Trial Outcomes & Findings for The Digital Wellbeing Project (NCT NCT05061966)
NCT ID: NCT05061966
Last Updated: 2023-06-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
270 participants
Primary outcome timeframe
4-week follow-up
Results posted on
2023-06-05
Participant Flow
Participant milestones
| Measure |
Online Resource Website
The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.
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.
|
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.
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).
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
135
|
|
Overall Study
COMPLETED
|
122
|
122
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
| Measure |
Online Resource Website
The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.
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.
|
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.
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).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
13
|
Baseline Characteristics
The Digital Wellbeing Project
Baseline characteristics by cohort
| Measure |
Online Resource Website
n=135 Participants
The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.
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.
|
Immi
n=135 Participants
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.
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).
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
120 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16.42 years
STANDARD_DEVIATION 1.51 • n=5 Participants
|
16.56 years
STANDARD_DEVIATION 1.46 • n=7 Participants
|
16.49 years
STANDARD_DEVIATION 1.49 • n=5 Participants
|
|
Sex/Gender, Customized
Multiple gender identities
|
56 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Single gender identity
|
79 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
64 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
135 participants
n=5 Participants
|
135 participants
n=7 Participants
|
270 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-week follow-upThe 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.
Outcome measures
| Measure |
Online Resource Website
n=122 Participants
The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.
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.
|
Immi
n=122 Participants
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.
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).
|
|---|---|---|
|
Coping Self-efficacy
Challenge
|
3.32 score on a scale
Standard Deviation .93
|
3.64 score on a scale
Standard Deviation .85
|
|
Coping Self-efficacy
Threat
|
3.92 score on a scale
Standard Deviation .69
|
3.85 score on a scale
Standard Deviation .77
|
|
Coping Self-efficacy
Resource
|
3.67 score on a scale
Standard Deviation .90
|
3.83 score on a scale
Standard Deviation .92
|
SECONDARY outcome
Timeframe: 4-week follow-upThe 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.
Outcome measures
| Measure |
Online Resource Website
n=122 Participants
The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.
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.
|
Immi
n=122 Participants
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.
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).
|
|---|---|---|
|
Identity Affirmation
|
5.08 units on a scale
Standard Deviation 1.30
|
5.10 units on a scale
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: 4-week follow-upThe 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
Outcome measures
| Measure |
Online Resource Website
n=122 Participants
The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.
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.
|
Immi
n=122 Participants
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.
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).
|
|---|---|---|
|
Internalization of Minority Stress
|
2.94 score on a scale
Standard Deviation 1.23
|
3.19 score on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: 4-week follow-upThe 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
Outcome measures
| Measure |
Online Resource Website
n=122 Participants
The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.
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.
|
Immi
n=122 Participants
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.
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).
|
|---|---|---|
|
Sense of Belonging to the Queer Community
|
18.21 units on a scale
Standard Deviation 6.24
|
17.15 units on a scale
Standard Deviation 6.99
|
SECONDARY outcome
Timeframe: 4-week follow-upThe 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.
Outcome measures
| Measure |
Online Resource Website
n=122 Participants
The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.
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.
|
Immi
n=122 Participants
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.
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).
|
|---|---|---|
|
Anxiety Symptoms
|
10.30 score on a scale
Standard Deviation 5.78
|
9.92 score on a scale
Standard Deviation 5.56
|
SECONDARY outcome
Timeframe: 4-week follow-upThe Patient Health Questionnaire-8 inventory has a range from 0 to 24. A summed score was computed, where higher scores indicate greater depression symptomatology.
Outcome measures
| Measure |
Online Resource Website
n=122 Participants
The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.
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.
|
Immi
n=122 Participants
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.
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).
|
|---|---|---|
|
Depression Symptoms
|
11.40 score on a scale
Standard Deviation 5.75
|
11.61 score on a scale
Standard Deviation 5.95
|
SECONDARY outcome
Timeframe: 4-week follow-upThe 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.
Outcome measures
| Measure |
Online Resource Website
n=122 Participants
The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.
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.
|
Immi
n=122 Participants
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.
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).
|
|---|---|---|
|
Cognitive and Behavioral Coping Skills
Self-distraction
|
3.23 units on a scale
Standard Deviation .65
|
3.23 units on a scale
Standard Deviation .65
|
|
Cognitive and Behavioral Coping Skills
Active coping
|
2.47 units on a scale
Standard Deviation .72
|
2.65 units on a scale
Standard Deviation .84
|
|
Cognitive and Behavioral Coping Skills
Emotional support
|
2.43 units on a scale
Standard Deviation .94
|
2.59 units on a scale
Standard Deviation .94
|
|
Cognitive and Behavioral Coping Skills
Instrumental support
|
2.30 units on a scale
Standard Deviation .87
|
2.64 units on a scale
Standard Deviation .90
|
|
Cognitive and Behavioral Coping Skills
Venting
|
2.42 units on a scale
Standard Deviation .82
|
2.48 units on a scale
Standard Deviation .86
|
|
Cognitive and Behavioral Coping Skills
Positive reframing
|
2.25 units on a scale
Standard Deviation .78
|
2.45 units on a scale
Standard Deviation .86
|
|
Cognitive and Behavioral Coping Skills
Planning
|
2.56 units on a scale
Standard Deviation .86
|
2.79 units on a scale
Standard Deviation .83
|
|
Cognitive and Behavioral Coping Skills
Acceptance
|
2.73 units on a scale
Standard Deviation .77
|
2.87 units on a scale
Standard Deviation .77
|
|
Cognitive and Behavioral Coping Skills
Self-blame
|
2.76 units on a scale
Standard Deviation .88
|
2.91 units on a scale
Standard Deviation .87
|
|
Cognitive and Behavioral Coping Skills
Substance use
|
1.38 units on a scale
Standard Deviation .78
|
1.33 units on a scale
Standard Deviation .74
|
|
Cognitive and Behavioral Coping Skills
Behavioral disengagement
|
1.99 units on a scale
Standard Deviation .82
|
2.01 units on a scale
Standard Deviation .80
|
Adverse Events
Online Resource Website
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Immi
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place