AnxietyNCT06083987
Sexual and Gender Minority Youth (SGMY) and Online Interventions to Increase Help-seeking for Anxiety and/or Depression
A study testing Intersectionality and Identity, Confidentiality and Educating Your Community in people with Anxiety and Depression, run by University of Pittsburgh at 1 site in United States.
Trial summary
the investigators will use 4 technology based tools (combinations of youtube videos, links to online resources, tiktok videos, and other media) in a study of 96 Sexual and Gender Minority Youth (SGMY) to determine the effectiveness of them in helping youth to seek out mental health help. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Adolescent Behavior
- What is being tested?
- Intersectionality and Identity, Confidentiality and Educating Your Community
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2024to 1 Jun 2024
- 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
List the inclusion criteria:
have access to a smartphone; have finished 6th grade; have access to and intellectual and physical ability to use the internet; fit demographic criteria (SGMY); and have symptoms of depression and/or anxiety that are mild or more severe (PHQ-8 and/or GAD-7 = 5 or above)
We will routinely monitor the sample to attempt to reach the following proportions:
50% ages 14-16 and 50% ages 17-19 50% identify as sexual minority but cisgender and 50% identify as not cisgender at least 40% identify as a racial or ethnic minority
If any of the proportions are reached (e.g. if 60% of recruited sample identify as not belonging to a racial or ethnic minority we will change screen settings to exclude those who are not
List the exclusion criteria:
no access to smart phone or internet, did not complete the 6th grade, not able to use internet, depression and anxiety are less than mild (PHQ-8 and GAD-7 scores <5); presently are in ongoing psychotherapy (i.e. have attended or plan to attend more than 1 session).
If they have been in therapy within the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Virtual Social Media Based Recruitment
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Optimizing Technology Interventions for Help-Seeking for Depression and Suicidality in Sexual and Gender Minority Youth
the investigators will use 4 technology based tools (combinations of youtube videos, links to online resources, tiktok videos, and other media) in a study of 96 Sexual and Gender Minority Youth (SGMY) to determine the effectiveness of them in helping youth to seek out mental health help. Participants will be divided into 1 of 16 groups and will interact with other participants anonymously on Discord. Each group will have access to 1, 2, 3, or all 4 of the tools which are categorized by a specific subject (except for one group who will have no access to the tools in order to compare this outcome against those who use the tools). There will be a survey before starting the Discord portion which will last 4 weeks, and a survey afterwards.
Read the detailed description
Only one-third of adolescents access treatment for depression, and many fail to interact with clinic-based mental health resources. Sexual and gender minority youth (SGMY) are at greater risk for severe mental health disorders and suicidality but even less likely to access mental health services, even when access is available.
Widespread factors - stigma, negative beliefs about treatment, lack of mental health knowledge - contribute to not seeking services. Mainstream mental health interventions fail to address unique factors to SGMY that inhibit help-seeking: double stigma (stigma around mental health as well as internalized homophobia and transphobia), concern about revealing SGM status, low family support, lack of access to SGM affirming mental health professionals.
Despite being hard-to-reach, SGMY at risk for depression are quite active online. Yet SGMY-specific evidence-based online interventions are lacking and community interventions do not enhance mental health help-seeking. Targeted online interventions are needed to address unique factors which prevent help-seeking but are themselves usable and engaging. The current proposal will use a user-informed efficient approach to technology intervention design considering the heterogeneity and specific needs of SGMY. The investigators will use the Behavioral Intervention Technology Model to design and study several intervention principles (IPs), or theoretical concepts including intervention aims and behavioral strategies, to understand which mechanisms of action hold promise while being iterating design and potential modalities.
The investigators will use human computer interaction (HCI) framework, Discover, Design/Build, and Test to develop and study several IPs. Specifically, will use HCI techniques to develop initial prototypes and seek iterative user feedback and evaluate 4 finalized low-fidelity prototypes using a factorial trial to understand each IP prototype's individual and combined feasibility, usability, acceptability, and change in help-seeking intention in an online sample of diverse (racially, ethnically, age, gender identity, sexual orientation) SGMY.
This will inform the development of a high-fidelity intervention which may include different components for specific SGMY subgroups to be evaluated in a larger clinical trial. The PI, Dr. Radovic, is a physician researcher in adolescent medicine and has conducted years of research using stakeholder-informed methods and HCI techniques to inform intervention development. By working with experts in SGM health, stakeholder engagement, intervention design, qualitative analysis, HCI design, and BIT development and testing, the investigators have an exciting opportunity to bridge the gap for SGM adolescents with depression and suicidality to motivate and equip adolescents with the tools needed to access treatment.
This proposal is responsive to NOT-MH-18-031 by conducting nimble iterative testing and NOT-MD-19-001 - testing stigma reduction interventions. Adolescents who are sexual and gender minority (or LGBTQ) have rising rates of depression, anxiety, and suicidality but are less likely to get mental health treatment than other adolescents due to stigma and low family support. These adolescents are quite active online. This study aims to understand what types of technology interventions are most promising for helping them to seek mental health help when indicated.
Due to the exploratory nature of this clinical trial, we originally considered multiple secondary outcomes. As we proceeded with the study and obtained formative information from qualitative interviews to inform initial prototypes, we further clarified our conceptual model regarding our interests in the main outcome of mental health help-seeking and subsequent improvement in depression and anxiety symptoms. This help-seeking we hypothesized may be influenced by help-seeking intention, social support, internalized stigmatization of identity (internalized homophobia, internalized transphobia), confidentiality concerns, and expectations of rejection by mental healthcare providers. These measures therefore remained as secondary outcomes which we examined, and all others were moved to Other Pre-specified outcome measures.
With regards to statistical analysis, due to limitations in sample size, and non-normality of data, we used non-parametric tests of statistical significance within the primary outcome of mental health help-seeking intention between each intervention compared to not that intervention and adjusted for multiple tests using false-discovery rate q-value calculated with the Yekutieli method in Stata.
- Conditions
- Anxiety, Depression, Adolescent Behavior, Sexual and Gender Minorities
- Being tested
- Intersectionality and Identity, Confidentiality, Educating Your Community, How to find Affirming Caregivers, Control Group - No Interventions
- Medical subject headings
- Anxiety Disorders, Depression, Adolescent Behavior, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intersectionality and IdentityBehavioural
Participants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on matters of intersectionality and identity. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it").
ConfidentialityBehavioural
Participants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on Confidentiality for caregivers. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it").
Educating Your CommunityBehavioural
Participants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on matters of the education of family and friends about identity. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it").
How to find Affirming CaregiversBehavioural
Participants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on matters of finding affirming caregivers. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it").
Control Group - No InterventionsBehavioural
Control Group - Will be given no interventions
| Study group | Role | What they receive |
|---|---|---|
| Control Group - No Interventions | Active comparator | Arm 1 will have not be given any of the interventions and will be a control group. Receives: Behavioral: Control Group - No Interventions |
| Intervention 1 - Intersectionality and Identity | Experimental | Arm 2 will be given access to intervention 1. It will have video and text content focused on identity and intersectionality. Receives: Behavioral: Intersectionality and Identity |
| Interventions 1 and 2 - Intersectionality and Identity/Confidentiality and Privacy | Experimental | Arm 3 will be given access to with the video and text content focused on intersectionality and confidentiality Receives: Behavioral: Intersectionality and Identity; Behavioral: Confidentiality |
| Interventions 1, 2, and 3 - Intersectionality/Confidentiality/Educational Tools | Experimental | Arm 4 will be given access to with the video and text content focused on intersectionality, confidentiality, and education about identity Receives: Behavioral: Intersectionality and Identity; Behavioral: Confidentiality; Behavioral: Educating Your Community |
| Interventions 1, 2, and 4 - Intersectionality/Confidentiality/Finding Affirming Care | Experimental | Arm 5 will be given access to interventions 1, 2, and 4, with the video and text content focused on intersectionality, confidentiality, and determining if caregivers are affirming Receives: Behavioral: Intersectionality and Identity; Behavioral: Confidentiality; Behavioral: How to find Affirming Caregivers |
| Interventions 1, 2, 3 and 4 - Intersectionality/Confidentiality/Educational Tools/Affirming Care | Experimental | Arm 6 will be given access to all 4 interventions, with the video and text content focused on intersectionality, confidentiality, education about identity, and determining if caregivers are affirming Receives: Behavioral: Intersectionality and Identity; Behavioral: Confidentiality; Behavioral: Educating Your Community; Behavioral: How to find Affirming Caregivers |
| Interventions 1 and 3 - Intersectionality and Identity/Educational Tools | Experimental | Arm 7 will be given access to interventions 1 and 3, with the video and text content focused on intersectionality and education about identity Receives: Behavioral: Intersectionality and Identity; Behavioral: Educating Your Community |
| Interventions 1, 3, and 4 - Intersectionality and Identity/Educational Tools/Finding Affirming Care | Experimental | Arm 8 will be given access to interventions 1, 3, and 4, with the video and text content focused on intersectionality, education about identity and determining if caregivers are affirming. Receives: Behavioral: Intersectionality and Identity; Behavioral: Educating Your Community; Behavioral: How to find Affirming Caregivers |
| Interventions 1 and 4 - Intersectionality and Identity/Finding Affirming Care | Experimental | Arm 9 will be given access to interventions 1 and 4, with the video and text content focused on intersectionality and determining if caregivers are affirming. Receives: Behavioral: Intersectionality and Identity; Behavioral: How to find Affirming Caregivers |
| Intervention 2 - Confidentiality and Privacy | Experimental | Arm 10 will be given access to intervention 2, with the video and text content focused on confidentiality Receives: Behavioral: Confidentiality |
| Interventions 2 and 3 - Confidentiality and Privacy/Educational Tools | Experimental | Arm 11 will be given access to interventions 2, and 3. Video and text content will focus on confidentiality and education about identity. Receives: Behavioral: Confidentiality; Behavioral: Educating Your Community |
| Interventions 2, 3 and 4 - Confidentiality and Privacy/Educational Tools/Finding Affirming Care | Experimental | Arm 12 will be given access to interventions 2, 3, and 4. Video and text content will focus on confidentiality, education about identity, and determine if caregivers are affirming. Receives: Behavioral: Confidentiality; Behavioral: Educating Your Community; Behavioral: How to find Affirming Caregivers |
| Interventions 2 and 4 - Confidentiality and Privacy/Finding Affirming Care | Experimental | Arm 13 will be given access to interventions 2 and 4. Video and text content will focus on confidentiality and determining if caregivers are affirming. Receives: Behavioral: Confidentiality; Behavioral: How to find Affirming Caregivers |
| Intervention 3 - Educational Tools | Experimental | Arm 14 will be given access to intervention 3. Video and text content will focus on education about identity Receives: Behavioral: Educating Your Community |
| Interventions 3 and 4 - Educational Tools/Finding Affirming Care | Experimental | Arm 15 will be given access to interventions 3 and 4. Video and text content will focus on educational tools about identity and determining if caregivers are affirming. Receives: Behavioral: Educating Your Community; Behavioral: How to find Affirming Caregivers |
| Intervention 4 - Finding Affirming Care | Experimental | Arm 16 will be given access to intervention 4, with video and text content focusing on determining if caregivers are affirming. Receives: Behavioral: How to find Affirming Caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - IP Use Proportion
Average proportions of IP components completed out of IP components available per individual participant (IP component defined as opportunity offered to interact with the intervention - some individuals will have more opportunities offered than others due to factorial randomization)
Measured: Over one month
Feasibility - IP Use Days
Average Proportion of days IP is used per individual (number of days session accessed over total offered which is 28 days)
Measured: Over one month
Feasibility - IP Use Time
Average length of time IP is used (length of session)
Measured: Over one month
Usability
System Usability Scale, min: 0, Max: 100, higher scores mean better usability
Measured: 1 month
Acceptability of the Intervention Principle
Open-ended questions about whether the Discord server and the tools used were: helpful; whether it was affirming of SGM status; if timing and amount of content were appropriate, if privacy and confidentiality were maintained, and if they had any negative consequences of participation (e.g. parent questioning them )
Measured: 1 month
Help-Seeking Intention From Counselor or Therapist - TAU vs Not TAU
single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help
Measured: 1 month
Help-Seeking Intention From Counselor or Therapist - Intervention 1 vs. Not 1
single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help
Measured: 1 month
Help-Seeking Intention From Counselor or Therapist - Intervention 2 vs. Not 2
single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help
Measured: 1 month
Help-Seeking Intention From Counselor or Therapist - Intervention 3 vs. Non-3
single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help
Measured: 1 month
Help-Seeking Intention From Counselor or Therapist - Intervention 4 vs. Not 4
single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help
Measured: 1 month
Secondary outcomes (40)
Social Support - TAU vs Not TAU
The Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.
Measured: 1 month
Social Support - Intervention 1 vs. Not 1
The Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.
Measured: 1 month
Social Support - Intervention 2 vs. Not 2
The Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.
Measured: 1 month
Social Support - Intervention 3 vs. Not 3
The Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.
Measured: 1 month
Social Support - Intervention 4 vs. Not 4
The Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.
Measured: 1 month
Internalized Homophobia - TAU vs Not TAU
Sexual Minority Adolescent Stress Inventory Internalized homonegativity subscale for the past 30 days. min: 0, max: 7. Higher score indicates greater internalized homophobia
Measured: 1 month
Internalized Homophobia - Intervention 1 vs Not 1
Sexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. - asked about past 30 days min: 0, max: 7. Higher score indicates greater internalized homophobia
Measured: 1 month
Internalized Homophobia - Intervention 2 vs Not 2
Sexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. - asked about past 30 days min: 0, max: 7. Higher score indicates greater internalized homophobia
Measured: 1 month
Internalized Homophobia - Intervention 3 vs Not 3
Sexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. - asked about past 30 days min: 0, max: 7. Higher score indicates greater internalized homophobia
Measured: 1 month
Internalized Homophobia - Intervention 4 vs Not 4
Sexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. - asked about past 30 days min: 0, max: 7. Higher score indicates greater internalized homophobia
Measured: 1 month
Internalized Transphobia - TAU vs Not TAU
Gender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia
Measured: 1 month
Internalized Transphobia - Intervention 1 vs Not 1
Gender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia
Measured: 1 month
Internalized Transphobia - Intervention 2 vs Not 2
Gender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia
Measured: 1 month
Internalized Transphobia - Intervention 3 vs Not 3
Gender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia
Measured: 1 month
Internalized Transphobia - Intervention 4 vs Not 4
Gender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia
Measured: 1 month
Expectance of Rejection Due to SGM Status TAU vs Not TAU
Single-item yes/no and open ended question - asked about past 30 days
Measured: 1 month
Expectance of Rejection Due to SGM Status Intervention 1 vs Not 1
Single-item yes/no and open ended question - asked about past 30 days
Measured: 1 month
Expectance of Rejection Due to SGM Status Intervention 2 vs Not 2
Single-item yes/no and open ended question - asked about past 30 days
Measured: 1 month
Expectance of Rejection Due to SGM Status Intervention 3 vs Not 3
Single-item yes/no and open ended question - asked about past 30 days
Measured: 1 month
Expectance of Rejection Due to SGM Status Intervention 4 vs Not 4
Single-item yes/no and open ended question - asked about past 30 days
Measured: 1 month
Confidentiality Concerns TAU vs Not TAU
Confidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality
Measured: 1 month
Confidentiality Concerns Intervention 1 vs Not 1
Confidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality
Measured: 1 month
Confidentiality Concerns Intervention 2 vs Not 2
Confidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality
Measured: 1 month
Confidentiality Concerns Intervention 3 vs Not 3
Confidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality
Measured: 1 month
Confidentiality Concerns Intervention 4 vs Not 4
Confidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality
Measured: 1 month
Receipt of Any Mental Health Treatment in Past 4 Weeks TAU vs Not TAU
Actual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns
Measured: 1 month
Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 1 vs Not 1
Actual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns
Measured: 1 month
Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 2 vs Not 2
Actual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns
Measured: 1 month
Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 3 vs Not 3
Actual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns
Measured: 1 month
Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 4 vs Not 4
Actual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns
Measured: 1 month
Depression Symptoms TAU vs Not TAU
Patient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.
Measured: 1 month
Depression Symptoms Intervention 1 vs Not 1
Patient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.
Measured: 1 month
Depression Symptoms Intervention 2 vs Not 2
Patient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.
Measured: 1 month
Depression Symptoms Intervention 3 vs Not 3
Patient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.
Measured: 1 month
Depression Symptoms Intervention 4 vs Not 4
Patient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.
Measured: 1 month
Anxiety Symptoms - TAU vs Not TAU
Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Measured: 1 month
Anxiety Symptoms - Intervention 1 vs Not 1
Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Measured: 1 month
Anxiety Symptoms - Intervention 2 vs Not 2
Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Measured: 1 month
Anxiety Symptoms - Intervention 3 vs Not 3
Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Measured: 1 month
Anxiety Symptoms - Intervention 4 vs Not 4
Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start8 Mar 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
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.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Randomised
- Intervention model
- Factorial
- Model description
- 96 participants randomly assigned to one of the 16 combinations of the four study intervention principles
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Ana Radovic, University of Pittsburgh
- Investigators
- Ana Radovic, MD, MSc, Principal investigator, University of Pittsburgh/UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083987
- Sponsor's protocol ID
- STUDY22070134
- Other IDs
- 5R21MD015806-02
- Status last verified
- Oct 2025
- First submitted
- 27 Sep 2023
- Last updated
- 21 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Trial outcome data can be accessed by contacting the study principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Technology Interventions for Help-Seeking for Depression and Suicidality in Sexual and Gender Minority Youth
- ClinicalTrials.gov ID
- NCT06083987
- Acronym / sponsor ID
- STUDY22070134
- Conditions
- Anxiety, Depression, Adolescent Behavior, Sexual and Gender Minorities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Posted 21 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the investigators will use 4 technology based tools (combinations of youtube videos, links to online resources, tiktok videos, and other media) in a study of 96 Sexual and Gender Minority Youth (SGMY) to determine the effectiveness of them in helping youth to seek out mental health help. Participants will be divided into 1 of 16 groups and will interact with other participants anonymously on Discord. Each group will have access to 1, 2, 3, or all 4 of the tools which are categorized by a specific subject (except for one group who will have no access to the tools in order to compare this outcome against those who use the tools). There will be a survey before starting the Discord portion which will last 4 weeks, and a survey afterwards.
Detailed description
Only one-third of adolescents access treatment for depression, and many fail to interact with clinic-based mental health resources. Sexual and gender minority youth (SGMY) are at greater risk for severe mental health disorders and suicidality but even less likely to access mental health services, even when access is available.
Widespread factors - stigma, negative beliefs about treatment, lack of mental health knowledge - contribute to not seeking services. Mainstream mental health interventions fail to address unique factors to SGMY that inhibit help-seeking: double stigma (stigma around mental health as well as internalized homophobia and transphobia), concern about revealing SGM status, low family support, lack of access to SGM affirming mental health professionals.
Despite being hard-to-reach, SGMY at risk for depression are quite active online. Yet SGMY-specific evidence-based online interventions are lacking and community interventions do not enhance mental health help-seeking. Targeted online interventions are needed to address unique factors which prevent help-seeking but are themselves usable and engaging. The current proposal will use a user-informed efficient approach to technology intervention design considering the heterogeneity and specific needs of SGMY. The investigators will use the Behavioral Intervention Technology Model to design and study several intervention principles (IPs), or theoretical concepts including intervention aims and behavioral strategies, to understand which mechanisms of action hold promise while being iterating design and potential modalities.
The investigators will use human computer interaction (HCI) framework, Discover, Design/Build, and Test to develop and study several IPs. Specifically, will use HCI techniques to develop initial prototypes and seek iterative user feedback and evaluate 4 finalized low-fidelity prototypes using a factorial trial to understand each IP prototype's individual and combined feasibility, usability, acceptability, and change in help-seeking intention in an online sample of diverse (racially, ethnically, age, gender identity, sexual orientation) SGMY.
This will inform the development of a high-fidelity intervention which may include different components for specific SGMY subgroups to be evaluated in a larger clinical trial. The PI, Dr. Radovic, is a physician researcher in adolescent medicine and has conducted years of research using stakeholder-informed methods and HCI techniques to inform intervention development. By working with experts in SGM health, stakeholder engagement, intervention design, qualitative analysis, HCI design, and BIT development and testing, the investigators have an exciting opportunity to bridge the gap for SGM adolescents with depression and suicidality to motivate and equip adolescents with the tools needed to access treatment.
This proposal is responsive to NOT-MH-18-031 by conducting nimble iterative testing and NOT-MD-19-001 - testing stigma reduction interventions. Adolescents who are sexual and gender minority (or LGBTQ) have rising rates of depression, anxiety, and suicidality but are less likely to get mental health treatment than other adolescents due to stigma and low family support. These adolescents are quite active online. This study aims to understand what types of technology interventions are most promising for helping them to seek mental health help when indicated.
Due to the exploratory nature of this clinical trial, we originally considered multiple secondary outcomes. As we proceeded with the study and obtained formative information from qualitative interviews to inform initial prototypes, we further clarified our conceptual model regarding our interests in the main outcome of mental health help-seeking and subsequent improvement in depression and anxiety symptoms. This help-seeking we hypothesized may be influenced by help-seeking intention, social support, internalized stigmatization of identity (internalized homophobia, internalized transphobia), confidentiality concerns, and expectations of rejection by mental healthcare providers. These measures therefore remained as secondary outcomes which we examined, and all others were moved to Other Pre-specified outcome measures.
With regards to statistical analysis, due to limitations in sample size, and non-normality of data, we used non-parametric tests of statistical significance within the primary outcome of mental health help-seeking intention between each intervention compared to not that intervention and adjusted for multiple tests using false-discovery rate q-value calculated with the Yekutieli method in Stata.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 16
- Model description
- 96 participants randomly assigned to one of the 16 combinations of the four study intervention principles
| Arm | Type | Receives |
|---|---|---|
| Control Group - No Interventions | Active comparator | Behavioral: Control Group - No InterventionsArm 1 will have not be given any of the interventions and will be a control group. |
| Intervention 1 - Intersectionality and Identity | Experimental | Behavioral: Intersectionality and IdentityArm 2 will be given access to intervention 1. It will have video and text content focused on identity and intersectionality. |
| Interventions 1 and 2 - Intersectionality and Identity/Confidentiality and Privacy | Experimental | Behavioral: Intersectionality and Identity, Behavioral: ConfidentialityArm 3 will be given access to with the video and text content focused on intersectionality and confidentiality |
| Interventions 1, 2, and 3 - Intersectionality/Confidentiality/Educational Tools | Experimental | Behavioral: Intersectionality and Identity, Behavioral: Confidentiality, Behavioral: Educating Your CommunityArm 4 will be given access to with the video and text content focused on intersectionality, confidentiality, and education about identity |
| Interventions 1, 2, and 4 - Intersectionality/Confidentiality/Finding Affirming Care | Experimental | Behavioral: Intersectionality and Identity, Behavioral: Confidentiality, Behavioral: How to find Affirming CaregiversArm 5 will be given access to interventions 1, 2, and 4, with the video and text content focused on intersectionality, confidentiality, and determining if caregivers are affirming |
| Interventions 1, 2, 3 and 4 - Intersectionality/Confidentiality/Educational Tools/Affirming Care | Experimental | Behavioral: Intersectionality and Identity, Behavioral: Confidentiality, Behavioral: Educating Your Community, Behavioral: How to find Affirming CaregiversArm 6 will be given access to all 4 interventions, with the video and text content focused on intersectionality, confidentiality, education about identity, and determining if caregivers are affirming |
| Interventions 1 and 3 - Intersectionality and Identity/Educational Tools | Experimental | Behavioral: Intersectionality and Identity, Behavioral: Educating Your CommunityArm 7 will be given access to interventions 1 and 3, with the video and text content focused on intersectionality and education about identity |
| Interventions 1, 3, and 4 - Intersectionality and Identity/Educational Tools/Finding Affirming Care | Experimental | Behavioral: Intersectionality and Identity, Behavioral: Educating Your Community, Behavioral: How to find Affirming CaregiversArm 8 will be given access to interventions 1, 3, and 4, with the video and text content focused on intersectionality, education about identity and determining if caregivers are affirming. |
| Interventions 1 and 4 - Intersectionality and Identity/Finding Affirming Care | Experimental | Behavioral: Intersectionality and Identity, Behavioral: How to find Affirming CaregiversArm 9 will be given access to interventions 1 and 4, with the video and text content focused on intersectionality and determining if caregivers are affirming. |
| Intervention 2 - Confidentiality and Privacy | Experimental | Behavioral: ConfidentialityArm 10 will be given access to intervention 2, with the video and text content focused on confidentiality |
| Interventions 2 and 3 - Confidentiality and Privacy/Educational Tools | Experimental | Behavioral: Confidentiality, Behavioral: Educating Your CommunityArm 11 will be given access to interventions 2, and 3. Video and text content will focus on confidentiality and education about identity. |
| Interventions 2, 3 and 4 - Confidentiality and Privacy/Educational Tools/Finding Affirming Care | Experimental | Behavioral: Confidentiality, Behavioral: Educating Your Community, Behavioral: How to find Affirming CaregiversArm 12 will be given access to interventions 2, 3, and 4. Video and text content will focus on confidentiality, education about identity, and determine if caregivers are affirming. |
| Interventions 2 and 4 - Confidentiality and Privacy/Finding Affirming Care | Experimental | Behavioral: Confidentiality, Behavioral: How to find Affirming CaregiversArm 13 will be given access to interventions 2 and 4. Video and text content will focus on confidentiality and determining if caregivers are affirming. |
| Intervention 3 - Educational Tools | Experimental | Behavioral: Educating Your CommunityArm 14 will be given access to intervention 3. Video and text content will focus on education about identity |
| Interventions 3 and 4 - Educational Tools/Finding Affirming Care | Experimental | Behavioral: Educating Your Community, Behavioral: How to find Affirming CaregiversArm 15 will be given access to interventions 3 and 4. Video and text content will focus on educational tools about identity and determining if caregivers are affirming. |
| Intervention 4 - Finding Affirming Care | Experimental | Behavioral: How to find Affirming CaregiversArm 16 will be given access to intervention 4, with video and text content focusing on determining if caregivers are affirming. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Intersectionality and IdentityParticipants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on matters of intersectionality and identity. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it"). | Behavioural | Intervention 1 - Intersectionality and Identity, Interventions 1 and 2 - Intersectionality and Identity/Confidentiality and Privacy, Interventions 1 and 3 - Intersectionality and Identity/Educational Tools, Interventions 1 and 4 - Intersectionality and Identity/Finding Affirming Care, Interventions 1, 2, 3 and 4 - Intersectionality/Confidentiality/Educational Tools/Affirming Care, Interventions 1, 2, and 3 - Intersectionality/Confidentiality/Educational Tools, Interventions 1, 2, and 4 - Intersectionality/Confidentiality/Finding Affirming Care, Interventions 1, 3, and 4 - Intersectionality and Identity/Educational Tools/Finding Affirming Care |
| ConfidentialityParticipants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on Confidentiality for caregivers. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it"). | Behavioural | Intervention 2 - Confidentiality and Privacy, Interventions 1 and 2 - Intersectionality and Identity/Confidentiality and Privacy, Interventions 1, 2, 3 and 4 - Intersectionality/Confidentiality/Educational Tools/Affirming Care, Interventions 1, 2, and 3 - Intersectionality/Confidentiality/Educational Tools, Interventions 1, 2, and 4 - Intersectionality/Confidentiality/Finding Affirming Care, Interventions 2 and 3 - Confidentiality and Privacy/Educational Tools, Interventions 2 and 4 - Confidentiality and Privacy/Finding Affirming Care, Interventions 2, 3 and 4 - Confidentiality and Privacy/Educational Tools/Finding Affirming Care |
| Educating Your CommunityParticipants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on matters of the education of family and friends about identity. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it"). | Behavioural | Intervention 3 - Educational Tools, Interventions 1 and 3 - Intersectionality and Identity/Educational Tools, Interventions 1, 2, 3 and 4 - Intersectionality/Confidentiality/Educational Tools/Affirming Care, Interventions 1, 2, and 3 - Intersectionality/Confidentiality/Educational Tools, Interventions 1, 3, and 4 - Intersectionality and Identity/Educational Tools/Finding Affirming Care, Interventions 2 and 3 - Confidentiality and Privacy/Educational Tools, Interventions 2, 3 and 4 - Confidentiality and Privacy/Educational Tools/Finding Affirming Care, Interventions 3 and 4 - Educational Tools/Finding Affirming Care |
| How to find Affirming CaregiversParticipants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on matters of finding affirming caregivers. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it"). | Behavioural | Intervention 4 - Finding Affirming Care, Interventions 1 and 4 - Intersectionality and Identity/Finding Affirming Care, Interventions 1, 2, 3 and 4 - Intersectionality/Confidentiality/Educational Tools/Affirming Care, Interventions 1, 2, and 4 - Intersectionality/Confidentiality/Finding Affirming Care, Interventions 1, 3, and 4 - Intersectionality and Identity/Educational Tools/Finding Affirming Care, Interventions 2 and 4 - Confidentiality and Privacy/Finding Affirming Care, Interventions 2, 3 and 4 - Confidentiality and Privacy/Educational Tools/Finding Affirming Care, Interventions 3 and 4 - Educational Tools/Finding Affirming Care |
| Control Group - No InterventionsControl Group - Will be given no interventions | Behavioural | Control Group - No Interventions |
Primary outcome
Feasibility - IP Use Proportion
Time frame: Over one month
Average proportions of IP components completed out of IP components available per individual participant (IP component defined as opportunity offered to interact with the intervention - some individuals will have more opportunities offered than others due to factorial randomization)
Feasibility - IP Use Days
Time frame: Over one month
Average Proportion of days IP is used per individual (number of days session accessed over total offered which is 28 days)
Feasibility - IP Use Time
Time frame: Over one month
Average length of time IP is used (length of session)
Usability
Time frame: 1 month
System Usability Scale, min: 0, Max: 100, higher scores mean better usability
Acceptability of the Intervention Principle
Time frame: 1 month
Open-ended questions about whether the Discord server and the tools used were: helpful; whether it was affirming of SGM status; if timing and amount of content were appropriate, if privacy and confidentiality were maintained, and if they had any negative consequences of participation (e.g. parent questioning them )
Help-Seeking Intention From Counselor or Therapist - TAU vs Not TAU
Time frame: 1 month
single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help
Help-Seeking Intention From Counselor or Therapist - Intervention 1 vs. Not 1
Time frame: 1 month
single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help
Help-Seeking Intention From Counselor or Therapist - Intervention 2 vs. Not 2
Time frame: 1 month
single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help
Help-Seeking Intention From Counselor or Therapist - Intervention 3 vs. Non-3
Time frame: 1 month
single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help
Help-Seeking Intention From Counselor or Therapist - Intervention 4 vs. Not 4
Time frame: 1 month
single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help
40 secondary outcomes
Social Support - TAU vs Not TAU
Time frame: 1 month
Social Support - Intervention 1 vs. Not 1
Time frame: 1 month
Social Support - Intervention 2 vs. Not 2
Time frame: 1 month
Social Support - Intervention 3 vs. Not 3
Time frame: 1 month
Social Support - Intervention 4 vs. Not 4
Time frame: 1 month
Internalized Homophobia - TAU vs Not TAU
Time frame: 1 month
Internalized Homophobia - Intervention 1 vs Not 1
Time frame: 1 month
Internalized Homophobia - Intervention 2 vs Not 2
Time frame: 1 month
Internalized Homophobia - Intervention 3 vs Not 3
Time frame: 1 month
Internalized Homophobia - Intervention 4 vs Not 4
Time frame: 1 month
Internalized Transphobia - TAU vs Not TAU
Time frame: 1 month
Internalized Transphobia - Intervention 1 vs Not 1
Time frame: 1 month
Internalized Transphobia - Intervention 2 vs Not 2
Time frame: 1 month
Internalized Transphobia - Intervention 3 vs Not 3
Time frame: 1 month
Internalized Transphobia - Intervention 4 vs Not 4
Time frame: 1 month
Expectance of Rejection Due to SGM Status TAU vs Not TAU
Time frame: 1 month
Expectance of Rejection Due to SGM Status Intervention 1 vs Not 1
Time frame: 1 month
Expectance of Rejection Due to SGM Status Intervention 2 vs Not 2
Time frame: 1 month
Expectance of Rejection Due to SGM Status Intervention 3 vs Not 3
Time frame: 1 month
Expectance of Rejection Due to SGM Status Intervention 4 vs Not 4
Time frame: 1 month
Confidentiality Concerns TAU vs Not TAU
Time frame: 1 month
Confidentiality Concerns Intervention 1 vs Not 1
Time frame: 1 month
Confidentiality Concerns Intervention 2 vs Not 2
Time frame: 1 month
Confidentiality Concerns Intervention 3 vs Not 3
Time frame: 1 month
Confidentiality Concerns Intervention 4 vs Not 4
Time frame: 1 month
Receipt of Any Mental Health Treatment in Past 4 Weeks TAU vs Not TAU
Time frame: 1 month
Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 1 vs Not 1
Time frame: 1 month
Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 2 vs Not 2
Time frame: 1 month
Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 3 vs Not 3
Time frame: 1 month
Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 4 vs Not 4
Time frame: 1 month
Depression Symptoms TAU vs Not TAU
Time frame: 1 month
Depression Symptoms Intervention 1 vs Not 1
Time frame: 1 month
Depression Symptoms Intervention 2 vs Not 2
Time frame: 1 month
Depression Symptoms Intervention 3 vs Not 3
Time frame: 1 month
Depression Symptoms Intervention 4 vs Not 4
Time frame: 1 month
Anxiety Symptoms - TAU vs Not TAU
Time frame: 1 month
Anxiety Symptoms - Intervention 1 vs Not 1
Time frame: 1 month
Anxiety Symptoms - Intervention 2 vs Not 2
Time frame: 1 month
Anxiety Symptoms - Intervention 3 vs Not 3
Time frame: 1 month
Anxiety Symptoms - Intervention 4 vs Not 4
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Trial outcome data can be accessed by contacting the study principal investigator.
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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.
Ana Radovic, MD, MSc principal investigator
University of Pittsburgh/UPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intersectionality and Identity, Confidentiality and Educating Your Community in people with Anxiety and Depression, run by University of Pittsburgh 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?
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 21 Oct 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 21 Oct 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?
Feasibility - IP Use Proportion (time frame: Over one month). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2025.