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Stress Disorders, Post-traumaticPSLIINCT02640690

Trauma-Sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma

A study testing Trauma Center Trauma Sensitive Yoga Intervention (TCTSY) and Cognitive Processing Therapy in people with Stress Disorders, Post-traumatic, run by VA Office of Research and Development at 2 sites 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

In this study, we are evaluating the effectiveness of a yoga intervention to treat posttraumatic stress disorder (PTSD), its associated symptoms of chronic pain and insomnia, and biological and physiological responses to trauma and PTSD in women Veterans who experienced military sexual trauma (MST). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Stress Disorders, Post-traumatic
What is being tested?
Trauma Center Trauma Sensitive Yoga Intervention (TCTSY) and Cognitive Processing Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
2 sitesUnited States
Study dates
1 Jan 2016to 30 Sep 2021
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women Veterans who experienced MST
  • Diagnosed with PTSD related to MST
  • Insomnia
  • Willing to participate in either TCTSY or CPT study intervention

Who cannot join

  • Schizophrenia with significant psychotic symptoms
  • Current, active suicidal intent or plan
  • Current substance abuse or dependence
  • Certain medical conditions that can contribute significantly to psychiatric symptoms, including:
  • poorly controlled hypo/hyperthyroidism
  • kidney or liver failure
Show all 11Show fewer
  • Dementia
  • Moderate or severe traumatic brain injury (TBI) or other cognitive impairment sufficient to interfere with ability to give informed consent
  • Pain due to acute injury (<3 months), post-surgical pain (<3 months) or pain due to malignancy; pain related to injury and surgery are excluded to reduce risk of exacerbating underlying injury
  • Receiving mental health treatment outside of the VA
  • Ongoing participation in mental health treatment at odds with study intervention (For Example: yoga, trauma-focused treatment)

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Trauma-sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma

In this study, we are evaluating the effectiveness of a yoga intervention to treat posttraumatic stress disorder (PTSD), its associated symptoms of chronic pain and insomnia, and biological and physiological responses to trauma and PTSD in women Veterans who experienced military sexual trauma (MST). If effective, this yoga intervention could reduce PTSD symptoms and chronic pain, improve sleep quality, and decrease the body's automatic "fight or flight" stress response and the damage this stress response causes in the body, including heart disease and diabetes. This intervention could improve these women Veterans' quality of life and social functioning, for example, going to work and having satisfying relationships with family and friends. This study may support an innovative, complementary and alternative PTSD treatment for women Veterans who experienced MST. This new, evidence-based PTSD treatment could supplement current PTSD treatments. Clinical guidelines for this yoga intervention could be implemented nationally in the VA health care system.

Read the detailed description

Objectives: The overall goal of this project is to maximize the health, social functioning, and quality of life of women Veterans with posttraumatic stress disorder (PTSD) who have experienced military sexual trauma (MST). The specific aims of this randomized controlled trial (RCT) are to evaluate the effectiveness of a trauma-sensitive yoga intervention designed specifically for women who experienced sexual trauma as compared to a gold-standard PTSD treatment, Cognitive Processing Therapy, to 1) treat PTSD and its co-morbid symptoms of chronic pain and insomnia, 2) improve social functioning and quality of life, and 3) reduce the biological and psychophysiologic responses associated with PTSD in women Veterans who experienced MST.

Research Plan: This five year RCT is the next step following the NRI Pilot Study (NRI 12-417) in which the investigators demonstrated the feasibility of recruitment, retention, randomization, intervention implementation, and data collection, including biological and psychophysiological data. Women Veterans seeking treatment for PTSD were recruited from a primary site (southeast US) and second site (northwest US) and were randomized to Trauma Center Trauma-Sensitive Yoga (TCTSY) (10 weekly sessions) or Cognitive Processing Therapy (CPT) (12 weekly sessions); both intervention protocols are data-driven. The target enrollment sample size is 210, with a target final sample of 100 or more. The investigators are conservatively allowing for 50%-60% retention, based on pilot study results.

Methods: Data Collection: Data are collected at four points, baseline through 3-months post-intervention. Outcome measures include self-report, clinical assessments and biologic and psychophysiologic markers. Specific outcomes include PTSD symptom severity, chronic pain, insomnia, social functioning, quality of life, cytokines (IL-6, IL-10), C-reactive protein, heart rate variability, and dark-enhanced startle. Data Analysis: Comparisons between the groups at baseline will be run using t-tests, Mann Whitney non-parametric tests, and chi-square tests as appropriate. Multilevel mixed models (MLM) will be used to analyze the differences between the groups over time. MLM adjusts for attrition (missing data) over time and applies appropriate correlation structure between the time points.

Clinical Relevance: Women Veterans experience MST and PTSD at alarming rates; consistently reported prevalence rates for both among VHA patient samples are 20% or more. MST and PTSD put this population at risk for significant physical and mental health symptoms, including chronic pain, suicide, and negative health behaviors. This RCT may provide sufficient evidence to support an innovative, complementary and alternative PTSD treatment for women Veterans who experienced MST. The positive effects of reducing distressing symptoms and PTSD-related psychophysiological stress would likely improve social functioning and quality of life and minimize the significant medical consequences of PTSD in this population. This new, evidence-based PTSD treatment could supplement existing evidence-based PTSD treatment modalities. Clinical guidelines for this innovative intervention based on evidence from this clinical trial could be disseminated to and implemented in VA Medical Centers nationwide.

Being tested
Trauma Center Trauma Sensitive Yoga Intervention (TCTSY), Cognitive Processing Therapy
Keywords
Stress Disorders, Post-traumatic, Yoga, Cognitive Therapy, Chronic Pain, Veterans, cytokines, acoustic startle reflex, women, heart rate variability, sexual trauma
Medical subject headings
Stress Disorders, Post-Traumatic, Chronic Pain, Sexual Trauma

What participants receive

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

  • Trauma Center Trauma Sensitive Yoga Intervention (TCTSY)Behavioural

    (10) 1-hour sessions of trauma sensitive yoga

  • Cognitive Processing TherapyBehavioural

    Also called Cognitive Processing Therapy-Cognitive

    (12) 1.5 hour sessions of cognitive processing therapy

Study groups in NCT02640690
Study groupRoleWhat they receive
Trauma Center Trauma-Sensitive Yoga (TCTSY)Experimental10-weekly 1-hour TCTSY Sessions
Receives: Behavioral: Trauma Center Trauma Sensitive Yoga Intervention (TCTSY)
Cognitive Processing Therapy (CPT)Active comparator12-weekly 1.5 hour CPT Sessions
Receives: Behavioral: Cognitive Processing Therapy

What is being measured

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

  1. Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention

    Clinician-Administered PTSD Scale for DSM-5 also known as CAPS-5 is the gold standard in PTSD assessment. The CAPS-5 is a structured interview that was used to assess current (past month) PTSD symptom severity. The CAPS-5 total symptom severity score is the sum of 20 items, each scored 0-4, to yield a score with a possible range of 0-80. Higher scores mean worse outcome.

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).

  2. PTSD Symptom Checklist-5 (PCL-5): Change in Mean Total Score From Baseline to 3-month Post-intervention

    The PTSD Symptom-Checklist -Version 5 (PCL-5) is a 20-item, self-report instrument that assesses the presence and severity of DSM-V PTSD symptoms in the last month. It was summed for a total severity score ranging from 0-80, with higher scores representing greater symptom severity (worse outcomes). Within group changes in mean total PCL-5 score from baseline to 3-month post-intervention are reported here.

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).

Secondary outcomes (14)
  1. Health-related Quality of Life: VR12, Mental Component Summary (MCS): Change in Mean MCS From Baseline to 3-month Post-intervention

    The VR-12 is a12-item self-rating scale that assess health-related quality of life in veterans and includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of two meta-scores: the Mental Component Summary and the Physical Component Summary. The Mental Component Score (MCS) measures mental aspects of quality of life and ranges from 0 (extremely poor mental health) to 100 (extremely good mental health). The VR-12 is veteran population-normed with each component to have a mean score of 50 and a standard deviation of 10. Scores greater than 50 represent above average health status (better outcomes). The change in the mean MCS from baseline to 3-months post-treatment are presented here.

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).

  2. Health-related Quality of Life: VR12, Physical Component: Change in Mean Subscale Score From Baseline to 3-month Post-intervention

    The VR-12 is a 12-item self-rating scale that assess health-related quality of life in veterans and includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of two meta-scores: the Physical Component Summary and the Mental Component Summary. The Physical Component Score (PCS) measures physical aspects of quality of life and ranges from 0 (extremely poor physical health) to 100 (extremely good physical health), thus has a possible range of 0-100. The VR-12 is veteran population-normed with each component to have a mean score of 50 and a standard deviation of 10. Scores greater than 50 represent above average health status (better outcomes).

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).

  3. BPI Pain Severity: Change in Total Severity Score From Baseline to 3-months Post-intervention

    The Brief Pain Inventory (BPI) contains three questions regarding pain severity. Pain severity is measured according to the worst pain experienced in the last three days, average pain in the last three days, and current pain; with each rated on an ordinal scale from "0" = "no pain" to "10" = "pain as bad as you can imagine." The pain severity score is the mean of the three pain severity item scores, with a potential range of 0-10; higher scores indicate worse outcomes.

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).

  4. BPI Pain Interference: Change in Total Interference Score From Baseline to 3-months Post-intervention

    The Brief Pain Inventory (BPI) contains seven questions regarding pain interference that are rated on an ordinal numerical scale with anchors of 0 (no pain/interference) to 10 (maximum pain/interference). Pain interference assesses how that pain has affected general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. The pain interference score is the mean of the seven pain interference item scores, with a potential range of 0-10; higher scores indicate worse outcomes.

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).

  5. Changes in C-reactive Proteins (CRP) From Baseline to 3-months Post-intervention; Within Group Changes; Primary Site Only

    C-reactive protein (CRP) is a non-specific marker of inflammation. Blood samples of 25 ml were drawn into EDTA-containing (purple top) tubes and stored in a -80o freezer until analysis. The normal range is 8-10 mg/L. Higher levels of CRP indicate worse outcomes. The unit of analysis is the natural log (LN) of raw data (mg/L).

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.

  6. Changes in IL-6 Pro-inflammatory Cytokine From Baseline to 3-months Post-intervention; Primary Site Only

    IL-6 is a pro-inflammatory cytokine. Blood samples of 25 ml were drawn into EDTA-containing (purple top) tubes and stored in a -80o freezer until analysis. The normal range is < 5.0 pg/mL. Higher values indicate more inflammation (worse outcomes). The unit of analysis in these results is the natural log (LN) of the value (pg/mL).

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.

  7. Changes in IL-10 Anti-inflammatory Cytokine From Baseline to 3-months Post-intervention; Primary Site Only

    IL-10 is an anti-inflammatory cytokine. Blood samples of 25 ml were drawn into EDTA-containing (purple top) tubes and stored in a -80o freezer until analysis. The range of normal values is 4.8 - 9.8 pg/mL. Values out of range can indicate inflammatory dysregulation.

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.

  8. Changes in the Beck Depression Inventory-II (BDI-II) Total Score From Baseline to 3-months Post-intervention (Within Group)

    The Beck Depression Inventory II (BDI-II) is a 21-question multiple-choice self-report inventory widely used for assessing the severity of depression. The BDI-II total score is the sum of the 21 items, with a possible range of 0-63. Higher scores indicate worse outcomes.

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.

  9. Changes in the Difficulties in Emotion Regulation Scale (DERS) Total Score From Baseline to 3-months Post-intervention (Within Group)

    The Difficulties in Emotion Regulation Scale (DERS) is a brief, 36-item, self-report questionnaire designed to assess multiple aspects of emotion dysregulation. The measure yields a total score as well as scores on six scales derived through factor analysis. The DERS total score is the mean of the 36 items score, with a potential range of 0-100. High scores indicate worse outcomes.

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.

  10. Changes in the PROMIS v2.0 Ability to Participate in Social Roles and Activities - Short Form 4a T-score From Baseline to 3-months Post-intervention (Within Group)

    Change in the PROMIS v2.0 - Ability to Participate in Social Roles and Activities -Short Form 4a (T-score) assesses the perceived ability to perform usual social roles and activities. Four items are worded negatively and are scored on a 5-point scale (5=never to 1= always). Responses are reverse-coded so that higher scores represent fewer limitations (better abilities). PROMIS measure scores are computed to a T-score, where 50 represents the mean for US general population, and 10 is the standard deviation. Within group differences in T-scores (change scores) from baseline to 3-month follow up (3-month follow up T-score minus baseline T-score) were calculated. Positive change scores are indicative of improvement in perceived ability to participate in social roles and activity at the study endpoint.

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.

  11. Changes in the PROMIS v2.0 Emotional Support 4a T-score From Baseline to 3-months Post-intervention (Within Group)

    The PROMIS v2.0 - Emotional Support 4a measure contains 4 items that assess perceived feelings of being cared for, valued, and having confidant relationships. Items are scored on a 5-point scale. Scores higher than 50 indicate more emotional support than the population mean. PROMIS measure scores are computed to a T-score, where 50 represents the mean for US general population, and 10 is the standard deviation. Within group differences in T-scores (change scores) from baseline to 3-month follow up were calculated (3-month follow up T-score minus baseline T-score). Positive change scores are indicative of improvement in perceived emotional support at the study endpoint.

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.

  12. Changes in the PROMIS v2.0 Satisfaction With Social Roles and Activities 4a T-score From Baseline to 3-months Post-intervention (Within Group)

    The 4-item PROMIS v2.0 - Satisfaction with Social Roles and Activities 4a was administered to participants at baseline and at 3-months post-intervention. The measure assesses satisfaction with performing social roles and activities. Items are scored on a 5-point scale and then reverse coded so that higher scores reflect great abilities to participate. Scores higher than 50 indicate higher perceived satisfaction than the population mean i.e., better outcomes. PROMIS measure scores are computed to a T-score, where 50 represents the mean for US general population, and 10 is the standard deviation. Within group differences in T-scores (change scores) from baseline to 3-month post-intervention were calculated (3-month follow up T-score minus baseline T-score). Positive change scores are indicative of improvement in satisfaction with social roles and activities at the study endpoint.

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.

  13. Changes in the PROMIS v2.0 Social Isolation 4a T-score From Baseline to 3-months Post-intervention (Within Group)

    The PROMIS v2.0 - Social Isolation 4a includes 4 items that assess feelings of isolation, companionship, and trust. The items scored on a five-point scale ("never" to "always"). PROMIS measure scores are computed to a T-score, where 50 represents the mean for US general population, and 10 is the standard deviation. Scores higher than 50 indicate more social isolation, i.e. worse outcomes. Within group differences in T-scores (change scores) from baseline to 3-month post-intervention were calculated (3-month follow up T-score minus baseline T-score). Positive change scores are indicative of increased social isolation at the study endpoint; negative change scores indicate decreased social isolation (better outcomes).

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.

  14. Changes in the Pittsburgh Sleep Quality Index Total Score From Baseline to 3-months Post-intervention (Within Group)

    The Pittsburgh Sleep Quality Index (PSQI) is a self-report scale consisting of 19 items that produce a global sleep quality score and the following 7 component scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. Total score is reported here and has a potential range of 0-21. Higher scores indicate poorer sleep quality.

    Measured: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week.

Timeline

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

  1. First posted29 Dec 2015 (estimated)
  2. Study start1 Jan 2016
  3. Primary completion26 Feb 2021
  4. Study completion30 Sep 2021

Resources

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
None (open label)
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02640690
Sponsor's protocol ID
NRI 15-151
Acronym
PSLII
Status last verified
Sep 2024
First submitted
16 Dec 2015
Last updated
8 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zaccari B, Loftis JM, Haywood T, Hubbard K, Clark J, Kelly UA. Synchronous Telehealth Yoga and Cognitive Processing Group Therapies for Women Veterans with Posttraumatic Stress Disorder: A Multisite Randomized Controlled Trial Adapted for COVID-19. Telemed J E Health. 2022 Mar 29:10.1089/tmj.2021.0612. doi: 10.1089/tmj.2021.0612. Online ahead of print.

    PubMed 35357957
  • Kelly U, Haywood T, Segell E, Higgins M. Trauma-Sensitive Yoga for Post-Traumatic Stress Disorder in Women Veterans who Experienced Military Sexual Trauma: Interim Results from a Randomized Controlled Trial. J Altern Complement Med. 2021 Mar;27(S1):S45-S59. doi: 10.1089/acm.2020.0417.

    PubMed 33788599
  • Zaccari B, Higgins M, Haywood TN, Patel M, Emerson D, Hubbard K, Loftis JM, Kelly UA. Yoga vs Cognitive Processing Therapy for Military Sexual Trauma-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2344862. doi: 10.1001/jamanetworkopen.2023.44862.

    PubMed 38064219
  • O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

    PubMed 37795783

Questions about this trial

What is this clinical trial studying?

A study testing Trauma Center Trauma Sensitive Yoga Intervention (TCTSY) and Cognitive Processing Therapy in people with Stress Disorders, Post-traumatic, run by VA Office of Research and Development at 2 sites 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 4 inclusion and 11 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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 8 Oct 2024). 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?

Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention (time frame: Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).). 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 NCT02640690, which also lists 4 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 8 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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