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University students are vulnerable to poor mental health, psychological distress, and loneliness relative to nonuniversity student peers. However, the rate of seeking mental health treatment among university students is low. Web-based psychological interventions may provide an opportunity for supporting vulnerable university students who are unlikely to otherwise seek support.
The aim of this study is to examine the feasibility, acceptability, safety, and efficacy of an existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program for use among Australian university students.
This is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control. The self-directed modules will be augmented with optional webchat or telephone coaching with a therapist. The recruitment target is 70 university students who do not present with a clinical mental health disorder. Allocation will be made in a 1:1 ratio and will occur after the initial baseline assessment. Assessments will be completed at baseline, upon completion of a 4-week waitlist (waitlist group only), upon completion of the program, and at 3 months after completion of the program.
The trial was funded in June 2018, and the protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021. The primary outcomes are feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress. The secondary outcomes are psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes.
The acceptability, feasibility, safety, and efficacy of a web-based mental health program in university students will be evaluated. Web-based mental health programs offer the opportunity to engage university students who may be reluctant to seek support through traditional face-to-face mental health services, and the transdiagnostic approach of the program has the potential to address the breadth of mental health concerns of university students.
Australian New Zealand Clinical Trial Registry ACTRN12618001604291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001604291
DERR1-10.2196/21307
Young adults aged 16 to 24 years report the highest prevalence of mental health disorders of any age group in the Australian population [
Despite the high rates of mental health disorders (including anxiety and depression [
Uprise (Uprise Services [
The primary aim of this trial is to evaluate the acceptability, feasibility, safety, and efficacy of the Uprise program in reducing mental health symptoms among Australian university students. The secondary aims include evaluating the holistic impact of the Uprise program and investigating whether the Uprise program influences psychological processes, such as emotion regulation, cognitive appraisals, and mindfulness. This trial extends on the outcomes of previous trials of similar web-based CBT interventions by examining the broader holistic impact of the intervention rather than focusing only on symptom reduction.
The study will be a pilot randomized waitlist-controlled trial, with two parallel groups, using a 1:1 allocation ratio. Waitlist was selected as the control condition to enable comparison of the Uprise program to students’ usual daily life, while ensuring that all participants had the opportunity to access the Uprise program.
Participants will initially undergo screening for eligibility via telephone interview (T0). Eligible participants will be invited to complete the baseline assessment (T1). Informed consent will be obtained at the baseline assessment. Following the baseline assessment, each consenting participant will be randomized to either the Uprise program or waitlist for the following 4 weeks. Those allocated to the Uprise program will be given access to the program and asked to complete one module per week across the following 4-week period. At the end of the program, these participants will be invited to complete an end-of-treatment assessment (T3). Participants allocated to waitlist will be asked to continue with their usual activities across the following 4-week period, at the end of which they will be invited to complete an end-of-waitlist assessment (T2). Waitlist participants will then be given access to the Uprise program and asked to complete one module per week for the following 4 weeks, at the end of which they will be invited to complete an end-of-treatment assessment (T3). Participants will also be invited to complete a semistructured interview at the end-of-treatment (T3) assessment regarding their experience with the intervention. The interview will be recorded and later transcribed for qualitative analysis. All participants will be invited to complete a follow-up assessment (T4) 3 months after their end-of-treatment (T3) assessment.
The Consolidated Standards of Reporting Trials (CONSORT) flow diagram of the study procedure is shown in
Consolidated Standards of Reporting Trials (CONSORT) diagram showing the trial design.
This trial will be coordinated from Swinburne University of Technology in Melbourne, Australia, and will aim to include students from multiple universities across Australia. Trial assessments will be conducted remotely via telephone and online questionnaires. The trial intervention will also be administered remotely via the Uprise web platform and phone app, with optional coaching calls conducted via either telephone or webchat according to participant preference.
Seventy participants will be recruited to the trial. Power analysis was conducted using G Power 2.0 for the mental health primary outcome variables (social anxiety and depression), with estimates based on published means and standard deviations and reported effects of similar interventions [
Participants will be recruited from Australian universities via social media advertisements, flyers, and student newsletter articles. At Swinburne University, students who are identified as being “at risk” of dropping out of the university owing to mental health concerns will also be emailed and invited to participate in the study. Identification of “at risk” students will be completed by Swinburne University student wellbeing officers according to whether a student did not receive a passing grade for one or more subjects in the previous semester. Student names and email addresses will be shared with the researchers for the purpose of targeted trial recruitment. No other details will be shared with the research team. This targeted recruitment approach has been included to reach vulnerable students who may not have otherwise been motivated to engage in a research study, as well as to emulate potential pathways to accessing the Uprise program if it were to be rolled out as a wellbeing program at universities.
Participants will be invited to register their interest in the study via direct email to the research team or by registering their interest on the study landing page. Some participants may directly comment on social media posts, in which case we will direct them to email the research team or visit the trial landing page. The research team will then email potential participants an information sheet and informed consent form. Once participants have provided their contact details and a preferred contact time, researchers will telephone participants to conduct eligibility screening. The study sponsors will not have access to any identifiable recruitment information.
Participants meeting the following criteria will be eligible for the study: (1) aged 17 to 26 years; (2) currently enrolled as a student at an Australian university; (3) competent in English reading and comprehension; and (4) able to receive phone or video conference calls or visit the research center for assessments. The exclusion criteria are as follows: (1) self-reported acute or distressing clinical psychiatric symptoms in the past month (ie, symptoms that the individual reported experiencing as distressing or interfering with their usual daily activities); (2) psychiatric hospitalization in the past month; (3) self-report of any level of suicidality risk; (4) self-report of moderate or severe levels of distress (score equal to or more than 25 on the Kessler Psychological Distress Scale) during screening assessment; (5) self-report of any level of risk of harm to others; and (6) self-report of any level of risk of damage to objects or property.
Participants who report mental health symptoms of a severity that deems them ineligible for the trial will be referred to appropriate mental health services. This is to ensure that these participants receive the appropriate level of care to address the severity of mental health symptoms, as the Uprise program is not designed to address severe symptoms or suicidality. To ensure equitable access to the trial and to minimize sampling bias, these participants will be given the option to undergo eligibility screening again at a later time and to participate in the trial should they meet criteria at this second screening.
Participants confirmed to be eligible following the screening assessment (T0) will be invited to complete the baseline assessment (T1). Following the baseline assessment, participants will be subject to random allocation to either waitlist or treatment with the Uprise program. Block randomization will be applied in this study with a 1:1 allocation ratio using random block sizes of 4 and 6. The randomization sequence will be generated using the Sealed Envelope online randomization sequence generator [
All outcome assessments will be completed online by participants. It is not possible to blind participants to their allocation owing to the nature of the trial design. The psychologists who provide “coaching” as part of the Uprise program will be blind to participant allocation.
Demographic variables will include age, gender, sexuality, ethnicity, work status, level of education, previously attempted university degrees, current university course load, postcode, and religion. The Lubben Social Network Scale-12 items (LSNS-12 [
SPIRIT schedule of enrolment, interventions, and assessments.
Variable | Study period | ||||||||
Enrolment | Baseline | Postallocation | Close out |
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Waitlist | End of waitlist | Uprise | End of treatment | 3-month follow-up |
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Timepoint | T0 | T1 | N/Aa | T2 | N/A | T3 | T4 |
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Eligibility screen | Yes | No | No | No | No | No | No |
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Informed consent | No | Yes | No | No | No | No | No |
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Allocation | No | Yes | No | No | No | No | No |
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Uprise program | No | No | No | No | Yes | No | No |
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Waitlist | No | No | Yes | No | No | No | No |
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Demographic form | No | Yes | No | No | Yes | No | No |
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UCLA-LS3b | No | Yes | No | Yes | No | Yes | Yes |
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CES-Dc | No | Yes | No | Yes | No | Yes | Yes |
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SIASd | No | Yes | No | Yes | No | Yes | Yes |
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DASS-21e | No | Yes | No | Yes | No | Yes | Yes |
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PANASf | No | Yes | No | Yes | No | Yes | Yes |
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K10g | Yes | No | No | Yes | No | Yes | Yes |
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LSNS-12h | No | Yes | No | Yes | No | Yes | Yes |
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ERQi | No | Yes | No | Yes | No | Yes | Yes |
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FFMQj | No | Yes | No | Yes | No | Yes | Yes |
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CBPQk | No | Yes | No | Yes | No | Yes | Yes |
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BCISl | No | Yes | No | Yes | No | Yes | Yes |
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PWB-42m | No | Yes | No | Yes | No | Yes | Yes |
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AQoL-8Dn | No | Yes | No | Yes | No | Yes | Yes |
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PHQo | No | Yes | No | Yes | No | Yes | Yes |
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SF-12p | No | Yes | No | Yes | No | Yes | Yes |
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WHO-5q | No | No | No | No | Yes | No | No |
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PSS-4r | No | No | No | No | Yes | No | No |
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Modified SDSs | No | No | No | No | Yes | No | No |
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Acceptability measure | No | No | No | No | Yes | No | No |
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Qualitative interview | No | No | No | No | No | Yes | No |
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aN/A: not applicable.
bUCLA-LS3: UCLA Loneliness Scale Version 3.
cCES-D: Centre for Epidemiological Studies-Depression.
dSIAS: Social Interaction Anxiety Scale.
eDASS-21: Depression, Anxiety, and Stress Scale-21 items.
fPANAS: Positive and Negative Affect Schedule-Trait and State versions.
gK10: Kessler Scale of Distress-10 items.
hLSNS-12: Lubben Social Network Scale-12 items.
iERQ: Emotion Regulation Questionnaire.
jFFMQ: Five Facet Mindfulness Questionnaire.
kCBPQ: Cognitive Behavioral Processes Questionnaire.
lBCIS: Beck Cognitive Insight Scale.
mPWB-42: Psychological Well-Being Scale-42 items.
nAQoL-8D: Assessment of Quality of Life-8 Dimensions.
oPHQ: Physical Health Questionnaire.
pSF-12: Short-Form Health Survey-12 items.
qWHO-5: World Health Organization-Five Well-Being Index.
rPSS-4: Perceived Stress Scale-4 items.
sSDS: Sheehan Disability Scale.
A self-report scale created by the developers of the Uprise program and designed to measure participant satisfaction with the program will be used to determine the acceptability of the program to participants. Participants will be asked to rate out of 10 how satisfied they were with each of the program modules and coaching calls, as well as how likely they are to recommend Uprise to friends or family. Attrition rates from the trial will also be used as indicators of acceptability. Themes identified from the qualitative interviews conducted at the end-of-treatment (T3) assessment will also be used to determine acceptability of the intervention. The interview will include questions regarding the participants’ experiences and preferences regarding the different modules of the Uprise program. Feasibility will be assessed by the proportion of interested people who complete the baseline assessment, the attrition rate across both groups, and the proportion of participants who complete the four core Uprise program modules within the 6-week intervention period. Safety will be determined according to the number of adverse events occurring across the trial period.
Psychological distress will be measured with the Kessler Scale of Distress-10 items (K10 [
The Perceived Stress Scale (PSS-4 [
The Psychological Well-Being Scale-42 items (PWB-42 [
The UCLA Loneliness Scale-Version 3 (UCLA-LS [
Question 1 from the Short-Form Health Survey-12 items (SF-12 [
The Emotion Regulation Questionnaire (ERQ [
The Uprise program will be made accessible to participants as both an app and a website. Participants will complete all intervention activities online at a time and location that is convenient for them. Activities will include a series of self-directed modules and optional coaching sessions with a psychologist or counsellor.
Participants will complete four core modules over 4 to 6 weeks, with an additional six optional modules. Each module consists of a short introductory video and a series of 1 to 6 additional videos or exercises. The module length ranges from 6 to 28 minutes. The modules are mindset, personal values, mindfulness, and stress management (outlined in
Outline of the Uprise module content.
Module | Content | |
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Mindset | Identifying unhelpful thinking styles and changing unhelpful thoughts. |
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Personal values | Identifying values system, making behavioral choices based on values system, and scheduling activities. |
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Mindfulness | Developing mindfulness skills to pay attention to and observe thoughts instead of trying to control and change them. |
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Stress management | Developing stress reduction and relaxation breathing skills. |
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Helping others | Skills for managing relationships with mental health in mind. |
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Perspective taking | Learning to understand the perspectives of others. |
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Advanced mindset | Advanced skills in retraining thinking related to stress, guilt, metacognition, and beliefs. |
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Improving sleep | Strategies to improve sleep habits. |
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Advanced mindfulness | Advanced skills in awareness and mindfulness. |
The Uprise program also provides participants with in-website links to telephone or online coaching sessions with a trained mental health professional at any point during the program. Participants will be able to choose from a list of psychologists and counsellors to select their “coach” and schedule weekly 30-minute telephone or webchat sessions with their coach. It will be up to the participant to decide whether to engage with this aspect of the program.
It will be clearly outlined to participants that the trial involves a waitlist control prior to enrolment, and informed consent will include agreement to undergo a 4-week waitlist period and an additional assessment prior to commencing the Uprise program. Waitlist participants will be instructed to continue with their usual activities throughout the waitlist period.
Summary data will be provided to describe the number of participants who registered interest in the trial, the number deemed ineligible for the trial and why, and the number who completed each stage of the trial.
Data will be analyzed on an intention-to-treat basis (ie, including all enrolled participants regardless of whether they completed the trial). Acceptability, feasibility, and safety will be evaluated using descriptive statistics. Qualitative interviews will be analyzed using the six-step approach by Braun and Clarke [
Results will be summarized as means and standard deviations (or median and range/percentage and number as appropriate) for both groups at baseline (T0) and for the relevant group at the end of waitlist (T2)/end of treatment (T3) for all outcome measures. For both groups, this will demonstrate their results at baseline and again 4 weeks after baseline.
Additionally, the
Multilevel linear mixed effects modeling (MLM) will be used to assess acute and long-term treatment effects in each of the outcome measures. MLM is a regression-based approach that is robust to missing data and provides a more powerful means of analyzing longitudinal data than the ANOVA family of analyses [
To assess short-term treatment effects, the trajectory of change in each of the outcomes will be examined from baseline (T1) to the end of waitlist (T2) for the waitlist group and from baseline (T1) to the end of treatment (T3) for the intervention group. The trajectory of change in each of the outcomes will be compared between groups. Each analysis will include time (fixed), group (fixed), and the fixed interaction between time and group (time × group) as predictors. A significant time × group interaction effect will indicate a differential rate of change in outcomes between the groups from baseline (T1) to the end of waitlist (T2)/end of treatment (T3).
To assess long-term treatment effects, the trajectory of change in outcomes from baseline (T1) to 3-month follow-up (T4) will be examined in the intervention group only. Sensitivity analysis will also be conducted to determine the trajectory of change from baseline (T1) to 3-month follow-up (T4) in the waitlist group only.
Secondary analyses will include per protocol analysis (only those who complete the four core modules within 6 weeks) and analyses controlling for moderator variables (eg, age, sex, baseline symptom severity, number of Uprise program modules completed, number of coaching calls completed, and number of days accessing the platform). We will report 95% confidence intervals for each test statistic.
Data collected in this pilot randomized control trial will be managed in accordance with GCP guidelines. Restrictions to the data will be made such that only those listed as authors in this protocol, as well as the host institutes, will have access to the data. The host institutes’ access will be specific to audit and regulatory processes and will not be used for any purpose outside the scope of the trial registry.
All researchers will be provided training on assessment administration and scoring, as well as relevant ethics procedures and protocols for managing and storing data. Assessment data will be collected online via the Qualtrics survey platform [
The Uprise program and online platform used in this study are existing clinical tools used in workplaces to support worker mental health. Uprise Services data security policies are fully compliant with Australian data protection and health record legislation [
The trial will be administered by Swinburne University of Technology. The study has been approved by Swinburne University Human Research Ethics Committee (SUHREC; project 2018/205). The trial will be conducted in accordance with the Declaration of Helsinki, GCP guidelines, and the Australian National Statement on Ethical Conduct in Human Research [
Any serious adverse events discovered by a research team member on the trial will be reported to the chief investigator Dr Michelle Lim and SUHREC. In the context of the trial, serious adverse events are defined as events that lead to participant death, are life-threatening, require inpatient hospitalization, or result in persistence of high disability/incapacity in accordance with the National Statement on Ethical Conduct in Human Research [
A trial management committee will involve the named authors on this protocol as well as an independent academic not associated with the project. The project will be coordinated by the chief investigator (MHL) who will also collaborate with senior coinvestigators (KDH and RE) with regard to overseeing the trial. The chief investigator will ensure that each member of the trial management committee holds current GCP training and will be responsible for ensuring the safety of the participants and that the quality of the trial is not compromised.
The trial was funded in June 2018, and this protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021.
The Uprise program is derived from evidence-based psychological interventions; however, the efficacy of the program has not previously been formally evaluated. Therefore, the aim of the study is to determine the acceptability, feasibility, and safety of Uprise, and evaluate its efficacy in addressing mental health symptoms in university students. The trial extends on previous similar trials by also considering the holistic impact of the Uprise program and specifically evaluating changes in psychological processes that are relevant to the intervention. Digital platforms, such as the Uprise program, have the potential to engage university students who may be reluctant to engage traditional face-to-face services.
Digital or web-based psychological interventions offer an opportunity to support vulnerable university students who are unlikely to otherwise seek support. Young people often use digital tools to interact with peers [
CONSORT eHEALTH Checklist V 1.6.1.
SPIRIT Checklist.
Assessment of Quality of Life-8 Dimensions
Beck Cognitive Insight Scale
Cognitive Behavioral Processes Questionnaire
cognitive behavioral therapy
Centre for Epidemiological Studies-Depression
Depression, Anxiety, and Stress Scale-21 items
Emotion Regulation Questionnaire
Five Facet Mindfulness Questionnaire
good clinical practice
Kessler Scale of Distress-10 items
Lubben Social Network Scale-12 items
multilevel linear mixed effects modeling
Positive and Negative Affect Schedule
Physical Health Questionnaire
Perceived Stress Scale-4 items
Psychological Well-Being Scale-42 items
Sheehan Disability Scale
Short-Form Health Survey-12 items
Social Interaction Anxiety Scale
Swinburne University Human Research Ethics Committee
UCLA Loneliness Scale Version 3
World Health Organization-Five Well-Being Index
The authors thank Ms Lily Thurston for assistance with formatting of the manuscript and Ms Taylah Argent for assistance with the tables and figures included in the manuscript. Medibank Private Ltd (Level 3, 720 Bourke Street, Docklands, VIC, 3008) provided funding to the Iverson Health Innovation Research Institute at Swinburne University of Technology for the study. The research team at Swinburne University is responsible for study design; the collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. Medibank Private Ltd and Uprise Services will provide no input for data collection, analysis, and interpretation, and will play no role in preparation of manuscripts.
MHL developed the project proposal and is responsible for the study implementation, study management, and supervision. KDH and RE contributed to refinement of the protocol, participant recruitment, and data collection. KDH drafted the initial version of the manuscript. RE and MHL were major contributors in writing the manuscript. All authors critically reviewed the manuscript for content and approved the final manuscript.
KDH is a director and shareholder of Wellbeing Strategies Pty Ltd. The other authors have no conflicts of interest.