Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
Study NCT ID:
NCT03821259
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2018-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'klaudia.suchorab@nhs.net', 'phone': '+44 1738 621151', 'title': 'Klaudia Suchorab', 'organization': 'University of Edinburgh/NHS Tayside'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 months', 'eventGroups': [{'id': 'EG000', 'title': 'Older Adults With Mental Health History', 'description': 'Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 0, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Trauma History Questionnaire (THQ; Green, 1996)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Older Adults With Mental Health History', 'description': 'Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.'}], 'classes': [{'title': 'Total number of traumatic events', 'categories': [{'measurements': [{'value': '5.93', 'spread': '3.42', 'groupId': 'OG000'}]}]}, {'title': 'Crime-related events', 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.88', 'groupId': 'OG000'}]}]}, {'title': 'General trauma and disasters', 'categories': [{'measurements': [{'value': '3.81', 'spread': '2.09', 'groupId': 'OG000'}]}]}, {'title': 'Unwanted sexual experiences and physical violence', 'categories': [{'measurements': [{'value': '0.97', 'spread': '1.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'This questionnaire measures lifetime exposure to a range of potentially traumatic experiences in three broad areas of (1) crime-related events, (2) general trauma and disasters, as well as (3) unwanted sexual experiences and physical violence, and (4) other unspecified extraordinarily stressful event . Participants will be required to answer 24 items in a yes/no. Total scores range from 0 to 24. Scores for subscales are as following: (1) crime-related events: 0 - 4; (2) general trauma and disasters: 0 - 13; (3) unwanted sexual experiences and physical violence: 0 - 6; (4) other: 0 -1. Higher scores indicate more traumatic events. The THQ was developed to be applicable to various populations and has been widely used in research. In a recent review of studies employing this measure, the THQ demonstrated sound psychometric properties, including a good interrater reliability and construct validity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Older Adults With Mental Health History', 'description': 'Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.'}], 'classes': [{'title': 'DERS total score', 'categories': [{'measurements': [{'value': '93.63', 'spread': '24.33', 'groupId': 'OG000'}]}]}, {'title': 'Acceptance of emotional responses', 'categories': [{'measurements': [{'value': '17.20', 'spread': '6.99', 'groupId': 'OG000'}]}]}, {'title': 'Engagement in goal-directed behaviours', 'categories': [{'measurements': [{'value': '16.59', 'spread': '4.76', 'groupId': 'OG000'}]}]}, {'title': 'Impulse control', 'categories': [{'measurements': [{'value': '12.26', 'spread': '5.37', 'groupId': 'OG000'}]}]}, {'title': 'Emotional awareness', 'categories': [{'measurements': [{'value': '14.56', 'spread': '4.37', 'groupId': 'OG000'}]}]}, {'title': 'Access to emotion regulation strategies', 'categories': [{'measurements': [{'value': '21.51', 'spread': '7.13', 'groupId': 'OG000'}]}]}, {'title': 'Emotional clarity', 'categories': [{'measurements': [{'value': '11.51', 'spread': '4.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 6 months', 'description': "This questionnaire measures six aspects of emotion regulation, including (1) acceptance of emotional responses, (2) engagement in goal-directed behaviours, (3) impulse control, (4) emotional awareness, (5) access to emotion regulation strategies and (6) emotional clarity. Participants will be required to answer 36 items by indicating the frequency of each item on a 5-point scale ranging from 1='almost never' to 5='almost always'. The total score ranges from 36 to 180. Subscales will be explored for the purpose of this study. The score ranges for each subscale are as following: (1) acceptance of emotional responses: 6 - 30, (2) engagement in goal-directed behaviours: 5 - 25, (3) impulse control: 6 - 30, (4) emotional awareness: 6 - 30, (5) access to emotion regulation strategies: 8 - 40 and (6) emotional clarity: 5 - 25. Higher scores indicate greater difficulties in emotion regulation. The DERS demonstrated a good internal consistency (α=.80-.89) and acceptable validity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Civilian Version of the PTSD Checklist (PCL-C; Weathers, Litz, Huska & Keane, 1994)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Older Adults With Mental Health History', 'description': 'Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.14', 'spread': '14.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 6 months', 'description': "This questionnaire measures PTSD symptoms in the civilian population. Participants will be required to answer 17 items by rating the intensity of their symptoms on a 5-point scale ranging from 1='not at all' to 5='extremely'. Total scores range from 17 to 85. Higher scores indicate greater symptom severity. The PCL-C demonstrated a high internal consistency (α=.87-.94), good test-retest reliability and positive correlations with other widely used PTSD scales. It has been reported that this measure is suitable for use with older adults with a recommended cut-off score of 37 to reliably diagnose PTSD in this population.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Group Identification Scale (GIS; Sani et al., 2012)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Older Adults With Mental Health History', 'description': 'Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.73', 'spread': '1.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'This questionnaire measures identification with three groups (i.e. family, community and a social group chosen by the participant from the list provided, e.g. a group of friends, a voluntary group or a sports group). Identification with each group is measured with 4 items which encompass a general sense of belonging and commonality with in-group members, e.g. "I have a sense of belonging to \\[my group\\]". Participants rate their answers on a 7-point scale from 1=\'strongly disagree\' to 7=\'strongly agree\'. Total scores for 4 items measuring identification with each group range from 4 to 28. The cut-off score for group identification is 20, hence individuals whose total score is ≥20 across 4 items will be considered as identifying with the given group. The total number of groups the participant can identify with ranges between 0 and 3 groups. This number will be used in the final analysis. The GIS demonstrated a good internal reliability (α=.85-.92) and construct validity.', 'unitOfMeasure': 'Number of groups participants identified', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Scottish Index of Multiple Deprivation (SIMD; Scottish Executive, 2016)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Older Adults With Mental Health History', 'description': 'Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.31', 'spread': '1.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'The SIMD measures socioeconomic deprivation according to postcode information and is the only readily available measure of socioeconomic deprivation which covers the whole population of Scotland. For the purpose of this study, we will report the postcode information based on their assigned quintile, which ranges from 1 (most deprived) to 5 (least deprived).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Older Adults With Mental Health History', 'description': 'Eligible participants, aged 65 and over in receipt of psychological treatment for PTSD, anxiety or depression, were recruited within the Older Adult Psychological Therapies service.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The study recruited an opportunistic sample of suitable participants who were identified and initially approached about the study by a psychologist involved in their care. Consequently no participants were excluded following their enrolment in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Older Adults With Mental Health History', 'description': 'Eligible participants, aged 65 and over in receipt of psychological treatment for PTSD, anxiety or depression, were recruited within the Older Adult Psychological Therapies service.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '72.17', 'spread': '4.67', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'The Civilian Version of the PTSD Checklist (PCL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '42.14', 'spread': '14.47', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Civilian Version of the PTSD Checklist (PCL-C; Blanchard, Jones-Alexander, Buckley, \\& Forneris, 1996; Weathers, Litz, Herman, Huska, \\& Keane, 1993) measures PTSD symptoms in the civilian population. Participants answered 17 items by rating levels of distress caused by each symptom in the past month on a 5-point scale (1 = not at all to 5 = extremely). Total scores range from 17 to 85. Higher scores indicate greater symptom severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-11', 'size': 252585, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-12-18T19:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-25', 'studyFirstSubmitDate': '2018-12-19', 'resultsFirstSubmitDate': '2019-10-07', 'studyFirstSubmitQcDate': '2019-01-28', 'lastUpdatePostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-10', 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Trauma History Questionnaire (THQ; Green, 1996)', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'This questionnaire measures lifetime exposure to a range of potentially traumatic experiences in three broad areas of (1) crime-related events, (2) general trauma and disasters, as well as (3) unwanted sexual experiences and physical violence, and (4) other unspecified extraordinarily stressful event . Participants will be required to answer 24 items in a yes/no. Total scores range from 0 to 24. Scores for subscales are as following: (1) crime-related events: 0 - 4; (2) general trauma and disasters: 0 - 13; (3) unwanted sexual experiences and physical violence: 0 - 6; (4) other: 0 -1. Higher scores indicate more traumatic events. The THQ was developed to be applicable to various populations and has been widely used in research. In a recent review of studies employing this measure, the THQ demonstrated sound psychometric properties, including a good interrater reliability and construct validity.'}, {'measure': 'The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)', 'timeFrame': 'through study completion, an average of 6 months', 'description': "This questionnaire measures six aspects of emotion regulation, including (1) acceptance of emotional responses, (2) engagement in goal-directed behaviours, (3) impulse control, (4) emotional awareness, (5) access to emotion regulation strategies and (6) emotional clarity. Participants will be required to answer 36 items by indicating the frequency of each item on a 5-point scale ranging from 1='almost never' to 5='almost always'. The total score ranges from 36 to 180. Subscales will be explored for the purpose of this study. The score ranges for each subscale are as following: (1) acceptance of emotional responses: 6 - 30, (2) engagement in goal-directed behaviours: 5 - 25, (3) impulse control: 6 - 30, (4) emotional awareness: 6 - 30, (5) access to emotion regulation strategies: 8 - 40 and (6) emotional clarity: 5 - 25. Higher scores indicate greater difficulties in emotion regulation. The DERS demonstrated a good internal consistency (α=.80-.89) and acceptable validity."}, {'measure': 'The Civilian Version of the PTSD Checklist (PCL-C; Weathers, Litz, Huska & Keane, 1994)', 'timeFrame': 'through study completion, an average of 6 months', 'description': "This questionnaire measures PTSD symptoms in the civilian population. Participants will be required to answer 17 items by rating the intensity of their symptoms on a 5-point scale ranging from 1='not at all' to 5='extremely'. Total scores range from 17 to 85. Higher scores indicate greater symptom severity. The PCL-C demonstrated a high internal consistency (α=.87-.94), good test-retest reliability and positive correlations with other widely used PTSD scales. It has been reported that this measure is suitable for use with older adults with a recommended cut-off score of 37 to reliably diagnose PTSD in this population."}, {'measure': 'The Group Identification Scale (GIS; Sani et al., 2012)', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'This questionnaire measures identification with three groups (i.e. family, community and a social group chosen by the participant from the list provided, e.g. a group of friends, a voluntary group or a sports group). Identification with each group is measured with 4 items which encompass a general sense of belonging and commonality with in-group members, e.g. "I have a sense of belonging to \\[my group\\]". Participants rate their answers on a 7-point scale from 1=\'strongly disagree\' to 7=\'strongly agree\'. Total scores for 4 items measuring identification with each group range from 4 to 28. The cut-off score for group identification is 20, hence individuals whose total score is ≥20 across 4 items will be considered as identifying with the given group. The total number of groups the participant can identify with ranges between 0 and 3 groups. This number will be used in the final analysis. The GIS demonstrated a good internal reliability (α=.85-.92) and construct validity.'}, {'measure': 'The Scottish Index of Multiple Deprivation (SIMD; Scottish Executive, 2016)', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'The SIMD measures socioeconomic deprivation according to postcode information and is the only readily available measure of socioeconomic deprivation which covers the whole population of Scotland. For the purpose of this study, we will report the postcode information based on their assigned quintile, which ranges from 1 (most deprived) to 5 (least deprived).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'Older adults are becoming a growing proportion of people utilising mental health services. However, the needs of this population are poorly understood despite the evidence that mental health conditions are manifested differently in old age. One of those conditions is Post Traumatic Stress Disorder (PTSD) which has been associated with an increased risk of adverse outcomes in old age, including health problems, difficulties in daily functioning, less satisfaction with life and multiple psychiatric co-morbidities, such as depression and anxiety. Despite the serious consequences, PTSD symptoms in old age tend to be underreported or misperceived as a physical illness or part of an ageing process.\n\nTraumatic life experiences do not necessarily lead to PTSD. Psychological resources, including emotional stability and social support, allow individuals to find appropriate coping strategies and maintain well-being in old age. Group identification, defined as a sense of belonging to a specific group, influences the response to social support and may be important in predicting distress in old age. On the other hand, socioeconomic deprivation is likely to increase this distress as exposure to traumatic events is more prevalent in disadvantaged populations.\n\nThe present study will investigate the impact of those factors on PTSD symptoms in later life. The researcher will recruit 85 older adults from the Older People Psychological Therapies Service, who are in receipt of psychological treatment for PTSD, anxiety or depression. Participants will be asked to provide basic demographic information, which will be used to describe the participant characteristics and to estimate the degree of socioeconomic deprivation. Participants will also complete five measures to screen for cognitive impairment and measure PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification.\n\nThe findings will help improve the diagnostic process and development of psychological treatments for PTSD in older adults by expanding our knowledge of this condition in later life.', 'detailedDescription': 'Aim of the study:\n\nTo investigate the importance and relative contribution of interpersonal and intra-individual factors, including lifetime trauma exposure, emotion regulation, social group belonging and socioeconomic deprivation in predicting PTSD symptoms in older adults.\n\nPrimary research questions:\n\n1. Will greater lifetime trauma exposure predict higher levels of PTSD symptoms in older adults?\n2. Will greater difficulties in emotion regulation predict higher levels of PTSD symptoms in older adults?\n3. Will a lower number of group identifications predict higher levels of PTSD symptoms in older adults?\n4. Will higher levels of socioeconomic deprivation predict higher levels of PTSD symptoms in older adults?\n\nSecondary research questions:\n\n1. What is the relative contribution of lifetime trauma exposure in predicting levels of PTSD symptoms in older adults?\n2. What is the relative contribution of difficulties in emotion regulation in predicting levels of PTSD symptoms in older adults?\n3. What is the relative contribution of group identifications in predicting levels of PTSD symptoms in older adults?\n4. What is the relative contribution of socioeconomic deprivation in predicting levels of PTSD symptoms in older adults?\n\nDesign:\n\nThe study will employ a cross-sectional, within-groups design. An opportunistic clinical sample of older adults, aged 65 and over, in receipt of psychological treatment for PTSD, anxiety or depression in the Older People Psychological Therapies Service in NHS Tayside will be recruited. Participants will be asked to provide basic demographic information and to complete five measures, screening for cognitive impermanent and measuring PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification. Correlation and multiple regression analyses will be used to answer the research hypotheses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'An opportunistic clinical sample of older adults, aged 65 and over, in receipt of psychological treatment for PTSD, anxiety or depression in the Older People Psychological Therapies Service in NHS Tayside will be recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 65 years and over\n* In receipt of psychological treatment for PTSD, anxiety or depression\n* Fluent English speaker\n* Ability to give consent\n\nExclusion Criteria:\n\n* Cognitive impairment (MoCA ≤20)\n* Under investigation for or a confirmed diagnosis of dementia\n* Currently experiencing an episode of a serious mental illness, e.g. psychosis\n* Ongoing substance misuse\n* Ongoing serious risk issues (i.e. risk of harm to self and others, suicidality)'}, 'identificationModule': {'nctId': 'NCT03821259', 'briefTitle': 'Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life: the Contribution of Cumulative Trauma Exposure, Emotion Regulation, Group Identifications, and Socioeconomic Deprivation', 'orgStudyIdInfo': {'id': 'CAHSS1802/04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Older adults with mental health history', 'description': 'Eligible participants, aged 65 and over, will be established in treatment for PTSD, anxiety or depression in the Older Adult Psychological Therapies service.', 'interventionNames': ['Other: Psychological measures']}], 'interventions': [{'name': 'Psychological measures', 'type': 'OTHER', 'description': 'Participants will be asked to provide basic demographic information and to complete five measures, screening for cognitive impermanent and measuring PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification.', 'armGroupLabels': ['Older adults with mental health history']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DD2 3PT', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Tayside Older People Psychological Therapies service', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}], 'overallOfficials': [{'name': 'Klaudia Suchorab, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Tayside/University of Edinburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Tayside', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}