Chronic Mental DisordersNCT05980832
Effect of Peer-Supported Psychosocial Skills Training in Individuals With Chronic Mental Disorder
A study testing Peer practitioner training - Peer Education Supported Psychosocial Skills Education and Peer Education Supported Psychosocial Skills Education in people with Chronic Mental Disorders and Peer Support, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to examine the effects of peer education-supported psychosocial skills training on stigma perceptions, social functionality and insight levels of chronic psychiatric patients followed up in a community mental health center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Mental Disorders, Peer Support, Psychosocial Skills Training
- What is being tested?
- Peer practitioner training - Peer Education Supported Psychosocial Skills Education and Peer Education Supported Psychosocial Skills Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jul 2023to 29 Sep 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For peer practitioner training:
- Being registered with the Community Mental Health Center (CMHC),
- Participating in the study voluntarily and being an instructor in 6 sessions of psychosocial skills training.
- Having a high level of functionality according to the functionality scale
- Not in the active period of the disease
- Being able to read and write and not have any communication problems in understanding and speaking Turkish.
Show all 15Show fewer
- Well-being for at least 6 months according to the treatment team and according to the records.
- For Peer-Supported Psychosocial Skills Training:
- Coming to CMHC regularly
- Volunteer to participate in the study and agree to attend 6-week sessions
- Not in the active period of the disease.
- Ability to read, write and communicate in Turkish
- Being healthy for at least 6 months according to the treatment team and records
- Having the experience of receiving standard psychosocial skills training by mental health professionals working in the institution for Experimental Group 1 and Control Group 1.
- Not having received standard psychosocial skills training by the mental health professionals working in the institution for Experiment Group 2 and Control Group 2 are the inclusion criteria determined for peer educator-supported psychosocial skills training.
Who cannot join
- Not registering with CMHC.
- Inability to give written informed consent to the study
- Inability to communicate in written or verbal Turkish at a level that will complete the assessments and be included in the groups.
- The emergence of acute illness symptoms during the education process
- The conflict between the patient giving the training and the patients participating in the group training constitutes the exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Mental Health and Diseases Hospital - Community Mental Health Center
Samsun
About this study
Official title: The Effect of Peer Education-Supported Psychosocial Skills Education Applied to Individuals With Chronic Mental Disorder on Patients' Perceptions of Stigma, Levels of Functionality and Insight
This study was designed to examine the effects of peer education-supported psychosocial skills training on stigma perceptions, social functionality and insight levels of chronic psychiatric patients followed up in a community mental health center.
The research was planned as a mixed method study conducted in a randomized controlled experimental study design and a qualitative study design. With the findings obtained, it is aimed to increase the social functionality of the patients, to increase the level of insight and to reduce the perception of stigma, and to close an important gap in the literature, thanks to peer education-supported psychosocial skills training.
Read the detailed description
Hypothesis(s) and Question(s):
The hypotheses of the quantitative method of the research are as follows; H1-1: Peer Education Supported Psychosocial Skills Training has an effect on the social functionality levels of patients.
H1-2: Peer Education Supported Psychosocial Skills Training has an effect on patients' perceptions of stigma.
H1-3: Peer Education Supported Psychosocial Skills Training has an effect on patients' insight levels.
The research questions of the qualitative method of the research are as follows:
Q(1): How do the changes experienced by people with chronic mental disorders affect their lives? Q(2): How does Peer Education Supported Psychosocial Skills Training affect patients' social functionality levels? Q(3): How does Peer Education Supported Psychosocial Skills Training affect patients' perceptions of stigma? Q(4): How does Peer Education Supported Psychosocial Skills Training affect patients' insight levels? Q(5): What are the experiences and opinions of the patients who participated in the Peer Education Supported Psychosocial Skills Training program?
The research question created for the research to be mixed method:
Q(Mixed): Do the themes revealed by the statements of the patients as a result of the qualitative research support the quantitative findings obtained as a result of the quantitative research?
Data Collection and Intervention
Firstly, A 13-hour practitioner training about psychosocial skills training supported by peer education and group management will be given by the research psychiatric nurse to 4 patients (one as peer leader, other as assistant, the other two as substitutes) selected according to the inclusion criteria of the study.
Individuals who are called peer trainers and who are subjected to practitioner training by the researcher psychiatric nurse will carry out the 6-session psychosocial skills training as leaders and assistant leaders. Researcher psychiatric nurse will support them in this process, even if they need it. It is thought that with the education given by peer educators, patients can benefit from each other's experiences and have an effect on the relevant variables. Groups will be determined by lot by the center staff from among the patients who have or have not received psychosocial skills training before.
In the research, "Descriptive Information Form" will be used by the researcher as a data collection tool, indicating the sociodemographic characteristics of the participants. The measurement of the variables specified in the research will be provided by the Self Stigma Scale, Beck Cognitive Insight Scale and Social Functioning Assessment Scale.
In order to evaluate the qualitative data, a semi-structured interview form consisting of questions about the effectiveness of education on the variables will be used by the researcher. After the pre-test application, a measurement will be made at the end of the sessions in the 2nd week, 4th week and 6th week in order to measure the effectiveness of the study during the application. Also, a measurement will be made in the 8th week for follow-up purposes.
After the collection of quantitative data, 5 people from both experimental groups will be selected and qualitative data will be collected with 10 participants in total. Individual and face-to-face interviews will be conducted with the patients who make up the experimental group, and the interviews will be audio recorded with the knowledge and consent of the participant. Individual interviews will be provided with a semi-structured form for the effectiveness of the training.
- Conditions
- Chronic Mental Disorders, Peer Support, Psychosocial Skills Training, Functionality, Stigmatization, Insight
- Being tested
- Peer practitioner training - Peer Education Supported Psychosocial Skills Education, Peer Education Supported Psychosocial Skills Education
- Medical subject headings
- Stereotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer practitioner training - Peer Education Supported Psychosocial Skills EducationOther
Psychosocial skills training-practitioner training will be given to 4 patients diagnosed with chronic mental disorder by the research psychiatry nurse.
Educational content
- Getting acquainted - briefing about the study
- The Importance, Aims and Objectives of Psychosocial Skills Education
- The importance of peer support
- The importance, aims and objectives of peer education supported psychosocial skills training
- Management of the meeting game, warm-up games and role plays
- 1st and 2nd session peer education supported psychosocial skills training
- 3rd and 4th session peer education supported psychosocial skills training
- The last 5th and 6th sessions of peer education are supported by psychosocial skills training.
- Key points and termination in group management. The training will be planned to last 10-13 hours in total. Trainer's booklet prepared by the researcher psychiatric nurse.
Peer Education Supported Psychosocial Skills EducationOther
It is a psychosocial skills training that will be given to both experimental groups in 6 sessions within 6 weeks. 2 of the 4 peer trainers who received the practitioner training will conduct the training. During the training period, the research psychiatric nurse will support.
Session titles are as follows:
- Session:Preparation Session
- Session: Understanding Mental Disorders
- Session: Developing Communication Skills
- Session: Developing Emotion Recognition and Expression Skills
- Session: Dealing with Daily Living Activities and Problems
- Session: Understanding the Stigma Experience
The duration of each session is determined as 90 minutes. Taking into account the patient's opinions breaks not exceeding 15 minutes will be given as needed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | It will consist of 10 patients who have received psychosocial skills training by the staff of the center, and a 6-week peer-supported psychosocial skills training will be given by the peer-leaders trained by the researcher psychiatric nurse. Receives: Other: Peer Education Supported Psychosocial Skills Education |
| Experimental Group 2 | Experimental | It will consist of 10 patients who have not received psychosocial skills training by the staff of the center, and a 6-week peer-supported psychosocial skills training will be given by the peer-leaders trained by the researcher psychiatric nurse. Receives: Other: Peer Education Supported Psychosocial Skills Education |
| Control Group 1 | No intervention | It will consist of 10 patients who have received psychosocial skills training by the center staff and no intervention will be applied. |
| Control Group 2 | No intervention | It will consist of 10 patients who have not received psychosocial skills training by the center staff and no intervention will be applied. |
| Peer Practitioner Training | Other | It is the group in which psychosocial skills training will be given to 4 patients with chronic mental disorders by a researcher psychiatric nurse. Receives: Other: Peer practitioner training - Peer Education Supported Psychosocial Skills Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionality (Social Functioning Assessment Scale)
This scale evaluates 19 items and four sub-dimensions in general in patients with schizophrenia. Among the factors, interpersonal explanations and entertainment consist of seven items, self-care seven items, independent living needs four items, and work-life one item. The scores that can be obtained from the scale are between 19 and 57, and a high score means that social functioning measures are high.
It is expected that there will be an increase in the functionality levels of the experimental groups.
Measured: 6 Weeks
Stigmatization (Self-Stigma Scale)
It is a 3-factor scale consisting of 17 items for patients evaluating self-stigmatization or internalized stigma, concealment of illness and perception of worthlessness in individuals with mental illness. A five-point Likert-type scale was created as "1=not at all suitable for me, 2=somewhat appropriate, 3=moderately appropriate, 4=generally appropriate, 5=completely appropriate". As the score obtained from the scale increases, the self-stigmatization of the patients increases. The Cronbach's alpha correlation coefficient value of the scale is 0.93, indicating high reliability.
It is expected that the stigma perceptions of the experimental groups will decrease.
Measured: 6 Weeks
Insight (Beck Cognitive Insight Scale)
The Turkish validity and reliability study of the scale developed to assess cognitive insight was conducted. The scale, which is a four-point Likert type, consists of 15 items and has 2 sub-dimensions "self-confidence" and "self-evaluation". The scoring system of the scale consists of "disagree" 0 points, "somewhat agree" 1 point, "mostly agree" 2 points, "strongly agree" 3 points. The total (composite) score of the scale is obtained by subtracting the self-evaluation items (1,3,4,5,6,8,12,14,15) from the self-confidence item scores (2,7,9,10,11,13). The total score range of the scale is between -18 and 27 points. A high score indicates a high level of insight. In the reliability study of the Turkish version of the scale, the internal consistency Cronbach's alpha coefficient was found to be 0.68.
It is expected that there will be an increase in the insight levels of the experimental groups.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start31 Jul 2023
- Primary completion4 Aug 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Mental DisordersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil İbrahim Bilkay, Tokat Gaziosmanpasa University
- Investigators
- Nermin Gürhan, Prof. Dr., Study director, Tokat Gaziosmanpa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980832
- Sponsor's protocol ID
- TOGU-HEM-HİB-01
- Status last verified
- Feb 2024
- First submitted
- 20 Jul 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The identity information of the participants will not be shared with other researchers. The statistical data of the research is planned to be published in a scientific journal.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peer Education-Supported Psychosocial Skills Education Applied to Individuals With Chronic Mental Disorder on Patients' Perceptions of Stigma, Levels of Functionality and Insight
- ClinicalTrials.gov ID
- NCT05980832
- Acronym / sponsor ID
- TOGU-HEM-HİB-01
- Conditions
- Chronic Mental Disorders, Peer Support, Psychosocial Skills Training, Functionality, Stigmatization, Insight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 8 Aug 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.
This study was designed to examine the effects of peer education-supported psychosocial skills training on stigma perceptions, social functionality and insight levels of chronic psychiatric patients followed up in a community mental health center.
The research was planned as a mixed method study conducted in a randomized controlled experimental study design and a qualitative study design. With the findings obtained, it is aimed to increase the social functionality of the patients, to increase the level of insight and to reduce the perception of stigma, and to close an important gap in the literature, thanks to peer education-supported psychosocial skills training.
Detailed description
Hypothesis(s) and Question(s):
The hypotheses of the quantitative method of the research are as follows; H1-1: Peer Education Supported Psychosocial Skills Training has an effect on the social functionality levels of patients.
H1-2: Peer Education Supported Psychosocial Skills Training has an effect on patients' perceptions of stigma.
H1-3: Peer Education Supported Psychosocial Skills Training has an effect on patients' insight levels.
The research questions of the qualitative method of the research are as follows:
Q(1): How do the changes experienced by people with chronic mental disorders affect their lives? Q(2): How does Peer Education Supported Psychosocial Skills Training affect patients' social functionality levels? Q(3): How does Peer Education Supported Psychosocial Skills Training affect patients' perceptions of stigma? Q(4): How does Peer Education Supported Psychosocial Skills Training affect patients' insight levels? Q(5): What are the experiences and opinions of the patients who participated in the Peer Education Supported Psychosocial Skills Training program?
The research question created for the research to be mixed method:
Q(Mixed): Do the themes revealed by the statements of the patients as a result of the qualitative research support the quantitative findings obtained as a result of the quantitative research?
Data Collection and Intervention
Firstly, A 13-hour practitioner training about psychosocial skills training supported by peer education and group management will be given by the research psychiatric nurse to 4 patients (one as peer leader, other as assistant, the other two as substitutes) selected according to the inclusion criteria of the study.
Individuals who are called peer trainers and who are subjected to practitioner training by the researcher psychiatric nurse will carry out the 6-session psychosocial skills training as leaders and assistant leaders. Researcher psychiatric nurse will support them in this process, even if they need it. It is thought that with the education given by peer educators, patients can benefit from each other's experiences and have an effect on the relevant variables. Groups will be determined by lot by the center staff from among the patients who have or have not received psychosocial skills training before.
In the research, "Descriptive Information Form" will be used by the researcher as a data collection tool, indicating the sociodemographic characteristics of the participants. The measurement of the variables specified in the research will be provided by the Self Stigma Scale, Beck Cognitive Insight Scale and Social Functioning Assessment Scale.
In order to evaluate the qualitative data, a semi-structured interview form consisting of questions about the effectiveness of education on the variables will be used by the researcher. After the pre-test application, a measurement will be made at the end of the sessions in the 2nd week, 4th week and 6th week in order to measure the effectiveness of the study during the application. Also, a measurement will be made in the 8th week for follow-up purposes.
After the collection of quantitative data, 5 people from both experimental groups will be selected and qualitative data will be collected with 10 participants in total. Individual and face-to-face interviews will be conducted with the patients who make up the experimental group, and the interviews will be audio recorded with the knowledge and consent of the participant. Individual interviews will be provided with a semi-structured form for the effectiveness of the training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Other: Peer Education Supported Psychosocial Skills EducationIt will consist of 10 patients who have received psychosocial skills training by the staff of the center, and a 6-week peer-supported psychosocial skills training will be given by the peer-leaders trained by the researcher psychiatric nurse. |
| Experimental Group 2 | Experimental | Other: Peer Education Supported Psychosocial Skills EducationIt will consist of 10 patients who have not received psychosocial skills training by the staff of the center, and a 6-week peer-supported psychosocial skills training will be given by the peer-leaders trained by the researcher psychiatric nurse. |
| Control Group 1 | No intervention | –It will consist of 10 patients who have received psychosocial skills training by the center staff and no intervention will be applied. |
| Control Group 2 | No intervention | –It will consist of 10 patients who have not received psychosocial skills training by the center staff and no intervention will be applied. |
| Peer Practitioner Training | Other | Other: Peer practitioner training - Peer Education Supported Psychosocial Skills EducationIt is the group in which psychosocial skills training will be given to 4 patients with chronic mental disorders by a researcher psychiatric nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Being registered with the Community Mental Health Center (CMHC),
- Participating in the study voluntarily and being an instructor in 6 sessions of psychosocial skills training.
- Having a high level of functionality according to the functionality scale
- Not in the active period of the disease
- Being able to read and write and not have any communication problems in understanding and speaking Turkish.
Key exclusion criteria (5 listed)
- Not registering with CMHC.
- Inability to give written informed consent to the study
- Inability to communicate in written or verbal Turkish at a level that will complete the assessments and be included in the groups.
- The emergence of acute illness symptoms during the education process
- The conflict between the patient giving the training and the patients participating in the group training constitutes the exclusion criteria.
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 |
|---|---|---|
| Peer practitioner training - Peer Education Supported Psychosocial Skills EducationPsychosocial skills training-practitioner training will be given to 4 patients diagnosed with chronic mental disorder by the research psychiatry nurse. Educational content 1. Getting acquainted - briefing about the study 2. The Importance, Aims and Objectives of Psychosocial Skills Education 3. The importance of peer support 4. The importance, aims and objectives of peer education supported psychosocial skills training 5. Management of the meeting game, warm-up games and role plays 6. 1st and 2nd session peer education supported psychosocial skills training 7. 3rd and 4th session peer education supported psychosocial skills training 8. The last 5th and 6th sessions of peer education are supported by psychosocial skills training. 9. Key points and termination in group management. The training will be planned to last 10-13 hours in total. Trainer's booklet prepared by the researcher psychiatric nurse. | Other | Peer Practitioner Training |
| Peer Education Supported Psychosocial Skills EducationIt is a psychosocial skills training that will be given to both experimental groups in 6 sessions within 6 weeks. 2 of the 4 peer trainers who received the practitioner training will conduct the training. During the training period, the research psychiatric nurse will support. Session titles are as follows: 1. Session:Preparation Session 2. Session: Understanding Mental Disorders 3. Session: Developing Communication Skills 4. Session: Developing Emotion Recognition and Expression Skills 5. Session: Dealing with Daily Living Activities and Problems 6. Session: Understanding the Stigma Experience The duration of each session is determined as 90 minutes. Taking into account the patient's opinions breaks not exceeding 15 minutes will be given as needed. | Other | Experimental Group 1, Experimental Group 2 |
Primary outcome
Functionality (Social Functioning Assessment Scale)
Time frame: 6 Weeks
This scale evaluates 19 items and four sub-dimensions in general in patients with schizophrenia. Among the factors, interpersonal explanations and entertainment consist of seven items, self-care seven items, independent living needs four items, and work-life one item. The scores that can be obtained from the scale are between 19 and 57, and a high score means that social functioning measures are high. It is expected that there will be an increase in the functionality levels of the experimental groups.
Stigmatization (Self-Stigma Scale)
Time frame: 6 Weeks
It is a 3-factor scale consisting of 17 items for patients evaluating self-stigmatization or internalized stigma, concealment of illness and perception of worthlessness in individuals with mental illness. A five-point Likert-type scale was created as "1=not at all suitable for me, 2=somewhat appropriate, 3=moderately appropriate, 4=generally appropriate, 5=completely appropriate". As the score obtained from the scale increases, the self-stigmatization of the patients increases. The Cronbach's alpha correlation coefficient value of the scale is 0.93, indicating high reliability. It is expected that the stigma perceptions of the experimental groups will decrease.
Insight (Beck Cognitive Insight Scale)
Time frame: 6 Weeks
The Turkish validity and reliability study of the scale developed to assess cognitive insight was conducted. The scale, which is a four-point Likert type, consists of 15 items and has 2 sub-dimensions "self-confidence" and "self-evaluation". The scoring system of the scale consists of "disagree" 0 points, "somewhat agree" 1 point, "mostly agree" 2 points, "strongly agree" 3 points. The total (composite) score of the scale is obtained by subtracting the self-evaluation items (1,3,4,5,6,8,12,14,15) from the self-confidence item scores (2,7,9,10,11,13). The total score range of the scale is between -18 and 27 points. A high score indicates a high level of insight. In the reliability study of the Turkish version of the scale, the internal consistency Cronbach's alpha coefficient was found to be 0.68. It is expected that there will be an increase in the insight levels of the experimental groups.
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 22 Feb 2024.
- Individual participant dataSharing planned: No. The identity information of the participants will not be shared with other researchers. The statistical data of the research is planned to be published in a scientific journal.
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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.
Nermin Gürhan, Prof. Dr. study director
Tokat Gaziosmanpa 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 Peer practitioner training - Peer Education Supported Psychosocial Skills Education and Peer Education Supported Psychosocial Skills Education in people with Chronic Mental Disorders and Peer Support, run by Tokat Gaziosmanpasa 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 15 inclusion and 5 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 22 Feb 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?
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?
Functionality (Social Functioning Assessment Scale) (time frame: 6 Weeks). The study lists 3 primary outcomes in all. 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 22 Feb 2024.