Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-31 @ 10:41 PM
Study NCT ID:
NCT05713305
Status:
COMPLETED
Last Update Posted:
2024-08-05
First Post:
2023-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of an Online Self-help Psychological Intervention on Non-ICU Specialty Care During the COVID-19 Outbreak
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2023-01-18', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in medical staff DASS-21( Depression Anxiety Stress Scale 21) after 28 days of intervention', 'timeFrame': '28 days after intervention', 'description': 'DASS-21 changes( 0-63), The larger the score, the worse the result'}], 'secondaryOutcomes': [{'measure': 'Proportion of depression and anxiety problems among different types of staff', 'timeFrame': '28 days after intervention', 'description': 'Proportion of depression and anxiety'}, {'measure': 'The degrees to which depression and anxiety problems occur in different types of staff', 'timeFrame': '28 days after intervention', 'description': 'The degrees to which depression and anxiety problems'}, {'measure': 'Incidence of posttraumatic stress disorder', 'timeFrame': '28 days after intervention', 'description': 'Incidence of posttraumatic stress disorder'}, {'measure': 'Well-being was measured with the WHO-5 well-being index', 'timeFrame': '28 days after intervention', 'description': 'Well-being was measured with the WHO-5 well-being index ( 0-25), The higher the score, the higher the happiness index'}, {'measure': 'Improvement in sleep quality', 'timeFrame': '28 days after intervention', 'description': 'Improvement in sleep quality( ISI), insomnia severity index ( 0-28) , The larger the score, the worse the result'}, {'measure': 'Results of the Depression Anxiety Stress Scale 21 scale after 3 months of intervention', 'timeFrame': 'Three months after intervention', 'description': 'DASS-21 changes( 0-63), The larger the score, the worse the result ，after three months of intervention'}, {'measure': 'Results of the Depression Anxiety Stress Scale 21 scale after 6 months of intervention', 'timeFrame': '6 months after intervention', 'description': 'DASS-21 changes( 0-63), The larger the score, the worse the result， after 6 months of intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV-2 Infection', 'Staff Attitude', 'Anxiety', 'Mental Health Issue']}, 'descriptionModule': {'briefSummary': 'Timely interventions may reduce the occurrence of post-traumatic stress disorder (PTSD) in ICU medical staff. Existing research suggests that either self-learning psychological relief methods or seeking online counseling or therapy from professional psychotherapists during the SARS-CoV-2 Omicron outbreak has the potential to alleviate the emotional distress and promote the physical and mental health of health care workers. Web-based online mental health interventions complemented by joint effective mental health advice can further reduce harmful negative effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or older\n2. Non-ICU professional staff providing direct health care services to critically ill SARS-CoV-2 Omicron patients in the ICU\n3. Signing the informed consent form\n\nExclusion Criteria:\n\n1. No reported acute suicidal tendencies\n2. No history of psychotic or dissociative symptoms\n3. Pregnancy or lactation\n4. Major family changes within the last 12 weeks( For e.g. death of immediate family member)\n5. Participated in other clinical trials'}, 'identificationModule': {'nctId': 'NCT05713305', 'briefTitle': 'Effect of an Online Self-help Psychological Intervention on Non-ICU Specialty Care During the COVID-19 Outbreak', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Effect of an Online Self-help Psychological Intervention on the Physical and Mental Health of Non-professional Staff Who Supported the ICU During the Omicron Outbreak: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2023-0023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Daily members of the intervention group were thought to provide three different forms of daily sessions each day, averaging 10-20 minutes. These sessions included psycho-educational and cognitive-behavioral exercises, music therapy, sleep hygiene, stress relief methods. Weekly online lecture sessions presented by professional mental health therapists. In-depth interviews are conducted both before and after the experiment to explore the feasibility of the intervention', 'interventionNames': ['Procedure: Online-based self-help psychological intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'They will receive official mental health recommendations on how to cope mentally with the pandemic. These recommendations inform about the importance of a daily structure, social contact, acceptance of negative emotions and strengthening of positive emotions, and stimulus control to assimilate SARS-CoV-2 Omicron-related news. In-depth interviews are conducted both before and after the experiment to explore the feasibility of the intervention', 'interventionNames': ['Procedure: Provide online mental health knowledge']}], 'interventions': [{'name': 'Online-based self-help psychological intervention', 'type': 'PROCEDURE', 'description': 'Daily members of the intervention group were thought to provide three different forms of daily sessions each day, averaging 10-20 minutes. These sessions included psycho-educational and cognitive-behavioral exercises, music therapy, sleep hygiene, stress relief methods. Weekly online lecture sessions presented by professional mental health therapists', 'armGroupLabels': ['Intervention group']}, {'name': 'Provide online mental health knowledge', 'type': 'PROCEDURE', 'description': 'They will receive official mental health recommendations on how to cope mentally with the pandemic. These recommendations inform about the importance of a daily structure, social contact, acceptance of negative emotions and strengthening of positive emotions, and stimulus control to assimilate SARS-CoV-2 Omicron-related news', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Zhejiang University anesthesiology department', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}