Mental Health IssueSPARKYNCT06153524
The Effect of Increasing Physical Activity or Reducing Mobile Phone Use on Mental Health in Young People in Austria
A study testing Physical activity and Smartphone time in people with Mental Health Issue, run by Danube University Krems at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Physical activity and Smartphone time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteAustria
- Study dates
- 9 Oct 2023to Apr 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Teresa O'Rourke contact
Austria1 site, 1 recruiting
- Recruiting
University for Continuing Education Krems
Krems, Lower Austria, 3500
Rachel Dale, PhD, rachel.dale@donau-uni.ac.at
Teresa O'Rourke, teresa.orourke@donau-uni.ac.at
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- Physical activity, Smartphone time
- Keywords
- intervention, adolescent, exercise, Fitbit, smartphone, depression, well-being
- Medical subject headings
- Motor Activity, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
12x weekly advice sessions and autonomous physical activity to gradually build up moderate-vigorous exercise.
Smartphone timeBehavioural
12x weekly advice sessions and autonomous use of replacement activities and strategies to gradually reduce daily smartphone use.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | 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. Receives: Behavioral: Physical activity |
| Smartphone | Experimental | 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. Receives: Behavioral: Smartphone time |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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: 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: 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?
Measured: 1 x per week during the intervention period (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start9 Oct 2023
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A three-arm randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danube University Krems
- Sponsor type
- University, hospital or other
- Collaborators
- University of Innsbruck, Austria, University of Vienna
- Responsible party
- Principal investigator, Rachel Dale, Danube University Krems
- Investigators
- Rachel Dale, PhD, Principal investigator, University for Continuing Education Krems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153524
- Sponsor's protocol ID
- 3757
- Acronym
- SPARKY
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised quantitative data will be stored open access on the DOOR repository of the University for Continuing Education Krems.
Publications
Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
PubMed 10568646Lowe B, Kroenke K, Herzog W, Grafe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004 Jul;81(1):61-6. doi: 10.1016/S0165-0327(03)00198-8.
PubMed 15183601Richardson LP, McCauley E, Grossman DC, McCarty CA, Richards J, Russo JE, Rockhill C, Katon W. Evaluation of the Patient Health Questionnaire-9 Item for detecting major depression among adolescents. Pediatrics. 2010 Dec;126(6):1117-23. doi: 10.1542/peds.2010-0852. Epub 2010 Nov 1.
PubMed 21041282Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.
PubMed 18388841Klein EM, Brahler E, Dreier M, Reinecke L, Muller KW, Schmutzer G, Wolfling K, Beutel ME. The German version of the Perceived Stress Scale - psychometric characteristics in a representative German community sample. BMC Psychiatry. 2016 May 23;16:159. doi: 10.1186/s12888-016-0875-9.
PubMed 27216151Haghayegh S, Khoshnevis S, Smolensky MH, Diller KR, Castriotta RJ. Accuracy of Wristband Fitbit Models in Assessing Sleep: Systematic Review and Meta-Analysis. J Med Internet Res. 2019 Nov 28;21(11):e16273. doi: 10.2196/16273.
PubMed 31778122Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
PubMed 21532953Kwon M, Kim DJ, Cho H, Yang S. The smartphone addiction scale: development and validation of a short version for adolescents. PLoS One. 2013 Dec 31;8(12):e83558. doi: 10.1371/journal.pone.0083558. eCollection 2013.
PubMed 24391787Schmidt J, Lamprecht F, Wittmann WW. [Satisfaction with inpatient management. Development of a questionnaire and initial validity studies]. Psychother Psychosom Med Psychol. 1989 Jul;39(7):248-55. German.
PubMed 2762479Dale R, Jesser A, Pieh C, O'Rourke T, Probst T, Humer E. Mental health burden of high school students, and suggestions for psychosocial support, 1.5 years into the COVID-19 pandemic in Austria. Eur Child Adolesc Psychiatry. 2023 Jun;32(6):1015-1024. doi: 10.1007/s00787-022-02032-4. Epub 2022 Jul 28.
PubMed 35900473
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06153524
- Acronym / sponsor ID
- SPARKY / 3757
- Conditions
- Mental Health Issue
- Keywords
- intervention, adolescent, exercise, Fitbit, smartphone, depression, well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Danube University KremsUniversity, hospital or other
- Collaborators
- University of Innsbruck, Austria, University of Vienna
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A three-arm randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Physical activityThe 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. |
| Smartphone | Experimental | Behavioral: Smartphone timeThe 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity12x weekly advice sessions and autonomous physical activity to gradually build up moderate-vigorous exercise. | Behavioural | Physical Activity |
| Smartphone time12x weekly advice sessions and autonomous use of replacement activities and strategies to gradually reduce daily smartphone use. | Behavioural | Smartphone |
Primary outcome
Change in depression score over time
Time frame: 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
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.
Change in anxiety score over time
Time frame: 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
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.
Change in well-being score over time
Time frame: 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
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.
9 secondary outcomes
Change in happiness score over time
Time frame: 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
Time frame: ISI-7 at pre-baseline and immediately at post-intervention (intervention=12weeks).
Change in sleep duration over time
Time frame: 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
Time frame: 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
Time frame: pre-baseline & post-intervention (14 weeks: 2-week baseline + 12-week intervention)
Change in smartphone addiction over time
Time frame: 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 frame: 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
Time frame: 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
Time frame: 1 x per week during the intervention period (12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 10568646Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
- Background: PubMed 15183601Lowe B, Kroenke K, Herzog W, Grafe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004 Jul;81(1):61-6. doi: 10.1016/S0165-0327(03)00198-8.
- Background: PubMed 21041282Richardson LP, McCauley E, Grossman DC, McCarty CA, Richards J, Russo JE, Rockhill C, Katon W. Evaluation of the Patient Health Questionnaire-9 Item for detecting major depression among adolescents. Pediatrics. 2010 Dec;126(6):1117-23. doi: 10.1542/peds.2010-0852. Epub 2010 Nov 1.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 18388841Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.
- Background: PubMed 27216151Klein EM, Brahler E, Dreier M, Reinecke L, Muller KW, Schmutzer G, Wolfling K, Beutel ME. The German version of the Perceived Stress Scale - psychometric characteristics in a representative German community sample. BMC Psychiatry. 2016 May 23;16:159. doi: 10.1186/s12888-016-0875-9.
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- Pre-registration of the study plan following open science principlesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymised quantitative data will be stored open access on the DOOR repository of the University for Continuing Education Krems.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa O'Rourke contact
Rachel Dale, PhD principal investigator
University for Continuing Education Krems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and Smartphone time in people with Mental Health Issue, run by Danube University Krems at 1 site in Austria.
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 6 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: status not confirmed, as of the sponsor's last update on 1 Dec 2023. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Dale, PhD (+4327328932531, rachel.dale@donau-uni.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression score over time (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06153524, which also lists 11 linked publications.
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 1 Dec 2023.