Development of Mental Health Outcomes Following the 2020 Petrinja Earthquake

NCT04911933 | Unknown DMC

• 1 other identifier: ZH/MS/2176-128-14-688-3/21
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Resilience- Assessing change over time

  baseline, 6 months, 12 months

• Social support - Assessing change over time

  baseline, 6 months, 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

The form of treatment involve systemic family therapy sessions every two weeks about an hour each.

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.

Interventions

Family Therapy BEHAVIORAL

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.

Also known as: Systemic Psychotherapy, Narrative Psychotherapy, Collaborative Therapy

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• People were in the earthquake area while it occured

You may not qualify if:

• People were not in the earthquake area while it occured

Sponsors & Collaborators

• Neuropsychiatric Hospital dr Ivan Barbot: lead

Study Sites (1)

Neuropsychiatric Hospital dr Ivan Barbot

Petrinja, Croatia

Location

MeSH Terms

Conditions

Mental Disorders; Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders; Panic Disorder; Psychological Well-Being

Interventions

Family Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dragan Puljic, MD

  Neuropsychiatric Hospital dr Ivan Barbot

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist Consultant

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: June 3, 2021
• Study Start: January 4, 2021
• Primary Completion: February 28, 2021
• Study Completion: December 31, 2021
• Last Updated: June 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)