NCT05563285

Brief Summary

Mobile-based technology is advancing at an unprecedented rate, and in the past decade, smartphone use has become common among today's university students, who have mental health. A lot of attention has been paid in the media to the existence of "smartphone addiction" or problematic smartphone use(Sohn et al., 2019).Overuse of smartphones can cause health problems(Adams \& Kisler, 2013; Demirci et al., 2015). As an interdisciplinary subject, this study aimed at university students' smartphone addiction behavior research, understand the information era of college students' way of behavior patterns, exercise and psychological intervention strategy is put forward, to evaluate exercise and MBI intervention,and reduction of university students' smartphone addiction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

September 25, 2022

Last Update Submit

October 1, 2022

Conditions

Keywords

ExerciseMindfulness-Based InterventionSmartphone AddictionEmotion RegulationInhibitory ControlFemale University Students

Outcome Measures

Primary Outcomes (9)

  • Mobile Phone Addiction Index (MPAI; Assessing Change)

    Smartphone addiction was assessed using the Mobile Phone Addiction Index (MPAI) (Leung, L. ,2008), which was translated into Chinese (Huang H,et,al.,2014) and is used widely in Chinese contexts (Zhao Y, 2019 \& Chen Y,et,al.,2019). The MPAI contains 17 items assessing four domains: inability to control craving, feeling anxious and lost, withdrawal/escape, and productivity loss. Each item is responded to from 1 ("not at all") to 5 ("always"). Final scores were summed and higher total scores reflect higher levels of smartphone addiction. The Cronbach's alpha of the MPAI was 0.86 in the present study.

    Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  • Smartphone behavior (Time spent on smartphone use; Assessing Change)

    Subjects (respondents) will answer through six relevant time categories. "Less than 10 minutes", "11-60 minutes", "1-2 hours", "3-4 hours", "5-6 hours", or "more than 6 hours". For the type of functionality of the smartphone software used, the subjects (respondents) used a 5-point Likert scale (0 = never, 1 = rarely, 2 = sometimes, 3 = usually, 4 = always).

    Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  • Heart rate (HR; Assessing Change from physiological state)

    Heart rate is used to measure exercise intensity, and Emotion regulation involves emotional responses (physiological components) such as heart rate (HR).

    Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  • Galvanic skin response (GSR; Assessing Change of physiological state)

    Emotion regulation involves emotional responses (physiological components) such as galvanic skin response (GSR)(Bosse, 2017).

    Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  • Electroencephalography (EEG; Assessing Change of physiological state)

    Emotion regulation involves emotional responses (physiological components) such as electroencephalography (EEG).

    Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  • Emotion Regulation Questionnaire (ERQ; Assessing Change)

    The Emotion Regulation Questionnaire (ERQ; Gross \& John, 2003)

    Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  • Positive and negative emotion scores (Assessing Change)

    Positive and negative emotion scores measured at different time points

    Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  • Response Inhibition (Assessing Change of Inhibitory control)

    The measured variables were reaction time (RT) and accuracy.

    Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  • Craving (Assessing Change)

    Craving for smartphones (modified desire for drinking questionnaire: Love, James, \& Willner, 1998)

    Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

Secondary Outcomes (2)

  • Psychological Symptoms (Assessing Change)

    Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  • Loneliness (Assessing Change)

    Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

Study Arms (2)

Exercise and Mindfulness-Based Intervention

EXPERIMENTAL

Patients in the intervention group will be provided exercise and mindfulness-based intervention was shown for the 1-8 weeks.

Behavioral: Exercise and Mindfulness-Based InterventionBehavioral: Control Group

Control Group

ACTIVE COMPARATOR

Control group will not receive exercise and mindfulness-based intervention however, primary care service providers and mental health professionals will provide any required routine care according to their clinical judgment and available resources.

Behavioral: Exercise and Mindfulness-Based InterventionBehavioral: Control Group

Interventions

1.Exercise Intervention 1st-2nd week: 15 min for Brisk walking. Intensity: HRmax (60%-65%); CR10 (5-6). 3rd-4th week: 20 min for Brisk walking. Intensity:HRmax (65%-70%); CR10 (6-7). 5th-6th week: 25 min for Brisk walking. BW: Intensity: HRmax(70%-75%); CR10 (6-7). 7th -8th week:30 min for Brisk walking. Exercise Intervention basic content: (1) Gradually increase the walking speed; (2) Slowly reduce the speed; (3) Rest for 5 min. 2\. Mindfulness-Based Intervention 1st-2nd week: 30 min for mindfulness training. 3rd-4th week: 35 min for mindfulness training. 5th-6th week: 40 min for mindfulness training. 7th-8th week: 45 min for mindfulness training. Mindfulness-Based Intervention basic content: (1) Yoga; (2) Mindful breathing; (3) Mindfulness meditation; (4) Body scan; (5) Mindfulness awareness; (6) RAIN technique; (7) Mindful Stretching; (8) Mindful walking; (9) Mindful running

Control GroupExercise and Mindfulness-Based Intervention
Control GroupBEHAVIORAL

The control group maintained their classes as usual, usual physical education sessions, and usual daily life.

Control GroupExercise and Mindfulness-Based Intervention

Eligibility Criteria

Age18 Years - 23 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female.
  • Aged 18 to 23.
  • Good health, no apparent speech disorder.
  • According to Leung's assessment scale, MAPI scores had to be more than 40 (out of 85) (Leung, 2008) .
  • Without cardiovascular, metabolic, renal, or pulmonary diseases, symptoms, psychological disorders, or a history of alcohol abuse.And no participation in similar research projects before (using medication for psychiatric problems and undergoing other psychotherapeutic remedies)
  • Have time to ensure that you can attend every counseling on time.
  • They did no longer take part in any structured exercise in the past three months (e.g., walking, Tai Chi, basketball, badminton, running, yoga, weight training, etc.), and without experience of mindfulness training.
  • Subjects were able to participate and complete exercise training independently without any assistive devices.
  • Capable to be engaged, participate or respond to the research question,and willing to give informed consent.

You may not qualify if:

  • Those who satisfy any of the following conditions shall be excluded:
  • Mobile Phone Addiction Index (MPAI) scores below 40 They had major disease (respiratory illness, musculoskeletal disorder, dementia and metabolic, cardiovascular disease, and renal, or pulmonary diseases) and any psychosis or other severe psychiatric disorders. Records of extreme physical or psychological problems, which includes different addictive disorders, psychotic disorders, primary depression, borderline personality disorder, or antisocial character disease primarily based on the clinical psychologist's view or observations and oral questioning.
  • Who are unable to move due to injury or illness and drop out of school .
  • Those who were undergoing other psychotherapeutic treatments were also excluded from the study.
  • Excluded students with sports contraindications and time conflicts.
  • They have participated with exercise in the past three months (e.g., walking, running, weight training, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yulin University

Yulin, Shaanxi, 719000, China

RECRUITING

Related Publications (7)

  • Billones R, Saligan L. What Works in Mindfulness Interventions for Medically Unexplained Symptoms? A Systematic Review. Asian Pac Isl Nurs J. 2020;5(1):1-11. doi: 10.31372/20200501.1082.

    PMID: 32704524BACKGROUND
  • Chang YK, Labban JD, Gapin JI, Etnier JL. The effects of acute exercise on cognitive performance: a meta-analysis. Brain Res. 2012 May 9;1453:87-101. doi: 10.1016/j.brainres.2012.02.068. Epub 2012 Mar 4.

    PMID: 22480735BACKGROUND
  • Fan H, Qi S, Huang G, Xu Z. Effect of Acute Aerobic Exercise on Inhibitory Control of College Students with Smartphone Addiction. Evid Based Complement Alternat Med. 2021 Aug 5;2021:5530126. doi: 10.1155/2021/5530126. eCollection 2021.

    PMID: 34394381BACKGROUND
  • Garland EL, Howard MO. Mindfulness-based treatment of addiction: current state of the field and envisioning the next wave of research. Addict Sci Clin Pract. 2018 Apr 18;13(1):14. doi: 10.1186/s13722-018-0115-3.

    PMID: 29669599BACKGROUND
  • Liu S, Xiao T, Yang L, Loprinzi PD. Exercise as an Alternative Approach for Treating Smartphone Addiction: A Systematic Review and Meta-Analysis of Random Controlled Trials. Int J Environ Res Public Health. 2019 Oct 15;16(20):3912. doi: 10.3390/ijerph16203912.

    PMID: 31618879BACKGROUND
  • Stanton MV, Matsuura J, Fairchild JK, Lohnberg JA, Bayley PJ. Mindfulness as a Weight Loss Treatment for Veterans. Front Nutr. 2016 Aug 15;3:30. doi: 10.3389/fnut.2016.00030. eCollection 2016.

    PMID: 27574603BACKGROUND
  • Zhou J, Wang L. Differences in the Effects of Reading and Aerobic Exercise Interventions on Inhibitory Control of College Students With Mobile Phone Addiction. Front Psychiatry. 2022 Mar 1;13:797780. doi: 10.3389/fpsyt.2022.797780. eCollection 2022.

    PMID: 35299822BACKGROUND

MeSH Terms

Conditions

Internet Addiction DisorderMotor ActivityEmotional Regulation

Interventions

ExerciseControl Groups

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorSelf-ControlSocial Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Liu Huange

    University Putra Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: In this experiment, the combination of Exercise and Mindfulness-Based Intervention method was used to intervene the smartphone addiction of female university students' emotion regulation and inhibitory control compared with the usual PE sessions method. Each parallel group has female separately.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2022

First Posted

October 3, 2022

Study Start

September 12, 2022

Primary Completion

December 25, 2022

Study Completion

January 20, 2023

Last Updated

October 4, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Since this is my doctoral thesis experiment, I won't share it until I graduate.

Locations