Post-partum DepressionNCT06208852
Virtual Patient Navigation During a Pandemic
A study testing Virtual Navigator Program in people with Post-partum Depression, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The sub-study will involve a rigorous mixed-methods design. The qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-partum Depression
- What is being tested?
- Virtual Navigator Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2023to 31 May 2026
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Qualitative Phase:
- Women who:
- Are either former participants from the R61 Phase (IRB 19-016174) of the Main RCT, or have been referred, are actively enrolled, or withdrawn from the R33 Phase (IRB 22-019784) of the Main RCT.
- Are > 18 years of age
- Speak and read in English
- Have access to a smart phone or computer tablet with internet access
Show all 14Show fewer
- Have an infant < 12 months of age
- Intervention Phase:
- Women who:
- Are not actively engaged with MH services
- Screen positive for postpartum depression (score>9) on the EPDS
- Are > 18 years of age
- Speak and read in English
- Have access to a cellular phone with texting capabilities
Who cannot join
- Qualitative Phase:
- Women who:
- Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) at enrollment.
- Report severe depressive symptoms (EPDS>20) at enrollment.
- Have a substantiated report of child maltreatment
- Children who:
Show all 15Show fewer
- Were born premature (estimated gestational age<35 weeks)
- Have been diagnosed with congenital malformations or genetic syndromes which place them at risk of developmental delays
- Are already currently receiving early intervention services for developmental delays at baseline
- Intervention Phase:
- Women who:
- Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) with a response of "sometimes," or "yes, quite often" at participating pediatric practice
- Report suicidality (i,e, suicidal ideation and/or behavior) on the EPDS (Question #10) and also endorse any of the follow up questions at a participating pediatric practice:
- Have you ever felt that life is not worth living? ii. Has this feeling occurred in the past week? iii. Have you ever wanted to kill yourself? iv. Did you ever make a plan to kill yourself? v. Have you ever attempted suicide?
- Have a substantiated report of child maltreatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms: Virtual Patient Navigation During a Pandemic
The sub-study will involve a rigorous mixed-methods design. The qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services. This information will be used to adapt an evidence-based patient navigation intervention for virtual use. For the intervention phase of the sub-study, 30 women with persistent postpartum depression symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period.
Read the detailed description
In the qualitative phase of the sub-study, 10 participants who are either former participants from the R61 Phase (IRB 19-016174) of the Main Randomized Clinical Trial (RCT), or have been referred, are actively enrolled, or withdrawn in the R33 Phase (IRB 22-019784) of the Main RCT, will be recruited to participate in semi-structured interviews. In the intervention phase of the sub-study, 30 eligible women who are either former participants from the R61 Phase (IRB 19-016174) of the Main RCT, or have been referred, enrolled but completed participation, or withdrawn from the R33 Phase (IRB 22-019784) of the Main RCT, but not actively engaged with mental health services, will be enrolled and consented to receive virtual patient navigation for 2 months. The qualitative phase will involve audio-recorded semi-structured interviews to identify barriers and facilitators to virtual and in-person mental health services. These interviews will then inform the intervention phase which involves the adaptation of an existing mental health navigation intervention for a virtual environment. For both phases of the sub-study, those who agree to participate will be asked to verbally agree to the approved HIPAA form and sign the informed consent form.
For the qualitative phase of the sub-study, 10 eligible women will participate in a 30-40 minute semi-structured interview. Following written informed consent, the participating mother will then participate in a 30-40 minute semi-structured interview. The interview will consist of questions regarding barriers and facilitators to accessing mental health services during a pandemic. The interviews will be audiotaped and transcribed. In the event that the interview cannot be completed in person, a research staff member will complete the interview over the phone with the participant. Transcripts of interviews will be reviewed by 2-3 investigators. Transcripts will be coded and emergent themes related to barriers and facilitators to virtual navigation will be identified using inductive means. Initial codes will be developed inductively through consensus of the investigative team. Themes pertaining to child and family factors and benefits and barriers to mental health service use in a virtual environment will be identified. Investigators will use NVivo, a qualitative software program, to facilitate coding of transcripts and identification of themes. This information will be used to adapt an evidence-based patient navigation intervention for virtual use.
For the intervention phase of the sub-study, 30 women with persistent postpartum depression symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period. These women will be enrolled and consented to receive virtual patient navigation for 2 months. Investigators will conduct rapid cycle testing in which the investigators will evaluate satisfaction, feasibility, and target engagement of the intervention after every 10 participants in order to make rapid cycle changes prior to enrolling the next 10 participants.
Women will communicate virtually with the patient navigator by means of telephone, text messaging, Facetime, or other virtual modality of their choice. The patient navigator will meet with families at the beginning of the study to review results of depression screens and community mental health resources. The patient navigator will partner with participants, engage them in the program, and provide ongoing communication with participants and mental health clinicians. The patient navigator will contact participants weekly by phone, text messaging, email, or any other modality depending on participant preference to monitor initiation and completion of referral, identify concerns and/or barriers to referral completion, and assist participants with problem-solving to identify potential barriers and solutions to complete mental health referrals. Specific barriers and proposed solutions will be identified in the qualitative study above. Using virtual means, the patient navigator will also communicate with mental health clinicians to clarify appointments and address emerging issues. A fidelity checklist will be adapted to assess self-reported task completion by the patient navigator.
All participants will be monitored monthly for depressive symptoms and suicidality. Those who report worsening depressive symptoms (EPDS>20) or suicidality (affirmative response to Question #10 on the EPDS) will be contacted immediately by study staff and an existing suicide protocol from the parent study will be initiated.
- Conditions
- Post-partum Depression
- Being tested
- Virtual Navigator Program
- Keywords
- post-partum depression, mental health, child and maternal health, patient navigator
- Medical subject headings
- Depression, Postpartum, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Navigator ProgramOther
For the intervention phase of the sub-study, 30 women with persistent PPD symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period. These women will be enrolled and consented to receive virtual patient navigation for 2 months. Investigators will conduct rapid cycle testing in which we will evaluate satisfaction, feasibility, and target engagement of the intervention after every 10 participants in order to make rapid cycle changes prior to enrolling the next 10 participants. Women will communicate virtually with the PN by means of telephone, text messaging, Facetime, or other virtual modality of their choice. The Primary Navigator (PN) will meet with families at the beginning of the study to review results of depression screens and community mental health (MH) resources. The PN will partner with participants, engage them in the program, and provide ongoing communication with participants and MH clinicians.
| Study group | Role | What they receive |
|---|---|---|
| Qualitative phase | No intervention | The qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services during the pandemic. This information will be used to adapt an evidence-based patient navigation intervention for virtual use. |
| Intervention Phase | Experimental | For the intervention phase of the sub-study, 30 women with persistent postpartum depression symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period. Receives: Other: Virtual Navigator Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative: Barriers and facilitators to virtual and in-person mental health services
the main objective is to identify barriers and facilitators to virtual and in-person mental health services in order to adapt a patient navigation intervention for virtual use.
Measured: Baseline
Intervention: Target engagement of the Patient Navigator
To determine target engagement of the virtual PN, changes in the The Barriers to Mental Health Services Scale Revised (BMHSS-R ) measured at baseline and at the 2-month follow-up visit will be assessed.
Measured: Baseline, 2 months.
Intervention: Feasibility
To assess the feasibility of the intervention, the proportion of eligible women who enroll and complete the study will be examined.
Measured: Baseline, 2 months
Intervention: Acceptability
To assess acceptability, participants will complete a measure of satisfaction that will include a closed question assessing their satisfaction with the virtual PN using a 5-point likert-scaled response category and an open-ended question concerning their likes and dislikes.
Measured: 2 months
Secondary outcomes (2)
Intervention: Changes in depressive symptoms
The EPDS is a validated 10-item self-report measure of depressive symptoms with strong evidence for reliability, validity, and utility in varying populations. It has been used extensively in mental health research and provides cutpoints to determine the severity of depressive symptoms. It includes a question on suicidal thoughts and wishes (#10) that will be used to monitor for suicidality. The total score will be used with scores of 10 or higher representing minor or moderate depression and scores of 20 or greater representing severe depression.
Measured: Baseline, 1month, 2 months
Intervention: Mental health treatment usage
Outside mental health treatment will be measured monthly using the item from the National Comorbidity Survey (NCS) concerning any mental health service use.
Measured: Baseline, 1 month, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start29 Jun 2023
- Primary completion31 May 2026
- Study completion31 May 2026
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-partum DepressionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The sub-study will involve a rigorous mixed-methods design. The qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services. This information will be used to adapt an evidence-based patient navigation intervention for virtual use. For the intervention phase of the sub-study, 30 women with persistent postpartum depression (PPD) symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- James Guevara, MD, MPH, Principal investigator, Children's Hospital of PhiladelphiaRhonda Boyd, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208852
- Sponsor's protocol ID
- 19-016174-B
- Other IDs
- R61MH118405, 19-016174
- Status last verified
- Jun 2026
- First submitted
- 21 Dec 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A complete, cleaned, and de-identified dataset will be made available to other investigators after all analyses have been conducted and within twelve months of the end of the final year of funding to allow for publication of all study aims. To obtain this data set, other investigators will need to contact the study Principal Investigator (PI) who will provide a data sharing agreement. The data sharing agreement will permit a deidentified data set to be shared once an Institutional Review Board (IRB) protocol has been approved at the investigators' home institution and the investigators have signed a pledge to not attempt to identify individual study subjects. The data set will be made available on a Compact Disc Read-Only Memory (CD-ROM) or through a secure File Transfer Protocol (FTP) site.
Publications
Guevara JP, Morales K, Mandell D, Mogul M, Charidah T, Luethke M, Min J, Clark R, Betancourt L, Boyd R. Social Media-based Parenting Program for Women With Postpartum Depressive Symptoms: An RCT. Pediatrics. 2023 Mar 1;151(3):e2022058719. doi: 10.1542/peds.2022-058719.
PubMed 36808207
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms: Virtual Patient Navigation During a Pandemic
- ClinicalTrials.gov ID
- NCT06208852
- Acronym / sponsor ID
- 19-016174-B
- Conditions
- Post-partum Depression
- Keywords
- post-partum depression, mental health, child and maternal health, patient navigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 17 Jan 2024 (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 sub-study will involve a rigorous mixed-methods design. The qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services. This information will be used to adapt an evidence-based patient navigation intervention for virtual use. For the intervention phase of the sub-study, 30 women with persistent postpartum depression symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period.
Detailed description
In the qualitative phase of the sub-study, 10 participants who are either former participants from the R61 Phase (IRB 19-016174) of the Main Randomized Clinical Trial (RCT), or have been referred, are actively enrolled, or withdrawn in the R33 Phase (IRB 22-019784) of the Main RCT, will be recruited to participate in semi-structured interviews. In the intervention phase of the sub-study, 30 eligible women who are either former participants from the R61 Phase (IRB 19-016174) of the Main RCT, or have been referred, enrolled but completed participation, or withdrawn from the R33 Phase (IRB 22-019784) of the Main RCT, but not actively engaged with mental health services, will be enrolled and consented to receive virtual patient navigation for 2 months. The qualitative phase will involve audio-recorded semi-structured interviews to identify barriers and facilitators to virtual and in-person mental health services. These interviews will then inform the intervention phase which involves the adaptation of an existing mental health navigation intervention for a virtual environment. For both phases of the sub-study, those who agree to participate will be asked to verbally agree to the approved HIPAA form and sign the informed consent form.
For the qualitative phase of the sub-study, 10 eligible women will participate in a 30-40 minute semi-structured interview. Following written informed consent, the participating mother will then participate in a 30-40 minute semi-structured interview. The interview will consist of questions regarding barriers and facilitators to accessing mental health services during a pandemic. The interviews will be audiotaped and transcribed. In the event that the interview cannot be completed in person, a research staff member will complete the interview over the phone with the participant. Transcripts of interviews will be reviewed by 2-3 investigators. Transcripts will be coded and emergent themes related to barriers and facilitators to virtual navigation will be identified using inductive means. Initial codes will be developed inductively through consensus of the investigative team. Themes pertaining to child and family factors and benefits and barriers to mental health service use in a virtual environment will be identified. Investigators will use NVivo, a qualitative software program, to facilitate coding of transcripts and identification of themes. This information will be used to adapt an evidence-based patient navigation intervention for virtual use.
For the intervention phase of the sub-study, 30 women with persistent postpartum depression symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period. These women will be enrolled and consented to receive virtual patient navigation for 2 months. Investigators will conduct rapid cycle testing in which the investigators will evaluate satisfaction, feasibility, and target engagement of the intervention after every 10 participants in order to make rapid cycle changes prior to enrolling the next 10 participants.
Women will communicate virtually with the patient navigator by means of telephone, text messaging, Facetime, or other virtual modality of their choice. The patient navigator will meet with families at the beginning of the study to review results of depression screens and community mental health resources. The patient navigator will partner with participants, engage them in the program, and provide ongoing communication with participants and mental health clinicians. The patient navigator will contact participants weekly by phone, text messaging, email, or any other modality depending on participant preference to monitor initiation and completion of referral, identify concerns and/or barriers to referral completion, and assist participants with problem-solving to identify potential barriers and solutions to complete mental health referrals. Specific barriers and proposed solutions will be identified in the qualitative study above. Using virtual means, the patient navigator will also communicate with mental health clinicians to clarify appointments and address emerging issues. A fidelity checklist will be adapted to assess self-reported task completion by the patient navigator.
All participants will be monitored monthly for depressive symptoms and suicidality. Those who report worsening depressive symptoms (EPDS>20) or suicidality (affirmative response to Question #10 on the EPDS) will be contacted immediately by study staff and an existing suicide protocol from the parent study will be initiated.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The sub-study will involve a rigorous mixed-methods design. The qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services. This information will be used to adapt an evidence-based patient navigation intervention for virtual use. For the intervention phase of the sub-study, 30 women with persistent postpartum depression (PPD) symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period.
| Arm | Type | Receives |
|---|---|---|
| Qualitative phase | No intervention | –The qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services during the pandemic. This information will be used to adapt an evidence-based patient navigation intervention for virtual use. |
| Intervention Phase | Experimental | Other: Virtual Navigator ProgramFor the intervention phase of the sub-study, 30 women with persistent postpartum depression symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Are either former participants from the R61 Phase (IRB 19-016174) of the Main RCT, or have been referred, are actively enrolled, or withdrawn from the R33 Phase (IRB 22-019784) of the Main RCT.
- Are > 18 years of age
- Speak and read in English
- Have access to a smart phone or computer tablet with internet access
- Have an infant < 12 months of age
Key exclusion criteria (15 listed)
- Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) at enrollment.
- Report severe depressive symptoms (EPDS>20) at enrollment.
- Have a substantiated report of child maltreatment
- Were born premature (estimated gestational age<35 weeks)
- Have been diagnosed with congenital malformations or genetic syndromes which place them at risk of developmental delays
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 |
|---|---|---|
| Virtual Navigator ProgramFor the intervention phase of the sub-study, 30 women with persistent PPD symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period. These women will be enrolled and consented to receive virtual patient navigation for 2 months. Investigators will conduct rapid cycle testing in which we will evaluate satisfaction, feasibility, and target engagement of the intervention after every 10 participants in order to make rapid cycle changes prior to enrolling the next 10 participants. Women will communicate virtually with the PN by means of telephone, text messaging, Facetime, or other virtual modality of their choice. The Primary Navigator (PN) will meet with families at the beginning of the study to review results of depression screens and community mental health (MH) resources. The PN will partner with participants, engage them in the program, and provide ongoing communication with participants and MH clinicians. | Other | Intervention Phase |
Primary outcome
Qualitative: Barriers and facilitators to virtual and in-person mental health services
Time frame: Baseline
the main objective is to identify barriers and facilitators to virtual and in-person mental health services in order to adapt a patient navigation intervention for virtual use.
Intervention: Target engagement of the Patient Navigator
Time frame: Baseline, 2 months.
To determine target engagement of the virtual PN, changes in the The Barriers to Mental Health Services Scale Revised (BMHSS-R ) measured at baseline and at the 2-month follow-up visit will be assessed.
Intervention: Feasibility
Time frame: Baseline, 2 months
To assess the feasibility of the intervention, the proportion of eligible women who enroll and complete the study will be examined.
Intervention: Acceptability
Time frame: 2 months
To assess acceptability, participants will complete a measure of satisfaction that will include a closed question assessing their satisfaction with the virtual PN using a 5-point likert-scaled response category and an open-ended question concerning their likes and dislikes.
2 secondary outcomes
Intervention: Changes in depressive symptoms
Time frame: Baseline, 1month, 2 months
Intervention: Mental health treatment usage
Time frame: Baseline, 1 month, 2 months
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 15 Jun 2026.
- Background: PubMed 36808207Guevara JP, Morales K, Mandell D, Mogul M, Charidah T, Luethke M, Min J, Clark R, Betancourt L, Boyd R. Social Media-based Parenting Program for Women With Postpartum Depressive Symptoms: An RCT. Pediatrics. 2023 Mar 1;151(3):e2022058719. doi: 10.1542/peds.2022-058719.
- Individual participant dataSharing planned: Yes. A complete, cleaned, and de-identified dataset will be made available to other investigators after all analyses have been conducted and within twelve months of the end of the final year of funding to allow for publication of all study aims. To obtain this data set, other investigators will need to contact the study Principal Investigator (PI) who will provide a data sharing agreement. The data sharing agreement will permit a deidentified data set to be shared once an Institutional Review Board (IRB) protocol has been approved at the investigators' home institution and the investigators have signed a pledge to not attempt to identify individual study subjects. The data set will be made available on a Compact Disc Read-Only Memory (CD-ROM) or through a secure File Transfer Protocol (FTP) site.
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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.
James Guevara, MD, MPH principal investigator
Children's Hospital of Philadelphia
Rhonda Boyd, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Navigator Program in people with Post-partum Depression, run by Children's Hospital of Philadelphia 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 14 inclusion and 15 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 15 Jun 2026. 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?
Qualitative: Barriers and facilitators to virtual and in-person mental health services (time frame: Baseline). The study lists 4 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 NCT06208852, 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 15 Jun 2026.