, and SilverCloud unguided). We 
will repeat this recruitment strategy until we reach our target sample size of at least 
400 students (i.e., a minimum of 100 students per intervention arm).  
Students who enrol in the study will complete a baseline assessment prior to 
randomization. Follow-up assessments will also be conducted at 3-months, 6-months 
and 12-months post intervention. Assessment will consist of online self-report 
questionnaires administered using QualtricsxM software to record the following: 
(a) 
Respondent contact information  
(b) 
Background information 

 
 
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(c) 
COVID-19  
(d) 
Physical health  
(e) 
Attention and concentration  
(f) 
Substance use  
(g) 
Symptoms of depression 
(h) 
Worry and anxiety  
(i) 
Panic attacks  
(j) 
Social anxiety  
(k) 
High mood 
(l) 
Obsessive-compulsive disorder  
(m) 
Stressful experiences  
(n) 
Other behavioural health problems  
(o) 
Self-harm  
(p) 
Personal relationships  
(q) 
Intervention evaluation for group therapy  
(r) 
Social networks 
(s) 
App and technology use  
(t) 
Treatment  
(u) 
Personality  
(v) 
Childhood experiences 
(w) 
University experiences 
 
Inclusion Criteria: 
(a) Aged 18 or older years. 
(b) Enrolled as a student at Stellenbosch University. 
(c) Provide Informed Consent and completed baseline assessment. 
(d) Access to internet and a device that support apps. 
 
Exclusion Criteria:  
(a) No internet availability or no device that supports apps. 
 
Enrolment in group intervention: 
Eligible students for the experiment group (i.e., online GCBT intervention) or control 
group (i.e., Mood Flow, SilverCloud guided, and SilverCloud unguided) will be sent 
an email inviting them to attend an online individual information session and briefing 

 
 
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about the group that they have been randomized to. The online individual information 
session will be conducted using the Microsoft Teams platform which is a free easy-
to-use virtual meeting space.  Information about the intervention they have been 
assigned to will also be sent via email. 
No incentives will be paid for participating in the intervention.  
 
Details of the online group CBT (GCBT) intervention: 
The online GCBT intervention we have developed and previously piloted in a 
pragmatic trial (Bantjes et al., 2021), will be delivered via Microsoft Teams (a secure 
web-based video conferencing platform) in 10 weekly workshops of 60-75 minutes. 
The content was drawn from common elements identified from GCBT interventions 
shown to be effective for university students (Hamamci, 2006; Peden, Hall, Rayens, 
& Beebe, 2000; Takagaki et al., 2016; Yang, Zhao, Chen, Zu, & Zhao, 2018; 
Zemestani, Davoodi, Honarmand, Zargar, & Ottaviani, 2016). The content was 
organised into five themes with each theme spanning two workshops. To make the 
intervention more engaging and relevant to the target population, we consulted 
regularly over the development period with a group of four student advisors to select 
suitable examples, plan activities, and inform the lay-out and design of materials. 
Consultation with the student advisors took place in an iterative process over the 
course of a year while we developed and refined the intervention materials. We also 
consulted with three Psychologists working in student counselling centres and the 
intervention materials were critically reviewed by two CBT experts.  
 
Participants assigned to the online GCBT intervention will be provided with 
electronic interactive pdf workbooks consisting of exercises and brief summaries of 
the main ideas and skills for each session before each workshop. Participants will be 
given the option to remain anonymous by keeping their web-cameras off and/or by 
using pseudonyms, although they will be encouraged to use web-cameras to show 
their faces during the workshops. Participants will also be invited to use the online 
chat function to type comments, questions, or responses during the sessions if they 
felt uncomfortable speaking in the group. Strategies that will be used to improve 
retention include giving participants permission to miss sessions but encouraging 
attendance at each new session, sending follow-up emails to students who missed 

 
 
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sessions prompting them to join the following week, and giving a brief recap of the 
previous workshop at the start of each new session.  
Sessions will be facilitated by registered counsellors (the equivalent of 
psychological technicians with four years of university training) and registered 
psychologists. A facilitators’ handbook, with detailed descriptions of the content of 
each session and facilitation guidelines will be provided and facilitators will be trained 
on group therapy facilitation. Online sessions will be recorded so that they could be 
reviewed during supervision.  
 
Control groups: 
The control groups will be directed to make use of one of three digital applications 
(apps); i.e., Mood Flow, SilverCloud (guided), and SilverCloud (unguided).  
 
Assessment schedule: 
As part of the study, the experimental group intervention participants will complete a 
baseline assessment at the start of the study and process assessments every two 
weeks. Follow-up assessment will also be administered to monitor symptom change 
(i.e., 3-month post-treatment, 6-month post-treatment, and 1-year post-treatment). The 
control group will only complete the baseline assessment and a 3-month follow up 
assessment.  
 
Management of risk 
If during the initial screening and recruitment or follow-up assessments, any participant 
endorses a “2” (more than half the days) or “3” (nearly every day) on the PHQ-9 
(Thoughts that you would be better off dead or of hurting yourself in some way), they 
will receive an automated message that provides a list or emergency resources. The 
email and text message will be sent immediately after endorsing the item. Students 
who report active suicidality with intent at any time during the study will be referred to 
appropriate campus-based crises services, and national suicide helplines. 
 
Statistical Analyses: 
Data will be cleaned and analysed with SPSS (version 27). Descriptive statistics will 
be used to summarise participant characteristics, attendance rates, and primary 
outcomes.  
We will evaluate aggregate intervention effects, as well as evaluate aggregate 

 
 
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differences across arms using conventional intent to treat (Gupta, 2011) and complier 
average causal effect (CACE) (Angrist, Imbens, & Rubin, 1996) analyses based on 
inverse probability weights to deal with loss to follow-up (Robins, Rotnitzky, & Zhao, 
1994). Log-binomial regression will be used to estimate remission and to report 
adjusted prevalence ratios with 95% CIs. If convergence problems occur, we will fall 
back on Poisson regression with robust variance estimation. We will calculate numbers 
needed to treat for each outcome (remission of anxiety, depression, and combined 
PHQ-ADS). To estimate CACE, we will use two-stage least squares (Wooldridge, 
2020) and control function procedures (Clarke & Windmeijer, 2012). We will evaluate 
the validity of the assumptions needed for this estimation and conduct sensitivity 
analyses. Distributions and correlates of dropout and missing data will be provided in 
reports.  
Process analyses will allow us to investigate the pathways through which the 
intervention affects the outcomes by investigating intermediate effects of the individual 
intervention rule (IIR) in predicting responses in the five-minute process assessments 
that will be carried out every two weeks with students in the intervention arm over the 
10 weeks of the intervention. The instrument used in these process assessments, the 
CBRSS (Miner, Schueller, Lattie, & Mohr, 2015), measures frequency of applying core 
cognitive skills (CSF) and core behavioral skills (BSF) during times of stress. We will 
also use the 4-item screening version of the GAD-7 and PHQ-9, the PHQ-4 (Kroenke, 
Spitzer, Williams, & Löwe, 2009), to assess anxiety-depression over each 2-week 
period. We will begin by investigating associations of the CSF and BSF measures both 
cross-sectionally and with a 2-week time-lag in predicting PHQ-9 scores. Our interest 
will be in determining whether CSF and BSF predictor PHQ-9 scores and if these 
associations increase over rime. 
We will also be interested in the associations of CSF and BSF data and 
individual differences in the slopes of PHQ-4 scores on CSF and BSF with the 
outcomes at the end of the intervention and in the 3-month, and 6-month follow-ups 
(i.e., academic attrition, performance, and engagement along with diagnostic 
classifications based on the GAD-7, PHQ-9, and PCL). We will also be interested in 
individual differences in mean values of CSF and BSF over the course of the 
intervention, changes (i.e., stronger changes in CSF and BSF over time for some 
students than others), and slopes of PHQ-9 scores on CSF and BSF scores in 
predicting long-term outcomes. We will be especially interested in the possibility of 
nonlinearities that document the existence of important minimum engagement 

 
 
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thresholds for achieving treatment effects (Chien et al., 2020). We will use a multilevel 
modelling framework to carry out these analyses. Finally, we will be interested in the 
extent to which the association of the IIR scores with long-term outcomes are mediated 
by the process measures obtained in the process assessments collected every two-
weeks.  
 
ETHICAL CONSIDERATIONS 
 
Consent: 
 
Eligible participants who satisfy the inclusion criteria and do not meet the exclusion 
criteria outlined in this proposal will be invited to participate in the online psychological 
group interventions and will be provided with an Online Informed Consent Form on 
participation in the research and online group intervention. The Online Consent Form 
outline: (a) aim of the research study, (b) risks and benefits of the research study, (c) 
assurance of confidentiality, (d) rights as a participant, including the right to refuse to 
answer any question, discontinue participation at any time, and withdraw from the 
study and (e) details on participating in online group interventions. No information 
obtained will be used without receiving the completed Informed Consent Form. After 
completing the consent form, participants will be emailed a pdf copy of the Informed 
Consent Form for their records.  
 
Potential risks: 
 
(a) Privacy. Participants who provided informed consent will be given details on the 
online intervention groups that they have been randomized to. Respective group 
facilitators will make a note of which students join which session as an online form 
of a register.  Each participant will be assigned and alphanumeric ID so that data is 
stored in a way that is not directly linked to any identifying information.  
 
All collected electronic data will be password protected and will be accessed only 
by authorized personnel. The data will only be used for this study and will be 
destroyed after a three-year period. Scientific publications or presentations on the 
results will only report analyses on an aggregated level. 
 

 
 
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(b) Discomfort. If participants experience discomfort when completing the study 
questionnaires or throughout the intervention, they can refuse to answer any 
questions.  Further, all participants may choose to discontinue the assessment/ 
intervention and/or withdraw from the study. This is outlined in the relevant 
Informed Consent Form. 
 
Clinical Risk and Benefits. There are risks with any intervention, most specifically 
that they will not work or that a person might get frustrated by this intervention 
approach. However, there also are benefits as the group nature of this intervention 
shows students that they are not alone. There is no reason to believe this intervention 
would not prove effective in university students given past research showing that 
psychological group interventions in depressed and anxious higher education students 
are effective (Conley et al., 2015). Additionally, there are a number of benefits for the 
greater community. Namely, the study will advance our collective understanding of the 
feasibility in using psychological skills training group interventions for treating 
symptoms of depression and anxiety in university students.  This information may then 
be utilized to develop more effective intervention programs. 
 
Institutional permission: 
 
We will seek institutional permission from the appropriate authorities at Stellenbosch 
University to conduct this study. 
 
MONITORING, ASSESSMENT, AND RISK MANAGEMENT OF  
PARTICIPANTS 
 
(a) The PIs will have the responsibility for continuous monitoring of data and safety of 
subjects in the study.  Data and safety monitoring will take place continuously 
throughout the study’s duration.  
 
(b) Following the initial baseline assessment, those participants who report severe 
symptoms of depression, or suicidality will receive an automated message that 
provides a list or emergency resources. 
 

 
 
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(c) Students’ identified as being at risk will be immediately referred to the SSVO for 
further assessment and management. They will not be discharged from the RCT, 
but we will insist that they are also receiving individual care at the same time and 
that they are aware of the crises services available to students’ (i.e. ER 24 crises 
line). The group facilitators will manage this referral process in collaboration with the 
SSVO. 
 
(d) All administrators will be trained and supervised by Professor Jason Bantjes. 
 
(e) Of note, the administrators will not specifically probe or assess suicide risk. 
However, in the unlikely situation that a participant explicitly states that he/she is 
suicidal, the participant would be provided with a list of emergency resources, per 
email and phone text message. 
 
(f) We will report both adverse events and all serious adverse events that occur during 
the course of the study to the Institutional Review Board (IRB). Specifically, we will 
record all adverse events in a tracking log based on IRB templates, which will be 
submitted to the IRB at each continuing review. 
 
(g) At the time of the continuing review we will provide the IRB with a summary of any 
unexpected and related adverse events as well as any other unanticipated 
problems that occurred since the last continuing review. 
 
(h) Adverse events and unanticipated problems will be reported to the IRB per PHRC 
reporting guidelines. We will report to the IRB any unanticipated problems and 
adverse events that occur: (a) during the conduct of the study, (b) after study 
completion, or (c) after subject withdrawal or completion. Reports will be submitted 
within 5 working days/7 calendar days of the date the investigator first becomes 
aware of the problem. 
 
(i) Throughout the study there may be circumstances where a subject’s participation 
may be terminated by the PI without the subject’s consent.  Specifically, potential 
reasons for participation termination may include: (a) increased participant 
suicidality, and (b) participant no longer satisfies inclusion criteria.  
 

 
 
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DATA STORAGE 
 
The data will be stored for a period of three years after the study has been 
completed. All data will be stored in a way that ensures it is de-identified (i.e., no data 
will be stored with names or other identifying info). This will be done by assigning 
each participant a unique identifier that cannot be linked to the individual simply by 
looking at it. A separate document will be stored in a different location containing the 
name, surname and accompanying unique identifier for each participant which will be 
used for follow-up assessment purposes. Only the data manager will have access to 
the document linking each participant to their unique identifier.  
 
 
 

 
 
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