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Smartphone AddictionCyberLife CareNCT03328637

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

A study testing Cognitive Behavioral Therapy in people with Smartphone Addiction, run by International Islamic University, Islamabad at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 to 19 years
Conditions the study is for
Smartphone Addiction
What is being tested?
Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 sitePakistan
Study dates
20 Sep 2017to 30 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Score more than 31 (for male) and 33 (for female) on Smart Phone Addiction Scale Short Version (SAS-SV).
  • Age range will be 12-19.
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Department of Psychology, International Islamic University Islamabad Pakistan

    Islamabad, Federal, 44000

Other trials in Pakistan

About this study

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.

Keywords
Smartphone Addiction, CBT, Evidence based intervention
Medical subject headings
Internet Addiction Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral TherapyBehavioural

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

Study groups in NCT03328637
Study groupRoleWhat they receive
InterventionExperimentalPatients 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.
Receives: Behavioral: Cognitive Behavioral Therapy
ControlNo interventionControl 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 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.

    Measured: 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 (4)
  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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.

  4. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2017
  2. Study start20 Sep 2017
  3. Primary completion30 Jul 2018
  4. Study completion30 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03328637
Sponsor's protocol ID
11/09/17-P01-DPEC
Acronym
CyberLife Care
Status last verified
Feb 2019
First submitted
4 Oct 2017
Last updated
26 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 24391787
  • 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. doi: 10.1016/0005-7967(94)00075-u.

    PubMed 7726811
  • Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.

    PubMed 16367493
  • 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.

    PubMed 22830144
  • Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.

    PubMed 9255702
  • Wright FD, Beck AT, Newman CF, Liese BS. Cognitive therapy of substance abuse: theoretical rationale. NIDA Res Monogr. 1993;137:123-46.

    PubMed 8289917
  • Khalily MT, Bhatti MM, Ahmad I, Saleem T, Hallahan B, Ali SA, Khan AA, Hussain B. Indigenously adapted cognitive-behavioral therapy for excessive smartphone use (IACBT-ESU): A randomized controlled trial. Psychol Addict Behav. 2021 Feb;35(1):93-101. doi: 10.1037/adb0000677. Epub 2020 Jul 23.

    PubMed 32700919

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy in people with Smartphone Addiction, run by International Islamic University, Islamabad at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03328637, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.

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