Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:38 AM
Study NCT ID:
NCT07457658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Therapy for Mobile Phone Addiction in Hospitalized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Simplified version of the Smartphone Addiction Scale (SAS-SV)', 'timeFrame': 'Baseline and Post-intervention (day 5)', 'description': 'The SAS-SV scale was developed by Min Kwon et al. in 2013, consisting of 10 items, and using a 6-level scoring method.'}], 'secondaryOutcomes': [{'measure': 'Self Rating Anxiety Scale (SAS)', 'timeFrame': 'Baseline and Post-intervention (day 5)', 'description': 'The scale consists of 20 items and uses a 4-level scoring system. The higher the total score, the higher the level of anxiety.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Baseline and Post-intervention (day 5)', 'description': '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.'}, {'measure': 'IAT Internet Addiction Questionnaire', 'timeFrame': 'Baseline and Post-intervention (day 5)', 'description': 'The scale consists of 20 items and is rated on a 5-point scale.'}, {'measure': 'General Self Efficacy Scale (GSES)', 'timeFrame': 'Baseline and Post-intervention (day 5)', 'description': 'The scale consists of 10 items and is rated on a 4-point scale.'}, {'measure': 'Self Control Strength Scale (SCS)', 'timeFrame': 'Baseline and Post-intervention (day 5)', 'description': 'The study used the revised Chinese version of the scale. The scale contains 19 items and adopts a 5-point scoring system.'}, {'measure': 'Self Rating Depression Scale (SDS)', 'timeFrame': 'Baseline and Post-intervention (day 5)', 'description': "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."}, {'measure': 'Pleasure Deficiency Questionnaire', 'timeFrame': 'Baseline and Post-intervention (day 5)', 'description': 'A Chinese version of 20 items, with a 6-level scoring system. The lower the score, the more obvious the lack of pleasure.'}, {'measure': 'Short Video Addiction Scale', 'timeFrame': 'Baseline and Post-intervention (day 5)', 'description': 'Used to measure addiction to short videos. Contains 14 items, using a 5-point scoring system.'}, {'measure': 'Social Media Barrier Scale (BSMAS)', 'timeFrame': 'Baseline and Post-intervention (day 5)', 'description': 'Used to measure social media addiction. The scale consists of 6 items and uses a 5-point scoring system.'}, {'measure': 'Pressure Perception Scale (PSS-10)', 'timeFrame': 'Baseline and Post-intervention (day 5)', 'description': 'Used to measure the subjective perceived level of stress. Using 10 item versions with a 5-point rating.'}, {'measure': 'Simplified Barratt Impulse Scale (BBIS) in Chinese', 'timeFrame': 'Baseline and Post-intervention (day 5)', 'description': 'The simplified scale consists of 8 items and uses a 4-point rating system.'}, {'measure': 'Happiness Index Scale (WHO-5)', 'timeFrame': 'Baseline and Post-intervention (day 5)', 'description': 'The scale consists of 5 items and adopts a 6-level scoring system.'}, {'measure': 'Severity of Game Addiction (IGDS9)', 'timeFrame': 'Baseline and Post-intervention (day 5)', 'description': 'The scale consists of 9 items and uses a 5-point scoring system'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Problematic use of mobile phones', 'cognitive behavioral therapy', 'psychotherapy'], 'conditions': ['Problematic Use of Mobile Phones']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 14 years old.\n* Willingness to treat problematic mobile phone usage behavior.\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* Previously received or currently undergoing CBT intervention for mobile phone addiction.\n* Cognitive impairment patients, critically ill patients, pregnant women, etc.\n* There are other situations that researchers consider unsuitable to participate in this study.'}, 'identificationModule': {'nctId': 'NCT07457658', 'acronym': 'CBT', 'briefTitle': 'Cognitive Behavioral Therapy for Mobile Phone Addiction in Hospitalized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sir Run Run Shaw Hospital'}, 'officialTitle': 'The Efficacy of Cognitive Behavioral Therapy for Mobile Phone Addiction and Emotional Improvement in Hospitalized Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2026-0156'}, 'secondaryIdInfos': [{'id': '2022ZD0211200', 'type': 'OTHER_GRANT', 'domain': 'STI 2030-Major Projects of China'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT Intervention Group', 'description': '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.', 'interventionNames': ['Other: Cognitive-behavioral therapy']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Besides traditional treatment in the ward, a self-designed self-help manual for mobile phone addiction was distributed.', 'interventionNames': ['Other: Traditional treatment in the ward']}], 'interventions': [{'name': 'Cognitive-behavioral therapy', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['CBT Intervention Group']}, {'name': 'Traditional treatment in the ward', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yanhui Liao', 'role': 'CONTACT', 'email': 'liaoyanhui@zju.edu.cn', 'phone': '+86 18814898844'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}