Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake

Depression Clinical Trial

Official title:

Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake in Croatia: a Longitudinal Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04911933
• Other study ID #: ZH/MS/2176-128-14-688-3/21
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: Neuropsychiatric Hospital dr Ivan Barbot
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: December 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• People were in the earthquake area while it occured

Exclusion Criteria:

• People were not in the earthquake area while it occured

Related Conditions & MeSH terms

• Anxiety
• Depression
• Disease
• Mental Disorders
• Mental Health Disorder
• Panic Disorder
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Family Therapy
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.

Locations

Country	Name	City	State
Croatia	Neuropsychiatric Hospital dr Ivan Barbot	Petrinja

Sponsors (1)

Lead Sponsor	Collaborator
Neuropsychiatric Hospital dr Ivan Barbot

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post traumatic stress symptoms - Assessing change over time	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
Primary	Depression and anxiety symptoms - Assessing change over time	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
Primary	Panic disorder symptoms - Assessing change over time	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	Resilience- Assessing change over time	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
Secondary	Social support - Assessing change over time	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