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

NCT06153524 | Unknown

• 1 other identifier: 3757
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue

Keywords

intervention; adolescent; exercise; Fitbit; smartphone; depression; well-being

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Change in happiness score over time

  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

  ISI-7 at pre-baseline and immediately at post-intervention (intervention=12weeks).

• Change in sleep duration over time

  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

  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

  pre-baseline & post-intervention (14 weeks: 2-week baseline + 12-week intervention)

Other Outcomes (1)

• Intervention acceptability

  Measured once immediately at post-intervention (intervention = 12 weeks)

Study Arms (3)

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.

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.

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.

Interventions

Physical activity BEHAVIORAL

12x weekly advice sessions and autonomous physical activity to gradually build up moderate-vigorous exercise.

Physical Activity

Smartphone time BEHAVIORAL

12x weekly advice sessions and autonomous use of replacement activities and strategies to gradually reduce daily smartphone use.

Smartphone

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Danube University Krems: lead
• University of Innsbruck: collaborator
• University of Vienna: collaborator

Study Sites (1)

University for Continuing Education Krems

Krems, Lower Austria, 3500, Austria

RECRUITING

Related Publications (11)

• 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.

  PMID: 10568646 BACKGROUND

• 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.

  PMID: 15183601 BACKGROUND

• 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.

  PMID: 21041282 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 18388841 BACKGROUND

• 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.

  PMID: 27216151 BACKGROUND

• 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.

  PMID: 31778122 BACKGROUND

• 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.

  PMID: 21532953 BACKGROUND

• 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.

  PMID: 24391787 BACKGROUND

• 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.

  PMID: 2762479 BACKGROUND

• 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.

  PMID: 35900473 BACKGROUND

Related Links

• Pre-registration of the study plan following open science principles

MeSH Terms

Conditions

Motor Activity; Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rachel Dale, PhD

  University for Continuing Education Krems

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Dale, PhD

CONTACT

+4327328932531; rachel.dale@donau-uni.ac.at

Teresa O'Rourke

CONTACT

teresa.orourke@donau-uni.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the interventions, no blinding can be involved
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: A three-arm randomised controlled trial

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: December 1, 2023
• Study Start: October 9, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available upon publication of the accompanying manuscripts and will remain online.
• Access Criteria: Open access

Locations

AU (1)