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Smartphone AddictionNCT05563285

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

A study testing Exercise and Mindfulness-Based Intervention in people with Smartphone Addiction and Mental Health Issue, run by Universiti Putra Malaysia at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 23 years, women only
Conditions the study is for
Smartphone Addiction, Mental Health Issue
What is being tested?
Exercise and Mindfulness-Based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
12 Sep 2022to 20 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 23 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Yulin University

    Yulin, Shaanxi, 719000

    Huange Liu, +8615619908568, liuhuange568@gmail.com

    Fengmeng Qi, +8617603915127, 583135958@qq.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Exercise and Mindfulness-Based Intervention, Control Group
Keywords
Exercise, Mindfulness-Based Intervention, Smartphone Addiction, Emotion Regulation, Inhibitory Control, Female University Students
Medical subject headings
Internet Addiction Disorder, Motor Activity, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise and Mindfulness-Based InterventionBehavioural

    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.

    1. 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 GroupBehavioural

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

Study groups in NCT05563285
Study groupRoleWhat they receive
Exercise and Mindfulness-Based InterventionExperimentalPatients in the intervention group will be provided exercise and mindfulness-based intervention was shown for the 1-8 weeks.
Receives: Behavioral: Exercise and Mindfulness-Based Intervention; Behavioral: Control Group
Control GroupActive comparatorControl 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.
Receives: Behavioral: Exercise and Mindfulness-Based Intervention; Behavioral: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  2. 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).

    Measured: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  3. 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).

    Measured: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  4. Galvanic skin response (GSR; Assessing Change of physiological state)

    Emotion regulation involves emotional responses (physiological components) such as galvanic skin response (GSR)(Bosse, 2017).

    Measured: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  5. Electroencephalography (EEG; Assessing Change of physiological state)

    Emotion regulation involves emotional responses (physiological components) such as electroencephalography (EEG).

    Measured: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  6. Emotion Regulation Questionnaire (ERQ; Assessing Change)

    The Emotion Regulation Questionnaire (ERQ; Gross \& John, 2003)

    Measured: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  7. Positive and negative emotion scores (Assessing Change)

    Positive and negative emotion scores measured at different time points

    Measured: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  8. Response Inhibition (Assessing Change of Inhibitory control)

    The measured variables were reaction time (RT) and accuracy.

    Measured: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  9. Craving (Assessing Change)

    Craving for smartphones (modified desire for drinking questionnaire: Love, James,

    \& Willner, 1998)

    Measured: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

Secondary outcomes (2)
  1. 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).

    Measured: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

  2. Loneliness (Assessing Change)

    used the Chinese version of the ULS-8 loneliness scale, which was translated by Zhou et al. for participation in China.

    Measured: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2022
  2. Study start12 Sep 2022
  3. Primary completion25 Dec 2022 (estimated)
  4. Study completion20 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05563285
Sponsor's protocol ID
Huange Liu
Status last verified
Oct 2022
First submitted
25 Sep 2022
Last updated
4 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Since this is my doctoral thesis experiment, I won't share it until I graduate.

Publications

  • 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.

    PubMed 32704524
  • 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.

    PubMed 22480735
  • 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.

    PubMed 34394381
  • 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.

    PubMed 29669599
  • 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.

    PubMed 31618879
  • 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.

    PubMed 27574603
  • 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.

    PubMed 35299822

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Mindfulness-Based Intervention in people with Smartphone Addiction and Mental Health Issue, run by Universiti Putra Malaysia at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Liu Huange (+8615619908568, liuhuange568@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mobile Phone Addiction Index (MPAI; Assessing Change) (time frame: Assessments will be conducted at baseline (after the screening), 4th week (1month) after the baseline, 8th week (2rd month)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05563285, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.

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