- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05563285
Effect of Exercise and MBI on Female Students' Emotion Regulation and Inhibitory Control of Smartphone Addiction
Effects of Exercise and Mindfulness-Based Intervention on Emotion Regulation and Inhibitory Control of Smartphone Addiction Among Female University Students
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was divided into two groups, the exercise and mindfulness-based intervention group, and the control group. This study evaluates the effect of 8-week exercise and MBI intervention on the capacity of emotional regulation measured by physiological and psychological state and inhibitory control of smartphone addiction in female university students. The sample was Chinese female university students aged 18-23 years with infrequent exercise for smartphone addiction.
According to the literature review, the frequency of brisk walking training in this experiment was scheduled for two times/week, with a total training duration of 8 weeks. Each training session was changed within two weeks. It ranged from 60 minutes in the first and second week to 90 minutes in the eighth week of the seventh week. Brisk walking was trained using maximum heart rate to control the intensity and measured using the Borg CR10 scale after training. All exercise techniques were taught before intervention.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Liu Huange
- Phone Number: +8615619908568
- Email: liuhuange568@gmail.com
Study Contact Backup
- Name: Soh kim geok
- Phone Number: 03-97698153
- Email: kims@upm.edu.my
Study Locations
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Shaanxi
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Yulin, Shaanxi, China, 719000
- Recruiting
- Yulin University
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Contact:
- Huange Liu
- Phone Number: +8615619908568
- Email: liuhuange568@gmail.com
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Contact:
- Fengmeng Qi
- Phone Number: +8617603915127
- Email: 583135958@qq.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise and Mindfulness-Based Intervention
Patients in the intervention group will be provided exercise and mindfulness-based intervention was shown for the 1-8 weeks.
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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
The control group maintained their classes as usual, usual physical education sessions, and usual daily life.
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Active Comparator: Control Group
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.
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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
The control group maintained their classes as usual, usual physical education sessions, and usual daily life.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mobile Phone Addiction Index (MPAI; Assessing Change)
Time Frame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
|
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.
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Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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Smartphone behavior (Time spent on smartphone use; Assessing Change)
Time Frame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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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).
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Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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Heart rate (HR; Assessing Change from physiological state)
Time Frame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
|
Heart rate is used to measure exercise intensity, and Emotion regulation involves emotional responses (physiological components) such as heart rate (HR).
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Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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Galvanic skin response (GSR; Assessing Change of physiological state)
Time Frame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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Emotion regulation involves emotional responses (physiological components) such as galvanic skin response (GSR)(Bosse, 2017).
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Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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Electroencephalography (EEG; Assessing Change of physiological state)
Time Frame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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Emotion regulation involves emotional responses (physiological components) such as electroencephalography (EEG).
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Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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Emotion Regulation Questionnaire (ERQ; Assessing Change)
Time Frame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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The Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)
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Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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Positive and negative emotion scores (Assessing Change)
Time Frame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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Positive and negative emotion scores measured at different time points
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Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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Response Inhibition (Assessing Change of Inhibitory control)
Time Frame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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The measured variables were reaction time (RT) and accuracy.
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Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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Craving (Assessing Change)
Time Frame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychological Symptoms (Assessing Change)
Time Frame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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Psychological symptom using the Depression Anxiety Stress Scale-21 (DASS-21).
to measure the emotional states (Oei et al., 2013) .
This questionnaire is a short version of a self-report instrument (21 items) which measures depression, anxiety and tension/stress (negative emotional states).
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Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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Loneliness (Assessing Change)
Time Frame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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used the Chinese version of the ULS-8 loneliness scale, which was translated by Zhou et al. for participation in China.
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Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Liu Huange, University Putra Malaysia
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: Brain Res. 2012 Aug 27;1470:159.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Huange Liu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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