Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
Study NCT ID:
NCT04386668
Status:
TERMINATED
Last Update Posted:
2020-10-08
First Post:
2020-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Let It Out (LIO) and COVID19: Testing an Online Emotional Disclosure-based Intervention During the COVID19 Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], '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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'whyStopped': 'Interim analysis indicated adaptations to intervention may be required.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kessler Psychological Distress Scale (K10)', 'timeFrame': '1 week post-intervention', 'description': '10-item self-report distress scale'}], 'secondaryOutcomes': [{'measure': 'Kessler Psychological Distress Scale (K10)', 'timeFrame': 'Immediately and 8 weeks post-intervention', 'description': '10-item self-report distress scale'}, {'measure': 'Perceived Stress Scale (PSS-10)', 'timeFrame': 'Immediately, 1 week and 8 weeks post-intervention', 'description': 'Self-report stress scale'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Immediately, 1 week and 8 weeks post-intervention', 'description': 'Self-report sleep scale'}, {'measure': 'Self-compassion scale (SCS)', 'timeFrame': 'Immediately, 1 week and 8 weeks post-intervention', 'description': 'Self-report self-compassion scale'}, {'measure': 'UCLA Loneliness Scale (UCLA LS)', 'timeFrame': 'Immediately, 1 week and 8 weeks post-intervention', 'description': 'Self-report loneliness scale'}, {'measure': 'Uptake of existing mental health services (MHS)', 'timeFrame': 'Immediately, 1 week and 8 weeks post-intervention', 'description': 'Self-report measure of MHS usage'}, {'measure': 'Mood and meaning', 'timeFrame': 'Immediately after each writing session', 'description': "3-item, 7-point, Likert scale measuring how personal and meaningful participants' felt their writing was and their mood"}, {'measure': 'Acceptability', 'timeFrame': 'Immediately post-intervention', 'description': 'Via an online feedback form'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID19', 'Coronavirus'], 'conditions': ['COVID19']}, 'descriptionModule': {'briefSummary': 'A randomised controlled trial designed to test whether an online expressive writing intervention (LIO-C) can reduce distress for English-speaking adults during the global COVID19 pandemic.\n\nHypothesis: LIO-C will improve distress (as measured by K10) in adults at 1 week post-intervention compared to a neutral writing control during the COVID19 pandemic.', 'detailedDescription': 'The world is currently experiencing unprecedented challenges caused by the global coronavirus (COVID19) pandemic. Many countries are enforcing measures to restrict movement of people to reduce the spread of the outbreak, including lock-downs, social distancing and self-isolation. These methods, although necessary to slow the spread of disease, will have negative effects on psychological well-being of large populations. Shortage of health care professionals and measures to restrict interpersonal contact means facilitated psychological interventions will not be feasible for many, at least during the height of the pandemic. There is therefore a need for self-directed psychological interventions that can be practically and quickly implemented online.\n\nEmotional disclosure-based therapies, such as expressive writing (EW), hold potential as low-cost, easy to implement means of support, with minimal requirement for facilitation. In its original format, EW involved writing daily for 15-20 minutes for 3-4 days about a traumatic event. Since its development, it has been adapted in many ways, including writing about positive events and writing about stress from a compassionate stance. There is evidence that such interventions can provide significant psychological and physical benefits in healthy populations and reduce the effects of natural disasters on health and well-being. However, to our knowledge this form of psychological intervention has not been tested during a rapidly evolving crisis or pandemic.\n\nThe aim of this study is to test whether an online self-compassion and EW based intervention (LIO-C) can reduce the negative effects of the COVID19 pandemic on health and well-being. The intervention is based on an existing intervention, LIO, that we previously developed for use in advanced disease populations, in collaboration with clinical and health psychologists, and patient and public representatives. For this study, we have adapted the intervention for people living through the current COVID19 pandemic by altering the writing prompts, and translating the intervention to an online hub. As this is an unfacilitated intervention, the instructions involve writing from a compassionate stance to minimise any potential short term negative effects associated with writing about difficult experiences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking adults over the age of 18\n* Able to read and write clearly in English\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04386668', 'acronym': 'LIO-C', 'briefTitle': 'Let It Out (LIO) and COVID19: Testing an Online Emotional Disclosure-based Intervention During the COVID19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Let It Out (LIO) and COVID19: a Randomised Controlled Trial of an Online Emotional Disclosure-based Intervention for Adults During the COVID19 Pandemic', 'orgStudyIdInfo': {'id': '15281/003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LIO-C', 'description': 'Participants receive LIO-C writing intervention', 'interventionNames': ['Other: Let It Out (LIO)-C']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Neutral writing control', 'description': 'Participants receive neutral writing control intervention', 'interventionNames': ['Other: Neutral writing control']}], 'interventions': [{'name': 'Let It Out (LIO)-C', 'type': 'OTHER', 'otherNames': ['expressive writing', 'emotional disclosure', 'expressive disclosure', 'therapeutic writing'], 'description': 'Participants complete three online 20-minute writing sessions in response to prompts asking them to write about their experiences during the COVID19 pandemic from a self-compassionate perspective', 'armGroupLabels': ['LIO-C']}, {'name': 'Neutral writing control', 'type': 'OTHER', 'description': 'Participants complete three online 20-minute writing sessions in response to neutral writing prompts', 'armGroupLabels': ['Neutral writing control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TN14 6DW', 'city': 'London', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'University College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Nuriye Kupeli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marie Curie Palliative Care Research Department, UCL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Fully anonymised participant data will be made available open access via ESRC data repository ReShare', 'accessCriteria': 'Open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}