Schizophrenia DisordersNCT06882538
The Effect of Mindfulness-Based Psychoeducation Programme Given Individually to Schizophrenia Patients on Internalised Stigma and Healthy Lifestyle Behaviours
A study testing awareness-based psychoeducation in people with Schizophrenia Disorders, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
Schizophrenia is a chronic, recurrent and disabling illness that usually lasts a lifetime and causes serious problems in quality of life and functioning. Psychoeducation programmes added to drug treatment in the treatment of schizophrenia have been shown to increase the knowledge of patients and their relatives about… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia Disorders
- What is being tested?
- awareness-based psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2025to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Having been diagnosed with schizophrenia
- TRSM registered and continuing
- Acceptance to work and training
Who cannot join
- Have not been diagnosed with schizophrenia
- If he/she does not agree to participate in the study
- If not registered with TRSM
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kastamonu Community Mental Health Centre
Kastamonu, Central, 37100
About this study
Schizophrenia is a chronic, recurrent and disabling illness that usually lasts a lifetime and causes serious problems in quality of life and functioning. Psychoeducation programmes added to drug treatment in the treatment of schizophrenia have been shown to increase the knowledge of patients and their relatives about the disease, coping skills, prevention of exacerbations and relapses of the disease, social functioning, insight into the disease, compliance with drug treatment and quality of life. Rehabilitated individuals diagnosed with schizophrenia who are registered and continuing at Kastamonu Training and Research Community Mental Health Centre will constitute the population, and individuals who continue between April 2024 and May 2024 will constitute the sample. The research will be conducted with schizophrenic patients in a pre-test-post-test, experimental and control group experimental design. Power analysis will be performed to determine the number of people to be sampled and calculated with the G*Power 3.1 programme. 40 people will be reached in the groups, 20 people in the experimental group and 20 people in the control group. In the evaluation of the data, descriptive statistical methods (Mean, Standard deviation) as well as the correlation test will be used to evaluate the relationship between the average scores before and after the training in the comparison of quantitative data. Wilcoxon related sample test will be used to make comparisons before and after the training. Personal Information Form, Internalised Stigma Scale in Mental Illness (ISIS) and Healthy Lifestyle Behaviours (HBSB) scale will be used to collect the data. Awareness-based psychoeducation programme will be applied to the experimental group. The aim of psychoeducation is to create a change in knowledge and behaviour towards healthy lifestyle behaviours (1- Self-actualisation, 2- Health responsibility, 3- Exercise, 4- Nutrition, 5- Interpersonal support, 6- Stress management) by reducing internalised stigma. Therefore, it will be evaluated whether the applied psychoeducation programme creates the intended change in knowledge and behaviour. This study will be conducted to examine the effect of a 6-week 12-session self-awareness-based psychoeducation programme given to schizophrenia patients on internalised stigma and healthy lifestyle behaviours. In this study, schizophrenic patients will be provided with regular psychoeducation to provide individual support, to ensure the development of coping skills for self-protection, and to gain knowledge and skills to gain a healthy lifestyle. After the prepared psychoeducation, a training guide will be created for the participants and will be given after the training, thus ensuring continuity of education.
Read the detailed description
Research Population/Sample or Study Group: If appropriate in terms of the study method, the population and sample should be explained here. Specify how the sample/study group will be selected, how they will be assigned to groups and which sampling method(s) (e.g. random-probability, snowball, convenience, purposive, cluster sampling) will be used.
Rehabilitated individuals diagnosed with schizophrenia who are registered and attending the Community Mental Health Centre will constitute the population, and individuals attending between April 2024 and May 2024 will constitute the sample. Power analysis will be performed to determine the number of people to be sampled and calculated with the G*Power 3.1 programme. In the literature, while there is an interventional study on stigmatisation among similar interventional studies for previously diagnosed schizophrenic patients, there is no study investigating stigmatisation and healthy lifestyle behaviours. The effect size was taken as 0.80 as a high level according to the t-test determined by Cohen (1988). In order to exceed the 95% value in determining the power of the study; 40 people, including 20 people in groups with a significance level of 5% and an effect size of 0.80, should be reached (df=68; t=1.668). Since the training covers a period of 6 weeks, schizophrenic individuals who are willing and will continue the training will be accepted.
Data Collection Tool:
Personal Information Form, Internalised Stigma Scale in Mental Illness (ISIS) and Healthy Lifestyle Behaviours (HBSB) scale will be used to collect the data.
Internalised Stigma Scale in Mental Illness (ISIS): Developed by Ritsher et al. (2003), RHIAS is a self-report scale consisting of 29 items and assessing internalised stigma . Turkish adaptation study was conducted by Ersoy and Varan 6. RHIDÖ is a four-point Likert-type scale. The scale has five subscales; 1. Alienation, 2. Confirmation of Stereotypes, 3. Perceived Discrimination, 4. Social Withdrawal and 5. Resistance to Stigmatisation. The items of the 'Resistance to Stigmatisation' subscale are reverse scored.
Total score varies between 29 and 116 points. High scores obtained from the RHIDÖ indicate a high level of internalised stigma. In Ersoy and Varan's study, the Cronbach Alpha value of the scale was 0.93. The scale has been authorised for use and is available in the appendices.
Healthy Lifestyle Behaviours (HLSB) Scale: Developed in 1987 by Walker, Sechrist and Pender, the HLSBS measures the health-promoting behaviours of the individual in relation to healthy lifestyle. It was adapted into Turkish by Esin, a validity and reliability study was conducted and Cronbach's Alpha internal consistency coefficient was found to be 0.91. The scale is a four-point Likert-type scale consisting of a total of 48 items and six subgroups. The score of each subgroup of the scale can be used alone or the total score of the whole scale can be used and gives the score of healthy lifestyle behaviours. The highest score for the whole scale is 192 and the lowest score is 48. A high score on the scale indicates better healthy lifestyle behaviours. All items of the scale are positive and there is no reverse-scored item. The subgroups of the scale are as follows: Self-actualisation; It consists of a total of 13 items covering 3, 8, 11, 12, 16, 17, 21, 23, 29, 34, 37, 44 and 48 questions. It determines the individual's life goals, individual self-development ability, and the extent to which he/she recognises and satisfies himself/herself. Health responsibility consists of a total of 10 items (2, 7, 15, 20, 20, 28, 32, 33, 42, 43 and 46). It determines the level of responsibility of the individual on his/her own health and the extent to which he/she participates in his/her health. Exercise; shows the level of exercise, which is an unchangeable element of healthy life, and consists of a total of 5 items (4, 13, 22, 30 and 38). Nutrition; It consists of a total of 6 items covering 1, 5, 14, 19, 26 and 35 questions. It determines the individual's values in choosing and organising meals and choosing food. Interpersonal support determines the communication and continuity level of the individual with his/her close environment and consists of 7 items (10, 18, 24, 25, 31, 39, and 47). Stress management consists of a total of 7 items (6, 9, 27, 36, 40, 41, and 45) that determine the individual's level of recognition of stress sources and stress control mechanisms.
Data Collection Process: The data will be collected by face-to-face interview method by the researchers. It will be done within the knowledge of the institutional staff within the time interval when they come to the community mental health centre. Pre-test applications will be made to individuals before psychoeducation is given. 6-week training will be given to individuals one by one. Each individual will be provided with 6 weeks of training. After the training, data collection tools will be applied again and post-tests will be created. 20 individuals will be included in the experimental group and 20 individuals will be included in the control group.
- Conditions
- Schizophrenia Disorders
- Being tested
- awareness-based psychoeducation
- Keywords
- schizophrenia, psychoeducation, internalised stigmatisation, healthy lifestyle behaviour
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
awareness-based psychoeducationOther
The aim of psychoeducation is to create a change in knowledge and behaviour towards healthy lifestyle behaviours (1- Self-actualisation, 2- Health responsibility, 3- Exercise, 4- Nutrition, 5- Interpersonal support, 6- Stress management) by reducing internalised stigma. Therefore, it will be evaluated whether the applied psychoeducation programme creates the intended change in knowledge and behaviour.
| Study group | Role | What they receive |
|---|---|---|
| Awareness-Based Psychoeducation | Experimental | Sessions
1. Meeting with the group members, introduction of the group process, explanation of the session topics,
2. Information about the management of schizophrenia
3. Information about the management of schizophrenia
4. Taking Responsibility in Health,
5. Gaining Positive Health Behaviours: Nutrition and Exercise, Hygiene practices skills training
6. Gaining Positive Health Behaviours: Using Interpersonal Communication and Supports, Anger Management
7. Acquiring Positive Health Behaviours: Self-actualisation,
8. Gaining Positive Health Behaviours: Managing Stress,
9. Gaining Positive Health Behaviours: Managing Stress, Progressive relaxation techniques
10. Dealing with stigmatisation
11. Dealing with stigmatisation Receives: Other: awareness-based psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of internalized stigma of schizophrenia patients
In this study, the level of internalized stigma in schizophrenia patients will be measured with the internalized stigma scale.
Measured: Four Week
Secondary outcomes (1)
Healthy lifestyle behaviors of schizophrenia patients participating in psychoeducation will be evaluated.
The frequency of healthy lifestyle behaviors of schizophrenia patients receiving psychoeducation will be measured.
Measured: Four Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start14 Feb 2025
- Primary completion20 Feb 2025
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients who were followed up at Kastamonu University Training and Research Hospital Community Mental Health Centre between April 2024 and May 2024 with a diagnosis of schizophrenia according to DSM-5 diagnostic criteria will be included in the study. All patients will be informed about the nature of the interview and scales and written informed consent will be obtained from patients who accept the evaluation. Written permission will be obtained from the Provincial Directorate of Health for the study. The study group patients will be divided into two groups and the training will be given in 12 sessions as two lessons of forty-five minutes each once a week and will be completed in approximately 6 weeks.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havva Kaçan, Kastamonu University
- Investigators
- Havva K KAÇAN, ASSOCIATE PROFESSOR DOCTOR, Principal investigator, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882538
- Sponsor's protocol ID
- 2024/20/4
- Other IDs
- 2024/20/4
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Psychoeducation Programme Given Individually to Schizophrenia Patients on Internalised Stigma and Healthy Lifestyle Behaviours
- ClinicalTrials.gov ID
- NCT06882538
- Acronym / sponsor ID
- 2024/20/4
- Conditions
- Schizophrenia Disorders
- Keywords
- schizophrenia, psychoeducation, internalised stigmatisation, healthy lifestyle behaviour
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 18 Mar 2025 (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.
Schizophrenia is a chronic, recurrent and disabling illness that usually lasts a lifetime and causes serious problems in quality of life and functioning. Psychoeducation programmes added to drug treatment in the treatment of schizophrenia have been shown to increase the knowledge of patients and their relatives about the disease, coping skills, prevention of exacerbations and relapses of the disease, social functioning, insight into the disease, compliance with drug treatment and quality of life. Rehabilitated individuals diagnosed with schizophrenia who are registered and continuing at Kastamonu Training and Research Community Mental Health Centre will constitute the population, and individuals who continue between April 2024 and May 2024 will constitute the sample. The research will be conducted with schizophrenic patients in a pre-test-post-test, experimental and control group experimental design. Power analysis will be performed to determine the number of people to be sampled and calculated with the G*Power 3.1 programme. 40 people will be reached in the groups, 20 people in the experimental group and 20 people in the control group. In the evaluation of the data, descriptive statistical methods (Mean, Standard deviation) as well as the correlation test will be used to evaluate the relationship between the average scores before and after the training in the comparison of quantitative data. Wilcoxon related sample test will be used to make comparisons before and after the training. Personal Information Form, Internalised Stigma Scale in Mental Illness (ISIS) and Healthy Lifestyle Behaviours (HBSB) scale will be used to collect the data. Awareness-based psychoeducation programme will be applied to the experimental group. The aim of psychoeducation is to create a change in knowledge and behaviour towards healthy lifestyle behaviours (1- Self-actualisation, 2- Health responsibility, 3- Exercise, 4- Nutrition, 5- Interpersonal support, 6- Stress management) by reducing internalised stigma. Therefore, it will be evaluated whether the applied psychoeducation programme creates the intended change in knowledge and behaviour. This study will be conducted to examine the effect of a 6-week 12-session self-awareness-based psychoeducation programme given to schizophrenia patients on internalised stigma and healthy lifestyle behaviours. In this study, schizophrenic patients will be provided with regular psychoeducation to provide individual support, to ensure the development of coping skills for self-protection, and to gain knowledge and skills to gain a healthy lifestyle. After the prepared psychoeducation, a training guide will be created for the participants and will be given after the training, thus ensuring continuity of education.
Detailed description
Research Population/Sample or Study Group: If appropriate in terms of the study method, the population and sample should be explained here. Specify how the sample/study group will be selected, how they will be assigned to groups and which sampling method(s) (e.g. random-probability, snowball, convenience, purposive, cluster sampling) will be used.
Rehabilitated individuals diagnosed with schizophrenia who are registered and attending the Community Mental Health Centre will constitute the population, and individuals attending between April 2024 and May 2024 will constitute the sample. Power analysis will be performed to determine the number of people to be sampled and calculated with the G*Power 3.1 programme. In the literature, while there is an interventional study on stigmatisation among similar interventional studies for previously diagnosed schizophrenic patients, there is no study investigating stigmatisation and healthy lifestyle behaviours. The effect size was taken as 0.80 as a high level according to the t-test determined by Cohen (1988). In order to exceed the 95% value in determining the power of the study; 40 people, including 20 people in groups with a significance level of 5% and an effect size of 0.80, should be reached (df=68; t=1.668). Since the training covers a period of 6 weeks, schizophrenic individuals who are willing and will continue the training will be accepted.
Data Collection Tool:
Personal Information Form, Internalised Stigma Scale in Mental Illness (ISIS) and Healthy Lifestyle Behaviours (HBSB) scale will be used to collect the data.
Internalised Stigma Scale in Mental Illness (ISIS): Developed by Ritsher et al. (2003), RHIAS is a self-report scale consisting of 29 items and assessing internalised stigma . Turkish adaptation study was conducted by Ersoy and Varan 6. RHIDÖ is a four-point Likert-type scale. The scale has five subscales; 1. Alienation, 2. Confirmation of Stereotypes, 3. Perceived Discrimination, 4. Social Withdrawal and 5. Resistance to Stigmatisation. The items of the 'Resistance to Stigmatisation' subscale are reverse scored.
Total score varies between 29 and 116 points. High scores obtained from the RHIDÖ indicate a high level of internalised stigma. In Ersoy and Varan's study, the Cronbach Alpha value of the scale was 0.93. The scale has been authorised for use and is available in the appendices.
Healthy Lifestyle Behaviours (HLSB) Scale: Developed in 1987 by Walker, Sechrist and Pender, the HLSBS measures the health-promoting behaviours of the individual in relation to healthy lifestyle. It was adapted into Turkish by Esin, a validity and reliability study was conducted and Cronbach's Alpha internal consistency coefficient was found to be 0.91. The scale is a four-point Likert-type scale consisting of a total of 48 items and six subgroups. The score of each subgroup of the scale can be used alone or the total score of the whole scale can be used and gives the score of healthy lifestyle behaviours. The highest score for the whole scale is 192 and the lowest score is 48. A high score on the scale indicates better healthy lifestyle behaviours. All items of the scale are positive and there is no reverse-scored item. The subgroups of the scale are as follows: Self-actualisation; It consists of a total of 13 items covering 3, 8, 11, 12, 16, 17, 21, 23, 29, 34, 37, 44 and 48 questions. It determines the individual's life goals, individual self-development ability, and the extent to which he/she recognises and satisfies himself/herself. Health responsibility consists of a total of 10 items (2, 7, 15, 20, 20, 28, 32, 33, 42, 43 and 46). It determines the level of responsibility of the individual on his/her own health and the extent to which he/she participates in his/her health. Exercise; shows the level of exercise, which is an unchangeable element of healthy life, and consists of a total of 5 items (4, 13, 22, 30 and 38). Nutrition; It consists of a total of 6 items covering 1, 5, 14, 19, 26 and 35 questions. It determines the individual's values in choosing and organising meals and choosing food. Interpersonal support determines the communication and continuity level of the individual with his/her close environment and consists of 7 items (10, 18, 24, 25, 31, 39, and 47). Stress management consists of a total of 7 items (6, 9, 27, 36, 40, 41, and 45) that determine the individual's level of recognition of stress sources and stress control mechanisms.
Data Collection Process: The data will be collected by face-to-face interview method by the researchers. It will be done within the knowledge of the institutional staff within the time interval when they come to the community mental health centre. Pre-test applications will be made to individuals before psychoeducation is given. 6-week training will be given to individuals one by one. Each individual will be provided with 6 weeks of training. After the training, data collection tools will be applied again and post-tests will be created. 20 individuals will be included in the experimental group and 20 individuals will be included in the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients who were followed up at Kastamonu University Training and Research Hospital Community Mental Health Centre between April 2024 and May 2024 with a diagnosis of schizophrenia according to DSM-5 diagnostic criteria will be included in the study. All patients will be informed about the nature of the interview and scales and written informed consent will be obtained from patients who accept the evaluation. Written permission will be obtained from the Provincial Directorate of Health for the study. The study group patients will be divided into two groups and the training will be given in 12 sessions as two lessons of forty-five minutes each once a week and will be completed in approximately 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Awareness-Based Psychoeducation | Experimental | Other: awareness-based psychoeducationSessions 1. Meeting with the group members, introduction of the group process, explanation of the session topics, 2. Information about the management of schizophrenia 3. Information about the management of schizophrenia 4. Taking Responsibility in Health, 5. Gaining Positive Health Behaviours: Nutrition and Exercise, Hygiene practices skills training 6. Gaining Positive Health Behaviours: Using Interpersonal Communication and Supports, Anger Management 7. Acquiring Positive Health Behaviours: Self-actualisation, 8. Gaining Positive Health Behaviours: Managing Stress, 9. Gaining Positive Health Behaviours: Managing Stress, Progressive relaxation techniques 10. Dealing with stigmatisation 11. Dealing with stigmatisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having been diagnosed with schizophrenia
- TRSM registered and continuing
- Acceptance to work and training
Key exclusion criteria (3 listed)
- Have not been diagnosed with schizophrenia
- If he/she does not agree to participate in the study
- If not registered with TRSM
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 |
|---|---|---|
| awareness-based psychoeducationThe aim of psychoeducation is to create a change in knowledge and behaviour towards healthy lifestyle behaviours (1- Self-actualisation, 2- Health responsibility, 3- Exercise, 4- Nutrition, 5- Interpersonal support, 6- Stress management) by reducing internalised stigma. Therefore, it will be evaluated whether the applied psychoeducation programme creates the intended change in knowledge and behaviour. | Other | Awareness-Based Psychoeducation |
Primary outcome
The level of internalized stigma of schizophrenia patients
Time frame: Four Week
In this study, the level of internalized stigma in schizophrenia patients will be measured with the internalized stigma scale.
1 secondary outcome
Healthy lifestyle behaviors of schizophrenia patients participating in psychoeducation will be evaluated.
Time frame: Four Week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
Patients With Schizophrenia-like Disorders
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.
Havva K KAÇAN, ASSOCIATE PROFESSOR DOCTOR principal investigator
Kastamonu 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 awareness-based psychoeducation in people with Schizophrenia Disorders, run by Kastamonu 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Havva K KAÇAN, ASSOCIATE PROFESSOR DOCTOR (05057753893, hkacan@kastamonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of internalized stigma of schizophrenia patients (time frame: Four Week). 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 18 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.