Posttraumatic Stress Disorder (PTSD)NCT01464892
Imagery Rescripting in the Treatment of Post Traumatic Stress Disorder (PTSD) Following Early Chronic Interpersonal Trauma
A study testing Imagery Rescripting and Reprocessing Therapy and STAIR + Imagery Rescripting in people with Posttraumatic Stress Disorder (PTSD), run by University of Amsterdam at 1 site in Netherlands.
Trial summary
Imagery Rescripting (IR)is a promising treatment for PTSD in adult survivors of early, chronic, interpersonal trauma (e.g. Smucker \& Dancu, 1999). So far, this protocol has not been investigated within a controlled setting with patients with PTSD following early, chronic, interpersonal trauma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Imagery Rescripting and Reprocessing Therapy and STAIR + Imagery Rescripting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2011to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a full diagnosis of post-traumatic stress disorder (PTSD) according to DSM-IV
- having experienced repeated or chronic interpersonal trauma by care-takers or authority figures before the age of 15
- between the age of 18 and 65 years
- sufficient fluency of Dutch to complete treatment and research-protocol
- participants using prescribed anti-depressant medication are required to be on a stable dose for at least 6 weeks before the beginning of treatment and remain on this dose throughout the treatment
Who cannot join
- psychosis
- bipolar disorder
- significant cognitive impairment
- substance dependence
- current use of benzodiazepines
- severe suicidal ideation or life-threatening automutilation
Show all 10Show fewer
- current trauma or threat
- unstable living circumstances
- antisocial personality disorder
- primary diagnosis of borderline personality disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rescripting With vs. Without Prior Stabilization in PTSD Following Early Chronic Interpersonal Trauma
Imagery Rescripting (IR)is a promising treatment for PTSD in adult survivors of early, chronic, interpersonal trauma (e.g. Smucker \& Dancu, 1999). So far, this protocol has not been investigated within a controlled setting with patients with PTSD following early, chronic, interpersonal trauma. The aim of the proposed study is to 1. investigate the efficacy of Imagery Rescripting and 2. check whether the efficacy of Imagery Rescripting can be improved by adding a stabilization phase (Skills training in affective and interpersonal regulation, STAIR) prior to this treatment. In a randomized controlled trial three conditions will be compared:
- Imagery Rescripting
- STAIR + Imagery Rescripting
- Wait-list control
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Imagery Rescripting and Reprocessing Therapy, STAIR + Imagery Rescripting
- Keywords
- Imagery rescripting, Imagery rescripting and reprocessing therapy, Skills Training in affective and interpersonal regulation, Post-traumatic Stress Disorder, Childhood abuse, Childhood sexual abuse
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagery Rescripting and Reprocessing TherapyBehavioural
Also called IRRT
This intervention is comprised of 16 sessions (twice a week) of trauma-focused imagery rescripting
STAIR + Imagery RescriptingBehavioural
A two-phased treatment. Phase 1 is comprised of 8 (weekly) sessions of Skills Training in Affective and Interpersonal Skills (STAIR). Phase 2 consists of 16 sessions (twice weekly) of trauma-focused imagery rescripting.
| Study group | Role | What they receive |
|---|---|---|
| Imagery Rescripting | Experimental | Not described Receives: Behavioral: Imagery Rescripting and Reprocessing Therapy |
| STAIR plus Imagery Rescripting | Active comparator | Not described Receives: Behavioral: STAIR + Imagery Rescripting |
| Wait-list control | No intervention | Participants from this arm are randomized to the two active conditions after 8 weeks of waiting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 8 weeks
comparison STAIR vs ImRs vs WL
Measured: baseline and 8 weeks
Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks
comparison STAIR vs ImRs vs WL
Measured: baseline and 8 weeks
Secondary outcomes (25)
Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks
Measured: baseline and 8 weeks
Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 8 weeks
Measured: baseline and 8 weeks
Change from Baseline in Inventory of Interpersonal Problems (IIP)at 8 weeks
Measured: baseline and 8 weeks
Change from Baseline in Dissociation Questionnaire (DIS-Q)at 8 weeks
Measured: baseline and 8 weeks
Change from Baseline in WHO-Quality of Life(WHO-QL)at 8 weeks
Measured: baseline and 8 weeks
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 8 weeks
Measured: baseline and 8 weeks
Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 8 weeks
Measured: baseline and 8 weeks
Posttreatment: Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs 24 weeks (WL/STAIR/ImRs)
Measured: baseline and max.24 weeks (depending on condition)
12-week follow-up: Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR/ImRs).
Measured: baseline and max. 36 weeks (depending on condition)
Post-treatment: Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR/ImRs)
Measured: baseline and max.24 weeks (depending on condition)
12-week fu: Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR)./ImRs).
Measured: baseline and max. 36 weeks (depending on condition)
Post-treatment: Change from Baseline in Beck Depression Inventory (BDI) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR).
Measured: baseline and max 24 weeks (depending on condition)
Change from Baseline in Beck Depression Inventory (BDI) at 20 weeks (ImRs) vs 12-week-fu: 8 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Measured: baseline and max 36 weeks (depending on condition)
Post-treatment: Change from Baseline in Buss-Durkee Hostility Inventory (BDHI) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR
Measured: baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in Buss-Durkee Hostility Inventory (BDHI) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Measured: baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in Inventory of Interpersonal Problems (IIP) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR).
Measured: baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in Inventory of Interpersonal Problems (IIP) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Measured: baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in Dissociation Questionnaire (DIS-Q) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)
Measured: baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in Dissociation Questionnaire (DIS-Q) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Measured: baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in WHO-Quality of Life(WHO-QL) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)
Measured: baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in WHO-Quality of Life(WHO-QL) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Measured: baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in Difficulties in Emotion Regulation Scale Post-treatment: Change from Difficulties in Emotion Regulation Scale (DERS) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)
Measured: baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in Difficulties in Emotion Regulation Scale (DERS) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Measured: baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in Structured Clinical Interview - Axis I (SCID-1) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)
Measured: baseline and max 36 weeks (depdending on condition)
12-week FU: Change from Baseline in Structured Clinical Interview - Axis I (SCID-1) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Measured: baseline and max 36 weeks (depdending on condition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mrs. M. Kindt, University of Amsterdam
- Investigators
- Merel Kindt, Prof dr, Principal investigator, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464892
- Sponsor's protocol ID
- 2009-KP-877
- Status last verified
- Dec 2021
- First submitted
- 25 Oct 2011
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescripting With vs. Without Prior Stabilization in PTSD Following Early Chronic Interpersonal Trauma
- ClinicalTrials.gov ID
- NCT01464892
- Acronym / sponsor ID
- 2009-KP-877
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- Imagery rescripting, Imagery rescripting and reprocessing therapy, Skills Training in affective and interpersonal regulation, Post-traumatic Stress Disorder, Childhood abuse, Childhood sexual abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of AmsterdamUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 4 Nov 2011 (estimated)
- 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.
Imagery Rescripting (IR)is a promising treatment for PTSD in adult survivors of early, chronic, interpersonal trauma (e.g. Smucker \& Dancu, 1999). So far, this protocol has not been investigated within a controlled setting with patients with PTSD following early, chronic, interpersonal trauma. The aim of the proposed study is to 1. investigate the efficacy of Imagery Rescripting and 2. check whether the efficacy of Imagery Rescripting can be improved by adding a stabilization phase (Skills training in affective and interpersonal regulation, STAIR) prior to this treatment. In a randomized controlled trial three conditions will be compared:
- Imagery Rescripting
- STAIR + Imagery Rescripting
- Wait-list control
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Imagery Rescripting | Experimental | Behavioral: Imagery Rescripting and Reprocessing Therapy |
| STAIR plus Imagery Rescripting | Active comparator | Behavioral: STAIR + Imagery Rescripting |
| Wait-list control | No intervention | –Participants from this arm are randomized to the two active conditions after 8 weeks of waiting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a full diagnosis of post-traumatic stress disorder (PTSD) according to DSM-IV
- having experienced repeated or chronic interpersonal trauma by care-takers or authority figures before the age of 15
- between the age of 18 and 65 years
- sufficient fluency of Dutch to complete treatment and research-protocol
- participants using prescribed anti-depressant medication are required to be on a stable dose for at least 6 weeks before the beginning of treatment and remain on this dose throughout the treatment
Key exclusion criteria (10 listed)
- psychosis
- bipolar disorder
- significant cognitive impairment
- substance dependence
- current use of benzodiazepines
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 |
|---|---|---|
| Imagery Rescripting and Reprocessing TherapyAlso: IRRTThis intervention is comprised of 16 sessions (twice a week) of trauma-focused imagery rescripting | Behavioural | Imagery Rescripting |
| STAIR + Imagery RescriptingA two-phased treatment. Phase 1 is comprised of 8 (weekly) sessions of Skills Training in Affective and Interpersonal Skills (STAIR). Phase 2 consists of 16 sessions (twice weekly) of trauma-focused imagery rescripting. | Behavioural | STAIR plus Imagery Rescripting |
Primary outcome
Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 8 weeks
Time frame: baseline and 8 weeks
comparison STAIR vs ImRs vs WL
Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks
Time frame: baseline and 8 weeks
comparison STAIR vs ImRs vs WL
25 secondary outcomes
Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in Inventory of Interpersonal Problems (IIP)at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in Dissociation Questionnaire (DIS-Q)at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in WHO-Quality of Life(WHO-QL)at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 8 weeks
Time frame: baseline and 8 weeks
Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 8 weeks
Time frame: baseline and 8 weeks
Posttreatment: Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs 24 weeks (WL/STAIR/ImRs)
Time frame: baseline and max.24 weeks (depending on condition)
12-week follow-up: Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR/ImRs).
Time frame: baseline and max. 36 weeks (depending on condition)
Post-treatment: Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR/ImRs)
Time frame: baseline and max.24 weeks (depending on condition)
12-week fu: Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR)./ImRs).
Time frame: baseline and max. 36 weeks (depending on condition)
Post-treatment: Change from Baseline in Beck Depression Inventory (BDI) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR).
Time frame: baseline and max 24 weeks (depending on condition)
Change from Baseline in Beck Depression Inventory (BDI) at 20 weeks (ImRs) vs 12-week-fu: 8 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Time frame: baseline and max 36 weeks (depending on condition)
Post-treatment: Change from Baseline in Buss-Durkee Hostility Inventory (BDHI) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR
Time frame: baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in Buss-Durkee Hostility Inventory (BDHI) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Time frame: baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in Inventory of Interpersonal Problems (IIP) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR).
Time frame: baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in Inventory of Interpersonal Problems (IIP) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Time frame: baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in Dissociation Questionnaire (DIS-Q) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)
Time frame: baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in Dissociation Questionnaire (DIS-Q) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Time frame: baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in WHO-Quality of Life(WHO-QL) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)
Time frame: baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in WHO-Quality of Life(WHO-QL) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Time frame: baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in Difficulties in Emotion Regulation Scale Post-treatment: Change from Difficulties in Emotion Regulation Scale (DERS) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)
Time frame: baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in Difficulties in Emotion Regulation Scale (DERS) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Time frame: baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in Structured Clinical Interview - Axis I (SCID-1) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)
Time frame: baseline and max 36 weeks (depdending on condition)
12-week FU: Change from Baseline in Structured Clinical Interview - Axis I (SCID-1) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Time frame: baseline and max 36 weeks (depdending on condition)
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 9 Dec 2021.
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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.
Merel Kindt, Prof dr principal investigator
University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagery Rescripting and Reprocessing Therapy and STAIR + Imagery Rescripting in people with Posttraumatic Stress Disorder (PTSD), run by University of Amsterdam at 1 site in Netherlands.
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 10 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 9 Dec 2021. 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 Netherlands. 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?
Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 8 weeks (time frame: baseline and 8 weeks). The study lists 2 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 9 Dec 2021; AzTrials last refreshed its copy on 6 Nov 2026.