Chronic InsomniaiBITNCT02724800

Implementation of Brief Insomnia Treatments - Clinical Trial

A study testing CBTI and BBTI in people with Chronic Insomnia, run by VA Pittsburgh Healthcare System at 1 site in United States.

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

The purpose of this study is to directly compare the effectiveness of two interventions for insomnia: Brief Behavioral Treatment for Insomnia (BBTI) vs. Cognitive Behavioral Therapy for Insomnia (CBTI). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Insomnia
What is being tested?: CBTI and BBTI
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 1 siteUnited States
Study dates: Apr 2016to Mar 2020
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 years old and older
Military Veteran
Insomnia Severity Index (ISI) ≥15 \& Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for insomnia disorder
If using sleep medications, medication and dosage have not been changed in the past month, and will remain unchanged for the duration of the treatment phase of the study (i.e., 4-8 weeks)
If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the treatment phase of the study (i.e., 4-8 weeks)

Who cannot join

Untreated, current, and severe PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID)
Untreated, current, and severe Major Depressive Disorder as determined by the SCID
Current/Past Psychotic or Bipolar disorder
Current substance or alcohol use disorder as determined by the SCID
Current unstable medical condition
Hospitalization in the previous 1 month for a medical condition or surgery for which recovery overlaps with the study onset and duration

Show all 14Show fewer

Seizure disorder, open skull brain injury, or moderate to severe traumatic brain injury (TBI)
Current, untreated, sleep disorders such as nightmare disorder, restless legs syndrome, circadian rhythm disorder (or shift work), or a suspected sleep disorder requiring polysomnographic assessment, such as obstructive sleep apnea or periodic leg movements as determined by the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR) Clinical Interview for DSM-5 Sleep-Wake Disorders and/or the STOP-BANG questionnaire
Moderate to severe cognitive impairment (St. Louis University Mental Status [SLUMS] exam ≤20) and/or diagnosis in medical record indicative of moderate to severe cognitive impairment
Unstable environment that is not in one's control (e.g., homeless, temporary group home, care taking duties at night)
Pregnancy and/or breast-feeding
STOP-BANG is not a true acronym but indicates the symptoms each item assess:
S-snores T-tired/sleepy O-observed apneas P-high blood pressure
B-body mass index A-age N-neck circumference G-gender

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240

Other trials in United States

About this study

Read the detailed description

Cognitive Behavioral Therapy for Insomnia (CBTI) is the evidence-based first line treatment for chronic insomnia. Randomized controlled trials and meta-analyses have established that CBTI is efficacious and effective. Despite the strong evidence for CBTI, chronic insomnia remains under-treated among Veterans because of several barriers that limit access to behavioral treatments. In recent years, the VA has taken substantial measures to train more clinicians to provide insomnia treatment; however, a deficit in treatment availability remains. In 2011, the VA began to train clinicians in CBTI as part of the VA's Evidence Based Psychotherapy (EBP) training program, with a goal to train 1000 clinicians. Even with 1000 VA clinicians trained in CBTI, a shortage of clinicians will likely remain due to the high prevalence of insomnia. High prevalence and a shortage of clinicians prevent the VA from meeting the care demand of Veterans with insomnia. While the CBTI roll-out is a significant investment from the VA, additional mechanisms, such as dissemination and implementation of other evidence-based treatments for insomnia with fewer implementation barriers, must be considered to address the high prevalence of insomnia.

The in-person delivery and length of treatment for CBTI may be one of barriers to accessing care. Briefer protocols that use multiple delivery modalities have recently been developed and may help to increase session attendance and treatment completion. These shorter insomnia treatments are often referred to as Brief Behavioral Treatment for Insomnia (BBTI) and consist of ≤4 sessions. Besides fewer and briefer sessions, and utilizing both in-person and phone delivery of treatment, BBTI also emphasizes the behavioral components of CBTI (i.e., stimulus control and sleep restriction) rather than a combined approach focusing on both behavioral and cognitive components. BBTI is efficacious in adults-studies with older adults and Veterans found BBTI resulted in a significant decrease in insomnia severity with Cohen's d effect sizes in the moderate to large range. Like CBTI, BBTI significantly improves insomnia severity and may also help to improve secondary outcomes like depression and anxiety.

Integration of newer insomnia treatments, like BBTI, will first depend on establishing its evidence directly compared to CBTI. Effectiveness trials of BBTI, especially those conducted with military Veterans in typical VA settings, have yet to be conducted. Before BBTI can be broadly implemented and integrated into the VA, it needs to be established as a clinically effective treatment for insomnia among Veterans and a statistically non-inferior treatment (not necessarily better or worse) for Veterans compared to CBTI.

Conditions: Chronic Insomnia
Being tested: CBTI, BBTI
Keywords: Insomnia, Veterans, Cognitive Behavioral Therapy for Insomnia, Brief Behavioral Treatment for Insomnia, Comparative Effectiveness Research
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

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

CBTIBehavioural
Also called Cognitive Behavioral Therapy for Insomnia
28 Veterans with chronic insomnia will be randomized to CBTI. The intervention will be delivered in 5 face-to-face session within an 8 week time period. The intervention will be delivered at the VA Pittsburgh Healthcare System. Treatment visits will last approximately 45 minutes.
BBTIBehavioural
Also called Brief Behavioral Treatment for Insomnia
28 Veterans with chronic insomnia will be randomized to BBTI. The intervention will be delivered over 4 consecutive weeks, which include individual face-to-face visits on Weeks 1 and 3 (option for telephone), and telephone appointments on Weeks 2 and 4. Interventions will be delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit is approximately 45-minutes, and the follow-up visit on Week 3 will last no more than 30 minutes. Brief (<20 minutes) telephone sessions will be conducted on Weeks 2 and 4.

Study groups in NCT02724800
Study group	Role	What they receive
CBTI	Active comparator	CBTI consists of five in-person sessions within an eight week period. Topics covered include: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. Receives: Behavioral: CBTI
BBTI	Active comparator	BBTI consists of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered include: sleep education, stimulus control, and sleep restriction. Receives: Behavioral: BBTI

What is being measured

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

Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI) 0-28; 0-7 (no symptoms), 8-14 (sub-threshold symptoms), 15-21 (moderately severe), 22-28 (severe) high scores indicate worse outcome/greater severity
Measured: post-treatment (BBTI: week 5; CBTI: week 6-9)

Secondary outcomes (13)

Patient Health Questionnaire (PHQ-9)
Patient Health Questionnaire (PHQ-9) 0-27; 0-5 (minimal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate-severe), 21-27 (severe) high scores indicate worse outcome/greater severity
Measured: post-treatment (BBTI: week 5; CBTI: week 6-9)
Generalized Anxiety Disorder (GAD-7)
Generalized Anxiety Disorder (GAD-7) 0-21; 0-5 (minimal), 6-10 (mild), 11-15 (moderate), 16-21 (severe) high scores indicate worse outcome/greater severity
Measured: post-treatment (BBTI: week 5; CBTI: week 6-9)
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
PTSD Checklist for DSM-5 (PCL-5) 0-76 (sleep item removed), higher scores indicate greater PTSD severity >33, likely PTSD diagnosis
Measured: post-treatment (BBTI: week 5; CBTI: week 6-9)
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
PROMIS Fatigue Scale 33.4 - 76.8 (T-score) The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a participant with a T-score of 50 is equal to the mean and a T-score of 40 is one SD below the mean. Scores less than 50 indicate less fatigue symptoms than an age and gender matched healthy population and scores greater than 50 indicate greater fatigue symptoms than an age and gender matched healthy population.
Measured: post-treatment (BBTI: week 5; CBTI: week 6-9)
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
PROMIS Global Health Physical Health: 16.2 - 67.7 (T-score) Mental Health: 21.2 - 67.6 (T-score) The T-score re-scales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a participant with a T-score of 50 is equal to the mean and a T-score of 40 is one SD below the mean. Scores less than 50 indicate worse quality of life than an age and gender matched healthy population and scores greater than 50 indicate better quality of life than an age and gender matched healthy population.
Measured: post-treatment (BBTI: week 5; CBTI: week 6-9)
Work and Social Adjustment Scale (WSAS)
Work and Social Adjustment Scale (WSAS) 0-40 higher scores indicate worse functioning
Measured: post-treatment (BBTI: week 5; CBTI: week 6-9)
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) 0-21 higher score indicates worse sleep quality, >5 indicates poor quality sleep
Measured: post-treatment (BBTI: week 5; CBTI: week 6-9)
Epworth Sleepiness Scale (ESS)
Epworth Sleepiness Scale (ESS) 0-24 higher score indicates greater sleepiness, >10 indicates excessive daytime sleepiness
Measured: post-treatment (BBTI: week 5; CBTI: week 6-9)
Dysfunctional Beliefs and Attitudes About Sleep (DBAS)
Dysfunctional Beliefs and Attitudes About Sleep (DBAS) 0-160 reported as mean score (sum of items answered / 10 for a range 0-16) higher scores indicate greater dysfunctional beliefs and attitudes
Measured: post-treatment (BBTI: week 5; CBTI: week 6-9)
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC) 1-7 higher score indicative of greater subjective improvement
Measured: post-treatment (BBTI: week 5; CBTI: week 6-9)
Sleep Diary
The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors Sleep Onset Latency (SOL) - lower is better Wake After Sleep Onset (WASO) - lower is better Early Morning Awakenings (EMA) - lower is better Total Wake Time (TWT) - lower is better Total Sleep Time (TST) - higher is better Time in Bed (TIB) - value depends on TWT and TST
Measured: post-treatment (BBTI: week 5; CBTI: week 6-9)
Sleep Diary - Sleep Efficiency
The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors Sleep Efficiency (total sleep time [TST] / time in bed [TIB]) x 100 - higher is better
Measured: post-treatment (BBTI: week 5; CBTI: week 6-9)
Sleep Diary - Sleep Quality
The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors Sleep Quality (SQ) 1-5 higher is better
Measured: post-treatment (BBTI: week 5; CBTI: week 6-9)

Timeline

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

Apr 2016Mar 2020

First posted31 Mar 2016 (estimated)
Study startApr 2016
Primary completionMar 2019
Study completionMar 2020

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 (2)Papers the sponsor has linked to this study.
Other trials for Chronic InsomniaStudies 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: Investigator
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02724800
Sponsor's protocol ID: Pro00001553
Other IDs: 1IK2HX001548-01A2
Acronym: iBIT
Status last verified: Jul 2020
First submitted: 21 Mar 2016
Last updated: 11 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bramoweth AD, Lederer LG, Youk AO, Germain A, Chinman MJ. Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy for Insomnia: Results of a Randomized Noninferiority Clinical Trial Among Veterans. Behav Ther. 2020 Jul;51(4):535-547. doi: 10.1016/j.beth.2020.02.002. Epub 2020 Feb 20.
PubMed 32586428
Bramoweth AD, Germain A, Youk AO, Rodriguez KL, Chinman MJ. A hybrid type I trial to increase Veterans' access to insomnia care: study protocol for a randomized controlled trial. Trials. 2018 Jan 26;19(1):73. doi: 10.1186/s13063-017-2437-y.
PubMed 29373993

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of Brief Insomnia Treatments - Clinical Trial
ClinicalTrials.gov ID: NCT02724800
Acronym / sponsor ID: iBIT / Pro00001553
Conditions: Chronic Insomnia
Keywords: Insomnia, Veterans, Cognitive Behavioral Therapy for Insomnia, Brief Behavioral Treatment for Insomnia, Comparative Effectiveness Research
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: VA Pittsburgh Healthcare SystemUS federal agency
Collaborators: VA Office of Research and Development
Study start: Apr 2016 (actual)
Primary completion: Mar 2019 (actual)
Study completion: Mar 2020 (actual)
First posted: 31 Mar 2016 (estimated)
Results: Posted 11 Aug 2020

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 (investigator)
Number of arms: 2

Arm	Type	Receives
CBTI	Active comparator	Behavioral: CBTICBTI consists of five in-person sessions within an eight week period. Topics covered include: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene.
BBTI	Active comparator	Behavioral: BBTIBBTI consists of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered include: sleep education, stimulus control, and sleep restriction.

Who may qualify

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

Key inclusion criteria (5 listed)

Age 18 years old and older
Military Veteran
Insomnia Severity Index (ISI) ≥15 \& Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for insomnia disorder
If using sleep medications, medication and dosage have not been changed in the past month, and will remain unchanged for the duration of the treatment phase of the study (i.e., 4-8 weeks)
If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the treatment phase of the study (i.e., 4-8 weeks)

Key exclusion criteria (14 listed)

Untreated, current, and severe PTSD as determined by the Structured Clinical Interview for DSM-5 (SCID)
Untreated, current, and severe Major Depressive Disorder as determined by the SCID
Current/Past Psychotic or Bipolar disorder
Current substance or alcohol use disorder as determined by the SCID
Current unstable medical condition

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
CBTIAlso: Cognitive Behavioral Therapy for Insomnia28 Veterans with chronic insomnia will be randomized to CBTI. The intervention will be delivered in 5 face-to-face session within an 8 week time period. The intervention will be delivered at the VA Pittsburgh Healthcare System. Treatment visits will last approximately 45 minutes.	Behavioural	CBTI
BBTIAlso: Brief Behavioral Treatment for Insomnia28 Veterans with chronic insomnia will be randomized to BBTI. The intervention will be delivered over 4 consecutive weeks, which include individual face-to-face visits on Weeks 1 and 3 (option for telephone), and telephone appointments on Weeks 2 and 4. Interventions will be delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit is approximately 45-minutes, and the follow-up visit on Week 3 will last no more than 30 minutes. Brief (<20 minutes) telephone sessions will be conducted on Weeks 2 and 4.	Behavioural	BBTI

Primary outcome

Insomnia Severity Index (ISI)
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Insomnia Severity Index (ISI) 0-28; 0-7 (no symptoms), 8-14 (sub-threshold symptoms), 15-21 (moderately severe), 22-28 (severe) high scores indicate worse outcome/greater severity

13 secondary outcomes

Patient Health Questionnaire (PHQ-9)
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Generalized Anxiety Disorder (GAD-7)
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Work and Social Adjustment Scale (WSAS)
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Epworth Sleepiness Scale (ESS)
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Dysfunctional Beliefs and Attitudes About Sleep (DBAS)
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Patient Global Impression of Change (PGIC)
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Sleep Diary
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Sleep Diary - Sleep Efficiency
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Sleep Diary - Sleep Quality
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)

Results and safety

Results posted to the registry on 11 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cognitive Behavioral Therapy for Insomnia (CBTI)	32	15
Brief Behavioral Treatment for Insomnia (BBTI)	31	22

Primary outcome: Insomnia Severity Index (ISI)

Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9). Mean (Standard Deviation). Unit: score on a scale

Measure	CBTI n = 17	BBTI n = 22
Value	9.6 (4.9)	11.0 (6.5)

CBTI vs BBTI: Mean Difference (Net): 2.2 (95% CI -0.9 to 5.6), p <0.05, Mixed Models Analysis

Population analysed: Participants who completed post-treatment ISI

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: baseline to 12-month follow-up (approximately 57-60 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CBTI	0 of 32 (0%)	0 of 32 (0%)	0 of 32
BBTI	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Limitations and caveats (from the sponsor): In general, higher than expected dropout leading to smaller number of participants analyzed. For sleep diaries, higher than expected dropout and poor completion at post-treatment resulted in small number analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32586428Bramoweth AD, Lederer LG, Youk AO, Germain A, Chinman MJ. Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy for Insomnia: Results of a Randomized Noninferiority Clinical Trial Among Veterans. Behav Ther. 2020 Jul;51(4):535-547. doi: 10.1016/j.beth.2020.02.002. Epub 2020 Feb 20.
Derived from this study: PubMed 29373993Bramoweth AD, Germain A, Youk AO, Rodriguez KL, Chinman MJ. A hybrid type I trial to increase Veterans' access to insomnia care: study protocol for a randomized controlled trial. Trials. 2018 Jan 26;19(1):73. doi: 10.1186/s13063-017-2437-y.

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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 CBTI and BBTI in people with Chronic Insomnia, run by VA Pittsburgh Healthcare System 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 5 inclusion and 14 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 11 Aug 2020. 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?

Yes. Results are posted in the registry (first posted 11 Aug 2020). 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?

Insomnia Severity Index (ISI) (time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)). 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 NCT02724800, which also lists 2 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 11 Aug 2020.