Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05563285
Other study ID # Huange Liu
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 12, 2022
Est. completion date January 20, 2023

Study information

Verified date October 2022
Source Universiti Putra Malaysia
Contact Liu Huange
Phone +8615619908568
Email liuhuange568@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date January 20, 2023
Est. primary completion date December 25, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 23 Years
Eligibility 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.)

Study Design


Intervention

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

Locations

Country Name City State
China Yulin University Yulin Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. — View 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. — View 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. Review. — View 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). pii: E3912. doi: 10.3390/ijerph16203912. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Primary 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). Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Primary 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). Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Primary Galvanic skin response (GSR; Assessing Change of physiological state) Emotion regulation involves emotional responses (physiological components) such as galvanic skin response (GSR)(Bosse, 2017). Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Primary Electroencephalography (EEG; Assessing Change of physiological state) Emotion regulation involves emotional responses (physiological components) such as electroencephalography (EEG). Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Primary Emotion Regulation Questionnaire (ERQ; Assessing Change) The Emotion Regulation Questionnaire (ERQ; Gross & John, 2003) Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Primary Positive and negative emotion scores (Assessing Change) Positive and negative emotion scores measured at different time points Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Primary Response Inhibition (Assessing Change of Inhibitory control) The measured variables were reaction time (RT) and accuracy. Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Primary Craving (Assessing Change) 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)
Secondary 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). Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
Secondary Loneliness (Assessing Change) used the Chinese version of the ULS-8 loneliness scale, which was translated by Zhou et al. for participation in China. Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT05064293 - Assisted Identification and Navigation of Early Mental Health Symptoms in Children N/A
Not yet recruiting NCT05886595 - Being Young : My Mental Health
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Not yet recruiting NCT04030858 - The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery N/A
Recruiting NCT04926675 - Development of a Money Advice Intervention Within IAPT N/A
Recruiting NCT06105970 - Chinese Community Sample of Hierarchical Model of Psychopathology
Recruiting NCT06038721 - Unified Protocol: Community Connections N/A
Not yet recruiting NCT04978194 - Effects of an Intervention on University Students' Mental Health and Learning During COVID-19 N/A
Completed NCT05056428 - Effects of Mindfulness Training on Emotional Care Strategies N/A
Recruiting NCT06144905 - Norwegian Microbiota Study in Anorexia Nervosa
Completed NCT06080685 - Efficacy of Character Strengths Intervention in Enhancing Character Strengths and Self-esteem Among Adolescents N/A
Not yet recruiting NCT06187701 - Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients N/A
Not yet recruiting NCT06430853 - Psychobiological Interventions in Pregnancy N/A
Not yet recruiting NCT06266936 - Smart Life Smart Living Intercontinental - Medical Students' Cohort
Not yet recruiting NCT06006936 - Testing an Evidence-Based Self-Help Program for Infertility-Related Distress in Women N/A
Not yet recruiting NCT05979649 - An Internet-Based Intervention With Peer Support for the Mental Health of Youths N/A
Recruiting NCT05492305 - Glucagon-like Peptide 1 (GLP1) Receptor Agonists and Mental Health
Not yet recruiting NCT05316948 - Mental Health and Sexuality in Adolescents and Young Adults
Completed NCT05598697 - Economic Evaluation of the MEWE Intervention N/A