Psychological DistressNCT06467071
Self Help Plus and Post-Migration Living Difficulties Support Intervention
A study testing SH+ combined with a session for PMLD in people with Psychological Distress and Psychological Trauma, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study will conduct a two-arm, single-blind, randomized controlled trial among Syrian refugee women living in Turkey who experience psychological distress. In the study, participants will be randomly assigned to either the SH+ intervention (n = 105) combined with a session on Post-Migration Living Difficulties… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Psychological Trauma, Mental Health
- What is being tested?
- SH+ combined with a session for PMLD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2024to 30 Mar 2025
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be adults (18 years and above),
- Selected among Syrian women residing in Turkey under temporary protection,
- Speak Arabic,
- Have not received any services from the Refugee Association before,
- A score of more than 16 on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0),
- A score of more than 15 on the Kessler-10 (K10) Psychological Distress Scale.
Who cannot join
- Have an acute medical condition,
- At risk of suicide,
- Have a severe mental disorder,
- Have severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Refugees and Asylum Seekers Assistance and Solidarity Association (RASAS)
Istanbul, Sultanbeyli
Zeynep Keklik, Psychologist
About this study
Official title: Self Help Plus and Post-Migration Living Difficulties Support Intervention: A Randomized Controlled Trial With Syrian Women Under Temporary Protection in Turkey
This study will conduct a two-arm, single-blind, randomized controlled trial among Syrian refugee women living in Turkey who experience psychological distress. In the study, participants will be randomly assigned to either the SH+ intervention (n = 105) combined with a session on Post-Migration Living Difficulties (PMLD) or Treatment as Usual (TAU) (n = 105). SH+ is a five-session guided self-help intervention focusing on stress management based on Acceptance and Commitment Therapy (ACT). In addition, a session discussing post-migration difficulties and possible problem-management techniques will be integrated after the SH+ intervention. This study aims to fill an important gap in refugee health and well-being research by focusing on the integrated expansion and implementation of an intervention program to address the psychosocial challenges faced by refugee Syrian women. The results will assess the effectiveness of the intervention on psychological distress, focusing on its potential positive effects on psychological distress, stress management, and adaptation processes. Furthermore, the impact of the intervention on the use of association services and psychological flexibility will be examined.
Read the detailed description
The number of displaced people worldwide has reached 110 million, underscoring the urgent need to investigate and address the psychosocial effects of conflict and displacement. Syrian refugees, the largest displaced population, face significant mental health challenges, including heightened risks of Post-Traumatic Stress Disorder (PTSD), depression, and anxiety due to both traumatic experiences and post-migration stressors. The World Health Organization's (WHO) Self-Help Plus (SH+) intervention provides a valuable psychological support tool to help manage stress and mitigate these difficulties. Additionally, post-migration living difficulties, such as social integration issues, employment barriers, and cultural adaptation, critically affect asylum seekers' adjustment to new environments and their mental health. Addressing both the psychological and psychosocial aspects is crucial for effectively mitigating the complex challenges faced by asylum seekers, emphasizing the need for comprehensive support to improve integration and well-being in post-migration contexts.
This study will conduct a two-arm, single-blind, randomized controlled trial among Syrian refugee women living in Turkey who experience psychological distress. Participants will be randomly assigned to one of two groups: the SH+ intervention combined with a session on Post-Migration Living Difficulties (PMLD) or Treatment as Usual (TAU). Each group will consist of 105 participants, totaling 210 participants in the study. The SH+ intervention is a five-session guided self-help program based on Acceptance and Commitment Therapy (ACT), focusing on stress management. This intervention is designed to be accessible and does not require a diagnosis, making it suitable for a wide audience and particularly useful in areas with limited mental health services.
In addition to the SH+ intervention, the intervention group will participate in a session specifically addressing post-migration living difficulties. This session will occur after the completion of the SH+ intervention and will focus on identifying and managing challenges such as social integration, employment barriers, and cultural adaptation. Using problem-management techniques, this session aims to empower participants by enhancing their coping skills, building solidarity through shared experiences, and providing information about local resources available for asylum seekers. The integrated intervention aims to strengthen the mental health of the participants and provide comprehensive support for adapting to their new country.
The study will measure several outcomes to assess the effectiveness of the intervention. Primary outcomes include the reduction of psychological distress, measured using standardized tools such as Kessler Psychological Distress (K10). Secondary outcomes will focus on psychosocial traits. Additionally, the study will examine the impact of the intervention on the use of association services and psychological flexibility, which is a key component of ACT.
The intervention aims to fill an important gap in refugee health and well-being research by focusing on the integrated expansion and implementation of a comprehensive intervention program to address the psychosocial challenges faced by Syrian refugee women. By combining SH+ with a PMLD session, the study seeks to provide a holistic approach to improving the mental health and well-being of participants, offering them the necessary tools and knowledge to navigate the complexities of post-migration life. The results of this study are expected to provide valuable insights into the effectiveness of integrated psychosocial interventions and inform future efforts to support displaced populations globally.
- Being tested
- SH+ combined with a session for PMLD
- Keywords
- Syrian Women Refugees, Self Help Plus, Post Migration Living Difficulties
- Medical subject headings
- Psychological Trauma, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SH+ combined with a session for PMLDBehavioural
The intervention integrates WHO's Self Help Plus (SH+) and a session for Post-Migration Living Difficulties (PMLD) for Syrian women. SH+ is a guided self-help program with five weekly sessions led by facilitators, aimed at managing stress and psychological distress without requiring a diagnosis. This scalable intervention is based on solid research, proven effective in reducing stress and preventing mental health disorders (Tol et al., 2020; Turrini et al., 2019). The PMLD session, based on WHO's Problem Management Plus (PM+), involves focus groups to identify post-migration challenges. Participants share experiences, learn coping strategies, discover local resources, and strengthen social support networks. This integrated approach aims to enhance mental health, address post-migration difficulties, and improve stress reduction skills, supporting adaptation to a new country.
| Study group | Role | What they receive |
|---|---|---|
| Self Help Plus (SH+) combined with a session for Post Migration Living Difficulties (PMLD) | Experimental | The intervention integrates Self Help Plus (SH+) and a session for Post-Migration Living Difficulties (PMLD) for Syrian women. Participants will be randomly assigned to the SH+ combined with the PMLD session (n = 105). The participants in the experimental arm will receive SH+ combined with the PMLD session, by non-specialist facilitators. Receives: Behavioral: SH+ combined with a session for PMLD |
| Treatment-As-Usual (TAU) | No intervention | 105 participants will be randomly allocated to the Treatment as Usual (TAU) group. Mental health services for asylum seekers in Turkey are provided by the Ministry of Health and different non-governmental organizations. These services include psychosocial support, counseling, mental health screenings, and psychotherapy (AIDA, 2020). As usual, treatment includes usual mental health support and assessment following the standard procedures of the Refugees Association Mental Health Unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Distress
Kessler Psychological Distress Scale (K10) The primary outcome measure of this study is the Kessler 10 (K10) scale developed by Kessler \& Mroczek (2002). This scale is designed to measure general psychological distress experienced in the past 30 days without a specific cause. The scale was translated into Arabic and validated by Easton et al. (2017). This 10-item scale assesses each item using a 5-point Likert scale (1: Never; 5: Always). As a result of the reliability studies conducted for the Arabic translation of the scale, Cronbach's alpha (α) value was found to be .88 (Easton et al., 2017).
Measured: Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Secondary outcomes (7)
Disability Assessment
WHO Disability Assessment Schedule (WHODAS 2.0) The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) is a 5-point Likert-type scale for general and clinical use, developed by Ustun et al. (2010) and validated by Akhtar et al. (2021) with a Cronbach's Alpha value of .74 for Arabic, and is designed to measure the disability of individuals.
Measured: Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Psychological Flexibility
The Acceptance and Action Questionnaire (AAQ-II) Within the scope of the study, the Acceptance and Action Questionnaire (AAQ-II) (Hayes et al., 2004) will be used to assess psychological flexibility. The translation of the scale into Arabic and validation study was conducted by Hemaid et al. (2016). The 7-item scale evaluates each item on a 7-point Likert scale (1: Never true; 7: Always true). As a result of the reliability studies conducted for the Arabic translation of the scale, Cronbach's Alpha (α) value was found to be .78 (Hemaid et al., 2016).
Measured: Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Symptoms of Post Traumatic Stress Disorder
PTSD Checklist for DSM-5 (PCL-5) The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) was developed by Weathers et al. (2013) as a 20-item 5-point Likert-type scale to measure PTSD symptoms and severity, and adapted into Arabic by Ibrahim et al. (2018) and gained validity and reliability with a Cronbach's Alpha value of .86.
Measured: Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Psychological Outcome Profiles
PSYCHLOPS PSYCHLOPS is a 6-point Likert-type scale with four and six items for pre and post-assessments, respectively, created by Ashworth et al. (2006) to assess individuals' psychological health conditions and the effects of their problems on their lives. The Arabic version has been used especially in studies on Syrian refugees (Acarturk et al., 2022; Uygun et al., 2020).
Measured: Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Well-being
The World Health Organization- Five Well-Being Index (WHO-5) The WHO-5 Well-being Index is a short self-report rating scale developed by WHO (1998) to assess subjective well-being and general mental health condition and interest in the last two weeks on a 6-point Likert scale (0: Never; 5: Always). As a result of the Arabic validity and reliability study conducted by Alshayea (2023), it was found reliable with a Cronbach's alpha value of .91.
Measured: Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Post Migration Living Difficulties
Post Migration Living Difficulties Checklist (PMLDC) The Post Migration Living Difficulties Checklist was developed by Silove et al. (1997) to measure post-asylum difficulties and related stress levels. It is a 17-item, 5-point Likert scale, the Arabic version of which has been used effectively in studies on forcibly displaced communities (Schick et al., 2016, 2018; Spaaij et al., 2023).
Measured: Baseline, during the intervention, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Service Uses
The study will include a service use inventory based on the Client Service Utilization Inventory (CSRI) (Beecham \& Knapp, 1992) to assess the frequency and duration of use of association services by participants in both arms.
Measured: After the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start20 Jun 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies 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
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Keklik, Medipol University
- Investigators
- Zeynep Keklik, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467071
- Sponsor's protocol ID
- SH+ZKX2
- Other IDs
- 0725E271X2
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon request and following the completion of the study, ensuring all necessary privacy and ethical guidelines are met. Interested researchers will need to submit a formal request and agree to use the data only for scientific purposes, adhering to any conditions set by the study's ethical committee and data-sharing policy.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Help Plus and Post-Migration Living Difficulties Support Intervention: A Randomized Controlled Trial With Syrian Women Under Temporary Protection in Turkey
- ClinicalTrials.gov ID
- NCT06467071
- Acronym / sponsor ID
- SH+ZKX2
- Keywords
- Syrian Women Refugees, Self Help Plus, Post Migration Living Difficulties
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 20 Jun 2024 (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.
This study will conduct a two-arm, single-blind, randomized controlled trial among Syrian refugee women living in Turkey who experience psychological distress. In the study, participants will be randomly assigned to either the SH+ intervention (n = 105) combined with a session on Post-Migration Living Difficulties (PMLD) or Treatment as Usual (TAU) (n = 105). SH+ is a five-session guided self-help intervention focusing on stress management based on Acceptance and Commitment Therapy (ACT). In addition, a session discussing post-migration difficulties and possible problem-management techniques will be integrated after the SH+ intervention. This study aims to fill an important gap in refugee health and well-being research by focusing on the integrated expansion and implementation of an intervention program to address the psychosocial challenges faced by refugee Syrian women. The results will assess the effectiveness of the intervention on psychological distress, focusing on its potential positive effects on psychological distress, stress management, and adaptation processes. Furthermore, the impact of the intervention on the use of association services and psychological flexibility will be examined.
Detailed description
The number of displaced people worldwide has reached 110 million, underscoring the urgent need to investigate and address the psychosocial effects of conflict and displacement. Syrian refugees, the largest displaced population, face significant mental health challenges, including heightened risks of Post-Traumatic Stress Disorder (PTSD), depression, and anxiety due to both traumatic experiences and post-migration stressors. The World Health Organization's (WHO) Self-Help Plus (SH+) intervention provides a valuable psychological support tool to help manage stress and mitigate these difficulties. Additionally, post-migration living difficulties, such as social integration issues, employment barriers, and cultural adaptation, critically affect asylum seekers' adjustment to new environments and their mental health. Addressing both the psychological and psychosocial aspects is crucial for effectively mitigating the complex challenges faced by asylum seekers, emphasizing the need for comprehensive support to improve integration and well-being in post-migration contexts.
This study will conduct a two-arm, single-blind, randomized controlled trial among Syrian refugee women living in Turkey who experience psychological distress. Participants will be randomly assigned to one of two groups: the SH+ intervention combined with a session on Post-Migration Living Difficulties (PMLD) or Treatment as Usual (TAU). Each group will consist of 105 participants, totaling 210 participants in the study. The SH+ intervention is a five-session guided self-help program based on Acceptance and Commitment Therapy (ACT), focusing on stress management. This intervention is designed to be accessible and does not require a diagnosis, making it suitable for a wide audience and particularly useful in areas with limited mental health services.
In addition to the SH+ intervention, the intervention group will participate in a session specifically addressing post-migration living difficulties. This session will occur after the completion of the SH+ intervention and will focus on identifying and managing challenges such as social integration, employment barriers, and cultural adaptation. Using problem-management techniques, this session aims to empower participants by enhancing their coping skills, building solidarity through shared experiences, and providing information about local resources available for asylum seekers. The integrated intervention aims to strengthen the mental health of the participants and provide comprehensive support for adapting to their new country.
The study will measure several outcomes to assess the effectiveness of the intervention. Primary outcomes include the reduction of psychological distress, measured using standardized tools such as Kessler Psychological Distress (K10). Secondary outcomes will focus on psychosocial traits. Additionally, the study will examine the impact of the intervention on the use of association services and psychological flexibility, which is a key component of ACT.
The intervention aims to fill an important gap in refugee health and well-being research by focusing on the integrated expansion and implementation of a comprehensive intervention program to address the psychosocial challenges faced by Syrian refugee women. By combining SH+ with a PMLD session, the study seeks to provide a holistic approach to improving the mental health and well-being of participants, offering them the necessary tools and knowledge to navigate the complexities of post-migration life. The results of this study are expected to provide valuable insights into the effectiveness of integrated psychosocial interventions and inform future efforts to support displaced populations globally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self Help Plus (SH+) combined with a session for Post Migration Living Difficulties (PMLD) | Experimental | Behavioral: SH+ combined with a session for PMLDThe intervention integrates Self Help Plus (SH+) and a session for Post-Migration Living Difficulties (PMLD) for Syrian women. Participants will be randomly assigned to the SH+ combined with the PMLD session (n = 105). The participants in the experimental arm will receive SH+ combined with the PMLD session, by non-specialist facilitators. |
| Treatment-As-Usual (TAU) | No intervention | –105 participants will be randomly allocated to the Treatment as Usual (TAU) group. Mental health services for asylum seekers in Turkey are provided by the Ministry of Health and different non-governmental organizations. These services include psychosocial support, counseling, mental health screenings, and psychotherapy (AIDA, 2020). As usual, treatment includes usual mental health support and assessment following the standard procedures of the Refugees Association Mental Health Unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must be adults (18 years and above),
- Selected among Syrian women residing in Turkey under temporary protection,
- Speak Arabic,
- Have not received any services from the Refugee Association before,
- A score of more than 16 on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0),
Key exclusion criteria (4 listed)
- Have an acute medical condition,
- At risk of suicide,
- Have a severe mental disorder,
- Have severe cognitive impairment
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 |
|---|---|---|
| SH+ combined with a session for PMLDThe intervention integrates WHO's Self Help Plus (SH+) and a session for Post-Migration Living Difficulties (PMLD) for Syrian women. SH+ is a guided self-help program with five weekly sessions led by facilitators, aimed at managing stress and psychological distress without requiring a diagnosis. This scalable intervention is based on solid research, proven effective in reducing stress and preventing mental health disorders (Tol et al., 2020; Turrini et al., 2019). The PMLD session, based on WHO's Problem Management Plus (PM+), involves focus groups to identify post-migration challenges. Participants share experiences, learn coping strategies, discover local resources, and strengthen social support networks. This integrated approach aims to enhance mental health, address post-migration difficulties, and improve stress reduction skills, supporting adaptation to a new country. | Behavioural | Self Help Plus (SH+) combined with a session for Post Migration Living Difficulties (PMLD) |
Primary outcome
Psychological Distress
Time frame: Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Kessler Psychological Distress Scale (K10) The primary outcome measure of this study is the Kessler 10 (K10) scale developed by Kessler \& Mroczek (2002). This scale is designed to measure general psychological distress experienced in the past 30 days without a specific cause. The scale was translated into Arabic and validated by Easton et al. (2017). This 10-item scale assesses each item using a 5-point Likert scale (1: Never; 5: Always). As a result of the reliability studies conducted for the Arabic translation of the scale, Cronbach's alpha (α) value was found to be .88 (Easton et al., 2017).
7 secondary outcomes
Disability Assessment
Time frame: Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Psychological Flexibility
Time frame: Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Symptoms of Post Traumatic Stress Disorder
Time frame: Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Psychological Outcome Profiles
Time frame: Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Well-being
Time frame: Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Post Migration Living Difficulties
Time frame: Baseline, during the intervention, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Service Uses
Time frame: After the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: Yes. Data will be shared upon request and following the completion of the study, ensuring all necessary privacy and ethical guidelines are met. Interested researchers will need to submit a formal request and agree to use the data only for scientific purposes, adhering to any conditions set by the study's ethical committee and data-sharing policy.
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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.
Zeynep Keklik study director
Medipol 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 SH+ combined with a session for PMLD in people with Psychological Distress and Psychological Trauma, run by Medipol 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Keklik (444 85 44, zeynep.keklik@std.medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Distress (time frame: Baseline, after the intervention (6 weeks after baseline), 3 months after the intervention, and 6 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2024.