Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake
Primary Purpose
Mental Health Disorder, Post Traumatic Stress Disorder, Depression
Status
Unknown status
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Family Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Mental Health Disorder focused on measuring disaster, earthquake, mental health, family therapy, resilience, social support, systemic psychotherapy, narrative psychotherapy
Eligibility Criteria
Inclusion Criteria:
- People were in the earthquake area while it occured
Exclusion Criteria:
- People were not in the earthquake area while it occured
Sites / Locations
- Neuropsychiatric Hospital dr Ivan Barbot
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Waitlist Control
Arm Description
The form of treatment involve systemic family therapy sessions every two weeks about an hour each.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT04911933
First Posted
March 12, 2021
Last Updated
May 27, 2021
Sponsor
Neuropsychiatric Hospital dr Ivan Barbot
1. Study Identification
Unique Protocol Identification Number
NCT04911933
Brief Title
Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake
Official Title
Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake in Croatia: a Longitudinal Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Neuropsychiatric Hospital dr Ivan Barbot
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorder, Post Traumatic Stress Disorder, Depression, Anxiety, Panic Disorder
Keywords
disaster, earthquake, mental health, family therapy, resilience, social support, systemic psychotherapy, narrative psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The form of treatment involve systemic family therapy sessions every two weeks about an hour each.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Family Therapy
Other Intervention Name(s)
Systemic Psychotherapy, Narrative Psychotherapy, Collaborative Therapy
Intervention 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.
Primary Outcome Measure Information:
Title
Post traumatic stress symptoms - Assessing change over time
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.
Time Frame
baseline, 6 months, 12 months
Title
Depression and anxiety symptoms - Assessing change over time
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.
Time Frame
baseline, 6 months, 12 months
Title
Panic disorder symptoms - Assessing change over time
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.
Time Frame
baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Resilience- Assessing change over time
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.
Time Frame
baseline, 6 months, 12 months
Title
Social support - Assessing change over time
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
Time Frame
baseline, 6 months, 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
People were in the earthquake area while it occured
Exclusion Criteria:
People were not in the earthquake area while it occured
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dragan Puljic, MD
Organizational Affiliation
Neuropsychiatric Hospital dr Ivan Barbot
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuropsychiatric Hospital dr Ivan Barbot
City
Petrinja
Country
Croatia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake
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