Digital Detox Study: A Randomized Controlled Trial

NCT06353451 | Completed

• 1 other identifier: EK GZ 67/2021-2024
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present RCT is to investigate the effect of smartphone screen time reduction on mental health indicators in healthy, 18-29 yo Austrian students. After inclusion and randomization to intervention- and control group, normal screen time behavior will be assessed for 10-days. After that, the mental health parameters will be carried out in both groups as a baseline survey (T0). After that, intervention group should limit smartphone screen time to less than 2 hours per day for three consecutive weeks. Control group should use smartphones as usual. After that, mental health parameters will be assessed again in both groups (post-intervention, T1). After T1, there are no further requirements regarding screen time. Mental health parameters will be assessed again in both groups at follow-up (T2). Main outcome parameters are 1) Well-Being (WHO-5), depressive symptoms (PHQ-9), stress (PSQ-20), and sleep quality (ISI). The primary hypothesis (stated at Open Science Framework before Enrollment: https://osf.io/a9k76) is that mental health indicators, particularly stress, depressive symptoms, and sleep quality will improve throughout the intervention compared to the control group as well as to baseline.

Conditions

Health Behavior

Keywords

Smartphone screen time; Digital Detox; Social Media Detox

Outcome Measures

Primary Outcomes (4)

• Depressive Symptoms

  Patient Health Questionnaire (PHQ-9): The PHQ-9 contains nine self-rating items on a four-point scale ranging from 0 ("not at all") to 3 ("nearly every day"), resulting in a total score from 0 to 27. Higher scores indicate more depressive symptoms.

  The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).

• Stress

  Perceived Stress Questionnaire (PSQ-20): Each item is rated from almost never (=1) to usually (= 4), with a sum score from 20 to 80. Higher scores indicate more stress.

  The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).

• Sleep Quality

  Insomnia Severity Index (ISI): The ISI comprises 7 self-reported items, each rated on a scale from 0 to 4, resulting in sum scores from 0 to 28. Higher scores indicate more insomnia symptoms or less sleep quality.

  The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).

• Well-being

  World Health Organization well-being questionnaire (WHO-5): The WHO-5 contains 5 items (0 to 5 points). Scores range from 0 (no well-being) to 25 points (maximal well-being).

  The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).

Secondary Outcomes (4)

• Problematic smartphone use

  The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).

• Body Appreciation

  The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).

• Anxiety Symptoms

  The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).

• Eating Disorder

  The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).

Other Outcomes (4)

• Physical Activity

  Physical activity was recorded from the beginning of the baseline phase for the duration of 5 weeks (2 weeks baseline, 3 weeks intervention) and stopped after intervention (=t1).

• Heart rate variability (HRV)

  HRV was recorded from the beginning of the baseline phase for the duration of 5 weeks (= 2 weeks baseline, 3 weeks intervention) and stopped after intervention (=t1).

• Resting Heart Rate (RHR)

  RHR was recorded from the beginning of the baseline phase for the duration of 5 weeks (= 2 weeks baseline, 3 weeks intervention) and stopped after intervention (=t1).

Study Arms (2)

Intervention Group

EXPERIMENTAL

Smartphone screen time should be reduced to less than 2 hours per day for 3 consecutive weeks. Screen time will be controlled by screenshots weekly.

Behavioral: Digital Detox

Control group

NO INTERVENTION

Smartphone usage behavior should continue unchanged. Screen time will be measured by uploaded screenshots weekly.

Interventions

Digital Detox BEHAVIORAL

In the intervention group, smartphone screen time will be reduced to less than 2 hours for 3 consecutive weeks.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• male/female
• daily screen time \> 3 h/d
• no mental disorder
• no ongoing psychotherapy
• no psychotropic drugs

You may not qualify if:

• \< 18 yo or \> 29 yo
• daily screen time \< 3 h/d
• mental disorder (self-statement)
• in ongoing psychotherapy
• psychotropic drug use

Sponsors & Collaborators

• Danube University Krems: lead

Study Sites (1)

Danube University Krems

Krems, Lower Austria, 3500, Austria

Location

Related Publications (1)

• Dale R, Haider K, Majdandzic J, Hoenigl A, Schwab J, Pieh C. The influence of smartphone reduction on heart rate variability: a secondary analysis from a randomised controlled trial. Health Psychol Behav Med. 2025 Aug 16;13(1):2546376. doi: 10.1080/21642850.2025.2546376. eCollection 2025.

  PMID: 40831581 DERIVED

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Christoph Pieh, MD

  Danube University Krems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor and Head of Department

Model Details: Two groups, non blinded, randomized controlled trial

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 9, 2024
• Study Start: October 23, 2023
• Primary Completion: January 21, 2024
• Study Completion: January 21, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)