- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05479344
My Journey: A Brief Contextual Behavioural Intervention Based on Meaning and Connection
Personal and Environmental Correlates of Problematic Internet and Smartphone Use
The present study will explore the underlying mechanisms of problematic Internet and smartphone use by focusing on how and when environmental factors affect the positive psychological intervention factors. Hence, the present study will provide scientific empirical evidence to design and formulate follow-up intervention strategies.
Aims:
I. Apply the dynamic system model of addictive behavior execution in Chinese adolescents with problematic Internet and smartphone use and use longitudinal data to track and explore the underlying mechanisms of environmental factors and personal factors on problematic Internet and smartphone use.
II. Identify positive psychological intervention factors that effectively prevent and reduce problematic Internet and smartphone use according to the interview and provide empirical evidence for other intervention designs.
III. Conducting a positive psychological intervention in an adolescent population to verify the protective effect of positive psychology factors on problematic Internet and smartphone use.
Hypotheses:
I. Environmental factors (e.g., child abuse and trauma, parenting behaviors, teachers' encouragement, peer support) will affect the problematic Internet and smartphone use through personal characteristics (e.g., meaning in life); II. The effect of environmental factors on problematic Internet and smartphone use through personal characteristics will be moderated by other positive psychological intervention factors (e.g., character strengths); III. Positive psychological intervention (e.g., meaning-based intervention, strengths-based intervention) is an effective intervention strategy to prevent and reduce problematic Internet and smartphone use.
Study Overview
Status
Conditions
Detailed Description
Problematic Internet and smartphone use are a psychosocial phenomenon in which individuals pay too much attention to and rely on the Internet, negatively affecting their mental and physical health, lives, and work. Many studies have shown that problematic Internet and smartphone use can bring adverse psychological effects (e.g., depression, anxiety, and negative emotions) and unfavorable physiological conditions (e.g., poor sleep quality and memory loss). The negative psychological and physiological effects can result in adverse academic and work performance outcomes. Many existing studies mainly explore the underlying mechanism of problematic Internet and smartphone use from personal factors such as mental health, metacognition, coping strategies, personality traits, motivation, and attachment styles. However, more and more studies have begun to focus on the effects of environmental factors, such as peer relationships and parenting styles, on problematic Internet and smartphone use. To fill the literature gaps, formulate effective preventive and remedial interventions, and explore whether, when, and how environmental factors (e.g., child abuse and trauma, parenting behaviors, teachers' encouragement, and peer support) affect problematic Internet and smartphone use is crucial.
The previous psychological interventions for problematic Internet and smartphone use focused on cognitive behavioral therapy, sand-play therapy, family programming, group programming, counseling programming, and educational programming. Different types of interventions reduced the severity of problematic Internet and smartphone use to varying degrees. However, the existing intervention strategies ignore the perspective of positive psychology. In the country, some scholars proposed to discuss the self-regulation of addicts from the perspective of positive psychology and especially proposed a meaning-centered approach as an essential supplement to mainstream addiction therapy. Besides, some scholars have also noticed the role of positive psychological intervention factors, such as meaning in life and the formation and development of problematic Internet and smartphone use. Therefore, exploring the positive psychological intervention factors, especially the meaning in life and the construction and development of problematic Internet and smartphone use, is the starting point for developing evidence-based intervention strategies.
According to the Dynamic System Model of Developmental Psychopathology and the Interaction of Person-Affect-Cognition-Execution model, the present study will explore the underlying mechanisms from environmental factors (e.g., child abuse and trauma, parenting behaviors, teachers' encouragement, peer support) to problematic Internet and smartphone use by testing the mediator role and moderator role of personal factors (e.g., the meaning of life, social media flow), predominantly positive psychological intervention factors (e.g., character strengths). Therefore, the present study integrated positive psychological intervention factors into the dynamic system model of addictive behavior execution and applies it to explore the formation and development mechanisms of problematic Internet and smartphone use (see Figure 1 and Figure 2). In addition, this study will implement an interview and meaning-centered intervention program among middle school students to validate the validity of the dynamic system model of addictive behavior execution from the interpretation of qualitative material and intervention practices.
Given the research variables' diversity and complexity, the present study intends to include at least 500 adolescents over 12 years of age. The present study uses convenience and snowball sampling in mainland China and Hong Kong. The present study will also invite participants to accept longitudinal tracking. Participants willing to participate in the subsequent two surveys will provide their contact information. Before the research, the parents' and children's online informed consent forms will be obtained for the minors' sample. This questionnaire survey was completed in the preliminary stage of this study (approved: 2020-21-CIR8-3), and the intervention directions and techniques for problematic Internet and smartphone use were determined based on the questionnaire survey results.
Semi-structured Interviews:
The investigators will use a method of semi-structured interviews with open-ended questions to collect data. Individual interviews, lasting between 45 and 60 minutes, will be conducted and recorded. All participants should provide consent to participate before being interviewed. The interviews were conducted in Mandarin. All the materials used in the study (e.g., the recruitment information and questionnaires) were presented in Chinese. Thirty adolescents will be recruited to participate in the interviews.
Randomized Controlled Trial:
The investigators will pilot test the proposed meaning-focused intervention using a randomized (1:1) parallel-group controlled, single-blind trial in middle school students. The middle school collaborators will help launch the advertisement regarding this study, brief potential participants, prescreen potential participants according to recruitment criteria, and recruit participants using the opportunity sampling method. The participants' written informed consent will be obtained before conducting the intervention. One hundred adolescents will be recruited to participate in a randomized controlled trial. Four sessions will be delivered to the intervention group 1 week apart, with around 90 minutes per session.
Descriptive analysis and latent profile analysis will be adopted to present the overall situation of the research sample; psychology measurement attributes of the measures will be tested using confirmatory factor analysis; the correlation and regression analysis will be used to explore the relationships between environmental factors, personal factors, and problematic Internet and smartphone use. The structural equation modeling will be conducted to verify the mediator or moderator roles of positive psychological intervention factors in the relationship between environmental factors and problematic Internet and smartphone use.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 401445
- Chongqing Datong High School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children or adolescents with experience in using technology.
- Older than 12 years and younger than 20 years.
- Native Chinese speakers.
Exclusion Criteria:
- Young people with no experience in using technology.
- Aged under 12 or over 20.
- Non-native speakers of Chinese.
- People who have undergone similar interventions within the past year.
- Persons with major mental or physical illnesses.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Contextual Behavioural Intervention Based on Meaning and Connection
The current intervention involves the identification of strengths (the first week, 90 minutes of intervention), the perception of the meaning in life (the second week, 90 minutes of intervention), the learning of strategies to develop plan (the third week, 90 minutes of intervention), and the understanding of emotion regulation strategies (the fourth week, 90 minutes of intervention).
|
The intervention strategy combines acceptance and commitment therapy, contextual behavioral science, and positive psychology interventions (strengths, meaning, hope) in the form of a single intervention set (each topic is a single 90-minute intervention, four single intervention combinations).
|
Other: Waiting list group
The waiting list group will receive the same intervention at the end of the 3-month follow-up test.
|
The intervention strategy combines acceptance and commitment therapy, contextual behavioral science, and positive psychology interventions (strengths, meaning, hope) in the form of a single intervention set (each topic is a single 90-minute intervention, four single intervention combinations).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Problematic Social Media Use
Time Frame: baseline, week 5, 3-month follow up
|
The 6-item Bergen Social media Addiction Scale will measure the severity of problematic social media use.
Bergen Social media Addiction Scale is a self-report measure designed to assess the symptoms of problematic social media use, with a higher total score suggesting more severe problematic use symptoms.
Scores range from 6 to 30.
|
baseline, week 5, 3-month follow up
|
Change of Problematic Smartphone Use
Time Frame: baseline, week 5, 3-month follow up
|
The 6-item Smartphone Application-Based Addiction Scale will measure the severity of problematic smartphone use.
Smartphone Application-Based Addiction Scale is a self-report measure designed to assess the symptoms of problematic smartphone use, with a higher total score suggesting more severe problematic use symptoms.
Scores range from 6 to 36.
|
baseline, week 5, 3-month follow up
|
Change of Internet Gaming Disorder
Time Frame: baseline, week 5, 3-month follow up
|
The 9-item Internet Gaming Disorder Scale-Short Form will measure the severity of internet gaming.
Internet Gaming Disorder Scale-Short Form is a self-report measure designed to assess the symptoms of internet gaming disorder, with a higher total score suggesting more severe internet gaming symptoms.
Scores range from 9 to 45.
|
baseline, week 5, 3-month follow up
|
Change of Depression and Anxiety Symptoms
Time Frame: baseline, week 5, 3-month follow up
|
Anxiety and depressive symptoms will be measured by the 4-item Patient Health Questionnaire for Depression and Anxiety (PHQ-4).
PHQ-4 is a self-report measure designed to assess the severity of depression and anxiety symptoms, with a higher total score suggesting higher levels of depression and anxiety symptoms.
Scores range from 0 to 12.
|
baseline, week 5, 3-month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Meaning in Life
Time Frame: baseline, week 5, 3-month follow up
|
The 24-item State of Meaning in Life Scale will be used to measure the meaning in life.
State of Meaning in Life Scale is a self-report measure designed to assess the six dimensions (need for meaning, meaning avoidance, meaning anxiety, meaning confusion, search for meaning, and presence of meaning) of meaning in life, with a higher mean score suggesting a higher levels of that state of meaning in life.
Scores range from 1 to 7.
|
baseline, week 5, 3-month follow up
|
Change of Difficulties in Emotion Regulation
Time Frame: baseline, week 5, 3-month follow up
|
The 18-item Difficulties in Emotion Regulation Scale Short Form (DERS-SF) will be used to measure the difficulties in regulating emotions.
DERS-SF is a self-report measure designed to six factors of difficulties in regulating emotions (regulation strategies, non-acceptance of emotional responses, impulse control difficulties, goal-directed difficulties, awareness difficulties, emotional clarity difficulties), with a higher total score denoted a higher level of difficulties in regulating emotions.
Scores range from 18 to 90.
|
baseline, week 5, 3-month follow up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Intolerance of Uncertainty
Time Frame: baseline, week 5, 3-month follow up
|
Intolerance of uncertainty will be measured by the 12-item Intolerance of Uncertainty Scale (IUS).
IUS is a self-reported instrument for measuring negative beliefs about and reactions to uncertainty, with a higher total score suggesting a higher degree of intolerance of uncertainty.
Scores range from 12 to 60.
|
baseline, week 5, 3-month follow up
|
Change of Body Appreciation
Time Frame: baseline, week 5, 3-month follow up
|
Body appreciation will be measured by the 10-item Body Appreciation Scale-2.
Body Appreciation Scale-2 is a self-reported instrument for measuring body appreciation, body acceptance and love, and adaptive appearance investment, with a higher mean score suggesting a higher level of positive body image.
Scores range from 1 to 5.
|
baseline, week 5, 3-month follow up
|
Change of Peer Phubbing
Time Frame: baseline, week 5, 3-month follow up
|
Peer phubbing will be measured by the 12-item Generic Scale of Being Phubbed.
Generic Scale of Being Phubbed is a self-reported instrument for measuring the phenomenon that individuals ignore others because they are focused on their phones, with a higher total score indicating a higher perceived level of phubbing behavior of others.
Scores range from 12 to 84.
|
baseline, week 5, 3-month follow up
|
Change of Perceived Encouragement
Time Frame: baseline, week 5, 3-month follow up
|
Perceived encouragement will be measured by the revised 10-item Academic Encouragement Scale.
There are two subscales (i.e., challenge-focused encouragement and potential-focused encouragement), and each scale contains five items.
A higher average score suggests a higher level of encouragement received from others in an educational setting.
Scores range from 1 to 6.
|
baseline, week 5, 3-month follow up
|
Change of Childhood Emotional Abuse and Neglect
Time Frame: baseline, week 5, 3-month follow up
|
Childhood emotional abuse and neglect will be measured by the emotional neglect (e.g., "felt loved," "felt close to each other") and emotional abuse (e.g., "called stupid、lazy or ugly by family," "felt emotional abused") subscales in the 28-item Childhood Trauma Questionnaire-Short Form.
It is designed for measuring child maltreatment, with a higher total score indicates a higher level of perceived emotional abuse and neglect.
Each subscale is varied from 5 to 25 scores, and the total scores of the two subscales range from 10 to 50.
|
baseline, week 5, 3-month follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yumei LI, Department of Social & Behavioural Sciences, City University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-22-CIR5-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaActive, not recruitingImprove Quality of LifeItaly
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Linkoeping UniversityRecruiting
-
South Valley UniversityActive, not recruitingDeterminants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRSHealth Related Quality of LifeEgypt
-
Region VästmanlandUnknownHealth Related Quality of Life