Mental Health DisorderNCT04911933
Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake
A study testing Family Therapy in people with Mental Health Disorder and Post Traumatic Stress Disorder, run by Neuropsychiatric Hospital dr Ivan Barbot at 1 site in Croatia.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Health Disorder, Post Traumatic Stress Disorder, Depression
- What is being tested?
- Family Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteCroatia
- Study dates
- 4 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- People were in the earthquake area while it occured
Who cannot join
- People were not in the earthquake area while it occured
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake in Croatia: a Longitudinal Study
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.
Read the 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.
- Conditions
- Mental Health Disorder, Post Traumatic Stress Disorder, Depression, Anxiety, Panic Disorder
- Being tested
- Family Therapy
- Keywords
- disaster, earthquake, mental health, family therapy, resilience, social support, systemic psychotherapy, narrative psychotherapy
- Medical subject headings
- Mental Disorders, Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders, Panic Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family TherapyBehavioural
Also called Systemic Psychotherapy, Narrative Psychotherapy, Collaborative 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The form of treatment involve systemic family therapy sessions every two weeks about an hour each. Receives: Behavioral: Family Therapy |
| Waitlist Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 months, 12 months
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.
Measured: baseline, 6 months, 12 months
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.
Measured: baseline, 6 months, 12 months
Secondary outcomes (2)
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.
Measured: baseline, 6 months, 12 months
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
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start4 Jan 2021
- Primary completion28 Feb 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuropsychiatric Hospital dr Ivan Barbot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dragan Puljic, MD, Neuropsychiatric Hospital dr Ivan Barbot
- Investigators
- Dragan Puljic, MD, Principal investigator, Neuropsychiatric Hospital dr Ivan Barbot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911933
- Sponsor's protocol ID
- ZH/MS/2176-128-14-688-3/21
- Status last verified
- May 2021
- First submitted
- 12 Mar 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake in Croatia: a Longitudinal Study
- ClinicalTrials.gov ID
- NCT04911933
- Acronym / sponsor ID
- ZH/MS/2176-128-14-688-3/21
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Neuropsychiatric Hospital dr Ivan BarbotUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Family TherapyThe form of treatment involve systemic family therapy sessions every two weeks about an hour each. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- People were in the earthquake area while it occured
Key exclusion criteria (1 listed)
- People were not in the earthquake area while it occured
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family TherapyAlso: Systemic Psychotherapy, Narrative Psychotherapy, Collaborative TherapyThere 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. | Behavioural | Intervention |
Primary outcome
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.
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.
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.
2 secondary outcomes
Resilience- Assessing change over time
Time frame: baseline, 6 months, 12 months
Social support - Assessing change over time
Time frame: baseline, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dragan Puljic, MD principal investigator
Neuropsychiatric Hospital dr Ivan Barbot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Therapy in people with Mental Health Disorder and Post Traumatic Stress Disorder, run by Neuropsychiatric Hospital dr Ivan Barbot at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post traumatic stress symptoms - Assessing change over time (time frame: baseline, 6 months, 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.