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

Sponsor

Universiti Putra Malaysia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05563285

Collaborator

(none)

Enrollment

Location

Arms

4.3

Anticipated Duration (Months)

15.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Smartphone Addiction Mental Health Issue	Behavioral: Exercise and Mindfulness-Based Intervention Behavioral: Control Group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Effects of Exercise and Mindfulness-Based Intervention on Emotion Regulation and Inhibitory Control of Smartphone Addiction Among Female University Students

Actual Study Start Date :

Sep 12, 2022

Anticipated Primary Completion Date :

Dec 25, 2022

Anticipated Study Completion Date :

Jan 20, 2023

Arms and Interventions

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.	Behavioral: Exercise and Mindfulness-Based Intervention 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 Behavioral: Control Group The control group maintained their classes as usual, usual physical education sessions, and usual daily life.
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.	Behavioral: Exercise and Mindfulness-Based Intervention 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 Behavioral: Control Group The control group maintained their classes as usual, usual physical education sessions, and usual daily life.

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.

Behavioral: Exercise and Mindfulness-Based Intervention

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

Behavioral: Control Group

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

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.

Behavioral: Exercise and Mindfulness-Based Intervention

Behavioral: Control Group

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

Outcome Measures

Primary Outcome Measures

Mobile Phone Addiction Index (MPAI; Assessing Change) [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.
Smartphone behavior (Time spent on smartphone use; Assessing Change) [Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)]
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) [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).
Galvanic skin response (GSR; Assessing Change of physiological state) [Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)]
Emotion regulation involves emotional responses (physiological components) such as galvanic skin response (GSR)(Bosse, 2017).
Electroencephalography (EEG; Assessing Change of physiological state) [Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)]
Emotion regulation involves emotional responses (physiological components) such as electroencephalography (EEG).
Emotion Regulation Questionnaire (ERQ; Assessing Change) [Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)]
The Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)
Positive and negative emotion scores (Assessing Change) [Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)]
Positive and negative emotion scores measured at different time points
Response Inhibition (Assessing Change of Inhibitory control) [Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)]
The measured variables were reaction time (RT) and accuracy.
Craving (Assessing Change) [Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)]
Craving for smartphones (modified desire for drinking questionnaire: Love, James, & Willner, 1998)

Secondary Outcome Measures

Psychological Symptoms (Assessing Change) [Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)]
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) [Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)]
used the Chinese version of the ULS-8 loneliness scale, which was translated by Zhou et al. for participation in China.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 23 Years

Sexes Eligible for Study:

Female

Accepts 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:

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.)