The Effect of Increasing Physical Activity or Reducing Mobile Phone Use on Mental Health in Young People in Austria

Study Overview
=================
Brief Summary
-----------------
Introduction: Data show adolescent mental health has declined in recent years, possibly due to increased uncertainty and loss of opportunities. The SPARKY study aims to test an at-home intervention which aims to promote autonomous healthy levels of physical activity and smartphone use, in turn reducing clinical mental illness symptoms and increasing wellbeing. Methods and analysis: Adolescents (14-19 years) in Austria and Germany will be recruited and randomised into one of three groups (physical activity, smartphone, control). The physical activity (PA) and smartphone time (ST) groups will be guided over 12-weeks to increase PA or decrease ST respectively. All groups will objectively measure PA using wrist-worn trackers and ST using an app and will regularly self-report on standardised mental health scales. Analyses will be run to assess the pre-post changes in mental health in the intervention groups compared to the control. Ethics and dissemination: The conduct of the trial was approved by the institutional research ethics board and written informed consent will be obtained from participants and the parents of those under 18. Data will be stored open access. Findings will be disseminated through conferences, media interviews and publications to peer-reviewed journals. Overall, mental health interventions are sorely needed in adolescents to counteract the effects of the pandemic and other uncertainties. The at-home nature of the intervention will promote autonomous healthy habit formation in youth.

Detailed Description
-----------------
Design: A three-arm randomised controlled trial with a physical activity group, a smartphone-use group and a control group. Outcome assessments are to be conducted at baseline, biweekly during the intervention, at three months (post-intervention), and at one month, six months and one year post-intervention (follow-ups). The study is not blinded. Hypotheses: The predictions can be divided into two categories: 1. improvements in mental health and 2. assessing behaviour change. All hypotheses are directional. Mental health: The primary hypothesis is that the intervention groups will show a greater improvement in their mental health than the control group from pre- to post-intervention. Secondly, it is predicted that these improvements in mental health will be sustained at the follow-up stage. Thirdly, those individuals who meet the goals will have better mental health than those who do not. Behaviour change: As a measure of the success of the intervention, it is predicted that those in the intervention groups will be more likely to meet the physical activity and screen time goals at post-intervention and follow-up than the control group. Finally, it can be predicted that merely tracking daily activity and screen time is enough to promote some behaviour change and therefore it is predicted that the control group will be more likely to meet the goals at post-intervention than pre-intervention.

Official Title
-----------------
The Effect of Increasing Physical Activity or Reducing Mobile Phone Use on Mental Health in Young People in Austria: a Randomised Controlled Trial

Conditions
-----------------
Mental Health Issue

Intervention / Treatment
-----------------
* Behavioral: Physical activity
* Behavioral: Smartphone time


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 14-19 own a smartphone use their phones more than 4 hours per days do less than 60 minutes of vigorous sport on 3 days per week and/or less than 60 minutes of moderate activity on 5 days per week. conduct work/school in German hair at least 1cm long Exclusion Criteria: should not be in current medical care or have physical constraints which affect movement. should not have a diagnosis of schizophrenia/psychotic disorder, substance use disorder, symptoms of an eating disorder (≥2 positive answers on SCOFF questionnaire). should not have dyed hair. Participants will complete an online screening questionnaire to assess eligibility for inclusion.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A three-arm randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity<br>The PA group will be guided by sports scientists to progressively build up to 60-minutes of daily moderate-vigorous exercise. The goals will be tailored to existing activity levels so as not to increase physical activity too quickly and will be set out in an action plan to be handed out at the beginning of the intervention. For the autonomous PA plan, participants from the PA group will be given Fitbits and a comprehensive manual of instructions to help them build their own weekly plan, and they will participate in weekly online meetings. The manual is structured with four main sections: 1. General information on training, 2. Moderate activity, 3. Vigorous activity, 4. Training agenda. The latter is for the participants to fill in after every training session. This information is then cross-checked by the PA specialists with the comments gathered during the weekly meetings. | Behavioral: Physical activity<br>* 12x weekly advice sessions and autonomous physical activity to gradually build up moderate-vigorous exercise.<br>|
| Experimental: Smartphone<br>The ST group will be guided by psychologists/psychotherapists to reduce their average daily phone use by 50% over the first two months of the intervention and to maintain this for the final month, and this will be measured using a screen time recording application. This intervention group will receive a list of nudge strategies (adapted from Olson et al., 2022) to add small barriers which guide them into reducing their phone use (e.g. disabling notifications, not using phone in bed). Participants will select three strategies (minimum) to try in the first month, then an additional two (minimum) for the second month. They will also receive a list of potential replacement activities to do instead of using their phone and are asked to choose which activities they want to try and/or list their own ideas. How easy/difficult each strategy is, how enjoyable the replacement activities are, and whether they want to change will be discussed in the meetings. | Behavioral: Smartphone time<br>* 12x weekly advice sessions and autonomous use of replacement activities and strategies to gradually reduce daily smartphone use.<br>|
| No Intervention: Control<br>The control group will receive basic written explanatory information on the study and will then simply record all their physical activity and screen time, without being set specific goals. This group will receive a list of mental health resources, all materials for increasing physical activity and reducing screen time and will be invited to a psychoeducation talk at the end of the study. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression score over time | Depression will be assessed using the 9-item self-report Patient Health Questionnaire (PHQ-9, validated in German). Items refer to the last two weeks and are rated on a 4-point Likert scale from not at all (0) to nearly every day (3). The scores range from 0-27 and cut-offs of ≥11 for those 18 or under and ≥10 for those over 18 indicate clinically relevant symptoms. Measured in all three groups online via the ESMira app. | pre-baseline, post-baseline (baseline = 2-weeks), every other week during the intervention period (12 weeks), at immediately at post-intervention (intervention = 12-weeks) and at 1-month, 6-months and 1-year post-intervention | 
| Change in anxiety score over time | Anxiety will be measure using the self-report Generalized Anxiety Disorder Scale (GAD-7; validated in German). The seven items on a four-point scale can result in a maximum score of 21 and the cut-offs for clinically relevant symptoms are ≥11 in those 18 and under and ≥10 in over 18s. Measured in all three groups online via the ESMira app. | pre-baseline, post-baseline (baseline = 2-weeks), every other week during the intervention period (12 weeks), at immediately at post-intervention (intervention = 12-weeks) and at 1-month, 6-months and 1-year post-intervention | 
| Change in well-being score over time | Well-being will be assessed using the World Health Organisation-five well-being index (WHO-5; validated in German) which consists of five items with scores ranging from 0 (no well-being) to 100 (maximal well-being). Measured in all three groups online via the ESMira app. | pre-baseline, post-baseline (baseline = 2-weeks), every other week during the intervention period (12 weeks), at immediately at post-intervention (intervention = 12-weeks) and at 1-month, 6-months and 1-year post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in happiness score over time | Happiness will be assessed using the Cantril ladder whereby participants are asked to rate the status of their lives on a scale of 1 (hopeless) to 10 (prospering). Measured in all three groups online via the ESMira app. | pre-baseline, post-baseline (baseline = 2-weeks), every other week during the intervention period (12 weeks), at immediately at post-intervention (intervention = 12-weeks) and at 1-month, 6-months and 1-year post-intervention | 
| Change in sleep quality over time | Sleep quality will be assessed with the Insomnia Severity Index (ISI-7; validated in German), a 5-point scale with a score of ≥22 representing severe insomnia symptoms. ISI-7 measured in all three groups online via the ESMira app. | ISI-7 at pre-baseline and immediately at post-intervention (intervention=12weeks). | 
| Change in sleep duration over time | Sleep duration will be assessed using the Fitbit Inspire 3 devices. While Fitbits are not as accurate as polysomnography, recent-generation models perform fairly well at estimating sleep parameters and will therefore be used for within-subject pre-post assessments but not for inter-group comparisons. Sleep duration measured daily via Fitbit tracker. | daily during baseline period (2 weeks), daily during intervention period (12 weeks) and daily during 1-month, 6-month and 1-year follow-ups (1 week each) | 
| Change in perceived stress score over time | Stress will be assessed using the Perceived Stress Scale (PSS-10; validated in German); a 10-item questionnaire with five-point scales. PSS-10 measured in all groups online via the ESMira app. | pre-baseline, post-baseline (baseline = 2-weeks), every other week during the intervention period (12 weeks), at immediately at post-intervention (intervention = 12-weeks) and at 1-month, 6-months and 1-year post-intervention | 
| Change in cortisol levels over time | Hair cortisol as a biomarker for chronic stress will be assessed. Hair samples will be collected by the participants themselves and sent by post. | pre-baseline & post-intervention (14 weeks: 2-week baseline + 12-week intervention) | 
| Change in smartphone addiction over time | Participants will complete the Smartphone Addiction Scale - short version (SAS-SV; validated in German). This scale is 10 items scored from 1-6 resulting in a maximum score of 60. The cut-off score considered as a smartphone addiction in adolescents is 31 for boys and 33 for girls. SAS-SV measured in all groups online via the ESMira app. | pre-baseline, post-baseline (baseline = 2-weeks), every other week during the intervention period (12 weeks), at immediately at post-intervention (intervention = 12-weeks) and at 1-month, 6-months and 1-year post-intervention | 
| Change in smartphone usage over time | Time spent using the smartphone will be assessed with an objective app to measure daily overall screen time (ESMira). | measured daily via the ESMira app over baseline period (2 weeks), during the intervention period (12 weeks) and daily during 1-month, 6-month and 1-year follow-ups (1 week each) | 
| Change in physical activity over time | Physical activity will primarily be measured using the Fitbit Inspire 3 devices. The Fitbit app designates activities as light, moderate or vigorous. Time spent in moderate and vigorous activity will be recorded. Furthermore, the question on how many days in the last week were you physically active for at least 60 minutes will be asked. This allows comparison to data previously collected on youth. | Measured daily via Fitbit trackers over baseline period (2 weeks), during the intervention period (12 weeks) and daily during 1-month, 6-month and 1-year follow-ups (1 week each). | 
| Qualitative measures | Qualitative measures will include content analysis of the weekly online meetings, which will be recorded for this purpose. The discussions each week will be free but will include the same overall structure (see interventions section). The first and last sessions will include additional questions for qualitative analysis: e.g. what are your current burdens/stressors? What is your current mood? | 1 x per week during the intervention period (12 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intervention, adolescent, exercise, Fitbit, smartphone, depression, well-being