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

Smartphone Addiction Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328637
• Other study ID #: 11/09/17-P01-DPEC
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: February 2019
• Source: International Islamic University, Islamabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Smartphone Addiction

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) consisting of weekly 12 sessions will focus on moderated and controlled use of smartphone instead of abstinence model.

Locations

Country	Name	City	State
Pakistan	Department of Psychology, International Islamic University Islamabad Pakistan	Islamabad	Federal

Sponsors (1)

Lead Sponsor	Collaborator
International Islamic University, Islamabad

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. — View Citation

Gani N, Saeed K, Minhas FA, Anjuman N, Waleed M, Fatima G. Assessment of patient satisfaction with mental health services in a tertiary care setting. J Ayub Med Coll Abbottabad. 2011 Jan-Mar;23(1):43-6. — View Citation

Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. — View Citation

Kwon M, Kim DJ, Cho H, Yang S. The smartphone addiction scale: development and validation of a short version for adolescents. PLoS One. 2013 Dec 31;8(12):e83558. doi: 10.1371/journal.pone.0083558. eCollection 2013. — View Citation

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. — View Citation

Wright FD, Beck AT, Newman CF, Liese BS. Cognitive therapy of substance abuse: theoretical rationale. NIDA Res Monogr. 1993;137:123-46. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smartphone Addiction Scale (SAS; Assessing Change)	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 a = .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.	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	Depression Anxiety Stress Scales (DASS-42)	It is 42 items scale developed by Levibond and Levibond (1995). It has three subscales and each of them contains 14 items. The depression scale, the anxiety scale and the stress scale. There are cut off scores established to categorize the individual scores in the mild, moderate, severe, and extremely severe categories. It has 4-point rating scale ranging from 1 (Did not apply to me at all) to 4 (Applies to me most of the time). This questionnaire will be used in the baseline and follow-ups assessment sessions.	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.
Secondary	Strengths and Difficulties Questionnaire	This scale has 25 items in all and uses a 3 point Likert scale supporting five factors: 'emotional symptoms', 'conduct problems', 'hyperactivity and attention deficit problems', 'peer relationship problems' and 'prosocial behavior' (Goodman, 1997). For the first four factors, the lower the score, the better, and for the last factor the higher the score, the better. This question will be also used in the baseline and follow-ups assessment sessions.	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.
Secondary	Satisfaction with Life Scale (SWLC)	Satisfaction with Life Scale (SWLC) is a 5-item scale designed to measure the global cognitive judgements of one's life satisfaction (Diener, Emmons, Larsen & Griffin, 1985). Participants indicate how much they agree or disagree with each of the five items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree. The higher score indicates higher satisfaction. This scale will be used in our baseline and follow-ups assessment sessions.	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.
Secondary	Client Satisfaction Questionnaire (CSQ)	The Client Satisfaction Questionnaire is a brief and simple scale to measure the patient satisfaction with mental health services (Gani, Saeed, Minhas, Anjuman, Waleed & Fatima, 2011). The questionnaire has 8 items and the participants have to respond on 4 point Likert scale ranging from 1 to 4. The total score of participant ranges from 8 to 32 where minimum score 8 reflects dissatisfaction and a maximum score 32 reflects maximum satisfaction. This questionnaire will be used after all of the intervention (CBT) sessions.	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

External Links

•   Number of smartphone users worldwide from 2014 to 2020 (in billions)