The Effect of Increasing Physical Activity or Reducing Mobile Phone Use on Mental Health in Young People in Austria
NCT ID: NCT06153524
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
144 participants
INTERVENTIONAL
2023-10-09
2025-04-30
Brief Summary
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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
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Hypotheses:
The predictions can be divided into two categories: 1. improvements in mental health and 2. assessing behaviour change. All hypotheses are directional.
1. 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.
2. 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Physical Activity
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.
Physical activity
12x weekly advice sessions and autonomous physical activity to gradually build up moderate-vigorous exercise.
Smartphone
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.
Smartphone time
12x weekly advice sessions and autonomous use of replacement activities and strategies to gradually reduce daily smartphone use.
Control
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.
No interventions assigned to this group
Interventions
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Physical activity
12x weekly advice sessions and autonomous physical activity to gradually build up moderate-vigorous exercise.
Smartphone time
12x weekly advice sessions and autonomous use of replacement activities and strategies to gradually reduce daily smartphone use.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
14 Years
19 Years
ALL
Yes
Sponsors
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University of Innsbruck
UNKNOWN
University of Vienna
OTHER
Danube University Krems
OTHER
Responsible Party
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Rachel Dale
Dr
Principal Investigators
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Rachel Dale, PhD
Role: PRINCIPAL_INVESTIGATOR
University for Continuing Education Krems
Locations
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University for Continuing Education Krems
Krems, Lower Austria, Austria
Countries
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Central Contacts
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Facility Contacts
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Rachel Dale, PhD
Role: primary
Teresa O'Rourke
Role: backup
References
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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.
Lowe 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.
Richardson 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.
Spitzer 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.
Lowe 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.
Klein 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.
Haghayegh 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.
Morin 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.
Kwon 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.
Schmidt 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.
Dale 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.
Related Links
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Pre-registration of the study plan following open science principles
Other Identifiers
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3757
Identifier Type: -
Identifier Source: org_study_id