Clinical trial NCT03328637: Smartphone Addiction and Its Effect on Mental Health: An Evidence Based Intervention for Amelioration
Official title: Smartphone Addiction and Its Effect on Mental Health: An Evidence Based Intervention for Amelioration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smartphone Addiction
Keywords: Smartphone Addiction
CBT
Evidence based intervention
Lead sponsor: International Islamic University, Islamabad
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a Randomized Controlled Trial (RCT) with single blind rating. The randomization of participants is across two groups (1) one provided with intervention of CBT and (2) the other group will be on Treatment As Usual (TAU)
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Score more than 31 (for male) and 33 (for female) on Smart Phone Addiction Scale Short Version (SAS-SV).
2. Age range will be 12-19.
3. Absence of diagnosis according to ICD-10 or DSM 5 mental disorder.
4. Participants will have to be living within the catchment area.
5. Capable to be engaged, participate or respond to the research question.
6. Willing to give informed consent.

Exclusion Criteria:

1. Temporary resident unlikely to be available for the follow ups.
2. 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.
3. Unable to engage, participate or respond to the research question.
4. Participants who attended psychiatric services

Primary outcomes:
measure: Smartphone Addiction Scale (SAS; Assessing Change)
timeFrame: 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.
Secondary outcomes:
measure: Depression Anxiety Stress Scales (DASS-42)
timeFrame: 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.
measure: Strengths and Difficulties Questionnaire
timeFrame: 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.
measure: Satisfaction with Life Scale (SWLC)
timeFrame: 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.
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 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
Other outcomes:
Locations:
city: Islāmābād
country: Pakistan
facility: Department of Psychology, International Islamic University Islamabad Pakistan
state: Federal
Study officials:
References:
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