Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-02-23 @ 3:19 PM
Study NCT ID:
NCT02920320
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2016-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iCompassion: Internet-based Self-help for More Self-compassion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-16', 'studyFirstSubmitDate': '2016-09-27', 'studyFirstSubmitQcDate': '2016-09-28', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression anxiety stress scale (DASS)', 'timeFrame': '8-week'}], 'secondaryOutcomes': [{'measure': 'Self-Compassion Scale', 'timeFrame': 'Baseline, 8-week, 6-month'}, {'measure': 'Mini International Neuropsychiatric Interview', 'timeFrame': 'Baseline, 8-week'}, {'measure': 'Forms of Self-Criticism and Self-Reassurance Scale', 'timeFrame': 'Baseline, 8-week, 6-month'}, {'measure': 'Comprehensive Inventory of Mindfulness Experiences', 'timeFrame': 'Baseline, 8-week, 6-month'}, {'measure': 'Positive and Negative Affective Schedule', 'timeFrame': 'Baseline, 8-week, 6-month'}, {'measure': 'Fear of Self-Compassion Scale', 'timeFrame': 'Baseline, 8-week, 6-month'}, {'measure': 'Satisfaction with Life Scale', 'timeFrame': 'Baseline, 8-week, 6-month'}, {'measure': 'Questionnaire for the Assessment of Adaptive and Maladaptive Shame', 'timeFrame': 'Baseline, 8-week, 6-month'}, {'measure': 'Rosenberg Self-Esteem Scale', 'timeFrame': 'Baseline, 8-week, 6-month follow-up'}, {'measure': 'Client Satisfaction Questionnaire', 'timeFrame': '8-week'}, {'measure': 'Depression anxiety stress scale (DASS)', 'timeFrame': '6-month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Self-criticism']}, 'descriptionModule': {'briefSummary': 'In this study, people who suffer from strong self-critical tendencies will be randomized to two study conditions. The first group receives an account to an internet-based self-help intervention. The second group is a waiting control group. In both conditions additional care or treatment is allowed. The aim of the study is to investigate the effectiveness of an internet-based self-help intervention on depressive, anxiety and stress symptoms compared to a waiting list. Assessments are at baseline, 8-week and 6-months post-randomization. After 8 weeks, participants in the waiting control group get also access to the intervention and fill out questionnaires after 8 weeks again.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Increased levels of self-criticism\n* 18 years or older\n* Internet account\n* Sufficient German language skills\n* Written informed consent\n\nExclusion Criteria:\n\n* Substance dependence, psychotic disorder, bipolar disorder\n* Acute suicidality'}, 'identificationModule': {'nctId': 'NCT02920320', 'acronym': 'iCompassion', 'briefTitle': 'iCompassion: Internet-based Self-help for More Self-compassion', 'organization': {'class': 'OTHER', 'fullName': 'University of Bern'}, 'officialTitle': 'iCompassion: Internet-based Self-help for More Self-compassion', 'orgStudyIdInfo': {'id': 'TK001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-based self-help', 'description': 'Internet-based self-help on the basis of the program "Mindfulness-Based Compassionate Living" (van den Brink \\& Koster, 2015). The self-help program consists of seven text-based sessions, various exercises (z.B. breathing meditations, diaries,) and tasks. Participants have the possibility for guidance to the program on request.', 'interventionNames': ['Other: Internet-based self-help program']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting control group'}], 'interventions': [{'name': 'Internet-based self-help program', 'type': 'OTHER', 'armGroupLabels': ['Internet-based self-help']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3012', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Tobias Krieger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}