Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-07 @ 7:13 PM
Study NCT ID:
NCT04408651
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2020-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Intensity Internet Therapy for Chronic Illness (@LIIT.CI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2020-05-20', 'studyFirstSubmitQcDate': '2020-05-28', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fear of contracting COVID-19 (Fear of contracting COVID-19 scale; FCCS)', 'timeFrame': 'Changes in results from: immediately pre-intervention and immediately post-intervention assessments', 'description': 'Higher scores indicate more fear of contracting COVID-19 (9-45)'}], 'primaryOutcomes': [{'measure': 'Depression and anxiety (Hospital Anxiety and Depression Scales; HADS)', 'timeFrame': 'Changes in results from: immediately pre-intervention and immediately post-intervention assessments', 'description': 'Higher scores indicate more depression and anxiety symptoms (0-21)'}], 'secondaryOutcomes': [{'measure': 'Illness shame (Chronic Illness Shame Scale; CISS)', 'timeFrame': 'Changes in results from: immediately pre-intervention and immediately post-intervention assessments', 'description': 'Higher scores indicate higher levels of illness shame (0-28)'}, {'measure': 'Psychological Flexibility (Comprehensive assessment of ACT processes; CompACT)', 'timeFrame': 'Changes in results from: immediately pre-intervention and immediately post-intervention assessments', 'description': 'Higher scores indicate higher levels of psychological flexibility (0-108)'}, {'measure': 'Self-compassion (Self-compassion scale; SCS)', 'timeFrame': 'Changes in results from: immediately pre-intervention and immediately post-intervention assessments', 'description': 'Higher scores indicate higher levels of self-compassion (subscale of the Self-compassion scale) (13-65)'}, {'measure': 'Self-criticism (Self-compassion scale; SCS)', 'timeFrame': 'Changes in results from: immediately pre-intervention and immediately post-intervention assessments', 'description': 'Higher scores indicate higher levels of self-cristicism (subscale of the Self-compassion scale) (13-65)'}, {'measure': 'Cognitive fusion (Cognitive Fusion Scale; CFQ-7)', 'timeFrame': 'Changes in results from: immediately pre-intervention and immediately post-intervention assessments', 'description': 'Higher scores indicate higher levels of cognitive fusion (0-28)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Medical Conditions']}, 'descriptionModule': {'briefSummary': "Chronic illness (CI) presents a significant and negative effect on quality of life and mental health. Further, emotion regulation has been considered of particular importance on the determination of chronic patients' well-being. Evidence suggests that Acceptance and Commitment Therapy (ACT) is an effective approach to improve psychological health in patients with CI. Further, there is some, although limited, evidence, that self-compassion training may be also useful in this context, and the inclusion of self-compassion elements in ACT interventions has even been the focus of attention by recent studies. Nevertheless, no study yet has compared the efficacy of these two types of intervention in CI. This is the aim of the present project - to analyse, in a low intensity eHealth intervention context, whether ACT or Compassion Focused Therapy (CFT) present superiority over the other in improving mental health and illness-related outcomes in CI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65\n* Previous diagnosis of a physical chronic medical condition\n* Easy access to internet and to a computer\n\nExclusion Criteria:\n\n* Receiving psychological intervention\n* Diagnosis of a severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or cognitive impairment.'}, 'identificationModule': {'nctId': 'NCT04408651', 'briefTitle': 'Low Intensity Internet Therapy for Chronic Illness (@LIIT.CI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Coimbra'}, 'officialTitle': 'Low Intensity Internet Therapy for Chronic Illness (@LIIT.CI): Testing the Efficacy of ACT and CFT Interventions', 'orgStudyIdInfo': {'id': 'LIIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acceptance and Commitment Therapy', 'interventionNames': ['Behavioral: LIIT.CI ACT']}, {'type': 'EXPERIMENTAL', 'label': 'Compassion-Focused Therapy', 'interventionNames': ['Behavioral: LIIT.CI CFT']}], 'interventions': [{'name': 'LIIT.CI ACT', 'type': 'BEHAVIORAL', 'description': '4-week online self-management intervention based on Acceptance and Commitment Therapy and adapted to people with chronic medical conditions', 'armGroupLabels': ['Acceptance and Commitment Therapy']}, {'name': 'LIIT.CI CFT', 'type': 'BEHAVIORAL', 'description': '4-week online self-management intervention based on Compassion-Focused Therapy and adapted to people with chronic medical conditions', 'armGroupLabels': ['Compassion-Focused Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000-115', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Inês Trindade', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Coimbra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Inês A Trindade', 'investigatorAffiliation': 'University of Coimbra'}}}}