A Human-Centered SH+ Trial for Earthquake Survivors

Study Overview
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Brief Summary
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The central aim of this research is to execute a randomized controlled trial aimed at assessing the impact and effectiveness of the group-based SH+ intervention among earthquake survivors in Türkiye. The principal focus lies in investigating the potential benefits of the intervention. The key parameter of interest will be the extent of psychological distress encountered by the participants. In addition, various secondary outcomes will also be evaluated, encompassing depression, anxiety, post-traumatic stress disorder (PTSD) symptoms, psychosocial well-being, and grief levels. The evaluation of the intervention's effectiveness on the sample of interest will hinge on the comparison of scores obtained during the pretest and posttest measurement phases. It is hypothesized that scores will exhibit a decline following the participants' engagement with the SH+ program over the span of five weeks. Specifically, the hypothesis being tested posits that there will be a notable reduction in depression, anxiety, post-traumatic stress, psychological distress, psychosocial impairment, and grief scores during the post-assessment stage in contrast to the pre-assessment stage. It is expected that the experimental group and the control group will demonstrate significant differences in depression, anxiety, post-traumatic stress, psychosocial impairment, and grief scores. The primary outcome measure of psychological distress will show a statistically significant difference between the experimental and control groups at both the immediate posttest assessment and the 3-month follow-up assessment.

Detailed Description
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On February 6 2023, Türkiye experienced two consecutive major earthquakes measuring 7.6 and 7.8 on the Richter scale, resulting in extensive devastation across 11 provinces. According to data provided by the World Health Organization, the earthquakes resulted in a death toll of 51,000 and affected 9.1 million people, causing the displacement of 3 million individuals and the provision of accommodation for over 3 million people. The region experienced numerous subsequent aftershocks. The aftermath saw the collapse or severe damage of no fewer than 298,000 buildings. Earthquakes represent a well-explored phenomenon. The devastating impact of these seismic events goes beyond mere physical destruction and loss of life; it extends to people's aspirations and future plans, causing disruptions to the natural trajectory of their lives. While the anguish experienced by those who've lost loved ones cannot be alleviated, and the reality of the disaster cannot be undone, there may be measures we can adopt to alleviate its repercussions. A fundamental protective element, psychological flexibility, emerges as a means to mitigate the adverse aftermath of earthquakes. This trait empowers individuals to embrace psychological liberation by acknowledging their present circumstances and openly investigating the facets that are within and beyond their control. Natural calamities possess the capacity to reshape our perspective on the world. Our outlook on the future, our self-perception, and our perception of others undergo transformation compared to our pre-earthquake mindset. The seismic event disrupts the innate cognitive flow, triggering introspection about personal safety, one's role in the world, and the significance underlying social connections. The once-steadfast sense of security is replaced by a belief that danger looms, with vulnerability a constant companion. Traditional cognitive-behavioral therapy (CBT) methods challenge such notions, insisting on factual validation, whereas Acceptance and Commitment Therapy (ACT) charts an alternate course. It's noteworthy that as psychological flexibility heightens, the intensity of posttraumatic stress symptoms follows suit. Self-Help Plus (SH+), an intervention developed by the World Health Organization (WHO), is designed as a group-oriented stress management program tailored for adults. Rooted in Acceptance and Commitment Therapy (ACT) principles, SH+ comprises five sessions dedicated to fostering five essential skills: grounding, disengaging from unhelpful thoughts, aligning actions with personal values, practicing kindness, and creating emotional space. Functioning as a facilitated intervention, SH+ seeks to equip participants with the tools to effectively navigate their own distress through a cost-effective and concise approach. In the context of earthquake-affected communities, the imperative lies in implementing interventions that are both scalable and grounded in evidence. Within this framework, SH+ emerges as a structured vehicle to nurture the development of these five core skills among earthquake survivors. The program follows a group format and spans five weeks. Group-based interventions provide a platform for individuals to exchange their experiences, garner social support, normalize their emotional responses, and cultivate coping mechanisms, all of which collectively contribute to an enhanced state of psychological well-being. It is the shared exchange of mutual experiences within a supportive environment that catalyzes the healing process. In this light, SH+ holds the potential to fulfill this role effectively.

Official Title
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Beyond Quake: A Human-Centered SH+ Randomized Controlled Trial for Earthquake Survivors

Conditions
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Grief Disorder, Prolonged

Intervention / Treatment
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* Behavioral: Beyond Quake: A Human-Centered SH+ Randomized Controlled Trial for Earthquake Survivors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for participation in this study, an individual must satisfy all of the following conditions: Age 18 years or older Have directly experienced the earthquake Exhibit elevated levels of psychological distress, indicated by a score exceeding 15 on the Kessler Psychological Distress Scale (K10) (Kessler et al., 2002) Display impaired psychosocial functioning, as evidenced by a score surpassing 16 on the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) (WHO, 2010) Exclusion Criteria: An individual meeting any of the subsequent criteria will not be included in this study: Presence of acute medical conditions Manifestation of imminent suicide risk or demonstration of acute needs/protection risks (assessed with Problem Management Plus (PM+) manual suicidality assessment) Affliction with severe mental disorders, such as psychotic disorders or substance dependence (assessed with PM+ manual, observation checklist), Experience of severe cognitive impairment, encompassing conditions like severe intellectual disability or dementia (PM+ manual observation checklist) Current utilization of mental health care Participants meeting exclusion criteria will be referred for appropriate treatment as required.

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: Beyond Quake: A Human-Centered SH+ Randomized Controlled Trial for Earthquake Survivors<br>The first phase of the study involves the execution of a randomized controlled trial (RCT). This phase will introduce an earthquake-adapted iteration of the SH+ intervention. Notable variations will be present compared to the original manual. While the conventional SH+ manual incorporates audio elements and paired discussions centered around specific topics, the version utilized in this study will diverge from this format. Specifically, audio components will be omitted, and the intervention will be directly delivered by the psychologist in person. Furthermore, the practice of paired discussions will encompass the entire group, fostering a collective environment for interaction. This inclusion of a personal, group-based approach within the SH+ intervention is intended to infuse a more humane dimension, thus facilitating the healing process. | Behavioral: Beyond Quake: A Human-Centered SH+ Randomized Controlled Trial for Earthquake Survivors<br>* The key parameter of interest will be the extent of psychological distress encountered by the participants. In addition, various secondary outcomes will also be evaluated, encompassing depression, anxiety, post-traumatic stress disorder (PTSD) symptoms, psychosocial well-being, and grief levels. The evaluation of the intervention's effectiveness on the sample of interest will hinge on the comparison of scores obtained during the pretest and posttest measurement phases.<br>|
| No Intervention: Treatment as Usual<br>Participants will undergo random assignment to either the treatment as usual (TAU) group or the intervention group. Upon completion of all measurements, the control group will be given the opportunity to receive the intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kessler Psychological Distress Scale (K10) | The key parameter of interest will be the extent of psychological distress encountered by the participants, indicated by a score exceeding 15 on the Kessler Psychological Distress Scale (K10). 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 (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Patient Health Questionnaire (PHQ-9) | 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. | Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment). | 
| The Generalized Anxiety Disorder Assessment (GAD-7) | 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 (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment). | 
| The PTSD Checklist for DSM-5 (PCL-5) | 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 (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment). | 
| The Prolonged Grief Disorder Assessment (PG-13) | The PG-13 is a 13-item scale that assesses prolonged grief disorder. For items 1, 2, 4, and 5, respondents provide ratings on a frequency scale, with options ranging from not at all to several times a day, scored from 1 to 5. Items 6 to 12, on the other hand, are assessed on an intensity scale, where respondents rate from not at all to overwhelmingly, also scored from 1 to 5. | Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment). | 
| Psychological Flexibility Scale | Psychological Flexibility Scale is a 28-item scale that measures psychological flexibility. Each item is scored from 1 (not at all) to 7 (all of the time). The lowest score that can be obtained from the scale is 28, while the highest score is 196. High scores from each subscale in the scale's items reflect high psychological flexibility. | Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment). | 
| WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) | 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 (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment). |