The Digital Wellbeing Project

Mental Health Clinical Trial

Official title:

Piloting a Web App for Sexual and Gender Minority Youth Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05061966
• Other study ID #: 849509
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: June 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 depression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: July 1, 2022
• Est. primary completion date: December 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health

Intervention

Behavioral:
• 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).
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	HopeLab Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4-week follow-up
Secondary	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.	4-week follow-up
Secondary	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	4-week follow-up
Secondary	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	4-week follow-up
Secondary	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.	4-week follow-up
Secondary	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.	4-week follow-up
Secondary	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.	4-week follow-up