- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07457658
Cognitive Behavioral Therapy for Mobile Phone Addiction in Hospitalized Patients (CBT)
March 3, 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
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
140
Phase
- 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
- Name: Yanhui Liao
- Phone Number: +86 18814898844
- Email: liaoyanhui@zju.edu.cn
Study Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self Rating Anxiety Scale (SAS)
Time Frame: Baseline and Post-intervention (day 5)
|
The scale consists of 20 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)
|
|
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)
|
|
Self Rating Depression Scale (SDS)
Time Frame: Baseline and Post-intervention (day 5)
|
The scale consists of 20 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)
|
|
Pleasure Deficiency Questionnaire
Time Frame: Baseline and Post-intervention (day 5)
|
A Chinese version of 20 items, with a 6-level scoring system.
The lower the score, the more obvious the lack of pleasure.
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
February 25, 2026
First Submitted That Met QC Criteria
March 3, 2026
First Posted (Actual)
March 9, 2026
Study Record Updates
Last Update Posted (Actual)
March 9, 2026
Last Update Submitted That Met QC Criteria
March 3, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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