Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT04394403
Status:
UNKNOWN
Last Update Posted:
2021-02-09
First Post:
2020-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Internet-based Self-Help Program for Managing Corona (COVID-19) Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized trial to either immediate or delayed access to the internet guided self-help program'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2020-05-18', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'completion rate of modules', 'timeFrame': '6 weeks', 'description': 'how many modules each individual completes, with less than 2 being considered dropout'}], 'primaryOutcomes': [{'measure': 'The CoRonavIruS Health Impact Survey (CRISIS)', 'timeFrame': 'change from Pre to post treatment (6 weeks),', 'description': 'change in a self-report measure of stress during the COVID-19 pandemic that ranges from 0-128. Higher means more symptomatic.'}, {'measure': 'The CoRonavIruS Health Impact Survey (CRISIS)', 'timeFrame': 'change from Pre to 6 months Follow-up', 'description': 'change in a self-report measure of stress during the COVID-19 pandemic that ranges from 0-128. Higher means more symptomatic.'}, {'measure': 'The CoRonavIruS Health Impact Survey (CRISIS)', 'timeFrame': 'change from Pre to 1 year Follow-up', 'description': 'change in a self-report measure of stress during the COVID-19 pandemic that ranges from 0-128. Higher means more symptomatic.'}], 'secondaryOutcomes': [{'measure': 'Depression, Anxiety, and Stress Scale- 21 item version: DASS-21', 'timeFrame': 'Weekly change during treatment and at pre and post (6 week) treatment evaluations', 'description': 'a self-report measure of depression, anxiety and stress, with each subscale ranging from 0-28. Higher means more symptomatic.'}, {'measure': 'Depression, Anxiety, and Stress Scale- 21 item version: DASS-21', 'timeFrame': 'change from pre to 6 month follow up', 'description': 'a self-report measure of depression, anxiety and stress, with each subscale ranging from 0-28. Higher means more symptomatic.'}, {'measure': 'Depression, Anxiety, and Stress Scale- 21 item version: DASS-21', 'timeFrame': 'change from pre to 1 year follow-up', 'description': 'a self-report measure of depression, anxiety and stress, with each subscale ranging from 0-28. Higher means more symptomatic.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress', 'Stress, Psychological']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.iterapi.se/sites/coronastress/', 'label': 'site website for guided self-help program'}]}, 'descriptionModule': {'briefSummary': 'The current study examines an adapted guided self-help stress reduction program, focusing on reducing stress in the time of COVID-19. Two studies are planned: 1) an international study in English in which individuals proficient in English throughout the world will participate and 2) a follow-up study in Hebrew.', 'detailedDescription': 'The current study examines an adapted guided self-help stress reduction program, focusing on reducing stress in the time of COVID-19. Two studies are proposed: 1) an international study in English in which individuals proficient in English throughout the world will participate and 2) a study in Hebrew. The first study will publicize via social media and participants will be randomized to either immediate participation or a 6 week waitlist period. Assessments will be conducted pre, (again after waitlist for the control group), posttx (after completion/cessation of the program), 6 month and 1 year followup. Two forms of assessment will be conducted: pre-post-follow-up (with the CRISIS measure) and weekly during the program (via the DASS-21). For the full program see: https://www.iterapi.se/sites/coronastress/'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Read/Write English,\n* feels stress due to Corona/COVID-19\n\nExclusion Criteria:\n\n* current psychological or psychiatric treatment,\n* current psychiatric illness,\n* suicidality,\n* psychosis,\n* bipolar,\n* severe dissociative symptoms,\n* in a currently severe traumatic situation,\n* having a serious medical illness.'}, 'identificationModule': {'nctId': 'NCT04394403', 'acronym': 'CoronaStress', 'briefTitle': 'Pilot Internet-based Self-Help Program for Managing Corona (COVID-19) Stress', 'organization': {'class': 'OTHER', 'fullName': 'Hebrew University of Jerusalem'}, 'officialTitle': 'Pilot Internet-based Self-Help Program for Managing Corona Stress vs. Waitlist Control', 'orgStudyIdInfo': {'id': 'coronastress'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'immediate guided self-help', 'description': 'In this condition, individuals will be given access to material and exercises based on CBT to reduce their stress', 'interventionNames': ['Behavioral: Internet-based guided self-help based on CBT principles']}, {'type': 'NO_INTERVENTION', 'label': 'waitlist', 'description': 'Individuals in this condition will wait 6 weeks before they are provided access to the guided self-help program'}], 'interventions': [{'name': 'Internet-based guided self-help based on CBT principles', 'type': 'BEHAVIORAL', 'otherNames': ['ICBT for CoronaStress'], 'description': 'Individuals are provided basic rationale of CBT to deal with stress, worry, anxiety, dysphoria, sleep difficulties, emotion dysregulation, and memories all related to COVID-19', 'armGroupLabels': ['immediate guided self-help']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9190501', 'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Jonathan Huppert, PhD', 'role': 'CONTACT', 'email': 'coronastress@mail.huji.ac.il', 'phone': '+97225883376'}, {'name': 'Jonathan D Huppert, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hebrew University of Jerusalem', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Jonathan Huppert, PhD', 'role': 'CONTACT', 'email': 'jonathan.huppert@mail.huji.ac.il', 'phone': '+97225883376'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebrew University of Jerusalem', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jonathan D. Huppert', 'investigatorAffiliation': 'Hebrew University of Jerusalem'}}}}