Clinical trial NCT06153524: The Effect of Increasing Physical Activity or Reducing Mobile Phone Use on Mental Health in Young People in Austria
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Keywords: intervention
adolescent
exercise
Fitbit
smartphone
depression
well-being
Lead sponsor: Danube University Krems
Sponsor class: OTHER
Collaborators: name: University of Innsbruck
name: University of Vienna
First posted: 2023-12-01
Enrollment: 144
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A three-arm randomised controlled trial
Primary purpose: PREVENTION

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.

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.

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.

Primary outcomes:
measure: Change in depression score over time
timeFrame: 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
measure: Change in anxiety score over time
timeFrame: 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
measure: Change in well-being score over time
timeFrame: 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:
measure: Change in happiness score over time
timeFrame: 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
measure: Change in sleep quality over time
timeFrame: ISI-7 at pre-baseline and immediately at post-intervention (intervention=12weeks).
measure: Change in sleep duration over time
timeFrame: 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)
measure: Change in perceived stress score over time
timeFrame: 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
measure: Change in cortisol levels over time
timeFrame: pre-baseline & post-intervention (14 weeks: 2-week baseline + 12-week intervention)
measure: Change in smartphone addiction over time
timeFrame: 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
measure: Change in smartphone usage over time
timeFrame: 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)
measure: Change in physical activity over time
timeFrame: 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).
measure: Qualitative measures
timeFrame: 1 x per week during the intervention period (12 weeks)
Other outcomes:
measure: Intervention acceptability
timeFrame: Measured once immediately at post-intervention (intervention = 12 weeks)
Locations:
city: Krems
country: Austria
facility: University for Continuing Education Krems
state: Lower Austria
Study officials:
affiliation: University for Continuing Education Krems
name: Rachel Dale, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.