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Using AI to investigate the effectiveness of smartphone delivered self-care strategies for psychological distress in university students.

An AI-response-adaptive randomised controlled trial of smartphone app-delivered self-care strategies for psychological distress in university students

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001223820
Acronym
Not applicable.
Enrollment
1683
Registered
2021-09-13
Start date
2021-11-09
Completion date
2022-11-03
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the study is to evaluate whether a specific AI technique (multi-arm contextual bandit combined with an adaptive group sequential study trial design) can be used to efficiently identify how well interventions work in a multi-arm randomised controlled trial in a mental health context. To test this idea, the study is comparing the effectiveness of three brief self-guided smartphone interventions based on mindfulness, physical activity and sleep hygiene, and an active control of mood monitoring (i.e. ecological momentary assessment), in reducing self-reported psychological distress in university students. Based on past research, we hypothesise that the mindfulness and physical activity conditions will be more effective than the sleep hygiene and active control conditions. We hypothesise that the novel method used in this study will be able to efficiently determine the effectiveness of the interventions.

Interventions

This study will include a 10-day baseline measurement period incorporating questionnaire batteries on Day 1 (baseline) and Day 10 (mid-point), plus Ecological Momentary Assessment (EMA) from Day 1 to Day 9. The intervention period is for a duration of 14 days. All interventions in this study will be delivered via a smartphone app. Each study participant will receive one study intervention, once, over a period of 2 weeks. Interventions are self-administered. Each arm of the trial is administere

This study will include a 10-day baseline measurement period incorporating questionnaire batteries on Day 1 (baseline) and Day 10 (mid-point), plus Ecological Momentary Assessment (EMA) from Day 1 to Day 9. The intervention period is for a duration of 14 days. All interventions in this study will be delivered via a smartphone app. Each study participant will receive one study intervention, once, over a period of 2 weeks. Interventions are self-administered. Each arm of the trial is administered via a common mobile app. During the intervention period, participants will only have access to the allocated intervention. All of the app content is designed specifically for this study. Participants are instructed to complete tasks within the app each day, however the time spent interacting with the app is at their discretion (however, see below for suggested time spent engaging with intervention activities). This study is an AI-adaptive group sequential RCT. The study proceeds as a series of discrete “mini-trials”, each recruiting a sample of participants who are allocated to study arms under the control of an AI algorithm. More details on this can be found in Study Design section. Participants who complete the study (i.e. finish post-intervention questionnairs) will receive a $30 electronic gift card in recognition of their contribution to the study. In addition, if participants complete the set of follow-up questionnaires, they will go into a draw to win one of three $50 electronic gift cards available to their mini-trial group. Arm 1 Mindfulness The mindfulness intervention starts with an introductory video (3 minutes), followed by five guided mindfulness practices delivered as audio recordings (3-5 minutes in duration each). The five guided mindfulness practices are: 1) Mindful breathing, 2) Unhooking from thoughts, 3) Body scan, 4) Mindful eating, and 5) Mindful walking. The introductory video is available to participants immediately after allocation to the intervention. The first mindfulness audio guide becomes available immediately after the introductory video has been completed. The subsequent mindfulness audio guides are sequentially released, at one day intervals (regardless of participant engagement). Participants are expected to complete a minimum of one mindfulness exercise daily at their convenience and for all modules to be completed at least once by end of the intervention period. Arm 2 Physical activity The physical activity intervention starts with an introductory infographic (i.e. illustrated text that participants read), then prompts participants to choose a goal each day to increase their physical activity that day. The introductory infographic demonstrates benefits of physical activity, Australian guidelines for physical activity, setting realistic goals, and tips to increase physical activity. For the daily goal setting, participants can choose to increase their step count, follow an evidence-based 7-minute high intensity circuit training (HICT) workout, engage in other activities such as social sport, gardening, yoga etc., or opt for a rest day. Participants can review the introductory infographic and goal setting information as many times as they please throughout the intervention, however new/additional information will not be presented as the intervention period proceeds. The HICT protocol includes the following exercises: Jumping jacks, Wall sit, Push up, Abdominal crunch, Step up onto a chair, Squat, Tricep dip on chair, Plank, High knees, Lunge, Pushup and rotation, Side plank. Participants will be invited to complete a daily log of physical activity (i.e. number of minutes they spent being physically active). Participants will not receive feedback on this log during the intervention; it is intended for the research team to monitor adherence. Time spent interacting with the app during the physical activity intervention is at the discretion of the participant and depends on the physical activity chosen for each day; however, participants are expected to log their activity and set a goal each day, which is expected to take at minimum approximately 3 minutes. It is expected that physical activity will be completed daily at each participant’s convenience, including 7-minute work out three times weekly or, alternatively, increasing steps by 10% weekly. Arm 3 Sleep Hygiene The sleep hygiene intervention centres around four brief, sequential modules covering key sleep hygiene concepts which are delivered via infographics. Each module takes up to five minutes to read. Modules include: 1. Why sleep (benefits of sleep), 2. Sleep habits (regular wake/sleep time, reducing naps, wind down routine), 3. Sleep environment (environmental adjustment including impact of electronics and stimulus control information), and 4. Daily activities for sleep (diet, reducing stimulants, physical activity). The modules are made available to participants as follows: module 1 is available to participants immediately after allocation to the intervention; module 2 becomes available immediately after a participant has completed Module 1. Module 3 and Module 4 are subsequently made available at two day intervals (regardless of participant engagement). Adherence to the interventions will be measured by accessing app analytics (i.e. module completion, number of times mindfulness audio is played, number of times physical activity goal for the day is registered), and self-reported log of engagement with the intervention (i.e. daily log of time spent practising mindfulness, being physically active, or sleeping).

Sponsors

University of New South Wales
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- 18 years or older; - Living in Australia; - Currently studying at an Australian university, TAFE or other higher education institution; - Fluent in English; - Own an up-to-date smartphone, with active mobile number and internet access; and - Are experiencing elevated psychological distress, indicated by a score of 20 or higher on the Kessler Psychological Distress Scale, 10 item version (K-10) at screening.

Exclusion criteria

- People who have reported significant thoughts of suicide in the past month, indicated by a score of greater than or equal to 21 on the Suicide Ideation Attributes Scale (SIDAS). - People who self-report a current diagnosis of psychosis or bipolar disorder; - People who have been previously recruited to the study (screened eligible and consented); - People who self-report that they expect major events or disruptions in the subsequent two months that would make it difficult to participate in the study; - People who indicate they cannot safely undertake a self-guided physical activity intervention (i.e. in which they control the intensity and type of activity involved) for any reason.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 9, 2026