NCT03328637

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

October 4, 2017

Last Update Submit

February 25, 2019

Conditions

Keywords

Smartphone AddictionCBTEvidence based intervention

Outcome Measures

Primary Outcomes (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.

    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)

  • 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.

  • 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

Study Arms (2)

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.

Behavioral: Cognitive Behavioral Therapy

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.

Interventions

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

Intervention

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, International Islamic University Islamabad Pakistan

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 24391787BACKGROUND
  • 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.

    PMID: 7726811BACKGROUND
  • 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.

    PMID: 16367493BACKGROUND
  • 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.

    PMID: 22830144BACKGROUND
  • 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.

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

    PMID: 8289917BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Internet Addiction Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 4, 2017

First Posted

November 1, 2017

Study Start

September 20, 2017

Primary Completion

July 30, 2018

Study Completion

July 30, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share
Shared Documents
SAP

Locations