Mental Health Outcomes of Earthquake Survivors in Türkiye

NCT05993507 | Completed

• 1 other identifier: 2023.214.IRB3.097
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue

Outcome Measures

Primary Outcomes (1)

• Change of the Patient Health Questionnaire-9 (PHQ-9) over time

  PHQ-9 is a 9 item questionnaire that measures the severity of depression symptoms. Items are scored as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. Higher scores indicate more severe depressive symptoms.

  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 (4)

• Change of the Generalized Anxiety Disorder-7 (GAD-7) over time

  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

• Change of the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 (DSM-5) (PCL-5) over time

  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

• Change of the Kessler Psychological Distress Scale (K-10) over time

  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

• Change of the World Health OrganizationDisability Assessment Schedule (WHODAS 2.0) over time

  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

Study Arms (1)

Problem Management Plus (PM+)

EXPERIMENTAL

As an open trial single group pre-post design, all participants in the study will receive PM+.

Behavioral: Problem Management Plus (PM+)

Interventions

Problem Management Plus (PM+) BEHAVIORAL

Problem Management Plus (PM+) is a brief, scalable intervention that is developed by World Health Organization for communities exposed to adversity. PM+ consists of five weekly in-person sessions of 90 minutes. The intervention integrates four evidence-based behavioural strategies: arousal reduction using a slow breathing exercise (session 1), problem-solving (session 2), behavioural activation by re-engaging with pleasant and task-oriented activities (session 3) and accessing social support (session 4). Homework practice is scheduled following each session and discussed in the next session. Psychoeducation is delivered in session 1 and relapse prevention is discussed in session 5. Facilitators will receive weekly supervisions by PM+ supervisors.

Problem Management Plus (PM+)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 32452336 BACKGROUND

• 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.

  PMID: 26407793 BACKGROUND

Study Officials

• Ayşenur Coşkun Toker, MA

  Koç University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 15, 2023
• Study Start: November 17, 2023
• Primary Completion: March 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)