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Smartphone Addiction and Its Effect on Mental Health: An Evidence Based Intervention for Amelioration (CyberLife Care)

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ClinicalTrials.gov Identifier: NCT03328637
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Muhammad Tahir Khalily, International Islamic University, Islamabad

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.


Condition or disease Intervention/treatment Phase
Smartphone Addiction Behavioral: Cognitive Behavioral Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Smartphone Addiction and Its Effect on Mental Health: An Evidence Based Intervention for Amelioration
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : August 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Intervention
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.
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.

No Intervention: Control
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.



Primary Outcome Measures :
  1. Smartphone Addiction Scale (SAS; Assessing Change) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Depression Anxiety Stress Scales (DASS-42) [ Time Frame: 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. ]
    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.

  2. Strengths and Difficulties Questionnaire [ Time Frame: 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. ]
    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.

  3. Satisfaction with Life Scale (SWLC) [ Time Frame: 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. ]
    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.

  4. Client Satisfaction Questionnaire (CSQ) [ Time Frame: 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328637


Locations
Pakistan
Department of Psychology, International Islamic University Islamabad Pakistan Recruiting
Islāmābād, Federal, Pakistan, 44000
Contact: Mujeeb M Bhatti, MS    923310444610    mujeeb.masood11@gmail.com   
Contact: Tamkeen Saleem, PHD    923325412281    tamkeen.saleem@iiu.edu.pk   
Sponsors and Collaborators
International Islamic University, Islamabad

Additional Information:
Publications:
Responsible Party: Muhammad Tahir Khalily, Professor, International Islamic University, Islamabad
ClinicalTrials.gov Identifier: NCT03328637     History of Changes
Other Study ID Numbers: 11/09/17-P01-DPEC
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Statistical Analysis Plan (SAP)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Muhammad Tahir Khalily, International Islamic University, Islamabad:
Smartphone Addiction
CBT
Evidence based intervention

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior