Multiple SclerosisCERT-MSNCT02717429
Cognitive and Emotion Regulation Training in MS
A study testing Mindfulness Meditation and Computerized Cognitive Training in people with Multiple Sclerosis, run by Ohio State University at 1 site in United States.
Trial summary
The investigators propose to conduct a randomized feasibility study of mindfulness meditation training (MMT) relative to an active cognitive training control group and waitlist control group in improving emotional regulation in individuals with MS. Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Mindfulness Meditation and Computerized Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 14 May 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 30 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 30-59 years of age
- Score higher than or equal to 23 on the Mini Mental Status Examination (MMSE)
- Corrected (near and far) visual acuity of 20/40 or better
- No previous experience with mindfulness or continuous meditation practice
- Absence of other co-morbid neurological disorders
- Relapse free for the last 30 days
Show all 10Show fewer
- No use of corticosteroids for the last 30 days
- Clinically definite diagnosis of MS
- Ability to use a computer and connect the internet from their home
- Generation of at least two worries and two ruminations during the daily diary portion of the study for the pre-assessment session
Who cannot join
- Below 30 years of age or above 59 years of age
- Score lower than 23 on the MMSE
- Corrected (near or far) visual acuity of 20/40 or greater
- Previous experience or participation in a mindfulness program
- Presence of co-morbid neurological disorders such as:
- Alzheimers
Show all 13Show fewer
- Parkinson's disease
- Dementia
- Presence of a relapse within the last 30 days
- Use of corticosteroids within the last 30 days
- Clinically isolated syndrome suggestive of MS
- No ability to use a computer and/or a lack of internet connection from their home
- No self-generated worries and ruminations in the week-long daily diary portion of the study at pre-assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychology, The Ohio State University
Columbus, Ohio, 43210
About this study
Official title: Cognitive and Emotion Regulation Training in Multiple Sclerosis
The investigators propose to conduct a randomized feasibility study of mindfulness meditation training (MMT) relative to an active cognitive training control group and waitlist control group in improving emotional regulation in individuals with MS. Individuals will complete pre- and post-assessments of emotional functioning through a week of daily diary entries, as well as self-report measures and a behavioral paradigm. Additionally, all participants will complete an evaluation of neuropsychological functioning, before and after intervention.
Read the detailed description
Epidemiological data provides evidence for the manifold increase in rates of depression and anxiety in individuals diagnosed with multiple sclerosis, relative to the general population. Such impaired affective processes, including deficits in emotion regulation have been linked to greater cognitive deficits, a lower quality of life, and greater disease progression in this population. Despite evidence of the deleterious impact of affective functioning on prevalence rates of mood and anxiety disorders; on poor cognitive functioning; and reduced quality of life, much of the targeted intervention research in MS has not directly tested the feasibility, and subsequent efficacy of a psychosocial intervention in improving affective regulation in this population. Thus, the investigators propose to conduct a randomized feasibility study of mindfulness training relative to an active cognitive training control group and waitlist control group in improving emotional regulation in individuals with MS. All individuals that contact the Clinical Neuroscience Laboratory (CNLab) with interest in this study will undergo a phone screening assessing inclusion/exclusion criteria. Those participants meeting I/E criteria will be invited for an online daily diaries portion of the study examining daily engagement in worry and rumination. After completing the week-long daily diary portion of the study, the participant will attend 1-2 in-person pre-assessment sessions, which will also be completed at the completion of the four week intervention. The pre-assessment will involve a thorough assessment of emotion regulation skills, both through self-report questionnaires and behavioral paradigms, and cognitive functioning. Following the assessment sessions, which will be conducted by blind assessors, participants will be randomized to the three groups. The 4-week mindfulness program will be closely modeled after the protocol developed by Dr. Jon Kabat-Zinn, where investigators will have the participants attend once-per-week sessions for 2 hours and complete around 40 minutes a day of homework assignments. The four weeks of mindfulness involve the practice of concentrative attention, where different objects are used as the focus of practices. For example, for the first two weeks, the investigators use breath as an anchor for the mind. With repeated practices, the objects of sensations, emotions, and thought processes are introduced. The classes are a mixture of experiential practices, discussions surrounding the experiences, and didactics on mindfulness. The control group, which will be used to compare the effects of mindfulness training on emotional and cognitive functioning of MS patients, will comprise of a cognitive training group, which will provide an attentional-training based approach. In this group, our focus will be to provide the individuals with cognitive training tasks to complete that have been shown to improve attentional ability. Homework will be reading and practicing using the cognitive video game exercises for the same duration, around 40 minutes daily, as the mindfulness group. Following the four weeks of the intervention, the questionnaires, week-long daily diaries, and behavioral tests from the pretest will be repeated a second time to obtain post-test data for comparison.
- Conditions
- Multiple Sclerosis
- Being tested
- Mindfulness Meditation, Computerized Cognitive Training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationBehavioural
The mindfulness meditation-training program is closely modeled after the 8-week mindfulness based stress reduction protocol developed by Dr. Jon Kabat-Zinn. The briefer four weeks of MMT involve the practice of concentrative attention, where different objects are used as the focus of meditative practices. For example, for the first two weeks, the investigators use breath as an anchor for attention. With repeated practices, the objects of sensations, emotions, and thought processes are introduced.
Computerized Cognitive TrainingBehavioural
The control group, which will be used to compare the effects of mindfulness training on emotional and cognitive functioning of MS patients, will comprise of a cognitive training group, which will provide an attentional-training based approach. In this group, the focus will be to provide the individuals with cognitive training tasks to complete that have been shown to improve attentional ability. The investigators will also discuss relevant MS-related material on cognitive deficits during these courses.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation Training (MMT) | Experimental | Participants will attend four weekly group mindfulness meditation sessions of a 2-hour duration. The classes are a mixture of experiential practices, discussions surrounding the experiences, and didactics on mindfulness. In addition to the time spent in session, participants will be asked to complete 40 minutes of daily homework, which includes further practice of in-session meditative exercises and brief readings. Receives: Behavioral: Mindfulness Meditation |
| Computerized Cognitive Training | Active comparator | The active control group will be in the form of a cognitive training course where the participants will meet for the same amount of time as the MMT group. Homework will be reading and engaging in cognitive video game exercises for the same duration, around 40 minutes daily, as the MMT group. Receives: Behavioral: Computerized Cognitive Training |
| Wait-List Control Group | No intervention | This group will be used to compare the effects of the two active comparison groups and will not receive any intervention for the four week period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Reported Engagement After Worry and Rumination Inductions
Participants will engage in worry and rumination inductions during both the pre- and post-intervention sessions. These worries and ruminations will be sampled from the daily diaries participants will fill out 7-days before the pre- and post-intervention sessions. Investigators will be examining the change in emotion and strategy implementation over the course of the worry and rumination inductions. Specifically, investigators will examine the change in reported negative and positive emotion related to the worry and rumination inductions from pre- to post-intervention. Further, investigators will examine the induction-related change in strategy implementation, specifically worry and rumination, over the 4-weeks of intervention.
Measured: Baseline and 4 weeks
Secondary outcomes (8)
Cognitive Performance on Brief Repeatable Battery (BRB)
Participants will perform the entire Brief Repeatable Battery before and after the intervention. Using the categorization developed by Sepulcher (2013), the 5 tests of the BRB will be analyzed using four cognitive domains: attention and executive functioning, verbal memory, visual memory, and word fluency. Based on the computerized cognitive training protocol employed in the current study, investigators hypothesize changes in attention and executive functioning along with visual memory in participants in the cognitive training group, followed by participants in the MMT group compared with the wait-list control participants.
Measured: Baseline and 4 weeks
Heart Rate Variability (HRV)
HRV data will be collected during worry and rumination inductions, as participants regulate their emotions, and at rest.
Measured: Baseline and 4 weeks
Daily Emotion Regulation Diary
Participants will be asked to fill out worry and ruminations using a diary-based methodology a week before the pre-intervention behavioral session and one week after the post-intervention sessions. Changes in average self-reported worry and rumination intensity, emotion regulation strategy use, and successful emotion regulation strategy implementation will be examined as a function of the intervention.
Measured: Baseline and 4 weeks
Improvements on a Self-Report Measure of Emotion Dysregulation
Emotion Dysregulation will be assessed using the Difficulties in Emotion Regulation Scale (DERS). Changes on the total score and sub-facets of DERS will be examined as a function of the intervention.
Measured: Baseline and 4 weeks
Improvements on a Self-Report Measure of Depression
Participants will be administered Beck Depression Inventory before and after the intervention. Change on this measure will be examined to assess the impact of the interventions on symptoms of depression.
Measured: Baseline and 4 weeks
Improvements on a Self-Report Measures of Anxiety
Participants will be administered Penn State Worry Questionnaire before and after the intervention. Change on this measure will be examined to assess the impact of the interventions on symptoms of worry.
Measured: Baseline and 4 weeks
Improvements on a Self-Report Measure of Perceived Stress
Participants will be administered the Perceived Stress Scale before and after the intervention. Changes in these measures will be examined as a function of the intervention.
Measured: Baseline and 4 weeks
Improvements on a Self-Report Measure of Quality of Life
Participants will be administered the Satisfaction with Life Scale before and after the intervention. Change in scores of this measure will be examined to assess changes in quality of life as a function of the interventions.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startOct 2015
- Primary completion14 May 2017
- Study completion14 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruchika Prakash, Ohio State University
- Investigators
- Ruchika S Prakash, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717429
- Sponsor's protocol ID
- 2014H0212
- Acronym
- CERT-MS
- Status last verified
- Apr 2018
- First submitted
- 21 Oct 2015
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Duraney EJ, Fisher ME, Manglani HR, Andridge RR, Nicholas JA, Prakash RS. Impact of mindfulness training on emotion regulation in multiple sclerosis: Secondary analysis of a pilot randomized controlled trial. Rehabil Psychol. 2022 Nov;67(4):449-460. doi: 10.1037/rep0000456. Epub 2022 Jul 28.
PubMed 35901401Schirda B, Duraney E, Lee HK, Manglani HR, Andridge RR, Plate A, Nicholas JA, Prakash RS. Mindfulness training for emotion dysregulation in multiple sclerosis: A pilot randomized controlled trial. Rehabil Psychol. 2020 Aug;65(3):206-218. doi: 10.1037/rep0000324. Epub 2020 May 7.
PubMed 32378922Manglani HR, Samimy S, Schirda B, Nicholas JA, Prakash RS. Effects of 4-week mindfulness training versus adaptive cognitive training on processing speed and working memory in multiple sclerosis. Neuropsychology. 2020 Jul;34(5):591-604. doi: 10.1037/neu0000633. Epub 2020 Apr 30.
PubMed 32352832
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Emotion Regulation Training in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02717429
- Acronym / sponsor ID
- CERT-MS / 2014H0212
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 14 May 2017 (actual)
- Study completion
- 14 May 2017 (actual)
- First posted
- 23 Mar 2016 (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.
The investigators propose to conduct a randomized feasibility study of mindfulness meditation training (MMT) relative to an active cognitive training control group and waitlist control group in improving emotional regulation in individuals with MS. Individuals will complete pre- and post-assessments of emotional functioning through a week of daily diary entries, as well as self-report measures and a behavioral paradigm. Additionally, all participants will complete an evaluation of neuropsychological functioning, before and after intervention.
Detailed description
Epidemiological data provides evidence for the manifold increase in rates of depression and anxiety in individuals diagnosed with multiple sclerosis, relative to the general population. Such impaired affective processes, including deficits in emotion regulation have been linked to greater cognitive deficits, a lower quality of life, and greater disease progression in this population. Despite evidence of the deleterious impact of affective functioning on prevalence rates of mood and anxiety disorders; on poor cognitive functioning; and reduced quality of life, much of the targeted intervention research in MS has not directly tested the feasibility, and subsequent efficacy of a psychosocial intervention in improving affective regulation in this population. Thus, the investigators propose to conduct a randomized feasibility study of mindfulness training relative to an active cognitive training control group and waitlist control group in improving emotional regulation in individuals with MS. All individuals that contact the Clinical Neuroscience Laboratory (CNLab) with interest in this study will undergo a phone screening assessing inclusion/exclusion criteria. Those participants meeting I/E criteria will be invited for an online daily diaries portion of the study examining daily engagement in worry and rumination. After completing the week-long daily diary portion of the study, the participant will attend 1-2 in-person pre-assessment sessions, which will also be completed at the completion of the four week intervention. The pre-assessment will involve a thorough assessment of emotion regulation skills, both through self-report questionnaires and behavioral paradigms, and cognitive functioning. Following the assessment sessions, which will be conducted by blind assessors, participants will be randomized to the three groups. The 4-week mindfulness program will be closely modeled after the protocol developed by Dr. Jon Kabat-Zinn, where investigators will have the participants attend once-per-week sessions for 2 hours and complete around 40 minutes a day of homework assignments. The four weeks of mindfulness involve the practice of concentrative attention, where different objects are used as the focus of practices. For example, for the first two weeks, the investigators use breath as an anchor for the mind. With repeated practices, the objects of sensations, emotions, and thought processes are introduced. The classes are a mixture of experiential practices, discussions surrounding the experiences, and didactics on mindfulness. The control group, which will be used to compare the effects of mindfulness training on emotional and cognitive functioning of MS patients, will comprise of a cognitive training group, which will provide an attentional-training based approach. In this group, our focus will be to provide the individuals with cognitive training tasks to complete that have been shown to improve attentional ability. Homework will be reading and practicing using the cognitive video game exercises for the same duration, around 40 minutes daily, as the mindfulness group. Following the four weeks of the intervention, the questionnaires, week-long daily diaries, and behavioral tests from the pretest will be repeated a second time to obtain post-test data for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation Training (MMT) | Experimental | Behavioral: Mindfulness MeditationParticipants will attend four weekly group mindfulness meditation sessions of a 2-hour duration. The classes are a mixture of experiential practices, discussions surrounding the experiences, and didactics on mindfulness. In addition to the time spent in session, participants will be asked to complete 40 minutes of daily homework, which includes further practice of in-session meditative exercises and brief readings. |
| Computerized Cognitive Training | Active comparator | Behavioral: Computerized Cognitive TrainingThe active control group will be in the form of a cognitive training course where the participants will meet for the same amount of time as the MMT group. Homework will be reading and engaging in cognitive video game exercises for the same duration, around 40 minutes daily, as the MMT group. |
| Wait-List Control Group | No intervention | –This group will be used to compare the effects of the two active comparison groups and will not receive any intervention for the four week period. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 30-59 years of age
- Score higher than or equal to 23 on the Mini Mental Status Examination (MMSE)
- Corrected (near and far) visual acuity of 20/40 or better
- No previous experience with mindfulness or continuous meditation practice
- Absence of other co-morbid neurological disorders
Key exclusion criteria (13 listed)
- Below 30 years of age or above 59 years of age
- Score lower than 23 on the MMSE
- Corrected (near or far) visual acuity of 20/40 or greater
- Previous experience or participation in a mindfulness program
- Presence of co-morbid neurological disorders such as:
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 |
|---|---|---|
| Mindfulness MeditationThe mindfulness meditation-training program is closely modeled after the 8-week mindfulness based stress reduction protocol developed by Dr. Jon Kabat-Zinn. The briefer four weeks of MMT involve the practice of concentrative attention, where different objects are used as the focus of meditative practices. For example, for the first two weeks, the investigators use breath as an anchor for attention. With repeated practices, the objects of sensations, emotions, and thought processes are introduced. | Behavioural | Mindfulness Meditation Training (MMT) |
| Computerized Cognitive TrainingThe control group, which will be used to compare the effects of mindfulness training on emotional and cognitive functioning of MS patients, will comprise of a cognitive training group, which will provide an attentional-training based approach. In this group, the focus will be to provide the individuals with cognitive training tasks to complete that have been shown to improve attentional ability. The investigators will also discuss relevant MS-related material on cognitive deficits during these courses. | Behavioural | Computerized Cognitive Training |
Primary outcome
Change in Reported Engagement After Worry and Rumination Inductions
Time frame: Baseline and 4 weeks
Participants will engage in worry and rumination inductions during both the pre- and post-intervention sessions. These worries and ruminations will be sampled from the daily diaries participants will fill out 7-days before the pre- and post-intervention sessions. Investigators will be examining the change in emotion and strategy implementation over the course of the worry and rumination inductions. Specifically, investigators will examine the change in reported negative and positive emotion related to the worry and rumination inductions from pre- to post-intervention. Further, investigators will examine the induction-related change in strategy implementation, specifically worry and rumination, over the 4-weeks of intervention.
8 secondary outcomes
Cognitive Performance on Brief Repeatable Battery (BRB)
Time frame: Baseline and 4 weeks
Heart Rate Variability (HRV)
Time frame: Baseline and 4 weeks
Daily Emotion Regulation Diary
Time frame: Baseline and 4 weeks
Improvements on a Self-Report Measure of Emotion Dysregulation
Time frame: Baseline and 4 weeks
Improvements on a Self-Report Measure of Depression
Time frame: Baseline and 4 weeks
Improvements on a Self-Report Measures of Anxiety
Time frame: Baseline and 4 weeks
Improvements on a Self-Report Measure of Perceived Stress
Time frame: Baseline and 4 weeks
Improvements on a Self-Report Measure of Quality of Life
Time frame: Baseline and 4 weeks
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 17 Apr 2018.
- Derived from this study: PubMed 35901401Duraney EJ, Fisher ME, Manglani HR, Andridge RR, Nicholas JA, Prakash RS. Impact of mindfulness training on emotion regulation in multiple sclerosis: Secondary analysis of a pilot randomized controlled trial. Rehabil Psychol. 2022 Nov;67(4):449-460. doi: 10.1037/rep0000456. Epub 2022 Jul 28.
- Derived from this study: PubMed 32378922Schirda B, Duraney E, Lee HK, Manglani HR, Andridge RR, Plate A, Nicholas JA, Prakash RS. Mindfulness training for emotion dysregulation in multiple sclerosis: A pilot randomized controlled trial. Rehabil Psychol. 2020 Aug;65(3):206-218. doi: 10.1037/rep0000324. Epub 2020 May 7.
- Derived from this study: PubMed 32352832Manglani HR, Samimy S, Schirda B, Nicholas JA, Prakash RS. Effects of 4-week mindfulness training versus adaptive cognitive training on processing speed and working memory in multiple sclerosis. Neuropsychology. 2020 Jul;34(5):591-604. doi: 10.1037/neu0000633. Epub 2020 Apr 30.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
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.
Ruchika S Prakash, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation and Computerized Cognitive Training in people with Multiple Sclerosis, run by Ohio State University at 1 site in United States.
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 10 inclusion and 13 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 17 Apr 2018. 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 States. 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 in Reported Engagement After Worry and Rumination Inductions (time frame: Baseline and 4 weeks). 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 NCT02717429, which also lists 3 linked publications.
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 17 Apr 2018.