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临床试验/NCT03328637
NCT03328637已完成不适用

Smartphone Addiction and Its Effect on Mental Health: An Evidence Based Intervention for Amelioration

International Islamic University, Islamabad2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Smartphone Addiction Scale (SAS; Assessing Change)

研究概览

简要总结

The use of Smartphone has been adopted faster than any other device in the history of digital electronics. Hence it is estimated that in 2016, 2.1 billion were found registered Smartphone users in the world and Pakistan was ranked 10th in the list of top 10 countries with largest number of mobile phone subscribers. Despite of its useful and timely utilization, the excessive use of Smartphone coerce the Individual to be dependent on the use of Smartphone psychologically and even physically. Furthermore, among the users, adolescents and young adults used Smartphone (90%) more than any other age groups. Moreover, this prevalence is expected to rise in the future due to the easy availability and swift changes and addition of new applications to Smartphone technology. Subsequently, the excessive and irrational use of Smartphone leads to Smartphone addiction which impact on individual mental health, physical health, and disrupt social, economic and educational functions. So, this study aims to assess the effectiveness of Cognitive Behavioral Therapy (CBT) as an evidence based remedy in the treatment of Smartphone addiction. The study will comprise of two groups; one will receive CBT (intervention group) and the other one will be on Treatment As Usual (TAU). The aim of the study is to assess the effectiveness of CBT primarily by measuring the addictive smartphone usage assessed by Smart Phone Addiction Scale (SAS) and also on secondary outcomes including time management, academic performance and social functioning of adolescents. These assessments will be conducted before intervention (on the baseline assessment sessions), during the Intervention and after the intervention (on follow up assessment sessions). A total of 120 students were calculated on the basis of 80% statistical power required to detect the effect as indicated by previous study and will be selected from different educational institutions. SPSS 23.0 will be used for data analysis. The primary analysis will be mixed ANOVA to compare the between group and within group means differences on measures used in the study. Multiple Hierarchical Regression analysis will also be used for the prediction of outcome variables from the demographics. The total duration of the study is one year.

This study primarily aims to assess the effectiveness of Cognitive Behavioral Therapy (CBT) as an evidence based remedy in the treatment for Smartphone addiction. The basic purpose is to minimize the severity of Smartphone addiction up to manageable level. Furthermore, there are certain psychiatric symptoms that are found to be associated with the addictive usage of Smartphone like stress, depression, anxiety, hyperactivity, attention deficits and conduct problems. The study design will also allow to assess the effectiveness of CBT on such outcomes: (a) The depression, anxiety and stress level of the participants (b) The time management of the participants (c) The emotional symptoms, conduct problems, hyperactivity and attention deficit problems, peer relationship problems and pro-social behavior aspects of the participants (d) The satisfaction level of the participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Score more than 31 (for male) and 33 (for female) on Smart Phone Addiction Scale Short Version (SAS-SV).
  • Age range will be 12-
  • Absence of diagnosis according to ICD-10 or DSM 5 mental disorder.
  • Participants will have to be living within the catchment area.
  • Capable to be engaged, participate or respond to the research question.
  • Willing to give informed consent.

排除标准

  • Temporary resident unlikely to be available for the follow ups.
  • Participants diagnosed according to ICD 10 or DSM 5 criteria, due to general medical condition or substance misuse, dementia, delirium, alcohol or drug dependence, schizophrenia, bipolar disorder, learning disability.
  • Unable to engage, participate or respond to the research question.
  • Participants who attended psychiatric services

研究组 & 干预措施

Intervention

Experimental

Patients in the intervention group will be provided Cognitive Behavioral Therapy (CBT). CBT is a common psychological intervention based on the notion that thoughts trigger the emotions. In CBT patients are trained to monitor their thoughts and identify those that trigger addictive feelings and actions while they learn new coping skills and ways to prevent a relapse (Beck, Wright, Newman & Liese, 2001). The treatment period of CBT is three months consisting of a weekly session and total 12 sessions. Initial stage of therapy is behavioral, centering on specific behaviors and situations. Latter on there is more of a focus on the cognitive assumptions and distortions that have developed and the effects of these on behavior.

干预措施: Cognitive Behavioral Therapy (Behavioral)

Control

No Intervention

Control group will not receive CBT however, primary care service providers and mental health professionals will provide any required routine care according to their clinical judgment and available resources.

结局指标

主要结局

Smartphone Addiction Scale (SAS; Assessing Change)

时间窗: Assessments will be conducted at baseline (after the screening), 6th week (1/2 month) after the baseline, 12th week (3rd month) after the baseline and at 6th month. The purpose of the outcome measure is to asses the change from baseline to follow-up.

Smartphone Addiction Scale (SAS) is used to asses the severity of smartphone dependency and addiction. It consists of 33 items (Kwon et al., 2013). Individuals have to respond on the Likert scale between 1-6, where 1 indicates strongly disagree and 6 indicates strongly agree. The amounts of answers were divided to three levels of addiction: low (1-66), medium (67-132) and high (133-198). Internal reliability of SAS was found to be α = .99. This scale will be used as a primary outcome and will be included in the baseline and follow ups assessment to assess the degree of change from baseline to 3rd month and 6th month follow-ups.

次要结局

  • Satisfaction with Life Scale (SWLC)(Assessments will be conducted at baseline (after the screening), 6th week (1/2 month) after the baseline, 12th week (3rd month) after the baseline and at 6th month.)
  • Client Satisfaction Questionnaire (CSQ)(The questionnaire will be employed on the 6th week (1/2 month) after the baseline, 12th week (3rd month) after the baseline and at 6th month)
  • Depression Anxiety Stress Scales (DASS-42)(Assessments will be conducted at baseline (after the screening), 6th week (1/2 month) after the baseline, 12th week (3rd month) after the baseline and at 6th month.)
  • Strengths and Difficulties Questionnaire(Assessments will be conducted at baseline (after the screening), 6th week (1/2 month) after the baseline, 12th week (3rd month) after the baseline and at 6th month.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Tahir Khalily

Professor

International Islamic University, Islamabad

研究点 (2)

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