ADHDNCT04978792
Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD?
A study testing Online self-compassion intervention in people with ADHD and Depression, run by University of Sheffield at 1 site in United Kingdom.
Trial summary
This study aims to investigate the effect that increasing levels of self-compassion may have on levels of perceived criticism, self-criticism, and mental health of adults with ADHD. A secondary aim of the study is to capture how feasible using an online self-guided self-compassion practice maybe with people with ADHD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ADHD, Depression, Stress
- What is being tested?
- Online self-compassion intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2021to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-report a formal diagnosis of ADHD
- Scores on the Adult ADHD Self Report Questionnaire (ASRS) meet the clinical cut-off.
- No previous engagement with self-compassion interventions/practice
Who cannot join
- No previous experiences of trauma.
- No PTSD
- No personality disorder
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Sheffield
Sheffield, South Yorkshire, S10 2TN
About this study
This study aims to investigate the effect that increasing levels of self-compassion may have on levels of perceived criticism, self-criticism, and mental health of adults with ADHD. A secondary aim of the study is to capture how feasible using an online self-guided self-compassion practice maybe with people with ADHD.
Research Questions
- Does a short self-guided self-compassion intervention increase levels of state and/or trait self-compassion in adults with ADHD over time?
- Are changes in state and/or trait self-compassion associated with changes in levels of self-criticism or perceived criticism?
- Are changes in state and/or trait self-compassion associated with improvements in mental health?
- Are changes in mental health mediated by changes in self-criticism or perceived criticism?
- Conditions
- ADHD, Depression, Stress, Self-Criticism, Anxiety, Wellbeing
- Being tested
- Online self-compassion intervention, Active Control
- Keywords
- self-compassion, criticism, ADHD, mental health
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online self-compassion interventionBehavioural
An online self-guided intervention that uses widely available exercises and information.
Active ControlBehavioural
Participants will complete written exercises and breathing exercises that are not associated with self-compassion
| Study group | Role | What they receive |
|---|---|---|
| Self-compassion Intervention | Experimental | The intervention will include 14 self-compassion exercises completed over a 3-week period. The intervention will include methods of psychoeducation, meditation, and self-compassion exercises similar to Beshai et al.'s (2020) self-compassion-based intervention. The psychoeducation will focus on self-compassion, the meditations will be kindness and loving meditations and self-compassion breaks. The self-compassion exercises will be based on the writing exercises available on Neff's self-compassion website. Receives: Behavioral: Online self-compassion intervention |
| Control Group | Active comparator | The active control will also include 14 exercises completed over a 3-week period. The 14 exercises will comprise of a psychoeducation video, writing exercises, video/audio-guided relaxation, and journal entries. The same psychoeducation video used in the intervention will be shown to participants, however, the other exercises will be altered to focus on factual information and not focused on self-compassion. The exercises will be matched to the self-compassion exercise so that similar exercises are completed in parallel time with the intervention. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trait Self-compassion
The self-compassion scale (SCS, Neff, 2003) consists of 26 items measured on a scale between 1-5 (never - always). The items include 3 sub-scales that represent compassionate self-responding (self-kindness, mindfulness and common humanity) and 3 sub-scales of uncompassionate self-responding (self-judgement, isolation and over-identification). To obtain a total self-compassion score, the uncompassionate items are reverse coded, the mean score for each subscale is calculated, then the mean of the six subscale scores added together is calculated. The mean scores can range between 1 - 5, whereby higher scores indicate higher self-compassion
Measured: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Change in state self-compassion
The State Self-Compassion Scale Short Form (SSCS-S; (Neff et al., 2021) is a six-item measure of state self-compassion. The six items are rated on a 5-point scale from 1 (not at all true for me) to 5 (very true for me), and responses are summed (after negatively worded questions are reverse coded) to provide a global state self-compassion measure. Higher scores equate to higher levels of state self-compassion.
Measured: 4x a week after intervention exercise complete.
Change in Perceived Criticism
An adapted version of The Perceived Criticism Scale (PCS) (Hooley \& Teasdale, 1989) will be used to measure how much criticism is "getting through" to individuals. The measure is a single question, "How critical do you think people in your nearest environment - such as family, friends, colleagues - are of you?", that is rated between 0 (not at all critical of me) to 10 (very critical of me). The measure can also include a second item also rated on a 1-10 scale that asks how upset the respondent may become when criticised.
Measured: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Change in wellbeing
The Mental Health Continuum Short Form (MHC-SF) (Keyes, 2009) will be used to measure the frequency of well-being symptoms (never [0] - every day [5]). The self-report questionnaire includes 14-items that measure emotional well-being (3-items), psychological well-being (6-items) and social well-being (5-items). A global well-being score between 0 - 70 is achieved by summing the scores for each item, whereby higher scores equal greater well-being. Subscale scores are calculated by summing the responses for each item of the corresponding sub-scale; emotional well-being scores can range between 0 - 15, social well-being scores can range between 0 - 25, and psychological well-being scores can range between 0 - 30.
Measured: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Change in Depression
The Patient Health Questionnaire - 9 (PHQ-9) (Kroenke et al., 2001) will be used to assess the severity of depressive symptoms and assess responses to treatment. The PHQ-9 has nine items that represent each of the DSM-IV (APA) criteria of depression. The items, such as "feeling down, depressed, or hopeless?", are rated on a scale of 0 (not at all) to 3 (nearly every day) to represent how frequently the symptoms are experienced over the previous two weeks. A total score is calculated by summing the scores for each item, providing a severity score between 0 and 27. Higher scores represent more severe depression, and scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe and severe depression, respectively.
Measured: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Change in Anxiety
General Anxiety Disorder- 7 (GAD-7) (Spitzer et al., 2006) will be used to assess the severity of anxiety. The GAD-7 includes 7 items that represent the DSM-IV (APA) clinical criteria. The items, such as "becoming easily annoyed or irritable", are scored on a scale between 0 (not at all) to 3 (nearly every day) to represent how frequently the symptoms are experienced over the previous two weeks. A total score between 0 - 21 is calculated by summing each individual item's rating. Higher scores represent more severe anxiety, and scores of 5, 10 and 15 are the cut-off points for mild, moderate and severe anxiety, respectively.
Measured: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Change in Stress
The Perceived Stress Scale (PSS, Cohen et al., 1983) will be used to measure participant's perception of stress. The 10-item self-report questionnaire includes four positively worded items and six negatively worded items that are rated on how frequently (never [0] - very often [4]) respondents perceive their lives as unpredictable, uncontrollable or overwhelming. Positively worded items are reverse scored, and each item response is summed to provide a total score of between 0 - 40 whereby higher scores equal higher perceived stress.
Measured: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
ADHD severity
The Adult ADHD Self-report Scale (ASRS; Kessler, 2010) will be used as a screening tool to assess the frequency of ADHD symptoms and as a measuring tool to assess any changes in ADHD symptomatology over time. The measure was created in association with the World Health Organisation (WHO) and is based on the clinical criteria presented in the DSM-IV (APA, 2013). Part A is a 6-item questionnaire that assesses the frequency to which ADHD symptoms are present on a 5-point Likert Scale (Never - Always). It is recommended that individuals who report "sometimes", "often" or "very often" to the first three questions, or "often", "very often" to the final three questions four or more items, have symptoms highly consistent with ADHD.
Measured: Baseline.
Changes in self-criticism
The Self-Critical Rumination Scale (SCRS, Smart et al., 2016) is a 10-item self-report questionnaire which measures the frequency of self-criticism on a 4-point scale from not at all (0) to very well (3). Self-criticism in this measure is conceptualised as a form of negative thinking that focuses on devaluing oneself. A total score is obtained by summing item responses, whereby higher scores equal greater self-criticism. Scores can range between 0 - 30.
Measured: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Secondary outcomes (5)
Fear of compassion
The Fears of Compassion for Self (FOC-FS) (Gilbert et al., 2011) subscale will measure the level of resistance respondents have in projecting compassion towards the self. The measure includes 15 items (e.g., "Getting on in life is about being tough rather than compassionate") that are rated on a scale between 0 (don't agree at all) ¬- 4 (completely agree). Item responses are summed to give a total score between 0 and 60 whereby higher scores indicate a greater fear of compassion towards the self.
Measured: Baseline
Acceptability of the Intervention
Acceptability of the intervention at post-intervention will be assessed following Sekhon et al.'s (2017) Theoretical Framework of Acceptability (TFA). A visual analogue rating scale will be used to measure: (1) affective attitude - how do you feel about the intervention?; (2) burden - how satisfied were you with the amount of time/effort the intervention required?; (3) ethicality - how well do you feel the intervention fits with your value system?; (4) self-efficacy - how confident are you that you could perform the intervention tasks?; (5) opportunity costs - to what extent did you have to give up something to take part in the intervention?; (6) perceived effectiveness - how confident are you that this intervention will improve your well-being?; (7) intervention coherence will be measured through a basic definitions quiz of self-compassion principles.
Measured: Immediately following intervention end
Change in daily Mood
Mood will be measured daily using two affective sliders that rate level of alertness and level of happiness/pleasure on a 10-point scale. The two item responses are added together to give an overall score of mood between 0 and 20, whereby higher scores equal a more positive mood.
Measured: Prior to each intervention session
Change in ADHD trait severity
The Adult ADHD Self-report Scale (ASRS; Kessler, 2010) will be used as a measuring tool to assess any changes in ADHD symptomatology over time. The measure was created in association with the World Health Organisation (WHO) and is based on the clinical criteria presented in the DSM-IV (APA, 2013). It consists of 18 items that question the frequency of ADHD symptoms from "never" to "very often" (0 - 4) over the previous 6 months. Part A consists of 6-items that are most predictive of the disorder. Part B includes an additional 12 items which act as additional cues to participants symptoms. A total score can be obtained by summing the scores. A higher total score would represent a more frequent display of ADHD symptoms, and scores can range between 0 - 72.
Measured: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Perfectionism
Hewitt \& Flett Multidimensional Perfectionism Scale (MPS-HW) Short form (2008), is a 15 item self-report questionnaire. Items are rated on a scale between 1-7 (Strongly disagree - strongly disagree), and is scored by summing responses to items. Higher scores indicate higher levels of perfectionism. Scores can range between 15 and 105.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start23 Sep 2021
- Primary completion25 Apr 2022
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Beaton, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978792
- Sponsor's protocol ID
- 172839
- Status last verified
- Jul 2022
- First submitted
- 9 Jul 2021
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected information will be anonymised and shared as part of open science protocol. Consent to share data will be obtained from participants prior to data collection.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD?
- ClinicalTrials.gov ID
- NCT04978792
- Acronym / sponsor ID
- 172839
- Conditions
- ADHD, Depression, Stress, Self-Criticism, Anxiety, Wellbeing
- Keywords
- self-compassion, criticism, ADHD, mental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- Sep 2022 (estimated)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effect that increasing levels of self-compassion may have on levels of perceived criticism, self-criticism, and mental health of adults with ADHD. A secondary aim of the study is to capture how feasible using an online self-guided self-compassion practice maybe with people with ADHD.
Research Questions
- Does a short self-guided self-compassion intervention increase levels of state and/or trait self-compassion in adults with ADHD over time?
- Are changes in state and/or trait self-compassion associated with changes in levels of self-criticism or perceived criticism?
- Are changes in state and/or trait self-compassion associated with improvements in mental health?
- Are changes in mental health mediated by changes in self-criticism or perceived criticism?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-compassion Intervention | Experimental | Behavioral: Online self-compassion interventionThe intervention will include 14 self-compassion exercises completed over a 3-week period. The intervention will include methods of psychoeducation, meditation, and self-compassion exercises similar to Beshai et al.'s (2020) self-compassion-based intervention. The psychoeducation will focus on self-compassion, the meditations will be kindness and loving meditations and self-compassion breaks. The self-compassion exercises will be based on the writing exercises available on Neff's self-compassion website. |
| Control Group | Active comparator | Behavioral: Active ControlThe active control will also include 14 exercises completed over a 3-week period. The 14 exercises will comprise of a psychoeducation video, writing exercises, video/audio-guided relaxation, and journal entries. The same psychoeducation video used in the intervention will be shown to participants, however, the other exercises will be altered to focus on factual information and not focused on self-compassion. The exercises will be matched to the self-compassion exercise so that similar exercises are completed in parallel time with the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-report a formal diagnosis of ADHD
- Scores on the Adult ADHD Self Report Questionnaire (ASRS) meet the clinical cut-off.
- No previous engagement with self-compassion interventions/practice
Key exclusion criteria (3 listed)
- No previous experiences of trauma.
- No PTSD
- No personality disorder
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 |
|---|---|---|
| Online self-compassion interventionAn online self-guided intervention that uses widely available exercises and information. | Behavioural | Self-compassion Intervention |
| Active ControlParticipants will complete written exercises and breathing exercises that are not associated with self-compassion | Behavioural | Control Group |
Primary outcome
Change in trait Self-compassion
Time frame: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
The self-compassion scale (SCS, Neff, 2003) consists of 26 items measured on a scale between 1-5 (never - always). The items include 3 sub-scales that represent compassionate self-responding (self-kindness, mindfulness and common humanity) and 3 sub-scales of uncompassionate self-responding (self-judgement, isolation and over-identification). To obtain a total self-compassion score, the uncompassionate items are reverse coded, the mean score for each subscale is calculated, then the mean of the six subscale scores added together is calculated. The mean scores can range between 1 - 5, whereby higher scores indicate higher self-compassion
Change in state self-compassion
Time frame: 4x a week after intervention exercise complete.
The State Self-Compassion Scale Short Form (SSCS-S; (Neff et al., 2021) is a six-item measure of state self-compassion. The six items are rated on a 5-point scale from 1 (not at all true for me) to 5 (very true for me), and responses are summed (after negatively worded questions are reverse coded) to provide a global state self-compassion measure. Higher scores equate to higher levels of state self-compassion.
Change in Perceived Criticism
Time frame: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
An adapted version of The Perceived Criticism Scale (PCS) (Hooley \& Teasdale, 1989) will be used to measure how much criticism is "getting through" to individuals. The measure is a single question, "How critical do you think people in your nearest environment - such as family, friends, colleagues - are of you?", that is rated between 0 (not at all critical of me) to 10 (very critical of me). The measure can also include a second item also rated on a 1-10 scale that asks how upset the respondent may become when criticised.
Change in wellbeing
Time frame: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
The Mental Health Continuum Short Form (MHC-SF) (Keyes, 2009) will be used to measure the frequency of well-being symptoms (never [0] - every day [5]). The self-report questionnaire includes 14-items that measure emotional well-being (3-items), psychological well-being (6-items) and social well-being (5-items). A global well-being score between 0 - 70 is achieved by summing the scores for each item, whereby higher scores equal greater well-being. Subscale scores are calculated by summing the responses for each item of the corresponding sub-scale; emotional well-being scores can range between 0 - 15, social well-being scores can range between 0 - 25, and psychological well-being scores can range between 0 - 30.
Change in Depression
Time frame: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
The Patient Health Questionnaire - 9 (PHQ-9) (Kroenke et al., 2001) will be used to assess the severity of depressive symptoms and assess responses to treatment. The PHQ-9 has nine items that represent each of the DSM-IV (APA) criteria of depression. The items, such as "feeling down, depressed, or hopeless?", are rated on a scale of 0 (not at all) to 3 (nearly every day) to represent how frequently the symptoms are experienced over the previous two weeks. A total score is calculated by summing the scores for each item, providing a severity score between 0 and 27. Higher scores represent more severe depression, and scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe and severe depression, respectively.
Change in Anxiety
Time frame: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
General Anxiety Disorder- 7 (GAD-7) (Spitzer et al., 2006) will be used to assess the severity of anxiety. The GAD-7 includes 7 items that represent the DSM-IV (APA) clinical criteria. The items, such as "becoming easily annoyed or irritable", are scored on a scale between 0 (not at all) to 3 (nearly every day) to represent how frequently the symptoms are experienced over the previous two weeks. A total score between 0 - 21 is calculated by summing each individual item's rating. Higher scores represent more severe anxiety, and scores of 5, 10 and 15 are the cut-off points for mild, moderate and severe anxiety, respectively.
Change in Stress
Time frame: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
The Perceived Stress Scale (PSS, Cohen et al., 1983) will be used to measure participant's perception of stress. The 10-item self-report questionnaire includes four positively worded items and six negatively worded items that are rated on how frequently (never [0] - very often [4]) respondents perceive their lives as unpredictable, uncontrollable or overwhelming. Positively worded items are reverse scored, and each item response is summed to provide a total score of between 0 - 40 whereby higher scores equal higher perceived stress.
ADHD severity
Time frame: Baseline.
The Adult ADHD Self-report Scale (ASRS; Kessler, 2010) will be used as a screening tool to assess the frequency of ADHD symptoms and as a measuring tool to assess any changes in ADHD symptomatology over time. The measure was created in association with the World Health Organisation (WHO) and is based on the clinical criteria presented in the DSM-IV (APA, 2013). Part A is a 6-item questionnaire that assesses the frequency to which ADHD symptoms are present on a 5-point Likert Scale (Never - Always). It is recommended that individuals who report "sometimes", "often" or "very often" to the first three questions, or "often", "very often" to the final three questions four or more items, have symptoms highly consistent with ADHD.
Changes in self-criticism
Time frame: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
The Self-Critical Rumination Scale (SCRS, Smart et al., 2016) is a 10-item self-report questionnaire which measures the frequency of self-criticism on a 4-point scale from not at all (0) to very well (3). Self-criticism in this measure is conceptualised as a form of negative thinking that focuses on devaluing oneself. A total score is obtained by summing item responses, whereby higher scores equal greater self-criticism. Scores can range between 0 - 30.
5 secondary outcomes
Fear of compassion
Time frame: Baseline
Acceptability of the Intervention
Time frame: Immediately following intervention end
Change in daily Mood
Time frame: Prior to each intervention session
Change in ADHD trait severity
Time frame: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.
Perfectionism
Time frame: Baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- self-compassion website where intervention exercises are found.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected information will be anonymised and shared as part of open science protocol. Consent to share data will be obtained from participants prior to data collection.
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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.
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 Online self-compassion intervention in people with ADHD and Depression, run by University of Sheffield at 1 site in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 29 Jul 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 United Kingdom. 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?
Results are not available in the source record.
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 in trait Self-compassion (time frame: Baseline. Immediately following intervention end point. One month (4 weeks) following intervention end point.). The study lists 9 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 29 Jul 2022.