Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 11:42 PM
Study NCT ID:
NCT04911933
Status:
UNKNOWN
Last Update Posted:
2021-06-03
First Post:
2021-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D016584', 'term': 'Panic Disorder'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005196', 'term': 'Family Therapy'}], 'ancestors': [{'id': 'D011615', 'term': 'Psychotherapy, Group'}, {'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-27', 'studyFirstSubmitDate': '2021-03-12', 'studyFirstSubmitQcDate': '2021-05-27', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post traumatic stress symptoms - Assessing change over time', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Post traumatic stress disorder symptoms using PTSD Checklist for DSM-5 (PCL-5) which is 4 item self-report questionnaire, corresponding to the DSM-5 symptom criteria for PTSD. It was was modified to make questions earthquake specific. The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely.".Higher score indicates higher symptoms for PTSD.'}, {'measure': 'Depression and anxiety symptoms - Assessing change over time', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'The Patient Health Questionnaire-4 (PHQ-4) is self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2). The PHQ-4 questionnaire answered on a four point Likert-type scale as "None", "Mild", "Moderate" or "Severe". Higher score indicates higher symptoms for depression and anxiety.'}, {'measure': 'Panic disorder symptoms - Assessing change over time', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Symptoms of panic disorder using the Severity Measure for panic disorder (PDSS), 7 item self-report questionnaire. Each item on the measure is rated on a 5-point scale (0=Never; 1=Occasionally; 2=Half of the time; 3=Most of the time, and 4=All of the time). The average total score is calculated by dividing the raw total score by number of items in the measure, with higher scores indicating greater severity of panic disorder symptoms.'}], 'secondaryOutcomes': [{'measure': 'Resilience- Assessing change over time', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'The six items of the Brief resilience scale (BRS) assess resilience as bouncing back from stress, whether it is related to resilience resources, and whether it is related to important health outcomes. BRS include an equal number of positive and negatively worded items. The BRS is scored by reverse coding items on scale from 1 to 5. Higher score indicates higher resilience.'}, {'measure': 'Social support - Assessing change over time', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'Oslo social support OSSS-3 consists of three items assessing the level of social support. The sum score ranges from 3 to 14, This continuous score was used to generate the normative data for the OSSS-3 for each scoring point as well as to determine group differences according to age and sex. The OSSS-3 sum score can be operationalized into three broad categories of social support. 3-8 poor social support ; 9-11 moderate social support; 12-14 strong social support'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['disaster', 'earthquake', 'mental health', 'family therapy', 'resilience', 'social support', 'systemic psychotherapy', 'narrative psychotherapy'], 'conditions': ['Mental Health Disorder', 'Post Traumatic Stress Disorder', 'Depression', 'Anxiety', 'Panic Disorder']}, 'descriptionModule': {'briefSummary': 'On 29 December 2020, an earthquake struck Petrinja in Croatia. The aim of this study is to assesses prevalence of symptoms of posttraumatic stress disorder, depression, anxiety, and panic disorder among exposed inhabitants and examine the effect of family therapy on mental health as part of a public health emergency response and rapid assessment.', 'detailedDescription': 'The strong earthquake measuring 6.4 on the Richter scale hit the area of Petrinja town in Croatia on December 29 2020, causing numerous casualties and widespread material damage. The maximum felt intensity was estimated at VIII (Heavily damaging) to IX (Destructive) on the European macroseismic scale, and it is the worst earthquake in Croatia in the last 140 years. Since the initial strong earthquake, the Petrinja area has been hit by numerous aftershocks, magnitudes ranging from 1.2 to 4.8 on the Richter scale, increasing distress of residents and contributing to further damage of houses and buildings. The earthquake and the constant aftershocks caused strong psychological and physiological reactions in children and adults directly affected as well as a large population of people living in the surrounding areas at the time when Croatia was facing a second "lockdown" during the COVID-19 pandemic.\n\nAs part of a public health emergency response, we conducted a rapid assessment among survivors in the most severely affected area by the earthquake. Findings from previous researches among survivors of natural disasters have been mixed in prevalence of mental health problems and treatments outcomes. The aim of this study is to assesses prevalence of symptoms of posttraumatic stress disorder, depression, anxiety, and panic disorder among exposed inhabitants and examine the effect of systemic family therapy on mental health during the first year following the earthquake. Qualitative methodology will be used to augment quantitative findings. The study sample consisted of 350 individuals residing in the earthquake area. Participants were selected from total number of patients requested psychological and psychiatric help during first two months after disaster. A follow up study will be conducted at 6 and 12 months to assess the change in their mental health status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People were in the earthquake area while it occured\n\nExclusion Criteria:\n\n* People were not in the earthquake area while it occured'}, 'identificationModule': {'nctId': 'NCT04911933', 'briefTitle': 'Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake', 'organization': {'class': 'OTHER', 'fullName': 'Neuropsychiatric Hospital dr Ivan Barbot'}, 'officialTitle': 'Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake in Croatia: a Longitudinal Study', 'orgStudyIdInfo': {'id': 'ZH/MS/2176-128-14-688-3/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The form of treatment involve systemic family therapy sessions every two weeks about an hour each.', 'interventionNames': ['Behavioral: Family Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Control', 'description': 'Participants assigned to the control condition will be placed on a waitlist for future enrollment. After primary data collection has ceased, those assigned to the control arm will receive the identical intervention delivered in the experimental condition.'}], 'interventions': [{'name': 'Family Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Systemic Psychotherapy', 'Narrative Psychotherapy', 'Collaborative Therapy'], 'description': 'There will be systemic family psychotherapy sessions every two weeks. Families and individuals who require a more intensive service will be referred to a higher level of care.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petrinja', 'country': 'Croatia', 'facility': 'Neuropsychiatric Hospital dr Ivan Barbot', 'geoPoint': {'lat': 45.4375, 'lon': 16.29}}], 'overallOfficials': [{'name': 'Dragan Puljic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neuropsychiatric Hospital dr Ivan Barbot'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuropsychiatric Hospital dr Ivan Barbot', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Psychiatrist Consultant', 'investigatorFullName': 'Dragan Puljic, MD', 'investigatorAffiliation': 'Neuropsychiatric Hospital dr Ivan Barbot'}}}}