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Effect of Exercise and MBI on Female Students' Emotion Regulation and Inhibitory Control of Smartphone Addiction

Primary Purpose

Smartphone Addiction, Mental Health Issue

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Exercise and Mindfulness-Based Intervention
Control Group
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Smartphone Addiction focused on measuring Exercise, Mindfulness-Based Intervention, Smartphone Addiction, Emotion Regulation, Inhibitory Control, Female University Students

Eligibility Criteria

18 Years - 23 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female.
  2. Aged 18 to 23.
  3. Good health, no apparent speech disorder.
  4. According to Leung's assessment scale, MAPI scores had to be more than 40 (out of 85) (Leung, 2008) .
  5. .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)
  6. Have time to ensure that you can attend every counseling on time.
  7. 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.
  8. Subjects were able to participate and complete exercise training independently without any assistive devices.
  9. 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:

    1. 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.
    2. Who are unable to move due to injury or illness and drop out of school .
    3. Those who were undergoing other psychotherapeutic treatments were also excluded from the study.
    4. Excluded students with sports contraindications and time conflicts.
    5. They have participated with exercise in the past three months (e.g., walking, running, weight training, etc.)

Sites / Locations

  • Yulin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise and Mindfulness-Based Intervention

Control Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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).
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).
Galvanic skin response (GSR; Assessing Change of physiological state)
Emotion regulation involves emotional responses (physiological components) such as galvanic skin response (GSR)(Bosse, 2017).
Electroencephalography (EEG; Assessing Change of physiological state)
Emotion regulation involves emotional responses (physiological components) such as electroencephalography (EEG).
Emotion Regulation Questionnaire (ERQ; Assessing Change)
The Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)
Positive and negative emotion scores (Assessing Change)
Positive and negative emotion scores measured at different time points
Response Inhibition (Assessing Change of Inhibitory control)
The measured variables were reaction time (RT) and accuracy.
Craving (Assessing Change)
Craving for smartphones (modified desire for drinking questionnaire: Love, James, & Willner, 1998)

Secondary Outcome Measures

Psychological Symptoms (Assessing Change)
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).
Loneliness (Assessing Change)
used the Chinese version of the ULS-8 loneliness scale, which was translated by Zhou et al. for participation in China.

Full Information

First Posted
September 25, 2022
Last Updated
October 1, 2022
Sponsor
Universiti Putra Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05563285
Brief Title
Effect of Exercise and MBI on Female Students' Emotion Regulation and Inhibitory Control of Smartphone Addiction
Official Title
Effects of Exercise and Mindfulness-Based Intervention on Emotion Regulation and Inhibitory Control of Smartphone Addiction Among Female University Students
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
December 25, 2022 (Anticipated)
Study Completion Date
January 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Putra Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smartphone Addiction, Mental Health Issue
Keywords
Exercise, Mindfulness-Based Intervention, Smartphone Addiction, Emotion Regulation, Inhibitory Control, Female University Students

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise and Mindfulness-Based Intervention
Arm Type
Experimental
Arm Description
Patients in the intervention group will be provided exercise and mindfulness-based intervention was shown for the 1-8 weeks.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise and Mindfulness-Based Intervention
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
The control group maintained their classes as usual, usual physical education sessions, and usual daily life.
Primary Outcome Measure Information:
Title
Mobile Phone Addiction Index (MPAI; Assessing Change)
Description
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.
Time Frame
Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Title
Smartphone behavior (Time spent on smartphone use; Assessing Change)
Description
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).
Time Frame
Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Title
Heart rate (HR; Assessing Change from physiological state)
Description
Heart rate is used to measure exercise intensity, and Emotion regulation involves emotional responses (physiological components) such as heart rate (HR).
Time Frame
Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Title
Galvanic skin response (GSR; Assessing Change of physiological state)
Description
Emotion regulation involves emotional responses (physiological components) such as galvanic skin response (GSR)(Bosse, 2017).
Time Frame
Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Title
Electroencephalography (EEG; Assessing Change of physiological state)
Description
Emotion regulation involves emotional responses (physiological components) such as electroencephalography (EEG).
Time Frame
Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Title
Emotion Regulation Questionnaire (ERQ; Assessing Change)
Description
The Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)
Time Frame
Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Title
Positive and negative emotion scores (Assessing Change)
Description
Positive and negative emotion scores measured at different time points
Time Frame
Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Title
Response Inhibition (Assessing Change of Inhibitory control)
Description
The measured variables were reaction time (RT) and accuracy.
Time Frame
Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Title
Craving (Assessing Change)
Description
Craving for smartphones (modified desire for drinking questionnaire: Love, James, & Willner, 1998)
Time Frame
Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Secondary Outcome Measure Information:
Title
Psychological Symptoms (Assessing Change)
Description
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).
Time Frame
Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Title
Loneliness (Assessing Change)
Description
used the Chinese version of the ULS-8 loneliness scale, which was translated by Zhou et al. for participation in China.
Time Frame
Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Huange
Phone
+8615619908568
Email
liuhuange568@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Soh Kim Geok
Phone
03-97698153
Email
kims@upm.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Huange
Organizational Affiliation
University Putra Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yulin University
City
Yulin
State/Province
Shaanxi
ZIP/Postal Code
719000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huange Liu
Phone
+8615619908568
Email
liuhuange568@gmail.com
First Name & Middle Initial & Last Name & Degree
Fengmeng Qi
Phone
+8617603915127
Email
583135958@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Since this is my doctoral thesis experiment, I won't share it until I graduate.
Citations:
PubMed Identifier
32704524
Citation
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.
Results Reference
background
PubMed Identifier
22480735
Citation
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.
Results Reference
background
PubMed Identifier
34394381
Citation
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.
Results Reference
background
PubMed Identifier
29669599
Citation
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.
Results Reference
background
PubMed Identifier
31618879
Citation
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.
Results Reference
background
PubMed Identifier
27574603
Citation
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.
Results Reference
background
PubMed Identifier
35299822
Citation
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.
Results Reference
background
Links:
URL
http://doi.org/10.1093/OCCMED/KQX063
Description
The Borg Rating of Perceived Exertion (RPE) scale

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Effect of Exercise and MBI on Female Students' Emotion Regulation and Inhibitory Control of Smartphone Addiction

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