StressNCT06773468
Evaluating Knowledge Mobilization Vehicles
A study testing stress management in people with Stress and Coping, run by McGill University at 1 site in Canada.
Trial summary
The present study examined the comparative effectiveness of self-directed (video, infographic) vs. non-self directed (workshop) modalities of online stress management resources and an inactive control condition in terms of their effectiveness and acceptability for university students. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Coping, Digital Intervention
- What is being tested?
- stress management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jan 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current university student
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Knowledge Mobilization for Stress Management in University Students
The present study examined the comparative effectiveness of self-directed (video, infographic) vs. non-self directed (workshop) modalities of online stress management resources and an inactive control condition in terms of their effectiveness and acceptability for university students.
Read the detailed description
University students have been reporting high levels of stress, which have been found to negatively impact their academic performance and overall well-being. Given these elevated levels of stress, a large number of students report using unhealthy coping behaviours such as alcohol and drug use or risky sexual behaviours to cope with daily stressors. High levels of stress can be harmful to students' quality of life and well-being (both physical and mental), as well as elevated stress over an extended period can hinder academic performance. To address the overwhelming demands for wellness services, online approaches to delivering stress management and well-being supports are being used on campuses as supplemental means of promoting student stress management, coping capacity, and well-being.
Growing research on the barriers associated with help-seeking and changes due to the pandemic have spurred a shift from in-person supports to online self-directed modalities. Evidence from research measuring the acceptability of digital mental health interventions in university students suggests that students rate these interventions with moderate to high acceptability, but students report concerns around the use of certain digital modalities such as privacy, credibility, and lack of guidance on how to get started and use the interventions. Research has demonstrated how these types of online support can be effective at enhancing university student well-being and decreasing stress. For example, an umbrella review of systematic reviews and meta-analyses to synthesize the literature on digital mental health interventions in higher education found that most interventions were effective at decreasing depression symptoms, anxiety, and stress in this context. Specifically, skills-training and cognitive behavioral therapy (CBT)-based interventions were found to be effective. However, it is important to highlight that the authors found that the effectiveness depended on the modality or delivery format of the intervention. Although there is evidence for their individual effectiveness when compared to inactive control groups, it is crucial to have a better theoretical understanding of their relative effectiveness to one another to make research-informed decisions in selecting instructional approaches to support students' coping capacity in higher education.
Therefore, the overarching objective of the current study is to investigate how stress management knowledge can be effectively put into action within the university context by comparing different modalities. The study seeks to investigate differences in response to self-directed vs. non self-directed approaches to sharing stress management knowledge with students against a control group, specifically in terms of acceptability and change over time on wellness outcomes while accounting for the role of strategy use frequency. Specifically, the first objective (1.1) was to compare and evaluate self-directed, non self-directed, and an inactive control group by assessing effectiveness as demonstrated in changes (pre/post/follow-up) on wellness outcomes (i.e., perceived stress, coping capacity, mindfulness, coping self-efficacy, and well-being), while (1.2) examining the role of strategy use frequency. The second objective (2) is to further examine specific differences between commonly used knowledge mobilization modalities for stress management strategies (workshop, video, infographic) and an inactive control group by assessing (2.1) acceptability (i.e., likelihood of use, satisfaction) and (2.2) effectiveness as demonstrated in changes (pre/post/follow-up) on the same wellness outcomes while (2.3) examining the role of strategy use frequency.
- Conditions
- Stress, Coping, Digital Intervention, University Students
- Being tested
- stress management
- Keywords
- stress, coping, digital intervention, self-directed, online resource, university students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress managementBehavioural
These different stress management modalities have been developed to ensure equivalent content across: (a) psychoeducation and strategy introduction; and (b) skills-based practice of strategies. Stress management strategies touched on 4 main areas which included (a) pause/break; (b) positive awareness; (c) kindness to self; and (d) social support.
| Study group | Role | What they receive |
|---|---|---|
| Workshop | Experimental | 30-minute online stress management workshop providing psychoeducation and strategy practice with links to strategies shared at the end Receives: Behavioral: stress management |
| Video | Experimental | a short 10-minute stress management video providing psychoeducation and strategy practice with links to strategies shared at the end Receives: Behavioral: stress management |
| Infographic | Experimental | a brief 3-page stress management interactive infographic (i.e., with psychoeducation and embedded links for strategy practice) Receives: Behavioral: stress management |
| Inactive control | No intervention | Waitlist inactive control that will receive all stress management materials at the end of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stress
The Perceived Stress Scale (PSS) is a widely used self-report measure of individuals' perception of stress. This measure contains 10 items in which participants indicate their experience of stress on a 5-point Likert scale (0 = never to 4 = very often). Items were adapted to reflect experiences during the past week and include statements such as "In the past week, how often have you felt difficulties were piling up so high that you could not overcome them?" Ratings were averaged across items such that higher scores represented greater perceived stress. The PSS has good reliability (Cronbach's α = .89), construct validity, and predictive validity with reports of psychological and physical symptoms.
Measured: Week 0, 4, and 7
Secondary outcomes (5)
Change in Satisfaction
The Response to Training is a researcher-developed questionnaire assessing participants' satisfaction with the intervention content and delivery. The questions were delivered according to the three levels of Kirkpatrick's New World Model (Kirkpatrick \& Kirkpatrick, 2016) as follows: (1) student viewers' response (i.e., satisfaction, engagement, relevance); (2) learning (i.e., knowledge, skills, attitude, confidence, commitment); (3) use of skills (i.e., willingness to use, frequency of use). All items are scored on a 6-point Likert-scales except for the strategy use item described below, where higher scores represent a better response to training. Sample items include "I would recommend the stress management resource to other university students" or "I am planning to use the strategies in the future..."
Measured: Week 4 and 7
Change in coping capacity
The Coping Index (CI; (Stallman, 2017), a 20-item measure of engagement with healthy and unhealthy coping strategies that are aligned with the health theory of coping framework (Stallman, 2020). The measure consists of items that list common healthy and unhealthy coping behaviours such as 'talk things over with family or friends', 'do relaxing activities', or 'have negative self-talk'. Participants are asked to indicate how often they engage in each behaviour listed when they feel stressed or distressed on a 4-point Likert scale (0 = I don't do this at all to 3 = I do this most of the time). This measure has been found to have satisfactory test-retest reliability with alpha = 0.71 (Stallman, 2019).
Measured: Week 0, 4, and 7
Change in mindfulness
The Five Facets of Mindfulness Questionnaire short form (FFMQ-15; (Baer et al., 2006, 2008) which is a 15-item self-report measure consisting of five subscales each assessing a specific facet of dispositional mindfulness: acting with awareness, describing, observing, non-reactivity, and non-judgmental acceptance. Items include "I'm good at finding words to describe my feelings" and "When I have distressing thoughts or images, I am able just to notice them without reacting". Participants rate their responses on a 5-point Likert scale (1 = never or very rarely true to 5 = very often or always true). The FFMQ-15 has good internal consistency with Cronbach alphas ranging from .64 to .83, as well as convergent validity (Gu et al., 2016). Higher scores on the FFMQ-15 represent higher mindfulness.
Measured: Week 0, 4, and 7
Change in coping self-efficacy
The Coping Self-Efficacy Scale (CSES; Chesney et al., 2006) which is a measure of one's confidence in effectively engaging in coping behaviors in the face of challenges. This measure contains 26 items in which participants indicate confidence in their coping strategies when it comes to handling challenges and stressors on an 11-point Likert scale (0 = cannot do at all to 10 = certain can do). The CSES states, "When things aren't going well for you, or when you're having problems, how confident or certain are you that you can do the following:" and include statements such as "find solutions to your most difficult problems" and "see things from the other person's point of view during a heated argument." Higher scores on the CSES represent higher coping-self efficacy.
Measured: Week 0, 4, and 7
Change in well-being
The Warwick-Edinburg Mental Well-Being Scale (WEMWBS; Tennant et al., 2007), which is a measure of positive mental health and consists of 14 positively worded items. Participants are asked to rate statements such as "I've been feeling good about yourself" on a 5-point Likert scale according to their experience over the past 2 weeks (1= none of the time; 5= all of the time). The WEMWBS has demonstrated good internal consistency in student (α = .89) and general population samples (α = .91) and was found to be psychometrically robust in validation studies (Stewart-Brown et al., 2011; Tennant et al., 2007).
Measured: Week 0, 4, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start9 Jan 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Heath, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773468
- Sponsor's protocol ID
- 22-11-006
- Other IDs
- SSHRC 430-2022-00172
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Restricted by our ethics board approval.
Publications
Harith S, Backhaus I, Mohbin N, Ngo HT, Khoo S. Effectiveness of digital mental health interventions for university students: an umbrella review. PeerJ. 2022 Mar 31;10:e13111. doi: 10.7717/peerj.13111. eCollection 2022.
PubMed 35382010Lattie EG, Adkins EC, Winquist N, Stiles-Shields C, Wafford QE, Graham AK. Digital Mental Health Interventions for Depression, Anxiety, and Enhancement of Psychological Well-Being Among College Students: Systematic Review. J Med Internet Res. 2019 Jul 22;21(7):e12869. doi: 10.2196/12869.
PubMed 31333198Bourdon JL, Moore AA, Long EC, Kendler KS, Dick DM. The relationship between on-campus service utilization and common mental health concerns in undergraduate college students. Psychol Serv. 2020 Feb;17(1):118-126. doi: 10.1037/ser0000296. Epub 2018 Oct 8.
PubMed 30299149LaMontagne LG, Doty JL, Diehl DC, Nesbit TS, Gage NA, Kumbkarni N, Leon SP. Acceptability, usage, and efficacy of mindfulness apps for college student mental health: A systematic review and meta-analysis of RCTs. J Affect Disord. 2024 Dec 15;367:951-971. doi: 10.1016/j.jad.2024.09.014. Epub 2024 Sep 10.
PubMed 39260578Harrer M, Adam SH, Baumeister H, Cuijpers P, Karyotaki E, Auerbach RP, Kessler RC, Bruffaerts R, Berking M, Ebert DD. Internet interventions for mental health in university students: A systematic review and meta-analysis. Int J Methods Psychiatr Res. 2019 Jun;28(2):e1759. doi: 10.1002/mpr.1759. Epub 2018 Dec 26.
PubMed 30585363Kern A, Hong V, Song J, Lipson SK, Eisenberg D. Mental health apps in a college setting: openness, usage, and attitudes. Mhealth. 2018 Jun 30;4:20. doi: 10.21037/mhealth.2018.06.01. eCollection 2018.
PubMed 30050916Frazier P, Gabriel A, Merians A, Lust K. Understanding stress as an impediment to academic performance. J Am Coll Health. 2019 Aug-Sep;67(6):562-570. doi: 10.1080/07448481.2018.1499649. Epub 2018 Oct 4.
PubMed 30285563Metzger IW, Blevins C, Calhoun CD, Ritchwood TD, Gilmore AK, Stewart R, Bountress KE. An examination of the impact of maladaptive coping on the association between stressor type and alcohol use in college. J Am Coll Health. 2017 Nov-Dec;65(8):534-541. doi: 10.1080/07448481.2017.1351445. Epub 2017 Jul 14.
PubMed 28708021
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Knowledge Mobilization for Stress Management in University Students
- ClinicalTrials.gov ID
- NCT06773468
- Acronym / sponsor ID
- 22-11-006
- Conditions
- Stress, Coping, Digital Intervention, University Students
- Keywords
- stress, coping, digital intervention, self-directed, online resource, university students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 14 Jan 2025 (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.
The present study examined the comparative effectiveness of self-directed (video, infographic) vs. non-self directed (workshop) modalities of online stress management resources and an inactive control condition in terms of their effectiveness and acceptability for university students.
Detailed description
University students have been reporting high levels of stress, which have been found to negatively impact their academic performance and overall well-being. Given these elevated levels of stress, a large number of students report using unhealthy coping behaviours such as alcohol and drug use or risky sexual behaviours to cope with daily stressors. High levels of stress can be harmful to students' quality of life and well-being (both physical and mental), as well as elevated stress over an extended period can hinder academic performance. To address the overwhelming demands for wellness services, online approaches to delivering stress management and well-being supports are being used on campuses as supplemental means of promoting student stress management, coping capacity, and well-being.
Growing research on the barriers associated with help-seeking and changes due to the pandemic have spurred a shift from in-person supports to online self-directed modalities. Evidence from research measuring the acceptability of digital mental health interventions in university students suggests that students rate these interventions with moderate to high acceptability, but students report concerns around the use of certain digital modalities such as privacy, credibility, and lack of guidance on how to get started and use the interventions. Research has demonstrated how these types of online support can be effective at enhancing university student well-being and decreasing stress. For example, an umbrella review of systematic reviews and meta-analyses to synthesize the literature on digital mental health interventions in higher education found that most interventions were effective at decreasing depression symptoms, anxiety, and stress in this context. Specifically, skills-training and cognitive behavioral therapy (CBT)-based interventions were found to be effective. However, it is important to highlight that the authors found that the effectiveness depended on the modality or delivery format of the intervention. Although there is evidence for their individual effectiveness when compared to inactive control groups, it is crucial to have a better theoretical understanding of their relative effectiveness to one another to make research-informed decisions in selecting instructional approaches to support students' coping capacity in higher education.
Therefore, the overarching objective of the current study is to investigate how stress management knowledge can be effectively put into action within the university context by comparing different modalities. The study seeks to investigate differences in response to self-directed vs. non self-directed approaches to sharing stress management knowledge with students against a control group, specifically in terms of acceptability and change over time on wellness outcomes while accounting for the role of strategy use frequency. Specifically, the first objective (1.1) was to compare and evaluate self-directed, non self-directed, and an inactive control group by assessing effectiveness as demonstrated in changes (pre/post/follow-up) on wellness outcomes (i.e., perceived stress, coping capacity, mindfulness, coping self-efficacy, and well-being), while (1.2) examining the role of strategy use frequency. The second objective (2) is to further examine specific differences between commonly used knowledge mobilization modalities for stress management strategies (workshop, video, infographic) and an inactive control group by assessing (2.1) acceptability (i.e., likelihood of use, satisfaction) and (2.2) effectiveness as demonstrated in changes (pre/post/follow-up) on the same wellness outcomes while (2.3) examining the role of strategy use frequency.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Workshop | Experimental | Behavioral: stress management30-minute online stress management workshop providing psychoeducation and strategy practice with links to strategies shared at the end |
| Video | Experimental | Behavioral: stress managementa short 10-minute stress management video providing psychoeducation and strategy practice with links to strategies shared at the end |
| Infographic | Experimental | Behavioral: stress managementa brief 3-page stress management interactive infographic (i.e., with psychoeducation and embedded links for strategy practice) |
| Inactive control | No intervention | –Waitlist inactive control that will receive all stress management materials at the end of the study |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Current university student
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| stress managementThese different stress management modalities have been developed to ensure equivalent content across: (a) psychoeducation and strategy introduction; and (b) skills-based practice of strategies. Stress management strategies touched on 4 main areas which included (a) pause/break; (b) positive awareness; (c) kindness to self; and (d) social support. | Behavioural | Infographic, Video, Workshop |
Primary outcome
Change in Stress
Time frame: Week 0, 4, and 7
The Perceived Stress Scale (PSS) is a widely used self-report measure of individuals' perception of stress. This measure contains 10 items in which participants indicate their experience of stress on a 5-point Likert scale (0 = never to 4 = very often). Items were adapted to reflect experiences during the past week and include statements such as "In the past week, how often have you felt difficulties were piling up so high that you could not overcome them?" Ratings were averaged across items such that higher scores represented greater perceived stress. The PSS has good reliability (Cronbach's α = .89), construct validity, and predictive validity with reports of psychological and physical symptoms.
5 secondary outcomes
Change in Satisfaction
Time frame: Week 4 and 7
Change in coping capacity
Time frame: Week 0, 4, and 7
Change in mindfulness
Time frame: Week 0, 4, and 7
Change in coping self-efficacy
Time frame: Week 0, 4, and 7
Change in well-being
Time frame: Week 0, 4, and 7
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 20 Jan 2025.
- Background: PubMed 35382010Harith S, Backhaus I, Mohbin N, Ngo HT, Khoo S. Effectiveness of digital mental health interventions for university students: an umbrella review. PeerJ. 2022 Mar 31;10:e13111. doi: 10.7717/peerj.13111. eCollection 2022.
- Background: PubMed 31333198Lattie EG, Adkins EC, Winquist N, Stiles-Shields C, Wafford QE, Graham AK. Digital Mental Health Interventions for Depression, Anxiety, and Enhancement of Psychological Well-Being Among College Students: Systematic Review. J Med Internet Res. 2019 Jul 22;21(7):e12869. doi: 10.2196/12869.
- Background: PubMed 30299149Bourdon JL, Moore AA, Long EC, Kendler KS, Dick DM. The relationship between on-campus service utilization and common mental health concerns in undergraduate college students. Psychol Serv. 2020 Feb;17(1):118-126. doi: 10.1037/ser0000296. Epub 2018 Oct 8.
- Background: PubMed 39260578LaMontagne LG, Doty JL, Diehl DC, Nesbit TS, Gage NA, Kumbkarni N, Leon SP. Acceptability, usage, and efficacy of mindfulness apps for college student mental health: A systematic review and meta-analysis of RCTs. J Affect Disord. 2024 Dec 15;367:951-971. doi: 10.1016/j.jad.2024.09.014. Epub 2024 Sep 10.
- Background: PubMed 30585363Harrer M, Adam SH, Baumeister H, Cuijpers P, Karyotaki E, Auerbach RP, Kessler RC, Bruffaerts R, Berking M, Ebert DD. Internet interventions for mental health in university students: A systematic review and meta-analysis. Int J Methods Psychiatr Res. 2019 Jun;28(2):e1759. doi: 10.1002/mpr.1759. Epub 2018 Dec 26.
- Background: PubMed 30050916Kern A, Hong V, Song J, Lipson SK, Eisenberg D. Mental health apps in a college setting: openness, usage, and attitudes. Mhealth. 2018 Jun 30;4:20. doi: 10.21037/mhealth.2018.06.01. eCollection 2018.
- Background: PubMed 30285563Frazier P, Gabriel A, Merians A, Lust K. Understanding stress as an impediment to academic performance. J Am Coll Health. 2019 Aug-Sep;67(6):562-570. doi: 10.1080/07448481.2018.1499649. Epub 2018 Oct 4.
- Background: PubMed 28708021Metzger IW, Blevins C, Calhoun CD, Ritchwood TD, Gilmore AK, Stewart R, Bountress KE. An examination of the impact of maladaptive coping on the association between stressor type and alcohol use in college. J Am Coll Health. 2017 Nov-Dec;65(8):534-541. doi: 10.1080/07448481.2017.1351445. Epub 2017 Jul 14.
- Individual participant dataSharing planned: No. Restricted by our ethics board approval.
Related trials for Stress
Recruiting
Stress Modulation and Dynamic Balance
Stress
Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico
Post-Traumatic Stress Disorder
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 stress management in people with Stress and Coping, run by McGill 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 1 inclusion and 1 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 20 Jan 2025. 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. 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 Stress (time frame: Week 0, 4, and 7). 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 NCT06773468, which also lists 8 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 20 Jan 2025.