A Scalable Psychological Intervention for Earthquake Survivors in Türkiye

Study Overview
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Brief Summary
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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.

Detailed Description
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On the 6th February, 2023, Türkiye experienced two consecutive earthquakes with magnitudes of 7.7 and 7.6. As a consequence of such a disaster, the increasing prevalence of mental health issues has resulted in increased need and demand for mental health and psychosocial support (MHPSS) services in the country. In order to reach a higher number of people on time, implementation of brief, scalable interventions addressing common mental health problems has garnered significant importance. One such intervention is Problem Management Plus that is developed by World Health Organization for communities that experienced adversities. PM+ is a 5-session psychological intervention that aims to improve common mental health problems by teaching participants evidence-based behavioral strategies (i.e., stress management, problem solving, behavioral activation and strengthening social support). Both the individual and group versions of PM+ were tested for feasibility, acceptability, and effectiveness in various countries among different populations, including the earthquake-affected communities in Nepal. This study will be the first to test the potential effectiveness of individual PM+ among earthquake survivors in Türkiye. The study will be designed as a pilot randomized controlled trial and the potential effectiveness of individual PM+ will be tested compared to Enhanced-Care as Usual (E-CAU) control group. The study is planned to be conducted at container cities in different earthquake regions (e.g., Koç Holding container cities in Hatay, Adıyaman or Malatya). After the baseline assessment, eligible 60 participants will be randomized to two arms: in either the PM+ (n=30) or only control group (E-CAU; n=30). If they will be randomized into the PM+ condition, the facilitator will plan five consecutive sessions (and one booster session) with the participants. The first session will take place no longer than one week after the pre-intervention assessment. The post-intervention assessment through the same measures used in the pretest will take place within 1 week after completion of the fifth session. Another post-intervention assessment (follow-up assessment) will be conducted after completion of the booster session. All study participants including drop-outs will be invited to all outcome assessments. After completion of the follow-up assessment, those in the E-CAU condition will be offered with PM+. The primary outcome measure will be depression and anxiety, posttraumatic stress, psychological distress and psychosocial functioning will be included as secondary outcome measures. In order to assess feasibility and acceptability of these interventions, and the possibility of scaling up as well, we will assess the recruitment and consent rates, the percentages of attendance of sessions, the protocol adherence, drop-out rates and qualitative assessments from the process evaluation.

Official Title
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A Pilot Randomized Controlled Trial of a Scalable Psychological Intervention for Enhancing Mental Health Outcomes Among Earthquake Survivors in Türkiye

Conditions
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Psychological Distress, Impaired Social Functioning, Depressive Symptoms

Intervention / Treatment
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* Behavioral: Problem Management Plus (PM+)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Problem Management Plus (PM+)<br>The experimental group will receive a 5-session individual PM+. | Behavioral: Problem Management Plus (PM+)<br>* 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<br>|
| No Intervention: Enhanced Care as Usual<br>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+. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Generalized Anxiety Disorder-7 (GAD-7) over time | GAD-7 is a 7-item measure of general anxiety symptoms that measures anxiety symptoms. Each item is scored from 0 (not at all) to 3 (nearly every day) providing a range between 0 and 21. Higher scores indicate higher levels of anxiety. | 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 | The PCL-5 is a 20-item questionnaire that assesses the symptoms of PTSD. Items are scored from 0 (not at all) to 4 (extremely) providing a range between 0 and 16. Higher scores indicate higher levels of PTSD 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 | 
| Change of the Kessler Psychological Distress Scale (K-10) over time | K-10 is a 10-item scale that assesses the psychological distress. Each item is scored from 1 (none of the time) to 5 (all of the time) and ranges between 10 and 50. Higher scores indicate more severe psychological distress. | 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 | WHODAS is a 12-item scale that assesses ability to engage in daily activities. Each item is scored from 0 (none) to 4 (extreme) and ranges between 0 and 48. Higher scores indicate more daily dysfunctioning. | 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 |