Mental HealthNCT05061966
The Digital Wellbeing Project
A study testing immi in people with Mental Health, run by University of Pennsylvania at 1 site in United States.
Trial summary
This goal of this randomized control trial is to test whether a web application that provides sexual and gender minority youth ages 13-19 (N=200) with tools for affirming their identities and coping with minority stress can affect key psychosocial outcomes, such as coping self-efficacy and symptoms of anxiety and… Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- immi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 1 Jul 2022
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Are between 13-19 years of age (inclusive)
- Self-identify as a sexual or gender minority
- Are English literate
- Reside within the United States
- Have access to a device that has internet access, a web browser, and SMS capabilities, such as a smartphone, computer, or tablet
- Willingness to participate in study activities
Who cannot join
- Not between 13-19 years of age (inclusive)
- Does not self-identify as a sexual or gender minority
- Is not English literate
- Does not reside within the United States
- Does not have access to a device that has internet access, a web browser, and SMS capabilities, such as a smartphone, computer, or tablet
- Unwilling to participate in study activities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Piloting a Web App for Sexual and Gender Minority Youth Mental Health
This goal of this randomized control trial is to test whether a web application that provides sexual and gender minority youth ages 13-19 (N=200) with tools for affirming their identities and coping with minority stress can affect key psychosocial outcomes, such as coping self-efficacy and symptoms of anxiety and depression.
- Conditions
- Mental Health
- Being tested
- immi, Control
- Keywords
- Sexual and Gender Minorities
- Medical subject headings
- Psychological Well-Being, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immiBehavioural
The intervention has four main content areas: 1) gender identity (the gender guide), 2) sexual orientation (the queerness guide), 3)stress and coping (the stress guide), and 4) internalized stigma (the internalized stigma guide).
ControlBehavioural
The control will have access to resources on the website, but will not receive any engagement reminders, matching the conditions present in real world contexts in which web-based resource lists are available.
| Study group | Role | What they receive |
|---|---|---|
| Online Resource website | Active comparator | The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth. Receives: Behavioral: Control |
| immi | Experimental | The intervention is a novel and scalable web application designed to provide sexual and gender minority youth with tools for affirming their identity and coping with minority stress. Receives: Behavioral: immi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coping Self-efficacy
The Stress Appraisals Measure for Adolescents includes three subscales (Challenge subscale; Threat subscale; Resources subscale). Each of these subscales is answered on a 5-point scale (1=strongly disagree to 5=strongly agree). A mean score was computed for each subscale, with higher values indicating greater endorsement of each respective stress appraisal.
Measured: 4-week follow-up
Secondary outcomes (6)
Identity Affirmation
The Lesbian, Gay and Bisexual Positive Identity Measure-Authenticity Subscale has a scoring range from 1 to 7 (1=strongly disagree to 7=strongly agree). A mean score was computed, whereby greater values indicate greater feelings of authenticity.
Measured: 4-week follow-up
Internalization of Minority Stress
The Coping with Discrimination Scale- Internalization Subscale has a scoring range from 1 to 6 (1=never to 6=always). We computed a mean score, where higher scores indicate greater internalization of blame for minority stress
Measured: 4-week follow-up
Sense of Belonging to the Queer Community
The Thwarted Belongingness subscale of the Interpersonal Needs Questionnaire is a 5-item scale that is answered on a 7-point scale (1=not at all true" to 7=very true for me). We computed a sum score ranging from 5 to 35, where higher scores indicate a lack of sense of belonging
Measured: 4-week follow-up
Anxiety Symptoms
The General Anxiety Disorder-7 scale has a range from 0 to 21. Scores were computed by summing the items. Higher scores indicate greater anxiety symptomatology.
Measured: 4-week follow-up
Depression Symptoms
The Patient Health Questionnaire-8 inventory has a range from 0 to 24. A summed score was computed, where higher scores indicate greater depression symptomatology.
Measured: 4-week follow-up
Cognitive and Behavioral Coping Skills
The Brief COPE inventory is comprised of 11 subscales: Self-distraction; Active coping; Emotional support; Instrumental support; Venting; Positive reframing; Planning; Acceptance; Self-blame; Substance use; and, Behavioral disengagement. Participants answered each subscale using a 4-point scale (1="I haven't been doing this at all" to 4="I've been doing this a lot"). A mean score was computed for each subscale, with higher values indicating greater use of that coping skill.
Measured: 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start15 Sep 2021
- Primary completion23 Dec 2021
- Study completion1 Jul 2022
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 (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- HopeLab Foundation
- Responsible party
- Sponsor
- Investigators
- Jose A Bauermeister, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061966
- Sponsor's protocol ID
- 849509
- Status last verified
- Jun 2023
- First submitted
- 14 Sep 2021
- Last updated
- 5 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the dataset.
Publications
Bauermeister J, Choi SK, Bruehlman-Senecal E, Golinkoff J, Taboada A, Lavra J, Ramazzini L, Dillon F, Haritatos J. An Identity-Affirming Web Application to Help Sexual and Gender Minority Youth Cope With Minority Stress: Pilot Randomized Controlled Trial. J Med Internet Res. 2022 Aug 1;24(8):e39094. doi: 10.2196/39094.
PubMed 35916700
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Web App for Sexual and Gender Minority Youth Mental Health
- ClinicalTrials.gov ID
- NCT05061966
- Acronym / sponsor ID
- 849509
- Conditions
- Mental Health
- Keywords
- Sexual and Gender Minorities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- HopeLab Foundation
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Posted 5 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This goal of this randomized control trial is to test whether a web application that provides sexual and gender minority youth ages 13-19 (N=200) with tools for affirming their identities and coping with minority stress can affect key psychosocial outcomes, such as coping self-efficacy and symptoms of anxiety and depression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Resource website | Active comparator | Behavioral: ControlThe comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth. |
| immi | Experimental | Behavioral: immiThe intervention is a novel and scalable web application designed to provide sexual and gender minority youth with tools for affirming their identity and coping with minority stress. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Are between 13-19 years of age (inclusive)
- Self-identify as a sexual or gender minority
- Are English literate
- Reside within the United States
- Have access to a device that has internet access, a web browser, and SMS capabilities, such as a smartphone, computer, or tablet
Key exclusion criteria (6 listed)
- Not between 13-19 years of age (inclusive)
- Does not self-identify as a sexual or gender minority
- Is not English literate
- Does not reside within the United States
- Does not have access to a device that has internet access, a web browser, and SMS capabilities, such as a smartphone, computer, or tablet
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 |
|---|---|---|
| immiThe intervention has four main content areas: 1) gender identity (the gender guide), 2) sexual orientation (the queerness guide), 3)stress and coping (the stress guide), and 4) internalized stigma (the internalized stigma guide). | Behavioural | immi |
| ControlThe control will have access to resources on the website, but will not receive any engagement reminders, matching the conditions present in real world contexts in which web-based resource lists are available. | Behavioural | Online Resource website |
Primary outcome
Coping Self-efficacy
Time frame: 4-week follow-up
The Stress Appraisals Measure for Adolescents includes three subscales (Challenge subscale; Threat subscale; Resources subscale). Each of these subscales is answered on a 5-point scale (1=strongly disagree to 5=strongly agree). A mean score was computed for each subscale, with higher values indicating greater endorsement of each respective stress appraisal.
6 secondary outcomes
Identity Affirmation
Time frame: 4-week follow-up
Internalization of Minority Stress
Time frame: 4-week follow-up
Sense of Belonging to the Queer Community
Time frame: 4-week follow-up
Anxiety Symptoms
Time frame: 4-week follow-up
Depression Symptoms
Time frame: 4-week follow-up
Cognitive and Behavioral Coping Skills
Time frame: 4-week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35916700Bauermeister J, Choi SK, Bruehlman-Senecal E, Golinkoff J, Taboada A, Lavra J, Ramazzini L, Dillon F, Haritatos J. An Identity-Affirming Web Application to Help Sexual and Gender Minority Youth Cope With Minority Stress: Pilot Randomized Controlled Trial. J Med Internet Res. 2022 Aug 1;24(8):e39094. doi: 10.2196/39094.
- Individual participant dataSharing planned: Yes. Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the dataset.
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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.
Jose A Bauermeister, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immi in people with Mental Health, run by University of Pennsylvania 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 6 inclusion and 6 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 5 Jun 2023. 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 5 Jun 2023). 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?
Coping Self-efficacy (time frame: 4-week follow-up). 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 NCT05061966, 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 5 Jun 2023.