Feasibility and Efficacy of Individual SH+ Intervention

February 22, 2025 updated by: Ceren Acarturk, Koç University

Pilot Randomized Controlled Trial on the Feasibility and Efficacy of Individual SH+ Intervention for Earthquake Survivors

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ceren Acarturk, Assoc. Prof.
  • Phone Number: +90 (532) 256 38 46
  • Email: cacarturk@ku.edu.tr

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Koc University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Feasibility and Efficacy of Individual SH+ Intervention
The first phase of the study involves executing a pilot randomized controlled trial (RCT) with an earthquake-adapted iteration of the SH+ intervention. This phase will introduce modifications to the traditional SH+ approach. Unlike the conventional SH+ manual, which includes audio elements and paired discussions centered around specific topics, the adapted version will omit the audio components. Instead, the intervention will be delivered directly by the psychologist on a one-on-one basis. Additionally, while the original SH+ format involves paired discussions within a group setting, this study will focus on individual sessions. The intervention aims to provide a more personalized approach, promoting a more individualized and humane dimension to the healing process.
Behavioral: Feasibility and Efficacy of Individual SH+ 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.
No Intervention: Treatment as Usual
Participants will undergo random assignment to either the treatment as usual (TAU) condition or the intervention condition. Upon completion of all measurements, the control condition will be given the opportunity to receive the intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Kessler Psychological Distress Scale (K10)
Time Frame: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Patient Health Questionnaire (PHQ-9)
Time Frame: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
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)
Time Frame: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
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)
Time Frame: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
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)
Time Frame: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
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
Time Frame: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
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)
Time Frame: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Koç University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ceren Acarturk, P.h.D, Koc University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023.292.IRB3.135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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