Postpartum DepressionNCT05423093
Virtual Group Psychoeducational Discussions With Spanish-Speaking Mothers of Infants in Pediatric Primary Care
A study testing Single-Session Virtual Group Psychoeducational Session about Postpartum Depression in people with Postpartum Depression and Postpartum Anxiety, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of the proposed research is to test the feasibility and acceptability of a virtual group session which is intended to be offered universally to Spanish-speaking parents of newborns/infants attending pediatric primary care. Read more about this study
- Who is it for?
- Ages 16 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Postpartum Anxiety
- What is being tested?
- Single-Session Virtual Group Psychoeducational Session about Postpartum Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2022to 28 Apr 2025
- 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 16 to 99 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent participants will be eligible if the preferred healthcare language is Spanish, if they are the mother of an infant (<2 months of age) attending participating pediatric practice, and if she is not felt to have a contraindication to participation (e.g., condition in the parent that would preclude the ability to reasonably participate in a virtual group session) by clinic staff
- Clinic staff participants - facilitators of virtual groups
Who cannot join
- <16 years old, preferred healthcare language not Spanish, not planning to attend participating practice, clinic staff determines contraindication to participation in group discussion
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Pediatric Group Well Child Visits for Detection of Maternal Depression in Latinas
The goal of the proposed research is to test the feasibility and acceptability of a virtual group session which is intended to be offered universally to Spanish-speaking parents of newborns/infants attending pediatric primary care. The virtual session is intended to (1) enhance patient/family education about postpartum depression (PPD) and (2) Provide an orientation to families regarding relevant clinic and community psychosocial support resources available. The investigators will conduct a single-arm, open pilot of the session, which will be co-delivered by existing clinic staff (including social work and community outreach staff). Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs. The overall aim of the project is to Develop and pilot a virtual group augmentation of standard individual well-child care to improve (1) clinic screening procedures, discussion about and initial management of maternal depressive symptoms with immigrant Latinas and (2) patient symptom recognition, symptom disclosure, and subsequent treatment engagement
Read the detailed description
The current study is designed as an open/single-arm pilot of the intervention (no comparison arm for this initial/preliminary study, which is also being offered as a clinic service).
Participants include Spanish-speaking parents of infants (6 months or younger) attending a pediatric practice.
Parents are recruited via flyers posted at the clinic as well as via referral from pediatric providers and staff (who can obtain permission from family for research staff to discuss the study with the family at the visit and/or to contact the family at a later time).
After screening, oral consent is obtained over the phone or zoom, and baseline measures are collected over the phone or zoom, prior to attendance at the intervention session.
Intervention Sessions will be offered at regular intervals, on at least a monthly basis, via Zoom. The sessions (desiged to last 45-60 minutes), which will be observed by research staff with permission of participants, are co-facilitated by a bilingual clinic social worker and bilingual community health worker.
Sessions consist of the following content:
- Introduction and discussion of the purpose of the session/group; (2) Overview of services available at the clinic; (3) information about postpartum depression, including a five minute video testimonial followed by facilitated discussion about (a) prevalence and signs of postpartum depression, discussion of postpartum depression screening procedures and rationale for screening at the pediatric office, discussion of self-care and social support, and discussion of community resources (a list of resources are also mailed to the participants); (4) Discussion about insurance and health care for the infant and mother, including free/sliding scale clinics offering primary care for adults and rationale for engaging in one's own primary care in addition to pediatric health care for the infant.
After the session (within 2 weeks post-session) the research team collects post-session measures (see outcome measures) and conducts semi-structured interviews with participants.
6 months after the session, the research team will administer questionnaires over the phone assessing feedback about the intervention, physical and mental health services utilization, and post-intervention assessments (see outcome measures)
- Conditions
- Postpartum Depression, Postpartum Anxiety
- Being tested
- Single-Session Virtual Group Psychoeducational Session about Postpartum Depression
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Session Virtual Group Psychoeducational Session about Postpartum DepressionBehavioural
Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention delivery | Experimental | Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff. Receives: Behavioral: Single-Session Virtual Group Psychoeducational Session about Postpartum Depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction as Assessed by the Intervention Satisfaction Survey
Completed by parent participants. 5-point likert scale from 1 (strongly disagree) to 5 (strongly agree), higher scores indicative of higher satisfaction. No established cutoff.
Measured: Within 2 weeks of attending video group session
Acceptability of Intervention Measure
Completed by parent participants. 4-question pragmatic measure designed to assess construct of intervention acceptability as perceived by participant. 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Higher scores indicate greater acceptability. Score for each participant calculated as mean score for each item (range 1-5)
Measured: Within 2 weeks of attending video group session
Secondary outcomes (7)
Pre-Post Intervention Change in Mental Health Care Stigma as Assessed by the Stigma Concerns About Mental Health Care (SCMHC) Scale
Completed by parent participants. The SCMHC is a 3-item measure assessing stigma-related barriers to the utilization of depression treatment (internalized stigma, fear of stigmatization, and stigma from family in seeking mental health care). Responses are coded as (0) disagree, (1) agree, and (7) don't know/refuse. Respondents receive one point for each response of "agree," which indicates agreement with the stigma-related barrier. The total scores range from 0 to 3 with higher scores indicating an increased internalization of stigma to mental health care
Measured: Baseline (pre-session); within 2 weeks post-session
Change in Depression Stigma as Assessed by the Adapted Personal Stigma Scale (PSS)
7 items, assess personal attitudes towards people with depression. Items answered on 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). Calculated as average item score, higher scores indicate higher levels of depression stigma.
Measured: Baseline (pre-session); within 2 weeks post-session
Postpartum Depression Knowledge as Assessed by Adapted Postpartum Depression Knowledge Measure
Measure of participant knowledge about postpartum depression knowledge- adapted and translated from the Ontario Rapid Risk Factor Surveillance Survey. Questions include whether the participant has heard of the concept of postpartum depression, asks participants to name symptoms of postpartum depression, and asks participants how common they would estimate the condition to be. There is no standard scale/scoring. Percent of participants answering affirmatively to the question "Have you heard of postpartum depression?" is reported.
Measured: Completed by participants at baseline (pre-session); within 2 weeks post-session; 6 months post session
Intention to Disclose if Developed Postpartum Depression Symptoms as Assessed by Questionnaire
Completed by parent participants. Single-question item: If I felt down, depressed, hopeless, or having little interest or pleasure in doing things I would try to contact someone at this clinic. Response options were No or Yes.
Measured: Baseline (pre-session); within 2 weeks post-session; and 6 months post-session
Intention to Seek Primary Care as Assessed by Survey Question
Developed for this study, single likert scale question asked of participants who did not have an identified primary care doctor: As a result of the video group session, I plan to identify a doctor that I can see regularly for my own check-ups. Adapted from National Latino and Asian American Study. Scale range from 1-5, 1= strongly agree; 2=agree; 3=neutral/no opinion, 4=disagree, 5=strongly disagree
Measured: Baseline, Within 2 weeks of attending video group session, 6 months post intervention
Self-reported Mental Health Service Utilization Within the Past 6 Months
Single item, adapted from National Latino and Asian American Study; question: "within the past 6 months, have you had a therapy session with a psychologist or therapist or another professional that lasted 30 minutes or longer"?. Response options included "Yes", "No", "Unsure", and "Prefer Not to Answer".
Measured: 6 months post-intervention
Psychosocial Resource Utilization as Assessed by Questionnaire
Completed by participant. Question developed for this project and translated/certified, assessing use of clinic ancillary services discussed in the intervention: In the past 2 months, have you used any of the resources that were discussed in the video session or on the clinic website? Responses could include "Yes", "No", or "Unsure"
Measured: 6-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start9 Jun 2022
- Primary completion30 Nov 2024
- Study completion28 Apr 2025
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 (5)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Rheanna Platt, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423093
- Sponsor's protocol ID
- IRB00170216
- Other IDs
- 1K23MH118431-01A1
- Status last verified
- Aug 2025
- First submitted
- 31 May 2022
- Last updated
- 3 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fothergill KE, Gadomski A, Solomon BS, Olson AL, Gaffney CA, Dosreis S, Wissow LS. Assessing the impact of a web-based comprehensive somatic and mental health screening tool in pediatric primary care. Acad Pediatr. 2013 Jul-Aug;13(4):340-7. doi: 10.1016/j.acap.2013.04.005.
PubMed 23830020Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Eghaneyan BH, Killian MO, Sanchez K, Cabassa LJ. Psychometric Properties of Three Measures of Stigma Among Hispanics with Depression. J Immigr Minor Health. 2021 Oct;23(5):946-955. doi: 10.1007/s10903-021-01234-3. Epub 2021 Jun 19.
PubMed 34152503Caplan S. A Pilot Study of a Novel Method of Measuring Stigma about Depression Developed for Latinos in the Faith-Based Setting. Community Ment Health J. 2016 Aug;52(6):701-9. doi: 10.1007/s10597-016-0005-7. Epub 2016 Apr 16.
PubMed 27085546Platt R, Richman R, Martin C, Martin KJ, Mendelson T. Feasibility and Acceptability of a Video Group Psychoeducational Intervention with Latina Immigrant Mothers to Enhance Infant Primary care. J Immigr Minor Health. 2024 Oct;26(5):945-952. doi: 10.1007/s10903-024-01612-7. Epub 2024 Jul 4.
PubMed 38963477
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Group Well Child Visits for Detection of Maternal Depression in Latinas
- ClinicalTrials.gov ID
- NCT05423093
- Acronym / sponsor ID
- IRB00170216
- Conditions
- Postpartum Depression, Postpartum Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Posted 7 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the proposed research is to test the feasibility and acceptability of a virtual group session which is intended to be offered universally to Spanish-speaking parents of newborns/infants attending pediatric primary care. The virtual session is intended to (1) enhance patient/family education about postpartum depression (PPD) and (2) Provide an orientation to families regarding relevant clinic and community psychosocial support resources available. The investigators will conduct a single-arm, open pilot of the session, which will be co-delivered by existing clinic staff (including social work and community outreach staff). Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs. The overall aim of the project is to Develop and pilot a virtual group augmentation of standard individual well-child care to improve (1) clinic screening procedures, discussion about and initial management of maternal depressive symptoms with immigrant Latinas and (2) patient symptom recognition, symptom disclosure, and subsequent treatment engagement
Detailed description
The current study is designed as an open/single-arm pilot of the intervention (no comparison arm for this initial/preliminary study, which is also being offered as a clinic service).
Participants include Spanish-speaking parents of infants (6 months or younger) attending a pediatric practice.
Parents are recruited via flyers posted at the clinic as well as via referral from pediatric providers and staff (who can obtain permission from family for research staff to discuss the study with the family at the visit and/or to contact the family at a later time).
After screening, oral consent is obtained over the phone or zoom, and baseline measures are collected over the phone or zoom, prior to attendance at the intervention session.
Intervention Sessions will be offered at regular intervals, on at least a monthly basis, via Zoom. The sessions (desiged to last 45-60 minutes), which will be observed by research staff with permission of participants, are co-facilitated by a bilingual clinic social worker and bilingual community health worker.
Sessions consist of the following content:
- Introduction and discussion of the purpose of the session/group; (2) Overview of services available at the clinic; (3) information about postpartum depression, including a five minute video testimonial followed by facilitated discussion about (a) prevalence and signs of postpartum depression, discussion of postpartum depression screening procedures and rationale for screening at the pediatric office, discussion of self-care and social support, and discussion of community resources (a list of resources are also mailed to the participants); (4) Discussion about insurance and health care for the infant and mother, including free/sliding scale clinics offering primary care for adults and rationale for engaging in one's own primary care in addition to pediatric health care for the infant.
After the session (within 2 weeks post-session) the research team collects post-session measures (see outcome measures) and conducts semi-structured interviews with participants.
6 months after the session, the research team will administer questionnaires over the phone assessing feedback about the intervention, physical and mental health services utilization, and post-intervention assessments (see outcome measures)
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention delivery | Experimental | Behavioral: Single-Session Virtual Group Psychoeducational Session about Postpartum DepressionParticipants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff. |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parent participants will be eligible if the preferred healthcare language is Spanish, if they are the mother of an infant (<2 months of age) attending participating pediatric practice, and if she is not felt to have a contraindication to participation (e.g., condition in the parent that would preclude the ability to reasonably participate in a virtual group session) by clinic staff
- Clinic staff participants - facilitators of virtual groups
Key exclusion criteria (1 listed)
- <16 years old, preferred healthcare language not Spanish, not planning to attend participating practice, clinic staff determines contraindication to participation in group discussion
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 |
|---|---|---|
| Single-Session Virtual Group Psychoeducational Session about Postpartum DepressionSession contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs. | Behavioural | Intervention delivery |
Primary outcome
Satisfaction as Assessed by the Intervention Satisfaction Survey
Time frame: Within 2 weeks of attending video group session
Completed by parent participants. 5-point likert scale from 1 (strongly disagree) to 5 (strongly agree), higher scores indicative of higher satisfaction. No established cutoff.
Acceptability of Intervention Measure
Time frame: Within 2 weeks of attending video group session
Completed by parent participants. 4-question pragmatic measure designed to assess construct of intervention acceptability as perceived by participant. 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Higher scores indicate greater acceptability. Score for each participant calculated as mean score for each item (range 1-5)
7 secondary outcomes
Pre-Post Intervention Change in Mental Health Care Stigma as Assessed by the Stigma Concerns About Mental Health Care (SCMHC) Scale
Time frame: Baseline (pre-session); within 2 weeks post-session
Change in Depression Stigma as Assessed by the Adapted Personal Stigma Scale (PSS)
Time frame: Baseline (pre-session); within 2 weeks post-session
Postpartum Depression Knowledge as Assessed by Adapted Postpartum Depression Knowledge Measure
Time frame: Completed by participants at baseline (pre-session); within 2 weeks post-session; 6 months post session
Intention to Disclose if Developed Postpartum Depression Symptoms as Assessed by Questionnaire
Time frame: Baseline (pre-session); within 2 weeks post-session; and 6 months post-session
Intention to Seek Primary Care as Assessed by Survey Question
Time frame: Baseline, Within 2 weeks of attending video group session, 6 months post intervention
Self-reported Mental Health Service Utilization Within the Past 6 Months
Time frame: 6 months post-intervention
Psychosocial Resource Utilization as Assessed by Questionnaire
Time frame: 6-months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23830020Fothergill KE, Gadomski A, Solomon BS, Olson AL, Gaffney CA, Dosreis S, Wissow LS. Assessing the impact of a web-based comprehensive somatic and mental health screening tool in pediatric primary care. Acad Pediatr. 2013 Jul-Aug;13(4):340-7. doi: 10.1016/j.acap.2013.04.005.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 34152503Eghaneyan BH, Killian MO, Sanchez K, Cabassa LJ. Psychometric Properties of Three Measures of Stigma Among Hispanics with Depression. J Immigr Minor Health. 2021 Oct;23(5):946-955. doi: 10.1007/s10903-021-01234-3. Epub 2021 Jun 19.
- Background: PubMed 27085546Caplan S. A Pilot Study of a Novel Method of Measuring Stigma about Depression Developed for Latinos in the Faith-Based Setting. Community Ment Health J. 2016 Aug;52(6):701-9. doi: 10.1007/s10597-016-0005-7. Epub 2016 Apr 16.
- Derived from this study: PubMed 38963477Platt R, Richman R, Martin C, Martin KJ, Mendelson T. Feasibility and Acceptability of a Video Group Psychoeducational Intervention with Latina Immigrant Mothers to Enhance Infant Primary care. J Immigr Minor Health. 2024 Oct;26(5):945-952. doi: 10.1007/s10903-024-01612-7. Epub 2024 Jul 4.
- Rapid Risk Factor Surveillance SystemLink provided by the sponsor.
- National Latino and Asian American Study DocumentsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Postpartum Depression
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
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.
Rheanna Platt, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Session Virtual Group Psychoeducational Session about Postpartum Depression in people with Postpartum Depression and Postpartum Anxiety, run by Johns Hopkins University 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 2 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 3 Sep 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 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 7 Aug 2025). 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?
Satisfaction as Assessed by the Intervention Satisfaction Survey (time frame: Within 2 weeks of attending video group session). 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 NCT05423093, which also lists 5 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 3 Sep 2025.