A Scalable Psychological Intervention for Earthquake Survivors in Türkiye

NCT06026306 | Completed

• 1 other identifier: 2023.271.IRB3.125
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This will be the first pilot randomized controlled trial (RCT) study that investigate the potential effectiveness of individual PM+ among earthquake survivors residing in container cities in Türkiye. The primary objective of this pilot study will be to test feasibility, acceptability, and potential effectiveness of individual PM+ for Turkish earthquake survivors, using RCT design which is considered the gold standard in research for evaluating effectiveness of interventions. Secondly, this study aims to test trial procedures in preparation for a future larger randomized controlled trial.

Conditions

Psychological Distress; Impaired Social Functioning; Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

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

  PHQ-9 is a 9-item questionnaire that aims to measure the depressive symptoms. Each item is scored from 0 (not at all) to 3 (nearly every day) providing a range between 0 and 27. Higher scores indicate more severe depressive symptoms.

  change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); which is expected to last an average of 7 weeks

Secondary Outcomes (5)

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

  change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); 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

  change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); which is expected to last an average of 7 weeks

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

  change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); which is expected to last an average of 7 weeks

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

  change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); which is expected to last an average of 7 weeks

• Change of the the psychological outcomes profiles (PSYCHLOPS) over time

  change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); which is expected to last an average of 7 weeks

Study Arms (2)

Problem Management Plus (PM+)

EXPERIMENTAL

The experimental group will receive a 5-session individual PM+.

Behavioral: Problem Management Plus (PM+)

Enhanced Care as Usual

NO INTERVENTION

The control (enhanced care as usual) group will receive the information about freely available psychological support options. E-CAU ranges from standard community care which may include any existing mental health support services available to earthquake survivors in container cities. The participants will be given flyers which include information about the services provided by the government and by non-governmental organizations. After completion of the post and follow-up assessment of experimental group, those in the E-CAU condition will be offered with PM+.

Interventions

Problem Management Plus (PM+) BEHAVIORAL

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

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 Kahramanmaraş earthquake
• Elevated level of psychological distress indicated by having a score of 15 or above on Kessler Psychological Distress Scale (K10)
• Impaired daily functioning indicated by having a score of 16 or above on WHO Disability Assessment Schedule (WHODAS)

You may not qualify if:

• imminent suicide risk (assessed with the PM+ manual suicidal thoughts interview),
• indications of severe mental disorders (e.g., psychotic disorders) or cognitive impairment (e.g., severe intellectual disability; assessed by the PM+ manual observation checklist),
• ongoing treatment in specialized mental health care.

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koç University

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• 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

• 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

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Ayşenur Coşkun Toker, PhD student

  Koç University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will not be blinded to their study arm because of the nature of the intervention, but outcome assessors will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: November 17, 2023
• Primary Completion: August 13, 2024
• Study Completion: August 30, 2024
• Last Updated: March 24, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)