Clinical trial NCT06091540: Feasibility and Efficacy of Individual SH+ Intervention
Official title: Pilot Randomized Controlled Trial on the Feasibility and Efficacy of Individual SH+ Intervention for Earthquake Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grief Disorder, Prolonged
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The central aim of this research is to execute a randomized controlled trial (RCT) to assess the impact and effectiveness of the individually-delivered 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 condition and the control condition 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: 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. One's outlook on the future, self-perception, and 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) often challenges these fears by demanding evidence-based thinking, while Acceptance and Commitment Therapy (ACT) offers a different approach. Notably, as psychological flexibility increases, so does one's capacity to manage posttraumatic stress symptoms. Self-Help Plus (SH+), an intervention developed by the World Health Organization (WHO), is designed as a stress management program based on the principles of ACT. Although originally intended for group settings, this study adapts the intervention for individual delivery, tailored specifically for adults affected by the earthquakes. 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. While SH+ was originally conceptualized as a group-based intervention designed to foster social support and shared experiences among participants, this study adapts it for a one-on-one format, emphasizing a more personalized therapeutic approach. This individualized intervention is structured to help participants navigate their distress in a targeted, cost-effective, and concise manner. In the context of earthquake survivors, SH+ has the potential to offer a structured, evidence-based method for developing crucial coping skills, even within the individualized delivery model.

Eligibility criteria: 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.

Primary outcomes:
measure: Kessler Psychological Distress Scale (K10)
timeFrame: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
Secondary outcomes:
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
measure: The Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
measure: The PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
measure: The Prolonged Grief Disorder Assessment (PG-13)
timeFrame: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
measure: Psychological Flexibility Scale
timeFrame: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
measure: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University
Study officials:
affiliation: Koç University
name: Ceren Acarturk, P.h.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tol WA, Augustinavicius J, Carswell K, Brown FL, Adaku A, Leku MR, Garcia-Moreno C, Ventevogel P, White RG, van Ommeren M. Translation, adaptation, and pilot of a guided self-help intervention to reduce psychological distress in South Sudanese refugees in Uganda. Glob Ment Health (Camb). 2018 Jul 27;5:e25. doi: 10.1017/gmh.2018.14. eCollection 2018.