Clinical trial NCT05993507: Mental Health Outcomes of Earthquake Survivors in Türkiye
Official title: A Scalable Psychological Intervention to Improve Mental Health Outcomes of Earthquake Survivors in Türkiye: An Open Trial Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim of this open trial pilot study will be to test feasibility, acceptability, and potential impact of Problem Management Plus (PM+), brief, scalable psychological intervention developed by WHO, for earthquake survivors in Türkiye. Secondly, this study aims to assess trial procedures in preparation for a future studies evaluating the effectiveness of PM+ intervention with earthquake survivors.

Detailed description: Considering the fact that around 16% of Turkey's population is affected by the February 6 earthquakes, reaching a higher number of people on time can be achieved through the implementation of brief, scalable interventions addressing common mental health problems. This will be the first study that investigate the individual PM+ among earthquake survivors in Türkiye. Testing these interventions will provide evidence for further use in future disasters.

The study will assess changes in depression, anxiety, posttraumatic stress symptoms, psychological distress, and psychosocial functioning scores before and after the intervention. The hypothesis to be examined posits that participants will have significantly lower depression, anxiety, posttraumatic stress, psychological distress and psychosocial functioning scores at the post assessment compared to pre-assessment.

This study will be designed as a single group pre-and post-test research. The sample will be adult earthquake survivors in Türkiye. A partnership has been formed with Travma ve Afet Ruh Sağlığı Çalışmaları Derneği (TARDE), a non-governmental organization working in the earthquake-stricken regions. 30 psychologists of TARDE have been trained for PM+ for their work with people who experienced the earthquake. The outcome measures will be assessed two times: once before and once after PM+ will be conducted. After the baseline assessment, all participants will receive the consecutive 5-session on individual PM+. The PM+ intervention consists of five weekly sessions incorporating evidence-based behavioral strategies.

Eligibility criteria: Inclusion Criteria:

* being 18 years or above
* being experienced the earthquake
* reported elevated level of psychological distress indicated by a score of \>15 on Kessler Psychological Distress Scale
* reported impaired daily functioning indicated by a score of \>16 on World Health Organization Disability Assessment Scale

Exclusion Criteria:

* imminent suicide risk (assessed with the PM+ manual suicidal thoughts interview)
* severe mental disorders (e.g., psychotic disorders) or cognitive impairment (e.g., severe intellectual disability (assessed by the PM+ manual observation checklist)

Primary outcomes:
measure: Change of the Patient Health Questionnaire-9 (PHQ-9) over time
timeFrame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
Secondary outcomes:
measure: Change of the Generalized Anxiety Disorder-7 (GAD-7) over time
timeFrame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
measure: Change of the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 (DSM-5) (PCL-5) over time
timeFrame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
measure: Change of the Kessler Psychological Distress Scale (K-10) over time
timeFrame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
measure: Change of the World Health OrganizationDisability Assessment Schedule (WHODAS 2.0) over time
timeFrame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University
Study officials:
affiliation: Koç University
name: Ayşenur Coşkun Toker, MA
role: STUDY_CHAIR
References:
citation: Sangraula M, Turner EL, Luitel NP, van 't Hof E, Shrestha P, Ghimire R, Bryant R, Marahatta K, van Ommeren M, Kohrt BA, Jordans MJD. Feasibility of Group Problem Management Plus (PM+) to improve mental health and functioning of adults in earthquake-affected communities in Nepal. Epidemiol Psychiatr Sci. 2020 May 26;29:e130. doi: 10.1017/S2045796020000414.
citation: Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.