Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-02-20 @ 1:49 AM
Study NCT ID:
NCT03677635
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2017-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Relationship Between Autobiographical Memory and Motivation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clementine.edwards@kcl.ac.uk', 'phone': '07557866053', 'title': 'Dr Clementine Edwards', 'organization': "King's College London"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '90 mins', 'description': 'Participants were monitored during their participation in the single testing session, which lasted approximately 90 mins, adverse events were not monitored for any period of time after this.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Guided autobiographical memory recall to enhance specificity and links to the future.\n\nGuided Autobiographical Memory Recall: Participants are asked to recall positive autobiographical memories with the assistance of prompts to promote specificity, generalisability and links to the future. The participants will also view a 5min psychoeducation video on the subject of memory specificity and motivation.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Recall without prompts or psychoeducation video.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-Intervention Motivation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Guided autobiographical memory recall to enhance specificity and links to the future.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Recall without prompts or psychoeducation video.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.01', 'spread': '4.15', 'groupId': 'OG000', 'lowerLimit': '69.21', 'upperLimit': '85.86'}, {'value': '72.89', 'spread': '5.79', 'groupId': 'OG001', 'lowerLimit': '65.12', 'upperLimit': '88.38'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Standardised Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '.21', 'ciUpperLimit': '.86', 'statisticalMethod': 'Standardised Effect Size', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after completing the intervention', 'description': 'A rating on a visual analogue scale assessing motivation to repeat the same activity recalled in the future. The scale is rated from 0-100 and a higher score indicated better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-Intervention Anticipatory Pleasure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Guided autobiographical memory recall to enhance specificity and links to the future.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Recall without prompts or psychoeducation video.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.35', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '86.58', 'spread': '4.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.05', 'ciLowerLimit': '-.59', 'ciUpperLimit': '.48', 'statisticalMethod': 'Standardised Effect Size', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Cohen's d was reported."}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after completing the intervention', 'description': 'A rating on a visual analogue scale assessing how pleasant that activity is anticipated to be if repeated. The scale is rated from 0-100 and a higher score indicated better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Guided autobiographical memory recall to enhance specificity and links to the future.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Recall without prompts or psychoeducation video.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 31 people with a diagnosis of non-affective psychosis participated between May 2017-Feb 2018.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Guided autobiographical memory recall to enhance specificity and links to the future.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Recall without prompts or psychoeducation video.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.62', 'spread': '10.98', 'groupId': 'BG000'}, {'value': '41.10', 'spread': '9.09', 'groupId': 'BG001'}, {'value': '39.55', 'spread': '10.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Clinical Assessment Interview for Negative Symptoms', 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'spread': '6.37', 'groupId': 'BG000'}, {'value': '17.1', 'spread': '6.82', 'groupId': 'BG001'}, {'value': '21.73', 'spread': '7.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Clinical Assessment Interview for Negative Symptoms (Kring, Gur, Blanchard, Horan, \\& Reise, 2013) was used to enable the assessment of both experiential and expressive negative symptoms. This takes the form of an interview schedule which is used alongside observations to complete the assessment (13 items, range: 0-52, higher score indicates greater severity of negative symptoms).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-14', 'size': 391276, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-04T06:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2017-02-10', 'resultsFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2018-09-17', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-30', 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-Intervention Motivation Score', 'timeFrame': 'Immediately after completing the intervention', 'description': 'A rating on a visual analogue scale assessing motivation to repeat the same activity recalled in the future. The scale is rated from 0-100 and a higher score indicated better outcome.'}], 'secondaryOutcomes': [{'measure': 'Post-Intervention Anticipatory Pleasure', 'timeFrame': 'Immediately after completing the intervention', 'description': 'A rating on a visual analogue scale assessing how pleasant that activity is anticipated to be if repeated. The scale is rated from 0-100 and a higher score indicated better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Negative Symptoms', 'Autobiographical Memory'], 'conditions': ['Psychosis']}, 'descriptionModule': {'briefSummary': 'People with a diagnosis of psychosis often experience low motivation and pleasure when thinking about doing future activities. This leads, quite understandably, to doing fewer activities they used to enjoy and not taking up opportunities to do new activities. One model suggests that this may be partly due to difficulties using memories of previous events to help boost motivation and anticipation before a future activity. Research shows that people with psychosis may recall previous events in less detail. These memories therefore may not be as helpful as they could be for motivation. This study will investigate this by asking people with experience of psychosis and low motivation who are seen by a care team in South London and Maudsley NHS Trust to attend two research sessions. In the first session the participants will be asked to recall memories of events from their lives and the researcher will assess how detailed the memories are and how much the participant refers to the past and future. Alongside this task the participants will also be asked to complete measures of symptoms such as low pleasure and motivation as well as a measure of depression. These will be used to find out if the detail and specificity of the memories are related to these symptoms in people with psychosis. The second half of the study will then investigate whether additional prompts to support positive memory retrieval can increase the specificity of this and subsequently improve mood, motivation and self-belief. Participants will be randomised to one of two groups. The clinical group will be guided through their memory recall using prompts and a control group will be asked to recall positive memories without prompts. If the investigators show that supporting memory recall is beneficial then memories for past events may be an important target for future therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of non-affective psychosis (as determined by medical records).\n* Above 18yrs old.\n* A score of at least 18 on the Clinical Assessment Interview for Negative Symptoms.\n* A sufficient command of the English language to engage with the research materials\n\nExclusion Criteria:\n\n* Lack of capacity to provide informed consent.\n* Primary diagnosis of intellectual disability, head injury, substance misuse or known organic cause of psychosis'}, 'identificationModule': {'nctId': 'NCT03677635', 'briefTitle': 'The Relationship Between Autobiographical Memory and Motivation', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Is There a Relationship Between Memory for Past Events and Motivation for Future Activities?', 'orgStudyIdInfo': {'id': '214063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Guided autobiographical memory recall to enhance specificity and links to the future.', 'interventionNames': ['Behavioral: Guided Autobiographical Memory Recall']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Recall without prompts or psychoeducation video.'}], 'interventions': [{'name': 'Guided Autobiographical Memory Recall', 'type': 'BEHAVIORAL', 'description': 'Participants are asked to recall positive autobiographical memories with the assistance of prompts to promote specificity, generalisability and links to the future. The participants will also view a 5min psychoeducation video on the subject of memory specificity and motivation.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BR3 3BX', 'city': 'London', 'country': 'United Kingdom', 'facility': 'South London and Maudsley NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 8AF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Institute of Psychiatry, Psychology & Neuroscience, KCL', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}