Attention ImpairedNCT05353231
Brief Mental Training and Internal Attentional Control
A study testing Mindful Disengagement from Thoughts Training (MDTT) in people with Attention Impaired and Mental Health Issue, run by University of Haifa at 1 site in Israel.
Trial summary
Previous research documented that real-time feedback on attention as well as related forms of mental training (e.g. mindfulness meditation) may be used to train and impact external attentional control. These approaches to mental training are designed to train meta-awareness in order to enable attentional control. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Impaired, Mental Health Issue, Rumination
- What is being tested?
- Mindful Disengagement from Thoughts Training (MDTT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- 23 May 2022to Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Brooding subscale in the Ruminative Responses Scale (RRS) - with score equal to or greater than 11
Who cannot join
- Endorsement of suicidal ideation ("Yes" answer to Patient Health Questionnaire - 9 Item
- Psychotic Symptoms, specifically auditory hallucinations
- Self-report lack of fluency in speaking or understanding Hebrew-language
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
University of Haifa
Haifa, 31905
Amit Bernstein, Ph.D., +972-4-828-8871, abernstein@psy.haifa.ac.il
About this study
Official title: Brief Mental Training and Internal Attentional Control in Repetitive Negative Thinking: Experimental Laboratory Investigation
Previous research documented that real-time feedback on attention as well as related forms of mental training (e.g. mindfulness meditation) may be used to train and impact external attentional control. These approaches to mental training are designed to train meta-awareness in order to enable attentional control. It is not yet known, however, whether such training targeting meta-awareness can be similarly used to impact internal attentional control. Thus, the investigators will test whether real-time feedback training and a brief mindfulness meditation training, relative to placebo control, will lead to greater internal attentional control among adults with elevated negative repetitive thinking.
Read the detailed description
Participants will complete all assessments and training in a single laboratory session. Participants (N=105) with elevated levels of negative repetitive thinking (Rumination Response Scale -Brooding >=11) will be randomly assigned to one of 3 intervention arms: Attention Feedback Awareness and Control Training (A-FACT; n=35), Mindful Disengagement from Thoughts Training (MDTT; n=35), or placebo control (n=35).
At pre- and post-intervention, the investigators will measure: (1) Subjective emotional reactivity in response to negative vs. neutral self-referential thoughts using the Simulated Thought Paradigm (STP)-Emotional Reactivity task; (2) Interoceptive attention (i.e. sensibility) of the subjective location, intensity and hedonic tone of bodily sensations, using the STP-Body Map task, and (3) internal attentional control (i.e. latency to disengage) using the STP-Digit Categorization Task.
At post-intervention assessment only, the investigators will measure: (1) Meta-awareness of internal attentional dyscontrol using the STP-Digit Categorization Task with Self-Caught Probes; (2) internal attentional control (i.e. selective attention) using the STP-One-Back Dichotic Listening Task as a measure of the generalizability of the expected primary effect on internal attentional control.
The primary aim is to test the effect of 2 active intervention arms, Attention Feedback Awareness and Control Training and Mindful Disengagement from Thoughts Training, relative to one another and placebo control, on internal attentional control from pre-to-post training among adults with elevated negative repetitive thinking. The investigators hypothesise that both active interventions conditions will yield improvement in internal attentional control, as measured by the Digit Categorization Task integrated with the Simulated Thoughts Paradigm, from pre-to-post intervention, relative to the placebo-control.
Secondary aims are to test the effects of the 2 active intervention arms, relative to one another and placebo control, on subjective emotional reactivity to negative self-referential thoughts, selection bias to negative self-referential thoughts, meta-awareness of attentional dyscontrol, as well as interoceptive attention to bodily sensations in response to negative self-referential thoughts. The investigators hypothesize that, relative to the control-placebo group, the active intervention groups will yield (a) reduced emotional reactivity to negative self-referential thoughts as measured in the Emotional Reactivity Task, (b) higher levels of meta-awareness of attentional dyscontrol as measured by the STP-Digit Categorization Task with Self-Caught Probes, and (c) higher levels of selective internal attentional control as measured by the STP-One-Back Dichotic Listening Task.
Additionally, the investigators hypothesize that, relative to the placebo control group and the Attention Feedback Awareness and Control Training group, the Mindful Disengagement from Thoughts Training group will yield enhanced interoceptive attention (i.e. sensibility) to a broader range of locations (e.g. peripheral body areas), intensities (e.g. subtle sensations) and hedonic tones (e.g. neutral and pleasant hedonic tones) of bodily sensations in response to self-referential thoughts, as measured by STP-Body Map task.
Finally, the investigators hypothesized non-inferiority between the active intervention groups with respect to all mentioned measured outcomes, with exception of the noted STP-Body-Map Task.
- Conditions
- Attention Impaired, Mental Health Issue, Rumination
- Being tested
- Attention Feedback Awareness and Control Training (A-FACT), Mindful Disengagement from Thoughts Training (MDTT), Placebo-Control
- Keywords
- Cognitive Change, Internal attention, Interoceptive attention, Meditation, Mindfulness, Computerized intervention, Attentional bias
- Medical subject headings
- Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Feedback Awareness and Control Training (A-FACT)Behavioural
A-FACT is designed to promote meta-awareness of moment-to-moment biased internal attention allocation (e.g. toward negative thoughts) and thereby internal attentional control.
Participants will be instructed that they will complete a task designed to reduce their attentional bias to some thoughts. Following a fixation que, the auditory neutral or negative simulated thought stimulus is delivered, and 500ms prior to termination of the auditory stimulus, a visual stimulus is presented until participants categorize the visual stimulus as greater than or smaller than 5 objects. Latency to disengage attention from each thought stimuli, at the trial-level, is repeatedly measured, and after each negative thought stimulus, trial-level feedback on the latency to disengage is delivered back to participants through a visual scale representing their attentional bias. Participants will complete approximately 100 trials in total wherein randomly 1 or 2 neutral trials follow each negative trial.
Mindful Disengagement from Thoughts Training (MDTT)Behavioural
MDTT is designed to promote meta-awareness of moment-to-moment biased internal attention allocation (e.g. toward negative thoughts) and thereby internal attentional control. Participants will be instructed that they will complete a task designed to reduce their attentional bias to some thoughts. Participants will first learn and practice a focused attention on the breath meditation. Then, participants will practice pressing a button each time they notice an inhalation or exhalation during the focused attention meditation. Next, during the meditation, participants will be presented the auditory neutral or negative simulated thought stimuli and will train internal attentional control by repeatedly disengaging their attention from these stimuli and back to their breath MDTT will thus entail 80 trials (40 negative, 40 neutral, ITI ≈ 10sec) during the focused attention on the breath meditation.
Placebo-ControlBehavioural
The condition is designed as a placebo control for the Attention Feedback Awareness and Control Training (A-FACT) training condition. Participants will be instructed that they will complete a task designed to reduce their attentional bias to some thoughts. Rather than the quantity categorization task with trial-level feedback, participants only engage in the quantity categorization task. The task is identical in all other ways to the A-FACT condition. Participants will complete approximately 100 trials in total wherein randomly 1 or 2 neutral trials follow each negative trial.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 - Attention Feedback Awareness and Control Training | Experimental | Not described Receives: Behavioral: Attention Feedback Awareness and Control Training (A-FACT) |
| Intervention 2 - Mindful Disengagement from Thoughts Training | Experimental | Not described Receives: Behavioral: Mindful Disengagement from Thoughts Training (MDTT) |
| Placebo | Placebo comparator | Not described Receives: Behavioral: Placebo-Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the STP-Digit Categorization Task
The STP-Digit Categorization Task (STP-DCT) will be used to measure change, from pre-intervention to post-intervention, in internal attentional disengagement. Attentional disengagement will be computed by the difference in reaction time on negative relative to neutral simulated thought stimuli as well as via a dynamic bias score calculated by subtracting the running mean of the 8 neutral trials window ( 4 neutral trials backwards and 4 neutral trials forward), from each negative trial reaction time that exceeds the 95%CI., dividing this distance by the 8 neutral trials window standard deviation (Amir, Ruimi, \& Bernstein, 2021). A positive score reflects greater difficulty to disengage from negative relative to neutral thought stimuli.
Measured: pre-intervention, immediately post-intervention
Secondary outcomes (4)
STP-One-Back Dichotic Listening Task
The STP-One-Back Dichotic Listening Task will be used to measure biased selective attention of negative simulated thought stimuli. Biased selective attention will be computed by the difference in accuracy for negative relative to neutral simulated thought stimuli. An accurate response (for each stimulus) is the correct left/right button press for the respective left/right channel in which a repetition of auditory neutral or negative simulated thought stimuli were presented - i.e., the stimulus delivered at trial n-1 was repeated on trial n (in the same channel); or the correct withholding of a response if no repetition was present. A positive bias score reflects greater selective attention to negative relative to neutral thought stimuli.
Measured: immediately post-intervention
STP-Digit Categorization Task (STP-DCT) with Self-Caught Probes
The STP-Digit Categorization Task (STP-DCT) with Self-Caught Probes will be used to measure meta-awareness of attentional disengagement from stimulated thoughts stimuli. While performing the STP-DCT task, participants are instructed to, on the trial-level, report when the simulated thought influenced their trial response (i.e., led to difficulty disengaging attention from thought to categorize the digit) by pressing a key immediately following trial response. Meta-awareness will be computed using the Diagnostic Odds Ratio (Ruimi, Hadash, Zvielli, Amir, Goldstein, \& Bernstein, 2018). Positive scores reflects degree of meta-awareness for difficulty to disengage from thought stimuli.
Measured: immediately post-intervention
Change in the STP-Emotional Reactivity Task
The STP-Emotional Reactivity Task will be used to measure change, from pre- to post-intervention, in emotional reactivity to negative simulated thought stimuli. Emotional reactivity will be computed as the difference between the mean of 5 subjective emotion stats (irritability, anger, anxiety, guilt, distress), each self-rated on a 5-point Likert-type scale, following one block of 20 neutral-, and then again one block of 20 negative- simulated thought stimuli. Positive scores reflect greater emotional reactivity in response to negative relative to neutral thought stimuli.
Measured: pre-intervention, immediately post-intervention
Change in the STP-Body Map Task
The STP-Body Map Task will be used to measure interoceptive attention via subjective assessment (i.e. sensibility) of bodily sensations, following negative and neutral stimuli (STP). The following interoceptive attention variables will be calculated: (1) Detection of bodily sensations (frequency (number) of bodily sensations); (2) Magnitude of bodily sensations (mean intensity of bodily (range from 1 to 5)); (3) Bias to hedonic tone of bodily sensations (proportion/percent of neutral, pleasant and unpleasant sensations), (4) Bias to central vs peripheral bodily sensations (e.g. proportion/percent of sensations in torso/head vs. legs/arms).
Measured: pre-intervention, immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start23 May 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention ImpairedStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Bernstein, Ph.D., Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353231
- Sponsor's protocol ID
- MDTT-AFACT
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Mental Training and Internal Attentional Control in Repetitive Negative Thinking: Experimental Laboratory Investigation
- ClinicalTrials.gov ID
- NCT05353231
- Acronym / sponsor ID
- MDTT-AFACT
- Conditions
- Attention Impaired, Mental Health Issue, Rumination
- Keywords
- Cognitive Change, Internal attention, Interoceptive attention, Meditation, Mindfulness, Computerized intervention, Attentional bias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 23 May 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Apr 2022 (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.
Previous research documented that real-time feedback on attention as well as related forms of mental training (e.g. mindfulness meditation) may be used to train and impact external attentional control. These approaches to mental training are designed to train meta-awareness in order to enable attentional control. It is not yet known, however, whether such training targeting meta-awareness can be similarly used to impact internal attentional control. Thus, the investigators will test whether real-time feedback training and a brief mindfulness meditation training, relative to placebo control, will lead to greater internal attentional control among adults with elevated negative repetitive thinking.
Detailed description
Participants will complete all assessments and training in a single laboratory session. Participants (N=105) with elevated levels of negative repetitive thinking (Rumination Response Scale -Brooding >=11) will be randomly assigned to one of 3 intervention arms: Attention Feedback Awareness and Control Training (A-FACT; n=35), Mindful Disengagement from Thoughts Training (MDTT; n=35), or placebo control (n=35).
At pre- and post-intervention, the investigators will measure: (1) Subjective emotional reactivity in response to negative vs. neutral self-referential thoughts using the Simulated Thought Paradigm (STP)-Emotional Reactivity task; (2) Interoceptive attention (i.e. sensibility) of the subjective location, intensity and hedonic tone of bodily sensations, using the STP-Body Map task, and (3) internal attentional control (i.e. latency to disengage) using the STP-Digit Categorization Task.
At post-intervention assessment only, the investigators will measure: (1) Meta-awareness of internal attentional dyscontrol using the STP-Digit Categorization Task with Self-Caught Probes; (2) internal attentional control (i.e. selective attention) using the STP-One-Back Dichotic Listening Task as a measure of the generalizability of the expected primary effect on internal attentional control.
The primary aim is to test the effect of 2 active intervention arms, Attention Feedback Awareness and Control Training and Mindful Disengagement from Thoughts Training, relative to one another and placebo control, on internal attentional control from pre-to-post training among adults with elevated negative repetitive thinking. The investigators hypothesise that both active interventions conditions will yield improvement in internal attentional control, as measured by the Digit Categorization Task integrated with the Simulated Thoughts Paradigm, from pre-to-post intervention, relative to the placebo-control.
Secondary aims are to test the effects of the 2 active intervention arms, relative to one another and placebo control, on subjective emotional reactivity to negative self-referential thoughts, selection bias to negative self-referential thoughts, meta-awareness of attentional dyscontrol, as well as interoceptive attention to bodily sensations in response to negative self-referential thoughts. The investigators hypothesize that, relative to the control-placebo group, the active intervention groups will yield (a) reduced emotional reactivity to negative self-referential thoughts as measured in the Emotional Reactivity Task, (b) higher levels of meta-awareness of attentional dyscontrol as measured by the STP-Digit Categorization Task with Self-Caught Probes, and (c) higher levels of selective internal attentional control as measured by the STP-One-Back Dichotic Listening Task.
Additionally, the investigators hypothesize that, relative to the placebo control group and the Attention Feedback Awareness and Control Training group, the Mindful Disengagement from Thoughts Training group will yield enhanced interoceptive attention (i.e. sensibility) to a broader range of locations (e.g. peripheral body areas), intensities (e.g. subtle sensations) and hedonic tones (e.g. neutral and pleasant hedonic tones) of bodily sensations in response to self-referential thoughts, as measured by STP-Body Map task.
Finally, the investigators hypothesized non-inferiority between the active intervention groups with respect to all mentioned measured outcomes, with exception of the noted STP-Body-Map Task.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 - Attention Feedback Awareness and Control Training | Experimental | Behavioral: Attention Feedback Awareness and Control Training (A-FACT) |
| Intervention 2 - Mindful Disengagement from Thoughts Training | Experimental | Behavioral: Mindful Disengagement from Thoughts Training (MDTT) |
| Placebo | Placebo comparator | Behavioral: Placebo-Control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Brooding subscale in the Ruminative Responses Scale (RRS) - with score equal to or greater than 11
Key exclusion criteria (3 listed)
- Endorsement of suicidal ideation ("Yes" answer to Patient Health Questionnaire - 9 Item
- Psychotic Symptoms, specifically auditory hallucinations
- Self-report lack of fluency in speaking or understanding Hebrew-language
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 |
|---|---|---|
| Attention Feedback Awareness and Control Training (A-FACT)A-FACT is designed to promote meta-awareness of moment-to-moment biased internal attention allocation (e.g. toward negative thoughts) and thereby internal attentional control. Participants will be instructed that they will complete a task designed to reduce their attentional bias to some thoughts. Following a fixation que, the auditory neutral or negative simulated thought stimulus is delivered, and 500ms prior to termination of the auditory stimulus, a visual stimulus is presented until participants categorize the visual stimulus as greater than or smaller than 5 objects. Latency to disengage attention from each thought stimuli, at the trial-level, is repeatedly measured, and after each negative thought stimulus, trial-level feedback on the latency to disengage is delivered back to participants through a visual scale representing their attentional bias. Participants will complete approximately 100 trials in total wherein randomly 1 or 2 neutral trials follow each negative trial. | Behavioural | Intervention 1 - Attention Feedback Awareness and Control Training |
| Mindful Disengagement from Thoughts Training (MDTT)MDTT is designed to promote meta-awareness of moment-to-moment biased internal attention allocation (e.g. toward negative thoughts) and thereby internal attentional control. Participants will be instructed that they will complete a task designed to reduce their attentional bias to some thoughts. Participants will first learn and practice a focused attention on the breath meditation. Then, participants will practice pressing a button each time they notice an inhalation or exhalation during the focused attention meditation. Next, during the meditation, participants will be presented the auditory neutral or negative simulated thought stimuli and will train internal attentional control by repeatedly disengaging their attention from these stimuli and back to their breath MDTT will thus entail 80 trials (40 negative, 40 neutral, ITI ≈ 10sec) during the focused attention on the breath meditation. | Behavioural | Intervention 2 - Mindful Disengagement from Thoughts Training |
| Placebo-ControlThe condition is designed as a placebo control for the Attention Feedback Awareness and Control Training (A-FACT) training condition. Participants will be instructed that they will complete a task designed to reduce their attentional bias to some thoughts. Rather than the quantity categorization task with trial-level feedback, participants only engage in the quantity categorization task. The task is identical in all other ways to the A-FACT condition. Participants will complete approximately 100 trials in total wherein randomly 1 or 2 neutral trials follow each negative trial. | Behavioural | Placebo |
Primary outcome
Change in the STP-Digit Categorization Task
Time frame: pre-intervention, immediately post-intervention
The STP-Digit Categorization Task (STP-DCT) will be used to measure change, from pre-intervention to post-intervention, in internal attentional disengagement. Attentional disengagement will be computed by the difference in reaction time on negative relative to neutral simulated thought stimuli as well as via a dynamic bias score calculated by subtracting the running mean of the 8 neutral trials window ( 4 neutral trials backwards and 4 neutral trials forward), from each negative trial reaction time that exceeds the 95%CI., dividing this distance by the 8 neutral trials window standard deviation (Amir, Ruimi, \& Bernstein, 2021). A positive score reflects greater difficulty to disengage from negative relative to neutral thought stimuli.
4 secondary outcomes
STP-One-Back Dichotic Listening Task
Time frame: immediately post-intervention
STP-Digit Categorization Task (STP-DCT) with Self-Caught Probes
Time frame: immediately post-intervention
Change in the STP-Emotional Reactivity Task
Time frame: pre-intervention, immediately post-intervention
Change in the STP-Body Map Task
Time frame: pre-intervention, immediately post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: Yes
Related trials for Attention Impaired
RecruitingPhase 1
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
Renal Impairment, Healthy Volunteers
Not yet recruiting
Pilot Study of Individualized Neurovisual Rehabilitation Following Acquired Brain Injury
Brain Injuries
Active, not recruiting
Psychosis TMS Study
Psychosis
RecruitingPhase 1
Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease
Sickle Cell Disease, Executive Dysfunction
Recruiting
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT
Head and Neck Cancer, Body Image Disturbance
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.
Amit Bernstein, Ph.D. principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Disengagement from Thoughts Training (MDTT) in people with Attention Impaired and Mental Health Issue, run by University of Haifa at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 24 May 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 Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amit Bernstein, Ph.D. (+972-4-828-8871, abernstein@psy.haifa.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the STP-Digit Categorization Task (time frame: pre-intervention, immediately post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.