Cognitive Behavioral Therapy for Mobile Phone Addiction in Hospitalized Patients (CBT)

July 28, 2026 updated by: Sir Run Run Shaw Hospital

The Efficacy of Cognitive Behavioral Therapy for Mobile Phone Addiction and Emotional Improvement in Hospitalized Patients: A Randomized Controlled Trial

Problematic mobile phone use is excessive dependence and use of electronic products and their functions, which affects the daily life of users. Previous studies have shown that mobile phone addiction is related to depression, anxiety severity, and stress, and it is negatively correlated with sleep quality. For hospitalized patients in the mental health department, symptoms such as anxiety, depression, and poor sleep are very common. Cognitive behavioral therapy has been widely applied in online gaming addiction and is also effective in intervening in mobile phone addiction. Therefore, Hospitalized patients in the mental health department will be randomized to either the CBT interventions or an control group. The main outcome measure is the Simplified Smartphone Addiction Scale (SAS-SV), measured before intervention and after the completion of the last brief intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 14 years old.
  • Willingness to treat problematic mobile phone usage behavior.
  • Voluntarily participate in this study and sign an informed consent form. If the subject is unable to read and sign the informed consent form due to reasons such as lack of legal capacity, or if the subject is a minor, their guardian must act as a proxy for the informed process and sign the informed consent form. If the subject lacks the ability to read the informed consent form (such as illiterate subjects), a witness must witness the informed process and sign the informed consent form.

Exclusion Criteria:

  • Having serious physical or mental illnesses (such as ongoing psychotic symptoms, manic episodes, or severely disabling neurological and psychiatric disorders), unable to cooperate with intervention.
  • Previously received or currently undergoing CBT intervention for mobile phone addiction.
  • Cognitive impairment patients, critically ill patients, pregnant women, etc.
  • There are other situations that researchers consider unsuitable to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CBT Intervention Group
Besides traditional treatment in the ward, a self-designed self-help manual for mobile phone addiction was distributed, and five psychological interventions were carried out.
Other: Cognitive-behavioral therapy
5 CBT intervention: the first intervention was conducted after the patient was hospitalized, completed relevant informed consent and pre-test, and lasted for about 30 minutes once; Follow up intervention 4 times: once a day for about 20 minutes. Traditional treatment in the ward includes drug therapy based on the different conditions of hospitalized patients, physical therapy such as work entertainment, Morita, biofeedback therapy, etc. Some patients may also receive transcranial magnetic stimulation therapy and psychological therapy.
Other: Control Group
Besides traditional treatment in the ward, a self-designed self-help manual for mobile phone addiction was distributed.
Other: Traditional treatment in the ward
Traditional treatment in the ward includes drug therapy based on the different conditions of hospitalized patients, physical therapy such as work entertainment, Morita, biofeedback therapy, etc. Some patients may also receive transcranial magnetic stimulation therapy and psychological therapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Simplified version of the Smartphone Addiction Scale (SAS-SV)
Time Frame: Baseline and Post-intervention (day 5)
The SAS-SV scale was developed by Min Kwon et al. in 2013, consisting of 10 items, and using a 6-level scoring method.
Baseline and Post-intervention (day 5)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline and Post-intervention (day 5)
Used to evaluate the sleep quality over the past month. This scale consists of 19 self-evaluation items and 5 self-evaluation items. Among them, the 19th self-evaluation item and 5 other evaluation items do not participate in scoring. The 18 self-evaluation items participating in the scoring process constitute 7 components, each of which is scored using a 4-point scoring method ranging from 0-3 points. The sum of the scores for each factor is the total PSQI score. A total score greater than 7 indicates the presence of sleep quality issues.
Baseline and Post-intervention (day 5)
IAT Internet Addiction Questionnaire
Time Frame: Baseline and Post-intervention (day 5)
The scale consists of 20 items and is rated on a 5-point scale.
Baseline and Post-intervention (day 5)
General Self Efficacy Scale (GSES)
Time Frame: Baseline and Post-intervention (day 5)
The scale consists of 10 items and is rated on a 4-point scale.
Baseline and Post-intervention (day 5)
Self Control Strength Scale (SCS)
Time Frame: Baseline and Post-intervention (day 5)
The study used the revised Chinese version of the scale. The scale contains 19 items and adopts a 5-point scoring system.
Baseline and Post-intervention (day 5)
Short Video Addiction Scale
Time Frame: Baseline and Post-intervention (day 5)
Used to measure addiction to short videos. Contains 14 items, using a 5-point scoring system.
Baseline and Post-intervention (day 5)
Social Media Barrier Scale (BSMAS)
Time Frame: Baseline and Post-intervention (day 5)
Used to measure social media addiction. The scale consists of 6 items and uses a 5-point scoring system.
Baseline and Post-intervention (day 5)
Pressure Perception Scale (PSS-10)
Time Frame: Baseline and Post-intervention (day 5)
Used to measure the subjective perceived level of stress. Using 10 item versions with a 5-point rating.
Baseline and Post-intervention (day 5)
Simplified Barratt Impulse Scale (BBIS) in Chinese
Time Frame: Baseline and Post-intervention (day 5)
The simplified scale consists of 8 items and uses a 4-point rating system.
Baseline and Post-intervention (day 5)
Happiness Index Scale (WHO-5)
Time Frame: Baseline and Post-intervention (day 5)
The scale consists of 5 items and adopts a 6-level scoring system.
Baseline and Post-intervention (day 5)
Severity of Game Addiction (IGDS9)
Time Frame: Baseline and Post-intervention (day 5)
The scale consists of 9 items and uses a 5-point scoring system
Baseline and Post-intervention (day 5)
Generalized Anxiety Disorder-7 （GAD7）
Time Frame: Baseline and Post-intervention (day 5)
The scale consists of 7 items and uses a 4-level scoring system. The higher the total score, the higher the level of anxiety.
Baseline and Post-intervention (day 5)
Patient Health Questionnaire-9（PHQ-9）
Time Frame: Baseline and Post-intervention (day 5)
The scale consists of 9 items and uses a 4-level scoring system. The higher the total score, the greater the individual's depressive mood.
Baseline and Post-intervention (day 5)
The Anhedonia Scale for Adolescents (ASA)
Time Frame: Baseline and Post-intervention (day 5)
A Chinese version of 14 items, with a 4-level scoring system.
Baseline and Post-intervention (day 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sir Run Run Shaw Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-0156
  • 2022ZD0211200 (Other Grant/Funding Number: STI 2030-Major Projects of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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