Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-01 @ 8:22 PM
Study NCT ID:
NCT04505904
Status:
COMPLETED
Last Update Posted:
2025-03-04
First Post:
2020-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oxytocin and Approach-avoid in Grief
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090382', 'term': 'Prolonged Grief Disorder'}], 'ancestors': [{'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arizmendi@email.arizona.edu', 'phone': '9168473623', 'title': 'Brian Arizmendi', 'organization': 'University of Arizona'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 hours per participant (two visits of three hours each). Participants were monitored for any adverse even to nasal spray during laboratory visit for data collection.', 'description': 'All adverse events encountered in this study are classified as "other" as they are not serious or all-cause mortality.', 'eventGroups': [{'id': 'EG000', 'title': 'Syntocinon', 'description': 'Participants with adverse event during syntocinon condition', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 2, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants with adverse events during placebo condition', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 1, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'notes': 'Participant discontinued functional MRI data collection due to nausea while in the scanner.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'notes': 'Participant experienced back pain while in the MRI scanner. Participant chose to discontinue study participation due to back pain.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incidental Finding', 'notes': "There was an incidental radiologic finding requiring follow-up by participant's primary care physician. Participant discontinued.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With Complicated Grief', 'description': 'Those with \\> =25 score on ICG'}, {'id': 'OG001', 'title': 'Noncomplicated Grief Group', 'description': 'Those scoring \\< 25 score on Inventory of Complicated Grief (ICG).'}], 'classes': [{'title': 'Syntocinon First', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'spread': '21', 'groupId': 'OG000'}, {'value': '18', 'spread': '18.9', 'groupId': 'OG001'}]}]}, {'title': 'Placebo First', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '21', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '11.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '120 minutes', 'description': 'Participants completed the approach avoid task twice per session, with reversed instructions on the second run (i.e., "pull for yellow" became "push for yellow"). Each seven-minute run of the task consisted of 144 2500ms trials (288 trials per visit, 576 trials total across runs/sessions; 500ms inter-trial-interval). Order of instructions (i.e., "push yellow" vs. "pull yellow") was randomized and counterbalanced across participants and sessions, to address potential for order effects/habituation. Stimuli were presented via Inquisit 4 (2014), in a pseudorandomized order determined by genetic algorithm (Wager \\& Nichols, 2003).\n\nRelative approach/avoidance bias was computed by subtracting median response time (RT; latency to joystick full extension) on PULL/approach trials in each stimulus category from PUSH/avoid trials in the same category (Rinck \\& Becker, 2007). Positive response bias values indicate relative approach bias; negative values indicate relative avoidance bias.', 'unitOfMeasure': 'Milliseconds (contrast score)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of note, for analysis purposes, we collapsed across crossover groups to yield two groups, complicated grief and non-complicated grief. This is consistent with reporting methods of other relevant literature in this area and allows for direct conceptual comparison to these previous studies.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'With Complicated Grief: Syntocinon First, Then Placebo', 'description': 'Crossover design. This arm designates the Complicated grief group, as designated to \\>=25 cutoff score on standardized measure (the Inventory of Complicated Grief) who received experimental condition at visit one, and placebo at visit two 7-10 days later.\n\nSyntocinon: Synthetic oxytocin spray, 24 IU per spray.\n\nPlacebo: Placebo spray with no active ingredient.'}, {'id': 'FG001', 'title': 'With Complicated Grief: Placebo First, Then Syntocinon', 'description': 'Crossover design. This arm designates the Complicated grief group, as designated to \\>=25 cutoff score on standardized measure (the Inventory of Complicated Grief) who received placebo condition at visit one, and syntocinon at visit two 7-10 days later.\n\nSyntocinon: Synthetic oxytocin spray, 24 IU per spray.\n\nPlacebo: Placebo spray with no active ingredient.'}, {'id': 'FG002', 'title': 'Without Complicated Grief: Syntocinon First, Then Placebo', 'description': 'Crossover design. This arm designates the Non-Complicated grief group, as designated to \\<25 cutoff score on standardized measure (the Inventory of Complicated Grief) who received experimental condition at visit one, and placebo at visit two 7-10 days later.\n\nSyntocinon: Synthetic oxytocin spray, 24 IU per spray.\n\nPlacebo: Placebo spray with no active ingredient.'}, {'id': 'FG003', 'title': 'Without Complicated Grief: Placebo First, Then Syntocinon', 'description': 'Crossover design. This arm designates the Non-Complicated grief group, as designated to \\<25 cutoff score on standardized measure (the Inventory of Complicated Grief) who received placebo condition at visit one, and experimental condition at visit two 7-10 days later.\n\nSyntocinon: Synthetic oxytocin spray, 24 IU per spray.\n\nPlacebo: Placebo spray with no active ingredient.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Complicated Grief', 'description': 'Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates the Complicated grief group, as designated to \\>25 cutoff score on standardized measure (the Inventory of Complicated Grief). All participants in this group received both synthetic oxytocin and placebo\n\nSyntocinon: Synthetic oxytocin spray, 24 IU per spray.\n\nPlacebo: Placebo spray with no active ingredient.'}, {'id': 'BG001', 'title': 'Noncomplicated Grief', 'description': 'Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates the noncomplicated grief group, as divided based on cutoff score on standardized measure (the Inventory of Complicated Grief)\n\nSyntocinon: Synthetic oxytocin spray, 24 IU per spray.\n\nPlacebo: Placebo spray with no active ingredient.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.96', 'spread': '6.68', 'groupId': 'BG000'}, {'value': '69.83', 'spread': '6.68', 'groupId': 'BG001'}, {'value': '69.45', 'spread': '6.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Inventory of Complicated Grief', 'classes': [{'categories': [{'measurements': [{'value': '35.18', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '14.47', 'spread': '6.36', 'groupId': 'BG001'}, {'value': '23.5', 'spread': '7.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total score range: 0-76, with higher score meaning higher symptom severity/burden.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Beck Depression Inventory - II', 'classes': [{'categories': [{'measurements': [{'value': '16.41', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '6', 'spread': '4.86', 'groupId': 'BG001'}, {'value': '10.4', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Range is 0 (absent) to 30 (highest possible symptom score, highest depression severity). Total Score is reported here.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-23', 'size': 103666, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-23T12:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2020-08-04', 'resultsFirstSubmitDate': '2021-07-09', 'studyFirstSubmitQcDate': '2020-08-06', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-10', 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task.', 'timeFrame': '120 minutes', 'description': 'Participants completed the approach avoid task twice per session, with reversed instructions on the second run (i.e., "pull for yellow" became "push for yellow"). Each seven-minute run of the task consisted of 144 2500ms trials (288 trials per visit, 576 trials total across runs/sessions; 500ms inter-trial-interval). Order of instructions (i.e., "push yellow" vs. "pull yellow") was randomized and counterbalanced across participants and sessions, to address potential for order effects/habituation. Stimuli were presented via Inquisit 4 (2014), in a pseudorandomized order determined by genetic algorithm (Wager \\& Nichols, 2003).\n\nRelative approach/avoidance bias was computed by subtracting median response time (RT; latency to joystick full extension) on PULL/approach trials in each stimulus category from PUSH/avoid trials in the same category (Rinck \\& Becker, 2007). Positive response bias values indicate relative approach bias; negative values indicate relative avoidance bias.'}]}, 'conditionsModule': {'keywords': ['Oxytocin', 'Approach/Avoid', 'Older adults', 'Complicated Grief'], 'conditions': ['Prolonged Grief Disorder', 'Bereavement']}, 'descriptionModule': {'briefSummary': "This is a completed project which was initiated prior to January 18,2017\n\nBackground: Theoretical models of complicated grief (CG) suggest that maladaptive approach (e.g., perseverative proximity-seeking of the deceased) or avoidance (e.g., excessive avoidance of reminders) behaviors interfere with a person's ability to integrate the loss and recover from their loved one's death. Due in part to conflicting evidence, little mechanistic understanding of how these behaviors develop in grief exists. We sought to (1) identify behavioral differences between CG and non-CG groups based on implicit bias for grief-, deceased-, and social-related stimuli, and (2) test the role of the neuropeptide oxytocin in shaping approach/avoidance bias.\n\nMethods: Widowed older adults with and without CG completed an approach/avoidance task measuring implicit bias for personalized, non-specific, grief-related, and other stimuli. In a double-blinded, randomized, counterbalanced design, each participant attended both an intranasal oxytocin session and a placebo session. Aims were to (1) identify differential effects of CG and stimulus type on implicit approach/avoidance bias \\[placebo session\\], and (2) investigate interactive effects of CG, stimulus type, and oxytocin vs. placebo on approach/avoidance bias \\[both sessions\\]."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Adult individual experiencing death of a spouse or partner between 6 and 36 months prior to enrollment\n\nExclusion Criteria:\n\n* Inability to comprehend English;\n* medical contraindications for other components of the study,\n* active suicidality\n* active homicidality\n* active psychotic symptoms\n* ongoing major health conditions such as cancer; uncontrolled hypertension; and medications likely to impact the oxytocin system (e.g., systemic corticosteroids).\n* pregnant status or suspected pregnant status\n* premenopausal status'}, 'identificationModule': {'nctId': 'NCT04505904', 'briefTitle': 'Oxytocin and Approach-avoid in Grief', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'A Pull to be Close: the Differentiating Effects of Oxytocin and Grief Stimulus Type on Approach Behavior in Complicated Grief', 'orgStudyIdInfo': {'id': 'CGOT1620'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Syntocinon First', 'description': 'Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates those who received syntocinon at visit one and placebo at visit two. Syntocinon is 24 IU dose administered intranasally in spray form.', 'interventionNames': ['Drug: Syntocinon', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo First', 'description': 'Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates those who received placebo at visit one, and syntocinon at visit two.', 'interventionNames': ['Drug: Syntocinon', 'Drug: Placebo']}], 'interventions': [{'name': 'Syntocinon', 'type': 'DRUG', 'description': 'Synthetic oxytocin spray, 24 IU per spray.', 'armGroupLabels': ['Placebo First', 'Syntocinon First']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo spray with no active ingredient.', 'armGroupLabels': ['Placebo First', 'Syntocinon First']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85721', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}