Post Traumatic Stress DisorderNETNCT04525469
Feasibility Trial of Narrative Exposure Therapy (NET) for Posttraumatic Stress Disorder (PTSD) During Pregnancy
A study testing Narrative Exposure Therapy in people with Post Traumatic Stress Disorder, run by Rush University Medical Center at 1 site in United States.
Trial summary
Posttraumatic stress disorder (PTSD) affects up to 35% of pregnant trauma survivors. Moreover, prenatal PTSD rates are up to 4 times higher among communities of color compared to white populations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Narrative Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2019to 1 May 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Fluent in English
- History of a DSM-V PTSD criterion A trauma at least 3 months prior to current pregnancy (a person has experienced, witnessed, or been confronted with an event or events that involve actual or threatened death or serious injury, or threat of physical integrity to oneself or others)
- A score of 33 or higher on the PTSD Checklist for the DSM-V with Life Events Checklist for DSM-5 and Criterion A.
Who cannot join
- Current manic or psychotic symptoms or primary psychotic diagnosis
- Serious cognitive impairment
- Concurrent psychotherapy
- Unstable dose of psychotropic medications (must be stable for 6 weeks)
- Serious medical complications of pregnancy (e.g., pre-eclampsia, HELLP syndrome, diagnosed fetal anomaly or death, threatened preterm birth, hospitalization for hypertensive disorders of pregnancy, unstable diabetes, premature rupture of membranes, preterm labor)
- Significant suicidal ideation
- Current legal actions related to trauma
- Patient will be 27 gestational weeks or more at the time of the eligibility session
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Posttraumatic stress disorder (PTSD) affects up to 35% of pregnant trauma survivors. Moreover, prenatal PTSD rates are up to 4 times higher among communities of color compared to white populations. PTSD during pregnancy has been linked to an increased risk of adverse perinatal and infant health outcomes and may even contribute to racial disparities in adverse perinatal outcomes. Although front-line treatments exist for PTSD, treatment research that specifically focus on pregnancy are extremely limited. Clinical studies examining the safety, acceptability, feasibility, and efficacy of treatments for PTSD during pregnancy are virtually non-existent. Thus, pregnant individuals with PTSD, particularly within low-income communities of color, are a vulnerable and underserved group in need of effective treatment approaches for their distress. Investigators propose to conduct a feasibility and acceptability study of a PTSD treatment, Narrative Exposure Therapy (NET), in a sample of pregnant individuals with PTSD in which low-income people of color are highly represented.
Aim 1: The purpose of Aim 1 will be to examine feasibility. Investigators will evaluate the recruitment and assessment procedures.
Read more
Aim 2: The purpose of Aim 2 will be to examine acceptability. Investigators will evaluate participant feedback of the NET intervention.
Aim 3: The purpose of Aim 3 will be to examine the proportion of participants demonstrating clinically meaningful reduction in PTSD and perinatal depression symptoms from pre- to post-treatment.
Investigators will aim to enroll up to 30 participants; participation will last up to ten months. Data sources will include questionnaires, electronic medical records, and qualitative feedback interviews.
With this study, investigators aim to fill a critical gap in knowledge of how to safely and effectively treat PTSD among a vulnerable and underserved population (i.e., perinatal individuals of color).
Read the detailed description
Investigators will conduct a feasibility and acceptability study of Narrative Exposure Therapy (NET) to treat up to 30 pregnant trauma survivors with clinically-significant symptoms of PTSD.
Up to 100 participants will be recruited with the aim of enrolling 30 participants in NET. Pregnant patients will be recruited from Rush OB/GYN resident training clinics. The racial/ethnic composition of patients served at these clinics (>70% ethno-racial minorities) will ensure that participants of color will be highly represented. Methods of recruitment include NET brochures that will be placed in the clinic's waiting rooms, OB/GYN physicians and nurse referring patients with a known history of trauma, and a 2-item screening measure -- the PTSD Checklist, Civilian Version (PCL-2) -- at the patient's initial OB appointment to facilitate recruitment.
Following initial referral, the study team will conduct a brief phone screen to ensure basic eligibility criteria are met, describe the study purpose, and schedule eligible participants for an initial study session (week 0). During the initial visit participants will sign informed consent and complete self-report measures (week 1 of the study) - after which they will then be enrolled in the intervention (weeks 1-6 of the study). Participants will complete post-treatment self-report measures and treatment evaluation measures at 1 week and 1-month following their last NET session (week 7 and week 10, respectively), and again at 1-month postpartum. The participant will also be invited to complete a qualitative feedback interview upon completion of the intervention (or early withdrawal from intervention).
Participants will be compensated for completion of all assessments and study components.
Due to the Coronavirus/COVID-19 pandemic, all study activities will be conducted via telephone or telehealth.
Schedule of Activities:
- Week 1: Consent and Pre-Intervention Clinical AND NET Session 1 Consent Session/Pre-Intervention Clinical interview
- Informed Consent: If patients are interested in participating in this study, they will undergo the informed consent procedure. A trained clinician with experience working with trauma survivors will verbally review the informed consent document.
- Interview and Self-Report Measures:
- Participation in Treatment while enrolled in the study: Patients may be in or seek psychological or psychiatric treatment and still enroll in the study, as long as they are not undergoing exposure therapy. If patients indicate that they are already or wish to seek such treatment, they will be asked to provide consent for study personnel to contact their mental health provider to obtain this single piece of information, as well as whether or not they are being prescribed anti-psychotics (which is a reason for study exclusion)
- NET Session 1
- For each weekly session, the content of each session will be taken from the NET manual, a developed manualized treatment. The NET manual can be accessed here: https://www.psychologytools.com/category/narrative-exposure-therapy-net/
- Weeks 2-6: Sessions 2-6 of NET
- Participants will also complete self-report measures before the beginning of each NET session via REDCap.
- 1 Week Post-treatment: Post-treatment Evaluation
- 1 Month Post-treatment 10: Post-treatment Evaluation
- 1 Month Postpartum: Follow-up Evaluation
- Qualitative Feedback Interview (upon completion of the intervention or early withdrawal from intervention)
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Narrative Exposure Therapy
- Keywords
- PTSD, Post Traumatic Stress Disorder, Perinatal, Pregnancy, Trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure TherapyBehavioural
Also called NET
NET involves: 1) diagnostic interview and psychoeducation, 2) laying out the Lifeline, 3) NET therapy sessions (constructing the trauma narrative in context of the life course), 4) final session rituals. Laying out the Lifeline (using rope or string) allows participants to take a bird's eye view of the events of their life using simple items such as flowers to represent positive events and stones to represent traumatic events. The focus of NET sessions is to encourage participants to describe the details of traumas and integrating the "cold" memories (i.e., facts) with the "hot" memories (e.g., cognitions, emotions, physiological feelings, and sensory information). The therapist makes notes after each session narrating the details of the traumas ("stones") and reads this at the beginning of each subsequent session. Final session rituals involve re-reading the trauma narrative, hopes for the future, and laying out the final Lifeline placing flowers for hopes and wishes for the future.
| Study group | Role | What they receive |
|---|---|---|
| Narrative Exposure Therapy | Experimental | NET is a fully-manualized evidence-based treatment for PTSD. Participants will receive 6 weekly 60-minute individual sessions of NET. Receives: Behavioral: Narrative Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility via recruitment rate
Investigators will compute the number of phone screens conducted, number of eligibility sessions completed, and number of subjects enrolled to obtain participant enrollment rates.
Measured: Screening to enrollment (Week 1)
Feasibility via retention rate (sessions completed/dropout rate)
Investigators will calculate the mean number of sessions attended and the dropout rate, recording reason for drop out, such as participants' desire to withdraw from the NET treatment vs. medical complications of pregnancy or early delivery.
Measured: Week 1 (NET Session 1) to Week 6 (NET Session 6)
Feasibility via retention rate (completion of follow-up questionnaires)
Investigators will calculate the mean number of follow-up questionnaires completed.
Measured: 1 Week Post-treatment (Post-treatment Evaluation), 1 Month Post-treatment (Post-treatment Evaluation), 1 Month Post-partum (Follow-up Evaluation)
Acceptability of the NET intervention via participant satisfaction
Investigators will compute mean ratings of satisfaction (adapted Client Satisfaction Questionnaire).
Measured: 1 Week Post-treatment (Post-treatment evaluation)
Acceptability of the NET intervention via participant expectancy
Investigators will compute mean ratings of expectancy via feasibility and acceptability questionnaires.
Measured: Week 1 (NET Session 1) , Week 2, Week 3, Week 4, Week 5, Week 6 (NET Sessions 6)
Acceptability of the NET intervention via perceived benefit
Investigators will compute mean ratings of perceived benefit via post-treatment evaluations.
Measured: 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)
Acceptability of the NET intervention via qualitative feedback
Primary outcome will include qualitative feedback regarding aspects of the NET intervention and its acceptability during pregnancy and in preparation for the transition to parenthood via a study-developed qualitative interview.
Measured: Upon study completion (up to 10 months) or upon early withdrawal from intervention
Change in Symptoms of PTSD
Investigators will use the Posttraumatic Check List for DSM-5 (PCL-5), a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
Measured: Week 1 (NET Session 1), 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)
Secondary outcomes (1)
Change in Symptoms of Perinatal Depression
Investigators will use the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report measure for depression screening in the perinatal period.
Measured: Week 1 (NET Session 1), 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start27 Feb 2019
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Stevens, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525469
- Sponsor's protocol ID
- 18111901-IRB01
- Acronym
- NET
- Status last verified
- Jul 2022
- First submitted
- 13 Aug 2020
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stevens NR, Miller ML, Soibatian C, Otwell C, Rufa AK, Meyer DJ, Shalowitz MU. Exposure therapy for PTSD during pregnancy: a feasibility, acceptability, and case series study of Narrative Exposure Therapy (NET). BMC Psychol. 2020 Dec 9;8(1):130. doi: 10.1186/s40359-020-00503-4.
PubMed 33298159
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of Narrative Exposure Therapy (NET) for Posttraumatic Stress Disorder (PTSD) During Pregnancy
- ClinicalTrials.gov ID
- NCT04525469
- Acronym / sponsor ID
- NET / 18111901-IRB01
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD, Post Traumatic Stress Disorder, Perinatal, Pregnancy, Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 25 Aug 2020 (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.
Posttraumatic stress disorder (PTSD) affects up to 35% of pregnant trauma survivors. Moreover, prenatal PTSD rates are up to 4 times higher among communities of color compared to white populations. PTSD during pregnancy has been linked to an increased risk of adverse perinatal and infant health outcomes and may even contribute to racial disparities in adverse perinatal outcomes. Although front-line treatments exist for PTSD, treatment research that specifically focus on pregnancy are extremely limited. Clinical studies examining the safety, acceptability, feasibility, and efficacy of treatments for PTSD during pregnancy are virtually non-existent. Thus, pregnant individuals with PTSD, particularly within low-income communities of color, are a vulnerable and underserved group in need of effective treatment approaches for their distress. Investigators propose to conduct a feasibility and acceptability study of a PTSD treatment, Narrative Exposure Therapy (NET), in a sample of pregnant individuals with PTSD in which low-income people of color are highly represented.
Aim 1: The purpose of Aim 1 will be to examine feasibility. Investigators will evaluate the recruitment and assessment procedures.
Aim 2: The purpose of Aim 2 will be to examine acceptability. Investigators will evaluate participant feedback of the NET intervention.
Aim 3: The purpose of Aim 3 will be to examine the proportion of participants demonstrating clinically meaningful reduction in PTSD and perinatal depression symptoms from pre- to post-treatment.
Investigators will aim to enroll up to 30 participants; participation will last up to ten months. Data sources will include questionnaires, electronic medical records, and qualitative feedback interviews.
With this study, investigators aim to fill a critical gap in knowledge of how to safely and effectively treat PTSD among a vulnerable and underserved population (i.e., perinatal individuals of color).
Detailed description
Investigators will conduct a feasibility and acceptability study of Narrative Exposure Therapy (NET) to treat up to 30 pregnant trauma survivors with clinically-significant symptoms of PTSD.
Up to 100 participants will be recruited with the aim of enrolling 30 participants in NET. Pregnant patients will be recruited from Rush OB/GYN resident training clinics. The racial/ethnic composition of patients served at these clinics (>70% ethno-racial minorities) will ensure that participants of color will be highly represented. Methods of recruitment include NET brochures that will be placed in the clinic's waiting rooms, OB/GYN physicians and nurse referring patients with a known history of trauma, and a 2-item screening measure -- the PTSD Checklist, Civilian Version (PCL-2) -- at the patient's initial OB appointment to facilitate recruitment.
Following initial referral, the study team will conduct a brief phone screen to ensure basic eligibility criteria are met, describe the study purpose, and schedule eligible participants for an initial study session (week 0). During the initial visit participants will sign informed consent and complete self-report measures (week 1 of the study) - after which they will then be enrolled in the intervention (weeks 1-6 of the study). Participants will complete post-treatment self-report measures and treatment evaluation measures at 1 week and 1-month following their last NET session (week 7 and week 10, respectively), and again at 1-month postpartum. The participant will also be invited to complete a qualitative feedback interview upon completion of the intervention (or early withdrawal from intervention).
Participants will be compensated for completion of all assessments and study components.
Due to the Coronavirus/COVID-19 pandemic, all study activities will be conducted via telephone or telehealth.
Schedule of Activities:
- Week 1: Consent and Pre-Intervention Clinical AND NET Session 1 Consent Session/Pre-Intervention Clinical interview
- Informed Consent: If patients are interested in participating in this study, they will undergo the informed consent procedure. A trained clinician with experience working with trauma survivors will verbally review the informed consent document.
- Interview and Self-Report Measures:
- Participation in Treatment while enrolled in the study: Patients may be in or seek psychological or psychiatric treatment and still enroll in the study, as long as they are not undergoing exposure therapy. If patients indicate that they are already or wish to seek such treatment, they will be asked to provide consent for study personnel to contact their mental health provider to obtain this single piece of information, as well as whether or not they are being prescribed anti-psychotics (which is a reason for study exclusion)
- NET Session 1
- For each weekly session, the content of each session will be taken from the NET manual, a developed manualized treatment. The NET manual can be accessed here: https://www.psychologytools.com/category/narrative-exposure-therapy-net/
- Weeks 2-6: Sessions 2-6 of NET
- Participants will also complete self-report measures before the beginning of each NET session via REDCap.
- 1 Week Post-treatment: Post-treatment Evaluation
- 1 Month Post-treatment 10: Post-treatment Evaluation
- 1 Month Postpartum: Follow-up Evaluation
- Qualitative Feedback Interview (upon completion of the intervention or early withdrawal from intervention)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Narrative Exposure Therapy | Experimental | Behavioral: Narrative Exposure TherapyNET is a fully-manualized evidence-based treatment for PTSD. Participants will receive 6 weekly 60-minute individual sessions of NET. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Fluent in English
- History of a DSM-V PTSD criterion A trauma at least 3 months prior to current pregnancy (a person has experienced, witnessed, or been confronted with an event or events that involve actual or threatened death or serious injury, or threat of physical integrity to oneself or others)
- A score of 33 or higher on the PTSD Checklist for the DSM-V with Life Events Checklist for DSM-5 and Criterion A.
Key exclusion criteria (8 listed)
- Current manic or psychotic symptoms or primary psychotic diagnosis
- Serious cognitive impairment
- Concurrent psychotherapy
- Unstable dose of psychotropic medications (must be stable for 6 weeks)
- Serious medical complications of pregnancy (e.g., pre-eclampsia, HELLP syndrome, diagnosed fetal anomaly or death, threatened preterm birth, hospitalization for hypertensive disorders of pregnancy, unstable diabetes, premature rupture of membranes, preterm labor)
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 |
|---|---|---|
| Narrative Exposure TherapyAlso: NETNET involves: 1) diagnostic interview and psychoeducation, 2) laying out the Lifeline, 3) NET therapy sessions (constructing the trauma narrative in context of the life course), 4) final session rituals. Laying out the Lifeline (using rope or string) allows participants to take a bird's eye view of the events of their life using simple items such as flowers to represent positive events and stones to represent traumatic events. The focus of NET sessions is to encourage participants to describe the details of traumas and integrating the "cold" memories (i.e., facts) with the "hot" memories (e.g., cognitions, emotions, physiological feelings, and sensory information). The therapist makes notes after each session narrating the details of the traumas ("stones") and reads this at the beginning of each subsequent session. Final session rituals involve re-reading the trauma narrative, hopes for the future, and laying out the final Lifeline placing flowers for hopes and wishes for the future. | Behavioural | Narrative Exposure Therapy |
Primary outcome
Feasibility via recruitment rate
Time frame: Screening to enrollment (Week 1)
Investigators will compute the number of phone screens conducted, number of eligibility sessions completed, and number of subjects enrolled to obtain participant enrollment rates.
Feasibility via retention rate (sessions completed/dropout rate)
Time frame: Week 1 (NET Session 1) to Week 6 (NET Session 6)
Investigators will calculate the mean number of sessions attended and the dropout rate, recording reason for drop out, such as participants' desire to withdraw from the NET treatment vs. medical complications of pregnancy or early delivery.
Feasibility via retention rate (completion of follow-up questionnaires)
Time frame: 1 Week Post-treatment (Post-treatment Evaluation), 1 Month Post-treatment (Post-treatment Evaluation), 1 Month Post-partum (Follow-up Evaluation)
Investigators will calculate the mean number of follow-up questionnaires completed.
Acceptability of the NET intervention via participant satisfaction
Time frame: 1 Week Post-treatment (Post-treatment evaluation)
Investigators will compute mean ratings of satisfaction (adapted Client Satisfaction Questionnaire).
Acceptability of the NET intervention via participant expectancy
Time frame: Week 1 (NET Session 1) , Week 2, Week 3, Week 4, Week 5, Week 6 (NET Sessions 6)
Investigators will compute mean ratings of expectancy via feasibility and acceptability questionnaires.
Acceptability of the NET intervention via perceived benefit
Time frame: 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)
Investigators will compute mean ratings of perceived benefit via post-treatment evaluations.
Acceptability of the NET intervention via qualitative feedback
Time frame: Upon study completion (up to 10 months) or upon early withdrawal from intervention
Primary outcome will include qualitative feedback regarding aspects of the NET intervention and its acceptability during pregnancy and in preparation for the transition to parenthood via a study-developed qualitative interview.
Change in Symptoms of PTSD
Time frame: Week 1 (NET Session 1), 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)
Investigators will use the Posttraumatic Check List for DSM-5 (PCL-5), a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
1 secondary outcome
Change in Symptoms of Perinatal Depression
Time frame: Week 1 (NET Session 1), 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)
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 22 Jul 2022.
- Derived from this study: PubMed 33298159Stevens NR, Miller ML, Soibatian C, Otwell C, Rufa AK, Meyer DJ, Shalowitz MU. Exposure therapy for PTSD during pregnancy: a feasibility, acceptability, and case series study of Narrative Exposure Therapy (NET). BMC Psychol. 2020 Dec 9;8(1):130. doi: 10.1186/s40359-020-00503-4.
- Individual participant dataSharing planned: No
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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 Narrative Exposure Therapy in people with Post Traumatic Stress Disorder, run by Rush University Medical Center 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 4 inclusion and 8 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 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility via recruitment rate (time frame: Screening to enrollment (Week 1)). The study lists 8 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 NCT04525469, which also lists 1 linked publication.
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 22 Jul 2022.