Stress, PsychologicalREDEFINENCT03571347
Self Help Plus for Asylum Seekers and Refugees in Europe
A study testing Self Help Plus and Enhanced Treatment As Usual in people with Stress, Psychological, run by Universita di Verona at 1 site in Italy.
Trial summary
Background The flow of asylum seekers and refugees moving to European and bordering countries has progressively increased in the last years. This population is exposed to physical and mental challenges before and during displacement, and suffer continuing hardships after arrival in a High-Income Country. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Self Help Plus and Enhanced Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2018to 31 Dec 2020
- 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
- Age 18 or above;
- Able to speak and understand the target languages: Arabic, and/or Urdu, and/or Dari, and/or English;
- Asylum seeker or refugee;
- Presence of psychological distress, as shown by a score of 3 or more at the 12 item General Health Questionnaire (GHQ-12 ≥ 3);
- Both oral and written informed consent to enter the study.
Who cannot join
- Presence of any mental disorders according to DSM-V and ICD-10, as shown by a positive M.I.N.I.;
- Acute medical conditions contraindicating study participation, based on clinical judgment of the health care professional with a clinical background who performs the screening;
- Clinical evidence of imminent suicide risk or suicide risk scored as "moderate or high" (or a positive suicidality behaviour disorder) by the M.I.N.I. (section SUICIDALITY);
- Clinical evidence that the decision-making capacity is impaired.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Refugee Emergency: DEFining and Implementing Novel Evidence-based Psychosocial Interventions
Background The flow of asylum seekers and refugees moving to European and bordering countries has progressively increased in the last years. This population is exposed to physical and mental challenges before and during displacement, and suffer continuing hardships after arrival in a High-Income Country. As a consequence, asylum seekers and refugees are extremely vulnerable to some common mental health conditions, i.e., post-traumatic stress disorder, anxiety, depression and other forms of disabling psychological distress. The World Health Organization has developed a new 5-session self-help intervention called Self-Help Plus (SH+) for managing stress and coping with adversity. SH+ has been evaluated in RCTs in low- and middle-income countries, however, there is no rigorous evidence on its cost-effectiveness in preventing the onset of mental disorders in HIC.
Objectives To evaluate the effectiveness and cost-effectiveness of the SH+ in asylum seekers and refugees with psychological distress resettled in six sites of five European countries (Italy, Austria, Germany, Finland, and two sites in the UK), as compared with enhanced treatment as usual (ETAU). The primary outcome is the reduction in the incidence of any mental disorders. Secondary outcomes are mental health symptoms, psychological functioning, well-being, drop-out rates, and economic outcomes.
Read more
Design This is a multicentre parallel-group randomized controlled trial, in which participants will have an equal probability (1:1) of being randomly allocated to the SH+ or the ETAU.
Methodology Asylum seekers and refugees who screen positive at the General Health Questionnaire (≥ 3) and without a formal diagnosis of any psychiatric disorders according to the M.I.N.I. International Neuropsychiatric Interview will enter the study. After random allocation they will receive the SH+ or the ETAU. Assessments will be performed by masked assessors immediately after intervention, at 6 months, and a 12 months after randomization.
Time frame The recruitment phase will last 12 months. After the screening, eligible participants will be assessed at baseline, post-intervention, and at 6- and 12-month follow-up. The SH+ delivery will be conducted in around 5 weeks.
Expected outcomes A reduction in the incidence of psychiatric diagnoses at 6-month follow-up, and a general improvement in mental health symptoms, psychological functioning, well-being, and economic outcomes at each assessment.
Read the detailed description
Asylum seekers and refugees will be randomized to receive the SH+ intervention or Enhanced Treatment as Usual. The SH+ has been developed by WHO and collaborators working in the humanitarian field, with expertise in global mental health and psychosocial interventions. SH+ consists of a pre-recorded audio course, delivered by facilitators in a group setting and complemented with an illustrated self-help book. SH+ was designed to be relevant for large adversity-affected populations: it is transdiagnostic, easily adaptable to different cultures and languages, and both meaningful and safe for people with and without mental disorders. The format of SH+ is innovative in that it seeks to ensure that key intervention components are delivered as intended without the burden of extensive facilitator training. SH+ programme is based on acceptance and commitment therapy (ACT), a form of cognitive-behavioral therapy, with distinct features. SH+ programme has two components: a pre-recorded course and an illustrated self-help book. Pre-recorded audio material (culturally adapted) is delivered across five 2-hour sessions to groups of up to 30 people. The audio material imparts key information about stress management and guides participants through individual exercises and small group discussions. To augment the audio recordings, an illustrated self-help book reviews all essential content and concepts 19. Written manuals help briefly-trained, non-specialist facilitators to conduct the course using the pre-recorded audio. The SH+ intervention will be delivered by briefly-trained, non-specialist facilitators.
The control intervention will receive Enhanced Treatment as Usual.
- Conditions
- Stress, Psychological
- Being tested
- Self Help Plus, Enhanced Treatment As Usual
- Keywords
- distress, post-traumatic stress disorder, prevention, asylum seekers, refugees, Self Help Plus, Europe
- Medical subject headings
- Stress, Psychological, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Help PlusBehavioural
5-session psychosocial intervention
Enhanced Treatment As UsualOther
Routine social support and/or care, and information about freely available mental health services, social services, NGOs, and community networks providing support to asylum seekers and refugees
| Study group | Role | What they receive |
|---|---|---|
| Self Help Plus | Experimental | SH+ programme has been developed by WHO and collaborators working in the humanitarian field, with expertise in global mental health and psychosocial interventions. SH+ programme consists of a pre-recorded audio course, complemented with bibliotherapy, and thanks to this format not requiring much time from experts for implementation. SH+ consists of 5 sessions. Receives: Behavioral: Self Help Plus |
| Enhanced Treatment As Usual | Other | Control arm participants will receive routine social support and/or care according to ordinary practice and following local regulations. Additionally, they will receive baseline and follow-up assessments according to the study schedule, and information about freely available mental health services, social services and community networks providing support to asylum seekers and refugees, and NGOs' contact details. Receives: Other: Enhanced Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric diagnosis at 6-month follow-up
The primary outcome will be the number of participants with a current psychiatric diagnosis 6 at six-month follow-up, as measured by the M.I.N.I.
Measured: 6-month follow-up
Secondary outcomes (10)
Psychological distress
Psychological distress will be measured through the General Health Questionnaire-12. The questionnaire asks whether the respondent has experienced a particular symptom or behaviour recently. Each item is rated on a four-point Likert scale (less than usual, no more than usual, rather more than usual, or much more than usual); and gives a total score of 36 or 12 based on the GHQ version and on the selected scoring methods.
Measured: Post-intervention; 6-month and 12-month follow-ups
Psychiatric diagnosis
Number of participants with a current psychiatric diagnosis as measured by the M.I.N.I.
Measured: Post-intervention; 6-month and 12-month follow-ups
Functioning
The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) is a generic assessment instrument assessing health and disability. It is used across all diseases, including mental, neurological and substance use disorders. It is simple to administer and applicable across cultures.
Measured: Post-intervention; 6-month and 12-month follow-ups
Depressive symptoms
Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item instrument measuring the presence and severity of depression. Major depression is diagnosed if five or more of the nine depressive symptom criteria have been present at least "more than half the days" in the past two weeks, and one of the symptoms includes depressed mood or anhedonia.
Measured: Post-intervention; 6-month and 12-month follow-ups
Subjective wellbeing
WHO-5 Wellbeing index. The WHO-5 Wellbeing Index is a 5-item questionnaire measuring current psychological wellbeing and quality of life, rather than psychopathology.
Measured: Post-intervention; 6-month and 12-month follow-ups
Self-defined psychosocial goals
The Psychological Outcome Profiles instrument (PSYCHLOPS) consists of four questions. It contains three domains: problems (2 questions), function (1 question) and wellbeing (1 question).
Measured: Post-intervention; 6-month and 12-month follow-ups
Symptoms of Post traumatic stress disorder
PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
Measured: Post-intervention; 6-month and 12-month follow-ups
Health-related quality of life
The EuroQol-5Dimension-3 level version (EQ-5D-3L). The EQ-5D-3L is applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys.
Measured: 6-month and 12-month follow-ups
Cost-effectiveness
The Client Service Receipt Inventory, European version (CSSRI-EU): Client sociodemographic and service receipt inventory (adapted version with other socio- demographic characteristics). The CSSRI is a research tool developed for collecting information that describes in detail the types and level of services that comprise the care package of each study member.
Measured: 6-month and 12-month follow-ups
Proportion of participants leaving the study early
Number of people leaving the study prematurely at any times, and reasons for discontinuation.
Measured: This information will be collecfted at any time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start1 Sep 2018
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
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 Stress, PsychologicalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RE-DEFINE is a prospective, multicentre, randomized, parallel-group trial that will follow study participants over a period of 12-months. Asylum seekers and refugees with psychological distress, but without a mental disorder according to the MINI International Neuropsychiatric Interview (M.I.N.I.) for DSM-V and ICD-10, will be randomly assigned to the Self Help Plus intervention or to enhanced treatment as usual (ETAU).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, VU University of Amsterdam, University of Vienna, University of Ulm, The International Federation of Red Cross and Red Crescent Societies, University of Turku, University of Liverpool, University of York
- Responsible party
- Principal investigator, Marianna Purgato, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571347
- Sponsor's protocol ID
- 779255
- Acronym
- REDEFINE
- Status last verified
- Nov 2022
- First submitted
- 18 Jun 2018
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Purgato M, Carswell K, Acarturk C, Au T, Akbai S, Anttila M, Baumgartner J, Bailey D, Biondi M, Bird M, Churchill R, Eskici S, Hansen LJ, Heron P, Ilkkursun Z, Kilian R, Koesters M, Lantta T, Nose M, Ostuzzi G, Papola D, Popa M, Sijbrandij M, Tarsitani L, Tedeschi F, Turrini G, Uygun E, Valimaki MA, Wancata J, White R, Zanini E, Cuijpers P, Barbui C, Van Ommeren M. Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials. BMJ Open. 2019 May 14;9(5):e030259. doi: 10.1136/bmjopen-2019-030259.
PubMed 31092670
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refugee Emergency: DEFining and Implementing Novel Evidence-based Psychosocial Interventions
- ClinicalTrials.gov ID
- NCT03571347
- Acronym / sponsor ID
- REDEFINE / 779255
- Conditions
- Stress, Psychological
- Keywords
- distress, post-traumatic stress disorder, prevention, asylum seekers, refugees, Self Help Plus, Europe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Collaborators
- World Health Organization, VU University of Amsterdam, University of Vienna, University of Ulm, The International Federation of Red Cross and Red Crescent Societies, University of Turku, University of Liverpool, University of York
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 Jun 2018 (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.
Background The flow of asylum seekers and refugees moving to European and bordering countries has progressively increased in the last years. This population is exposed to physical and mental challenges before and during displacement, and suffer continuing hardships after arrival in a High-Income Country. As a consequence, asylum seekers and refugees are extremely vulnerable to some common mental health conditions, i.e., post-traumatic stress disorder, anxiety, depression and other forms of disabling psychological distress. The World Health Organization has developed a new 5-session self-help intervention called Self-Help Plus (SH+) for managing stress and coping with adversity. SH+ has been evaluated in RCTs in low- and middle-income countries, however, there is no rigorous evidence on its cost-effectiveness in preventing the onset of mental disorders in HIC.
Objectives To evaluate the effectiveness and cost-effectiveness of the SH+ in asylum seekers and refugees with psychological distress resettled in six sites of five European countries (Italy, Austria, Germany, Finland, and two sites in the UK), as compared with enhanced treatment as usual (ETAU). The primary outcome is the reduction in the incidence of any mental disorders. Secondary outcomes are mental health symptoms, psychological functioning, well-being, drop-out rates, and economic outcomes.
Design This is a multicentre parallel-group randomized controlled trial, in which participants will have an equal probability (1:1) of being randomly allocated to the SH+ or the ETAU.
Methodology Asylum seekers and refugees who screen positive at the General Health Questionnaire (≥ 3) and without a formal diagnosis of any psychiatric disorders according to the M.I.N.I. International Neuropsychiatric Interview will enter the study. After random allocation they will receive the SH+ or the ETAU. Assessments will be performed by masked assessors immediately after intervention, at 6 months, and a 12 months after randomization.
Time frame The recruitment phase will last 12 months. After the screening, eligible participants will be assessed at baseline, post-intervention, and at 6- and 12-month follow-up. The SH+ delivery will be conducted in around 5 weeks.
Expected outcomes A reduction in the incidence of psychiatric diagnoses at 6-month follow-up, and a general improvement in mental health symptoms, psychological functioning, well-being, and economic outcomes at each assessment.
Detailed description
Asylum seekers and refugees will be randomized to receive the SH+ intervention or Enhanced Treatment as Usual. The SH+ has been developed by WHO and collaborators working in the humanitarian field, with expertise in global mental health and psychosocial interventions. SH+ consists of a pre-recorded audio course, delivered by facilitators in a group setting and complemented with an illustrated self-help book. SH+ was designed to be relevant for large adversity-affected populations: it is transdiagnostic, easily adaptable to different cultures and languages, and both meaningful and safe for people with and without mental disorders. The format of SH+ is innovative in that it seeks to ensure that key intervention components are delivered as intended without the burden of extensive facilitator training. SH+ programme is based on acceptance and commitment therapy (ACT), a form of cognitive-behavioral therapy, with distinct features. SH+ programme has two components: a pre-recorded course and an illustrated self-help book. Pre-recorded audio material (culturally adapted) is delivered across five 2-hour sessions to groups of up to 30 people. The audio material imparts key information about stress management and guides participants through individual exercises and small group discussions. To augment the audio recordings, an illustrated self-help book reviews all essential content and concepts 19. Written manuals help briefly-trained, non-specialist facilitators to conduct the course using the pre-recorded audio. The SH+ intervention will be delivered by briefly-trained, non-specialist facilitators.
The control intervention will receive Enhanced Treatment as Usual.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RE-DEFINE is a prospective, multicentre, randomized, parallel-group trial that will follow study participants over a period of 12-months. Asylum seekers and refugees with psychological distress, but without a mental disorder according to the MINI International Neuropsychiatric Interview (M.I.N.I.) for DSM-V and ICD-10, will be randomly assigned to the Self Help Plus intervention or to enhanced treatment as usual (ETAU).
| Arm | Type | Receives |
|---|---|---|
| Self Help Plus | Experimental | Behavioral: Self Help PlusSH+ programme has been developed by WHO and collaborators working in the humanitarian field, with expertise in global mental health and psychosocial interventions. SH+ programme consists of a pre-recorded audio course, complemented with bibliotherapy, and thanks to this format not requiring much time from experts for implementation. SH+ consists of 5 sessions. |
| Enhanced Treatment As Usual | Other | Other: Enhanced Treatment As UsualControl arm participants will receive routine social support and/or care according to ordinary practice and following local regulations. Additionally, they will receive baseline and follow-up assessments according to the study schedule, and information about freely available mental health services, social services and community networks providing support to asylum seekers and refugees, and NGOs' contact details. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or above;
- Able to speak and understand the target languages: Arabic, and/or Urdu, and/or Dari, and/or English;
- Asylum seeker or refugee;
- Presence of psychological distress, as shown by a score of 3 or more at the 12 item General Health Questionnaire (GHQ-12 ≥ 3);
- Both oral and written informed consent to enter the study.
Key exclusion criteria (4 listed)
- Presence of any mental disorders according to DSM-V and ICD-10, as shown by a positive M.I.N.I.;
- Acute medical conditions contraindicating study participation, based on clinical judgment of the health care professional with a clinical background who performs the screening;
- Clinical evidence of imminent suicide risk or suicide risk scored as "moderate or high" (or a positive suicidality behaviour disorder) by the M.I.N.I. (section SUICIDALITY);
- Clinical evidence that the decision-making capacity is impaired.
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 |
|---|---|---|
| Self Help Plus5-session psychosocial intervention | Behavioural | Self Help Plus |
| Enhanced Treatment As UsualRoutine social support and/or care, and information about freely available mental health services, social services, NGOs, and community networks providing support to asylum seekers and refugees | Other | Enhanced Treatment As Usual |
Primary outcome
Psychiatric diagnosis at 6-month follow-up
Time frame: 6-month follow-up
The primary outcome will be the number of participants with a current psychiatric diagnosis 6 at six-month follow-up, as measured by the M.I.N.I.
10 secondary outcomes
Psychological distress
Time frame: Post-intervention; 6-month and 12-month follow-ups
Psychiatric diagnosis
Time frame: Post-intervention; 6-month and 12-month follow-ups
Functioning
Time frame: Post-intervention; 6-month and 12-month follow-ups
Depressive symptoms
Time frame: Post-intervention; 6-month and 12-month follow-ups
Subjective wellbeing
Time frame: Post-intervention; 6-month and 12-month follow-ups
Self-defined psychosocial goals
Time frame: Post-intervention; 6-month and 12-month follow-ups
Symptoms of Post traumatic stress disorder
Time frame: Post-intervention; 6-month and 12-month follow-ups
Health-related quality of life
Time frame: 6-month and 12-month follow-ups
Cost-effectiveness
Time frame: 6-month and 12-month follow-ups
Proportion of participants leaving the study early
Time frame: This information will be collecfted at any time.
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 7 Nov 2022.
- Derived from this study: PubMed 31092670Purgato M, Carswell K, Acarturk C, Au T, Akbai S, Anttila M, Baumgartner J, Bailey D, Biondi M, Bird M, Churchill R, Eskici S, Hansen LJ, Heron P, Ilkkursun Z, Kilian R, Koesters M, Lantta T, Nose M, Ostuzzi G, Papola D, Popa M, Sijbrandij M, Tarsitani L, Tedeschi F, Turrini G, Uygun E, Valimaki MA, Wancata J, White R, Zanini E, Cuijpers P, Barbui C, Van Ommeren M. Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials. BMJ Open. 2019 May 14;9(5):e030259. doi: 10.1136/bmjopen-2019-030259.
- Individual participant dataSharing planned: No
Related trials for Stress, Psychological
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
Financial Tools Access and Navigation (FinTAN)
Serious Mental Illness, Financial Hardship
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Help Plus and Enhanced Treatment As Usual in people with Stress, Psychological, run by Universita di Verona at 1 site in Italy.
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 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: finished, as of the sponsor's last update on 7 Nov 2022. 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 Italy. 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?
Psychiatric diagnosis at 6-month follow-up (time frame: 6-month follow-up). 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 NCT03571347, 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 7 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.