Clinical trial NCT05563285: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Smartphone Addiction
Mental Health Issue
Keywords: Exercise
Mindfulness-Based Intervention
Smartphone Addiction
Emotion Regulation
Inhibitory Control
Female University Students
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Mobile Phone Addiction Index (MPAI; Assessing Change)
timeFrame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
measure: Smartphone behavior (Time spent on smartphone use; Assessing Change)
timeFrame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
measure: Heart rate (HR; Assessing Change from physiological state)
timeFrame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
measure: Galvanic skin response (GSR; Assessing Change of physiological state)
timeFrame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
measure: Electroencephalography (EEG; Assessing Change of physiological state)
timeFrame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
measure: Emotion Regulation Questionnaire (ERQ; Assessing Change)
timeFrame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
measure: Positive and negative emotion scores (Assessing Change)
timeFrame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
measure: Response Inhibition (Assessing Change of Inhibitory control)
timeFrame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
measure: Craving (Assessing Change)
timeFrame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Secondary outcomes:
measure: Psychological Symptoms (Assessing Change)
timeFrame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
measure: Loneliness (Assessing Change)
timeFrame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Other outcomes:
Locations:
city: Yulin
country: China
facility: Yulin University
state: Shaanxi
Study officials:
affiliation: University Putra Malaysia
name: Liu Huange
role: PRINCIPAL_INVESTIGATOR
References:
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.
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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.
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.
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.
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.
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.