- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04911933
Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake
Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake in Croatia: a Longitudinal Study
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
As 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Petrinja, Croatia
- Neuropsychiatric Hospital dr Ivan Barbot
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- People were in the earthquake area while it occured
Exclusion Criteria:
- People were not in the earthquake area while it occured
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Intervention
The form of treatment involve systemic family therapy sessions every two weeks about an hour each.
|
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.
Other Names:
|
|
NO_INTERVENTION: Waitlist Control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post traumatic stress symptoms - Assessing change over time
Time Frame: baseline, 6 months, 12 months
|
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.
|
baseline, 6 months, 12 months
|
|
Depression and anxiety symptoms - Assessing change over time
Time Frame: baseline, 6 months, 12 months
|
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.
|
baseline, 6 months, 12 months
|
|
Panic disorder symptoms - Assessing change over time
Time Frame: baseline, 6 months, 12 months
|
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.
|
baseline, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resilience- Assessing change over time
Time Frame: baseline, 6 months, 12 months
|
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.
|
baseline, 6 months, 12 months
|
|
Social support - Assessing change over time
Time Frame: baseline, 6 months, 12 months
|
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
|
baseline, 6 months, 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dragan Puljic, MD, Neuropsychiatric Hospital dr Ivan Barbot
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZH/MS/2176-128-14-688-3/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
University of MinnesotaCompletedDepression SymptomsUnited States
Clinical Trials on Family Therapy
-
Stanford UniversityNational Institute of Mental Health (NIMH)CompletedAnorexia NervosaUnited States, Canada
-
Institut Mutualiste MontsourisFondation de l'Avenir; U1178 INSERM; PHRC Interrégionnal 2015; Fondation Sandrine... and other collaboratorsRecruitingAnorexia NervosaFrance
-
Gina DimitropoulosUniversity Health Network, TorontoCompleted
-
University of California, Los AngelesNational Institute of Mental Health (NIMH)CompletedPsychosisUnited States, Canada
-
Stanford UniversityUniversity of ChicagoCompleted
-
Ohio State UniversityNational Institute on Drug Abuse (NIDA)Completed
-
Social Insurance Institution, FinlandTurku University Hospital; University of TurkuCompletedADHD | Asperger Syndrome | Child Behavior DisordersFinland
-
Drexel UniversityNational Institute of Mental Health (NIMH)CompletedDepression | Suicide | Family RelationshipsUnited States
-
University of PittsburghNational Institute of Mental Health (NIMH); Lifespan; Rhode Island CollegeCompletedAnorexia Nervosa | Eating DisordersUnited States
-
University Hospital, AkershusRådgivning om SpiseforstyrrelserTerminatedAnorexia Nervosa | Atypical Anorexia NervosaNorway