Grief Disorder, ProlongedNCT06091540
Feasibility and Efficacy of Individual SH+ Intervention
A study testing Feasibility and Efficacy of Individual SH+ Intervention in people with Grief Disorder, Prolonged, run by Koç University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Grief Disorder, Prolonged
- What is being tested?
- Feasibility and Efficacy of Individual SH+ Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 24 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Grief Disorder, Prolonged
- Being tested
- Feasibility and Efficacy of Individual SH+ Intervention
- Medical subject headings
- Prolonged Grief Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility and Efficacy of Individual SH+ InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility and Efficacy of Individual SH+ Intervention | Experimental | 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. Receives: Behavioral: Feasibility and Efficacy of Individual SH+ Intervention |
| Treatment as Usual | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline (Before the intervention) to post assessment (1 week and 3 months after the pre-assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Oct 2024
- Primary completion24 Dec 2024
- Study completion24 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Grief Disorder, ProlongedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Acarturk, Koç University
- Investigators
- Ceren Acarturk, P.h.D, Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091540
- Sponsor's protocol ID
- 2023.292.IRB3.135
- Status last verified
- Feb 2025
- First submitted
- 16 Oct 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30128161
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial on the Feasibility and Efficacy of Individual SH+ Intervention for Earthquake Survivors
- ClinicalTrials.gov ID
- NCT06091540
- Acronym / sponsor ID
- 2023.292.IRB3.135
- Conditions
- Grief Disorder, Prolonged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feasibility and Efficacy of Individual SH+ Intervention | Experimental | Behavioral: Feasibility and Efficacy of Individual SH+ InterventionThe 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. |
| Treatment as Usual | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feasibility and Efficacy of Individual SH+ InterventionThe 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. | Behavioural | Feasibility and Efficacy of Individual SH+ Intervention |
Primary outcome
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.
6 secondary outcomes
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).
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).
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 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).
Psychological Flexibility Scale
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 30128161Tol 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ceren Acarturk, P.h.D principal investigator
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feasibility and Efficacy of Individual SH+ Intervention in people with Grief Disorder, Prolonged, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06091540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.