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Psychological DistressYOLO UQNCT07701330

A Single-Arm Trial of a Web-Based Acceptance and Commitment Therapy Mental Health Promotion Intervention for University Students

A study testing YOLO intervention: 4-week web-based intervention in people with Psychological Distress and Academic Stress, run by The University of Queensland at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

University students experience high rates of psychological distress and frequently encounter barriers to accessing professional mental health support. Web-based interventions may provide a scalable and accessible approach for promoting mental health and well-being in university settings. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Psychological Distress, Academic Stress
What is being tested?
YOLO intervention: 4-week web-based intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
626 participants
Where
1 siteAustralia
Study dates
25 Jun 2019to 31 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Currently enrolled student at the University of Queensland.
  • Aged 18 years or older.
  • Sufficient computer and internet literacy;
  • Fluent knowledge of the English language.
  • Able to access the web-based platform.

Who cannot join

  • Current high risk of suicide or self-harm;
  • Severe cognitive impairment or neurocognitive difficulties that would prevent informed consent, completion of self-report assessments, or meaningful engagement with the self-guided online intervention.
  • Current severe psychiatric or medical condition that would make participation inappropriate or unsafe, or that would require more intensive clinical care than can be provided by a self-guided mental health promotion program.

Trial locations and contacts

1 site in 1 country.

Australia1 site
  • School of Psychology, University of Qeensland

    Saint Lucia, Queensland, 4072

Other trials in Australia

About this study

University students experience high rates of psychological distress and frequently encounter barriers to accessing professional mental health support. Web-based interventions may provide a scalable and accessible approach for promoting mental health and well-being in university settings. Acceptance and Commitment Therapy (ACT) is a transdiagnostic behavioural intervention that aims to increase psychological flexibility and has demonstrated beneficial effects on a range of psychological and academic outcomes among university students.

YOLO (You Only Live Once) is a four-week, self-guided, web-based ACT mental health promotion program developed for university students. Previous pilot and randomized controlled evaluations of YOLO demonstrated significant improvements in psychological well-being, distress, and academic functioning. Following these encouraging findings, YOLO was integrated into the University of Queensland's suite of digital well-being resources for students, and the present study was designed to evaluate its university-wide implementation using a prospective single-arm interventional approach.

The study aims to evaluate the preliminary effectiveness of the YOLO program in improving psychological distress, well-being, life satisfaction, academic performance, and psychological flexibility/inflexibility processes. In addition, the study will examine the feasibility, acceptability, usability, and engagement associated with participation in the intervention and investigate whether changes in psychological flexibility/inflexibility processes are associated with improvements in mental health and well-being outcomes. Findings from this study are expected to inform the future implementation and dissemination of web-based ACT interventions within university settings.

Read the detailed description

Mental health concerns among university students represent an important public health issue. International epidemiological studies indicate that approximately 19.2% to 50% of university students meet the diagnostic criteria for at least one mental health disorder. Despite the high prevalence of psychological difficulties, a substantial proportion of affected students do not seek professional support, with estimates ranging from 65% to 85%. At the same time, university counselling and health services have reported increasing demand, increasing clinical complexity, and insufficient resources to adequately address student needs.

The widespread use of online resources by university students for obtaining health-related information and support suggests that web-based delivery may provide a feasible and acceptable approach to mental health promotion. In addition to increasing accessibility, web-based interventions may overcome common barriers to seeking support, such as perceived stigma, time constraints, and competing academic responsibilities. Previous research has further demonstrated that highly distressed university students often report a preference for web-based psychological interventions.

The wide range of psychological difficulties experienced by university students suggests that interventions targeting common underlying processes across symptoms may be particularly appropriate. Although digital mental health interventions have demonstrated effectiveness across various conditions, many existing programs are designed for specific disorders and may therefore have limited utility in universal student populations. In addition, interventions that focus primarily on symptom reduction do not necessarily promote the development of positive psychological resources and skills associated with flourishing and optimal functioning. Consequently, transdiagnostic interventions that target shared risk and protective processes may offer a more comprehensive framework for promoting mental health and well-being among university students.

Acceptance and Commitment Therapy (ACT) is an empirically supported transdiagnostic intervention that aims to enhance psychological flexibility. A substantial body of evidence supports the effectiveness of ACT in improving mental health and well-being outcomes across adult populations. Evidence from university settings has also demonstrated promising outcomes for ACT-based interventions. Among university students, participation in ACT programs has been associated with improvements in psychological flexibility, self-compassion, educational values, and academic outcomes, including academic performance and grade point average. ACT-based interventions have also been linked to reductions in anxiety, depression, stress, and broader psychological distress.

The present study uses a prospective single-arm interventional design to evaluate the university-wide implementation of the program. All participants will receive immediate access to the same four-week web-based intervention and no control condition will be included. To support both implementation and evaluation objectives, participants may enrol in one of two assessment pathways. The Full research Arm includes assessments at T1 (baseline/pre-intervention), T2 (post-intervention, 4 weeks), and T3 (3-month follow-up). Data obtained from this pathway will be used to evaluate preliminary effectiveness, feasibility, acceptability, usability, and potential mechanisms of change associated with participation in the program. Participants enrolled in the Minimal research Arm will complete a brief baseline assessment prior to accessing the intervention. Data collected through this pathway will be used exclusively for descriptive and implementation purposes, including the evaluation of program reach, uptake, and engagement. The two pathways differ only in the extent of assessment and follow-up procedures and do not represent different intervention conditions. Only participants enrolled in the Full research Arm will contribute data to the effectiveness analyses and the examination of potential mechanisms of change.

Participant email addresses will be used solely for study administration purposes, including sending automated reminders and invitations to complete follow-up assessments. Personally identifiable information will not be linked to survey responses or disclosed to individuals outside the research team. All data will be stored securely in de-identified and aggregated formats in accordance with institutional data management procedures.

The study hypothesises that participation in YOLO will be associated with improvements in psychological distress, well-being, life satisfaction, academic outcomes, and psychological flexibility/inflexibility processes, including experiential Avoidance, cognitive defusion, valued living, education values, and present-moment awareness. Changes in outcomes will be examined using repeated-measures analyses across assessment time points. Potential mechanisms of change will be investigated by examining whether changes in psychological flexibility/inflexibility processes mediate changes in primary outcomes. Findings from both assessment pathways will be used to inform future implementation and dissemination of the YOLO program within university settings, and the results will be disseminated through scientific publications and reports.

Being tested
YOLO intervention: 4-week web-based intervention
Keywords
Student mental health, university students, digital mental health, Acceptance and Commitment Therapy, psychological flexibility, mental health promotion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YOLO intervention: 4-week web-based interventionBehavioural

    The study includes two assessment pathways (Full research Arm and Minimal research Arm), but these do not constitute separate intervention arms because all participants will receive immediate access to the web-based YOLO program after providing informed consent. The intervention consists of four online modules, each based on the core principles of Acceptance and Commitment Therapy (ACT), and participants will be encouraged to complete one module per week. The program is designed to promote psychological flexibility through the following topics:

    1. values and committed action;
    2. cognitive defusion;
    3. acceptance and willingness;
    4. mindfulness and the observing self.

    Each module includes animated presentations, YouTube videos, audio recordings, and experiential exercises grounded in ACT principles. To support engagement, participants will receive automated reminders, one supplementary learning activity per module, module summaries upon completion, and invitations to complete.

Study groups in NCT07701330
Study groupRoleWhat they receive
YOLO interventionExperimentalThe study includes two assessment pathways (Full research Arm and Minimal research Arm), but these do not constitute separate intervention arms because all participants will receive immediate access to the web-based YOLO program after providing informed consent. The intervention consists of four online modules, each based on the core principles of Acceptance and Commitment Therapy (ACT), and participants will be encouraged to complete one module per week. The program is designed to promote psychological flexibility through the following topics: 1. values and committed action; 2. cognitive defusion; 3. acceptance and willingness; 4. mindfulness and the observing self. Each module includes animated presentations, YouTube videos, audio recordings, and experiential exercises grounded in ACT principles. To support engagement, participants will receive automated reminders, one supplementary learning activity per module, module summaries upon completion, and invitations to complete
Receives: Behavioral: YOLO intervention: 4-week web-based intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distress

    The Depression Anxiety and Stress Scales 21 (DASS-21) is a 21-item self-report measure assessing three core symptom dimensions of negative emotional states: depression, anxiety, and stress. Each item is rated on a 4-point scale from 0 ("Did not apply to me at all") to 3 ("Applied to me very much, or most of the time"), referring to the past week.

    Subscale and total scores are calculated by summing the relevant items. Higher scores indicate greater severity of depression, anxiety, and stress symptoms.

    Measured: T1 (baseline); T2 (post-intervention, 4 weeks); T3 (follow-ups, 3 months)

  2. Well-being

    The Mental Health Continuum Short Form (MHC-SF) is a 14-item measure assessing positive mental health across three dimensions: emotional, social, and psychological well-being. Each item is rated on a 6-point frequency scale from 0 ("Never") to 5 ("Every day"), referring to the past month.

    Total and subscale scores are calculated by summing or averaging the relevant items. Higher scores indicate greater well-being.

    Measured: T1 (baseline); T2 (post-intervention, 4 weeks); T3 (follow-ups, 3 months)

  3. Academic performance

    This self-report questionnaire assesses students perceived academic functioning. Items are rated on a 10-point scale from 1 ("Performing at your worst") to 10 ("Performing at your best"), with an additional "Not applicable" option where relevant.

    Scores are calculated by averaging the valid items. Higher scores indicate better perceived academic performance and academic functioning. The total score reflects the mean level of perceived academic performance across the retained academic functioning items.

    Measured: T1 (baseline); T2 (post-intervention, 4 weeks); T3 (follow-ups, 3 months)

  4. Life satisfaction

    The Satisfaction with Life Scale (SWLS) is a 5-item measure assessing global cognitive judgements of satisfaction with one's life. Each item is rated on a 7-point scale from 1 ("Strongly disagree") to 7 ("Strongly agree").

    Total scores are calculated by summing the 5 items, with higher scores indicating greater life satisfaction.

    Measured: T1 (baseline); T2 (post-intervention, 4 weeks); T3 (follow-ups, 3 months)

Secondary outcomes (5)
  1. Experiential Avoidance

    The Acceptance and Action Questionnaire-II (AAQ-II) is a 7-item self-report measure assessing psychological inflexibility and experiential avoidance, reflecting the extent to which individuals are unwilling to experience unwanted thoughts and feelings while pursuing valued actions. Each item is rated on a 7-point Likert scale ranging from 1 ("Never true") to 7 ("Always true").

    Total scores are calculated by summing the 7 items, with higher scores indicating greater psychological inflexibility and experiential avoidance.

    Measured: T1 (baseline); T2 (post-intervention, 4 weeks); T3 (follow-ups, 3 months)

  2. Cognitive fusion

    The Cognitive Fusion Questionnaire (CFQ; Gillanders et al., 2014) is a 7-item self-report measure assessing the extent to which individuals become entangled with, or dominated by, their thoughts and treat them as literal truths. Each item is rated on a 7-point Likert scale ranging from 1 ("Never true") to 7 ("Always true").

    Total scores are calculated by summing the 7 items, with higher scores indicating greater cognitive fusion.

    Measured: T1 (baseline); T2 (post-intervention, 4 weeks); T3 (follow-ups, 3 months)

  3. Valued living

    The Engaged Living Scale-Short Form (ELS-SF) is a 9-item self-report measure assessing the extent to which individuals live in accordance with their personal values and experience a sense of fulfilment in daily life. The scale includes dimensions of value-consistent action and life fulfilment.

    Total scores are calculated by summing or averaging the relevant items, with higher scores indicating greater engaged, value-consistent living.

    Measured: T1 (baseline); T2 (post-intervention, 4 weeks); T3 (follow-ups, 3 months)

  4. Education values

    The Personal Values Questionnaire-II (PVQ-II) is a 9-item adapted version of the Personal Values Questionnaire designed to assess the extent to which individuals' behaviours within the educational domain are consistent with their personally held values and academic goals. The measure captures value-consistent action in academic contexts, reflecting the degree of alignment between what individuals consider important and how they behave in their studies. Scores are calculated by averaging the relevant items, with higher scores indicating greater value-consistent behaviour in education.

    Measured: T1 (baseline); T2 (post-intervention, 4 weeks); T3 (follow-ups, 3 months)

  5. Present moment awareness

    The Mindful Attention Awareness Scale (MAAS) is a 15-item self-report measure assessing an individual's tendency to attend to and be aware of present-moment experiences in everyday life. Each item is rated on a 6-point Likert scale ranging from 1 ("Almost always") to 6 ("Almost never").

    Total scores are calculated by averaging the 15 items, with higher scores indicating greater present-moment awareness and mindfulness.

    Measured: T1 (baseline); T2 (post-intervention, 4 weeks); T3 (follow-ups, 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start25 Jun 2019
  3. Primary completion31 Aug 2025
  4. Study completion31 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
626 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07701330
Sponsor's protocol ID
HE001551
Acronym
YOLO UQ
Status last verified
Jul 2026
First submitted
7 Jul 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in the published article may be made available upon reasonable request to the corresponding author, subject to approval by the study investigators.

Questions about this trial

What is this clinical trial studying?

A study testing YOLO intervention: 4-week web-based intervention in people with Psychological Distress and Academic Stress, run by The University of Queensland at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distress (time frame: T1 (baseline); T2 (post-intervention, 4 weeks); T3 (follow-ups, 3 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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