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A pilot study for delivering self-care strategies for psychological distress in university students using a smartphone app.

Delivering self-care strategies for psychological distress in university students using a smartphone app: A pilot study in preparation for an AI-response-adaptive randomised controlled non-inferiority trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001092886
Enrollment
292
Registered
2021-08-18
Start date
2021-07-15
Completion date
2021-09-09
Last updated
2021-12-27

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

Conditions

None listed

Brief summary

This study is a pilot to inform a larger RCT that will use Artificial Intelligence (AI) and adaptive trial methods to discover the most effective treatments to provide to Australian university students, 25% of whom experience severe psychological distress and, consequently, drop out of study or go on to develop more severe psychiatric disorders in their peak years. Both the pilot study and the planned RCT (to be registered after this pilot study) will compare app-delivered self-care intervention for psychological distress in tertiary students based on mindfulness, physical activity and sleep hygiene, with an active control condition consisting of Ecological Momentary Assessment (daily mood monitoring). The current pilot study aims to test the feasibility of the study infrastructure, including study app, intervention content, and the algorithm.

Interventions

This pilot 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 admin

This pilot 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 intervention that have been allocated to. All of the app content has been designed specifically for this study. Participant 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). 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). 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 minimum one mindfulness exercise daily at their convenience and for all modules to be completed at least once by end of treatment period. Arm 2 Physical activity The physical activity intervention starts with an introductory infographic, 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 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 increasing their physical activity throughout the day). 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 (i.e. illustrated text that participants read). 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).

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

The key inclusion criteria are: - 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 (e.g. anxiety, stress or low mood).

Exclusion criteria

The key exclusion criteria are: - 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 indicate limited availability to participate in a digital intervention; - People who indicate that any aspect of their personal circumstances would prevent them from taking part in a physical activity intervention, if allocated to receive this treatment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 5, 2026