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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

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:

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:
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

NCT ID

NCT05563285

First Posted

September 25, 2022

Last Updated

October 1, 2022

Sponsor

Universiti Putra Malaysia

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

Studies a U.S. FDA-regulated Device Product

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

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

Time Frame