The Digital Wellbeing Project

NCT ID: NCT05061966

Last Updated: 2023-06-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2022-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Online Resource website

The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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.

immi

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.

Group Type EXPERIMENTAL

immi

Intervention Type BEHAVIORAL

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).

Interventions

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immi

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).

Intervention Type BEHAVIORAL

Control

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Are between 13-19 years of age (inclusive)
2. Self-identify as a sexual or gender minority
3. Are English literate
4. Reside within the United States
5. Have access to a device that has internet access, a web browser, and SMS capabilities, such as a smartphone, computer, or tablet
6. Willingness to participate in study activities

Exclusion Criteria

1. Not between 13-19 years of age (inclusive)
2. Does not self-identify as a sexual or gender minority
3. Is not English literate
4. Does not reside within the United States
5. Does not have access to a device that has internet access, a web browser, and SMS capabilities, such as a smartphone, computer, or tablet
6. Unwilling to participate in study activities
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HopeLab Foundation

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose A Bauermeister, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35916700 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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849509

Identifier Type: -

Identifier Source: org_study_id

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