Excessive WorryNCT03216382

The Impact of the Attention Training Technique on Attention Control and High Worry

A study testing Attention Training Technique in people with Excessive Worry, run by Toronto Metropolitan University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Excessive Worry
What is being tested?: Attention Training Technique
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 95 participants
Where: 1 siteCanada
Study dates: 15 Aug 2017to 26 Jun 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Score of 65 or higher on the Penn State Worry Questionnaire.
Endorsement of chronic worry as per the description of Generalized Anxiety Disorder (GAD) (American Psychiatric Association, 2013).

Who cannot join

Has current or past history of psychosis or mania, or endorse symptoms consistent with a diagnosis of a substance use disorder in the past 12 months
Report clinically significant suicidal ideation, intent, or plan
Participants will be excluded if they are currently receiving psychological treatment or counseling (e.g., cognitive behaviour therapy, supportive counseling, etc.), unless this treatment is infrequent (once monthly or less) or the participant has been receiving consistent weekly treatment for at least 12 weeks and still meets all other eligibility criteria
Are taking psychotropic medications and have had a change in dose in the past 12 weeks. If they have recently discontinued a psychotropic medication, they will be included if it has been at least 1 month since discontinuation, or 3 months if they had been taking fluoxetine/Prozac. If a participant is taking benzodiazepines on an 'as needed' basis they will be included and their use of this medication will be noted. Daily benzodiazepine usage will exclude participants, and if participants have ever taken benzodiazepines daily, they must be abstinent for at least one year.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Ryerson University
Toronto, Ontario, M5B 2K3

Other trials in Canada

About this study

Excessive and uncontrollable worry has been associated with deficits in attention control. The Attention Training Technique (ATT; Wells, 1990) is a 12-minute audio recording that was developed to train attention control, so that individuals could learn to shift their attention away from maladaptive cognitive processes such as worry. The technique has shown to be promising at reducing symptoms across a variety of mental disorders (Knowles, Foden, El-Deredy, \& Wells, 2016) and is recommended for use in people who suffer from chronic worry. To date, little research has been conducted examining the benefits of using this technique in such a population. The present study aims to examine the immediate and short term effects of weekly ATT practice, compared to a control condition, in a population that suffers from high levels of worry about a variety of topics. About one-hundred participants who suffer from chronic worry will be randomly assigned to listen to the ATT or a control recording, every day for a week. Changes in attention control, worry, and cognitive processes will be examined over the course of the intervention period.

Read the detailed description

People who suffer from pathological worry report that they worry to an excessive degree and that they find it very difficult to control their worry. Deficits in attention control may help to explain why people who worry pathologically find it difficult to shift their attention away from their worry, and back to the task at hand. The Attention Training Technique (ATT; Wells, 1990) was developed to train attentional control, so that individuals could learn to shift the focus of their attention away from maladaptive cognitive processes such as worry. Despite being recommended for use in populations that suffer from excessive worry, there is a dearth of research examining the effects of ATT in such a population. The study aims to examine the immediate (during the intervention) and short-term (right after finishing the intervention) effects of listening to the ATT, compared to the control recording, on attention, worry, and other cognitive processes. This will be the first study to our knowledge to examine the effects of 1 week of daily ATT practice in a sample of people who suffer from chronic worry, and will provide important information for optimizing the treatment of worry in this population.

Conditions: Excessive Worry
Being tested: Attention Training Technique, Control Condition
Keywords: High worry, Anxiety, Attention Training Technique, Attention Control, Attention, Mindfulness, Attention Bias, Worry, Pathological Worry, Anxiety Disorder
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Attention Training TechniqueBehavioural
The ATT is a 12-minute audio recording that includes sounds and a voice guiding attention to the sounds. The sounds play continuously during the training task.
Control ConditionBehavioural
In the control condition, participants listen to an audio recording with the same sounds as the ATT recording, and a voice that delivers placebo instructions.

Study groups in NCT03216382
Study group	Role	What they receive
Attention Training Technique	Experimental	Participants in this arm will listen to the Attention Training Technique. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day. Receives: Behavioral: Attention Training Technique
Control Condition	Placebo comparator	Participants in this arm will listen to the control condition recording. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day. Receives: Behavioral: Control Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

Breathing Focus Task -Negative Intrusions
Behavioural measure of attention control over worry. Number of negative thought intrusions reported during the post-worry breathing focus period (i.e. a period of focused breathing after a period of worry). Scores range from 0-12. A greater number means more negative thought intrusions.
Measured: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
Daily Worry Questions
A daily self-report measure of the frequency, duration, intensity and uncontrollability of worry. Only uncontrollability of worry was used (see Data Analysis Plan for rationale). Scores range from 0-6. Higher scores represent greater uncontrollability of worry.
Measured: Completed every evening for two weeks. The first week will take place before beginning the ATT/ control intervention. The second week will take place during the intervention period.

Secondary outcomes (8)

Penn State Worry Questionnaire-Past Week
Self-report measure of the degree of worry experienced over the past week. Scores range from 15 to 75. Higher scores indicate higher worry over the past week.
Measured: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
Self-Attention Rating Scale
A daily self-report measure of focus of attention (from internal to externally focused). The scale ranges from 0 to 6. 0 represents entirely externally focused and 6 represents entirely internally focused.
Measured: Completed before and after listening to the recoding (immediate change) and every evening for two weeks. The first week will take place before beginning the ATT/ control intervention. The second week will take place during the intervention period.
Attention Network Task (ANT)
Behavioural measure of general attentional control, using reaction time. A larger number suggests lower attention control, whereas a smaller number suggests greater attention control.
Measured: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
Metacognition Questionnaire 30 (MCQ-30) Cognitive Self Consciousness Subscale
Self-report measure of focus of attention. Scores range from 6- 24. Greater scores represent greater self-focused attention.
Measured: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
Metacognitions Questionnaire 30 (MCQ-30) Negative Beliefs About the Uncontrollability of Thoughts and Danger Subscale
Self-report measure of beliefs about the uncontrollability and dangerousness of worry. Scores range from 6-24. Greater scores represent greater negative beliefs about worry.
Measured: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
Attention Control Scale
Self-report measure of attentional control. Scores range from 20-80. Greater scores indicate greater self-reported attention control.
Measured: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
Dot Probe
Behavioural measure of attentional bias to threat related words, measured in reaction time. A larger positive number indicates a greater bias to threat information while a negative number indicates the participant was faster to respond to neutral information.
Measured: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
Southampton Mindfulness Questionnaire
Self-report measure of mindfulness. Scores range from 0-96. Greater scores indicate greater self-reported mindfulness.
Measured: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 201726 Jun 2019

First posted13 Jul 2017
Study start15 Aug 2017
Primary completion26 Jun 2019
Study completion26 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Excessive WorryStudies 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
Model description: Baseline outcome measures will be completed at the first visit to the lab. Participants will then engage in a week of reporting on their worry and attention on their own, before coming back to the lab to recomplete the outcome measures. They will then be randomly assigned to the intervention or control condition and will engage in a week of daily listening to the corresponding recording for their condition on their own, while reporting on their worry and attention again during that week. Outcome measures will be completed again at the lab immediately following the intervention.
Masking: Single blind
Who is masked: Participant
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03216382
Sponsor's protocol ID: 2017-186
Status last verified: Jun 2021
First submitted: 11 Jul 2017
Last updated: 2 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Results of the study will be disseminated via conference presentations, journal publications, and through our lab website. Upon request, de-identified aggregate participant data may be made available to a publishing journal or individual research group. Individual research groups interested in accessing de-identified data will be required to submit a proposal detailing their intended use of the data. Their qualifications will be reviewed based on their proposal and CVs. Individual research groups approved for access will be required to agree to not attempt to re-identify participants, not further distribute data, and not use the data for purposes other than specified in their original proposal. No individual data will be shared.

Publications

Wells A. Panic disorder in association with relaxation induced anxiety: An attentional training approach to treatment. Behavior Therapy, 21(3): 273-280, 1990.
Knowles MM, Foden P, El-Deredy W, Wells A. A Systematic Review of Efficacy of the Attention Training Technique in Clinical and Nonclinical Samples. J Clin Psychol. 2016 Oct;72(10):999-1025. doi: 10.1002/jclp.22312. Epub 2016 Apr 29.
PubMed 27129094
Stewart KE, Antony MM, Koerner N. A randomized experimental analysis of the attention training technique: Effects on worry and relevant processes in individuals with probable generalized anxiety disorder. Behav Res Ther. 2021 Jun;141:103863. doi: 10.1016/j.brat.2021.103863. Epub 2021 Apr 10.
PubMed 33872957

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of the Attention Training Technique on Attention Control and High Worry
ClinicalTrials.gov ID: NCT03216382
Acronym / sponsor ID: 2017-186
Conditions: Excessive Worry
Keywords: High worry, Anxiety, Attention Training Technique, Attention Control, Attention, Mindfulness, Attention Bias, Worry
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Toronto Metropolitan UniversityUniversity, hospital or other
Collaborators: Ministry of Research, Innovation and Science, Ontario
Study start: 15 Aug 2017 (actual)
Primary completion: 26 Jun 2019 (actual)
Study completion: 26 Jun 2019 (actual)
First posted: 13 Jul 2017 (actual)
Results: Posted 2 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Baseline outcome measures will be completed at the first visit to the lab. Participants will then engage in a week of reporting on their worry and attention on their own, before coming back to the lab to recomplete the outcome measures. They will then be randomly assigned to the intervention or control condition and will engage in a week of daily listening to the corresponding recording for their condition on their own, while reporting on their worry and attention again during that week. Outcome measures will be completed again at the lab immediately following the intervention.

Arm	Type	Receives
Attention Training Technique	Experimental	Behavioral: Attention Training TechniqueParticipants in this arm will listen to the Attention Training Technique. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day.
Control Condition	Placebo comparator	Behavioral: Control ConditionParticipants in this arm will listen to the control condition recording. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Score of 65 or higher on the Penn State Worry Questionnaire.
Endorsement of chronic worry as per the description of Generalized Anxiety Disorder (GAD) (American Psychiatric Association, 2013).

Key exclusion criteria (4 listed)

Has current or past history of psychosis or mania, or endorse symptoms consistent with a diagnosis of a substance use disorder in the past 12 months
Report clinically significant suicidal ideation, intent, or plan
Participants will be excluded if they are currently receiving psychological treatment or counseling (e.g., cognitive behaviour therapy, supportive counseling, etc.), unless this treatment is infrequent (once monthly or less) or the participant has been receiving consistent weekly treatment for at least 12 weeks and still meets all other eligibility criteria
Are taking psychotropic medications and have had a change in dose in the past 12 weeks. If they have recently discontinued a psychotropic medication, they will be included if it has been at least 1 month since discontinuation, or 3 months if they had been taking fluoxetine/Prozac. If a participant is taking benzodiazepines on an 'as needed' basis they will be included and their use of this medication will be noted. Daily benzodiazepine usage will exclude participants, and if participants have ever taken benzodiazepines daily, they must be abstinent for at least one year.

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 Training TechniqueThe ATT is a 12-minute audio recording that includes sounds and a voice guiding attention to the sounds. The sounds play continuously during the training task.	Behavioural	Attention Training Technique
Control ConditionIn the control condition, participants listen to an audio recording with the same sounds as the ATT recording, and a voice that delivers placebo instructions.	Behavioural	Control Condition

Primary outcome

Breathing Focus Task -Negative Intrusions
Time frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
Behavioural measure of attention control over worry. Number of negative thought intrusions reported during the post-worry breathing focus period (i.e. a period of focused breathing after a period of worry). Scores range from 0-12. A greater number means more negative thought intrusions.
Daily Worry Questions
Time frame: Completed every evening for two weeks. The first week will take place before beginning the ATT/ control intervention. The second week will take place during the intervention period.
A daily self-report measure of the frequency, duration, intensity and uncontrollability of worry. Only uncontrollability of worry was used (see Data Analysis Plan for rationale). Scores range from 0-6. Higher scores represent greater uncontrollability of worry.

8 secondary outcomes

Penn State Worry Questionnaire-Past Week
Time frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
Self-Attention Rating Scale
Time frame: Completed before and after listening to the recoding (immediate change) and every evening for two weeks. The first week will take place before beginning the ATT/ control intervention. The second week will take place during the intervention period.
Attention Network Task (ANT)
Time frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
Metacognition Questionnaire 30 (MCQ-30) Cognitive Self Consciousness Subscale
Time frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
Metacognitions Questionnaire 30 (MCQ-30) Negative Beliefs About the Uncontrollability of Thoughts and Danger Subscale
Time frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
Attention Control Scale
Time frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
Dot Probe
Time frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
Southampton Mindfulness Questionnaire
Time frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).

Results and safety

Results posted to the registry on 2 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Attention Training Technique	41	34
Control Condition	54	44

Primary outcome: Breathing Focus Task -Negative Intrusions

Time frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).. Mean (Standard Deviation). Unit: score on a scale

Measure	Attention Training Technique n = 33	Control Condition n = 42
Visit 1	2.85 (2.32)	2.55 (1.99)
Visit 2	2.45 (2.53)	2.26 (1.93)
Visit 3	1.79 (2.13)	1.64 (1.82)

Attention Training Technique vs Control Condition: p = .93, ANOVA

Population analysed: Participants were only included on this analyses if they had data for all time points. 3 participants were not included (1 from ATT, 2 from control).

Primary outcome: Daily Worry Questions

Time frame: Completed every evening for two weeks. The first week will take place before beginning the ATT/ control intervention. The second week will take place during the intervention period.. Mean (Standard Deviation). Unit: units on a scale

Measure	Attention Training Technique n = 34	Control Condition n = 44
Day 1	3.66 (1.14)	3.15 (1.52)
Day 2	3.56 (1.83)	3.63 (1.70)
Day 3	2.86 (1.78)	3.34 (1.83)
Day 4	3.48 (1.75)	3.28 (1.80)
Day 5	3.34 (1.50)	3.41 (1.62)
Day 6	3.11 (1.50)	3.17 (1.54)
Day 7	3.56 (1.48)	3.18 (1.66)
Day 8	3.55 (1.60)	3.56 (1.52)

Attention Training Technique vs Control Condition: p = .74, Mixed Models Analysis
Attention Training Technique vs Control Condition: p = .44, Mixed Models Analysis

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Attention Training Technique	0 of 34 (0%)	0 of 34 (0%)	0 of 34
Control Condition	0 of 44 (0%)	0 of 44 (0%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundWells A. Panic disorder in association with relaxation induced anxiety: An attentional training approach to treatment. Behavior Therapy, 21(3): 273-280, 1990.
Background: PubMed 27129094Knowles MM, Foden P, El-Deredy W, Wells A. A Systematic Review of Efficacy of the Attention Training Technique in Clinical and Nonclinical Samples. J Clin Psychol. 2016 Oct;72(10):999-1025. doi: 10.1002/jclp.22312. Epub 2016 Apr 29.
Derived from this study: PubMed 33872957Stewart KE, Antony MM, Koerner N. A randomized experimental analysis of the attention training technique: Effects on worry and relevant processes in individuals with probable generalized anxiety disorder. Behav Res Ther. 2021 Jun;141:103863. doi: 10.1016/j.brat.2021.103863. Epub 2021 Apr 10.
Lab WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No. Results of the study will be disseminated via conference presentations, journal publications, and through our lab website. Upon request, de-identified aggregate participant data may be made available to a publishing journal or individual research group. Individual research groups interested in accessing de-identified data will be required to submit a proposal detailing their intended use of the data. Their qualifications will be reviewed based on their proposal and CVs. Individual research groups approved for access will be required to agree to not attempt to re-identify participants, not further distribute data, and not use the data for purposes other than specified in their original proposal. No individual data will be shared.

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.

Kathleen E Stewart, Bsc principal investigator

Toronto Metropolitan 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 Attention Training Technique in people with Excessive Worry, run by Toronto Metropolitan University at 1 site in Canada.

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 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 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 Canada. 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?

Yes. Results are posted in the registry (first posted 2 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Breathing Focus Task -Negative Intrusions (time frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).). 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?

On the ClinicalTrials.gov record for NCT03216382, 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 2 Jul 2021.