Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-03-07 @ 10:56 PM
Study NCT ID:
NCT03839966
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2019-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computerized Intervention for Loneliness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will not know if they are receiving the active or control treatment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to receive one of two treatments'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2019-02-11', 'studyFirstSubmitQcDate': '2019-02-11', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'UCLA Loneliness Scale (ULS)', 'timeFrame': 'Change in loneliness from baseline to post treatment (4weeks) and three month follow up (16 weeks)', 'description': 'A 20 item Self report scale measuring loneliness. Scales range from 0 to 60 with higher scores indicating a higher level of loneliness.'}], 'secondaryOutcomes': [{'measure': 'Multidimensional Scale of Perceived Social Support', 'timeFrame': 'Change in Perceived Social Support from baseline to post treatment (4weeks) and three month follow up (16 weeks)', 'description': 'Self-report scale that measures perceived levels of social support. Scores range from 12 to 84 with higher scores indicating higher levels of perceived social support. The three subscales (friends, family and significant other) all have a range of 4 to 28 with higher scores indicating higher levels of perceived social support.'}, {'measure': 'Social Phobia inventory', 'timeFrame': 'Change in social anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)', 'description': 'Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.'}, {'measure': 'State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)', 'timeFrame': 'Change in overall anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)', 'description': 'Self-report measure used to assess overall anxiety symptoms. Scores range from 21 to 84 with higher scores indicating higher levels of overall anxiety.'}, {'measure': 'Center for Epidemiological Studies Depression Scale (CES-D)', 'timeFrame': 'Change in depression symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)', 'description': 'Self-report measure used to assess depressive symptoms. Total scores range from 0 to 60 with higher scores indicating a higher level of depressive symptoms.'}, {'measure': 'Interpersonal Needs Questionnaire (INQ)', 'timeFrame': 'Change in suicide vulnerability from baseline to post treatment (4 weeks) and three month follow up (16 weeks)', 'description': 'Self report measure of suicide vulnerability. Total scores range from 15 to 105, with higher scores indicating a higher vulnerability for suicide.'}, {'measure': 'Interpretations Questionnaire- Social Subscale (IQ-S)', 'timeFrame': 'Change in interpretation style from baseline to post treatment (4 weeks) and three month follow up (16 weeks)', 'description': 'Self report measure of interpretation bias of ambiguous social situations. Scales range from 0-44 with higher scores indicating a higher level of negative interpretation bias in social situations.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Loneliness']}, 'descriptionModule': {'briefSummary': 'This study assesses whether a month long computerized interpretation bias modification intervention will reduce levels of loneliness compared to a control treatment.', 'detailedDescription': 'This study hopes to assess whether a month long interpretation bias modification intervention will reduce levels of loneliness compared to a control treatment. Participants will be randomized into an active treatment condition or a control treatment that involves a healthy living and relaxation protocol. The investigators hypothesize that participants in the IBM condition will have lower levels of negative interpretation bias and loneliness than those in the healthy habits condition at post treatment and follow up. The investigators further hypothesize that the effects of IBM on loneliness will be accounted for by changes in interpretation bias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Score of \\>48 on the UCLA Loneliness Scale\n\nExclusion Criteria:\n\n* Concurrent psychotherapy for social anxiety or depression\n* Unstable psychotropic medication status (i.e. a change within the last month)\n* History of psychotic or (hypo)manic symptoms\n* Alcohol or other substance abuse or dependence within the last three months\n* Previous participation in a similar IBM study'}, 'identificationModule': {'nctId': 'NCT03839966', 'briefTitle': 'Computerized Intervention for Loneliness', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Computerized Intervention for Loneliness', 'orgStudyIdInfo': {'id': '2018.25994'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Treatment', 'description': 'Interpretation Bias Modification for Loneliness', 'interventionNames': ['Behavioral: Interpretation Bias Modification for Loneliness']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Treatment', 'description': 'Healthy Habits Psychoeducation and Relaxation.', 'interventionNames': ['Behavioral: Healthy Habits Psychoeducation and Relaxation']}], 'interventions': [{'name': 'Interpretation Bias Modification for Loneliness', 'type': 'BEHAVIORAL', 'description': 'Participants will receive eight treatment sessions. They will be presented with ambiguous training scenarios on a computer screen. Scenarios will be presented in two discrete formats: a word-sentence relatedness task (adapted from Beard \\& Amir, 2008 and Beard, Weisberg, \\& Amir, 2011), and a sentence completion and comprehension task (adapted from paradigms used by Mathews and Mackintosh (2000), Steinman and Teachman (2010), and Beard and Amir (2008)). Both of these formats have been used to reduce maladaptive threat interpretations and increase benign interpretations.', 'armGroupLabels': ['Active Treatment']}, {'name': 'Healthy Habits Psychoeducation and Relaxation', 'type': 'BEHAVIORAL', 'description': 'Participants will receive eight computerized sessions consisting of psychoeducation on healthy behaviors as well as relaxing video clips with pleasant music (e.g., videos of rainforests, wildlife, and space). These sessions will be matched for time with the active condition, lasting approximately 25-30 minutes each. Psychoeducation will cover the topics of exercise, diet, hygiene, social support, healthy activities, and sleep. The relaxing videos will be presented after the psycho-education in each session. At the conclusion of the study, participants will be provided with the active IBM treatment free of charge if they wish to receive it.', 'armGroupLabels': ['Control Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32306', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida State University, Department of Psychology', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jesse Cougle', 'investigatorAffiliation': 'Florida State University'}}}}