Trial Outcomes & Findings for A Trial of Online LGBTQ-affirmative Cognitive Behavioral Therapy to Reduce Depression and Associated Health Risks Among Young Adults (NCT NCT04408469)
NCT ID: NCT04408469
Last Updated: 2024-05-03
Results Overview
Distress will be measured using the Brief Symptom Inventory (BSI). The BSI is an 18 item measure that uses a 0-4 rating scale for each item. An overall score of 72 would be the highest possible score on the measure and would indicate an extreme level of overall distress.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Baseline, 4 months, 8 months
Results posted on
2024-05-03
Participant Flow
Recruitment started in May 2020 and ended in May 2021. Participants for this study were recruited from social media, mobile dating apps, LGBTQ community organizations, and via peer recruitment and referral.
Participant milestones
| Measure |
Online EQuIP
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
|
Self-Monitoring
Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
Self-monitoring control: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
Baseline
|
60
|
60
|
|
Overall Study
4-month Post-baseline
|
41
|
53
|
|
Overall Study
8-month Post-baseline
|
48
|
49
|
|
Overall Study
COMPLETED
|
48
|
49
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
| Measure |
Online EQuIP
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
|
Self-Monitoring
Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
Self-monitoring control: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
9
|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
|
Overall Study
Dismissal due to ineligibility
|
0
|
1
|
Baseline Characteristics
A Trial of Online LGBTQ-affirmative Cognitive Behavioral Therapy to Reduce Depression and Associated Health Risks Among Young Adults
Baseline characteristics by cohort
| Measure |
Online EQuIP
n=60 Participants
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
|
Self-Monitoring
n=60 Participants
Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
Self-monitoring control: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.83 years
STANDARD_DEVIATION 3.00 • n=5 Participants
|
22.03 years
STANDARD_DEVIATION 3.51 • n=7 Participants
|
21.93 years
STANDARD_DEVIATION 3.25 • n=5 Participants
|
|
Sex/Gender, Customized
Gender identity · Cisgender woman
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender identity · Cisgender man
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender identity · Transgender woman
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender identity · Transgender man
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender identity · Nonbinary (e.g., genderqueer, agender, gender fluid)
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender identity · Other
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 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/Ethnicity, Customized
Race/ethnicity · American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Asian
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Black/African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Native Hawaiian/Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White, Hispanic/Latinx
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White, Non-Hispanic/Latinx
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Multiracial/Multiple Races
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sexual Orientation
Asexual
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sexual Orientation
Bisexual
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sexual Orientation
Gay
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sexual Orientation
Lesbian
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sexual Orientation
Pansexual
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sexual Orientation
Queer
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
U.S. Region
Northeast
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sexual Orientation
Other
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex Assigned at Birth
Female
|
42 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Sex Assigned at Birth
Male
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex Assigned at Birth
Intersex
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
U.S. Region
South
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Education Degree
Less than high school
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education Degree
Some high school
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Education Degree
High school diploma or GED
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Education Degree
Some college
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Education Degree
Associate's degree
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education Degree
4-year college degree
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Education Degree
Some graduate school
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Education Degree
Advanced graduate school degree
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
U.S. Region
Midwest
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
U.S. Region
West
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Difficulty Meeting Basic Needs
Not very hard
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Difficulty Meeting Basic Needs
Somewhat hard
|
26 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Difficulty Meeting Basic Needs
Very hard
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Financial Worry
|
3.23 score on a scale
STANDARD_DEVIATION 1.01 • n=5 Participants
|
3.23 score on a scale
STANDARD_DEVIATION 1.17 • n=7 Participants
|
3.23 score on a scale
STANDARD_DEVIATION 1.09 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 months, 8 monthsPopulation: The decrease in participants from baseline to post-baseline assessments reflect withdrawals, participants lost to follow-up, and participants dismissed from the study.
Distress will be measured using the Brief Symptom Inventory (BSI). The BSI is an 18 item measure that uses a 0-4 rating scale for each item. An overall score of 72 would be the highest possible score on the measure and would indicate an extreme level of overall distress.
Outcome measures
| Measure |
Online EQuIP
n=60 Participants
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
|
Self-Monitoring
n=60 Participants
Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
Self-monitoring control: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
|
|---|---|---|
|
Change in Distress
Baseline
|
1.43 score on a scale
Standard Error 0.07
|
1.57 score on a scale
Standard Error 0.09
|
|
Change in Distress
4-month Post-baseline
|
1.22 score on a scale
Standard Error 0.11
|
1.34 score on a scale
Standard Error 0.11
|
|
Change in Distress
8-month Post-baseline
|
1.07 score on a scale
Standard Error 0.10
|
1.21 score on a scale
Standard Error 0.09
|
PRIMARY outcome
Timeframe: Baseline, 4 months, 8 monthsPopulation: The decrease in participants from baseline to post-baseline assessments reflect withdrawals, participants lost to follow-up, and participants dismissed from the study.
Depression will be measured using the Center for Epidemiological Studies -- Depression Scale (CESD). This 20-item measure uses a 0-3 rating (Rarely or none of the time - Most or all of the time) scale and sums across the items with items 3, 11, 14, and 16 reversed. for a minimum score of 0 and a maximum score of 60. Higher scores indicate greater severity of depression. In cases with internally missing data (items not answered), the sums are computed after imputation of the missing values: # items on scale / # actually answered, multiplied by the sum obtained from the answered items. A higher score indicates more depressive symptomatology during the past week.
Outcome measures
| Measure |
Online EQuIP
n=60 Participants
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
|
Self-Monitoring
n=60 Participants
Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
Self-monitoring control: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
|
|---|---|---|
|
Change in Depression
Baseline
|
14.17 score on a scale
Standard Error 0.36
|
15.41 score on a scale
Standard Error 0.47
|
|
Change in Depression
4-month post-baseline
|
12.68 score on a scale
Standard Error 0.57
|
13.45 score on a scale
Standard Error 0.50
|
|
Change in Depression
8-month post-baseline
|
12.44 score on a scale
Standard Error 0.48
|
13.38 score on a scale
Standard Error 0.50
|
PRIMARY outcome
Timeframe: Baseline, 4 months, 8 monthsPopulation: The decrease in participants from baseline to post-baseline assessments reflect withdrawals, participants lost to follow-up, and participants dismissed from the study.
Depression severity will be measured using the Overall Depression Severity \& Impairment Scale (ODSIS). This 5 item measure uses a 0-4 rating scale and sums across the items for a maximum score of 20. The higher the score, the greater the severity of depression.
Outcome measures
| Measure |
Online EQuIP
n=60 Participants
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
|
Self-Monitoring
n=60 Participants
Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
Self-monitoring control: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
|
|---|---|---|
|
Change in Depression Severity
Baseline
|
7.20 score on a scale
Standard Error 0.54
|
8.40 score on a scale
Standard Error 0.58
|
|
Change in Depression Severity
4-month post-baseline
|
6.07 score on a scale
Standard Error 0.73
|
6.98 score on a scale
Standard Error 0.58
|
|
Change in Depression Severity
8-month post-baseline
|
6.15 score on a scale
Standard Error 0.74
|
6.63 score on a scale
Standard Error 0.73
|
PRIMARY outcome
Timeframe: Baseline, 4 months, 8 monthsPopulation: The decrease in participants from baseline to post-baseline assessments reflect withdrawals, participants lost to follow-up, and participants dismissed from the study.
Anxiety symptoms will be measured by the Overall Anxiety Severity \& Impairment Scale (OASIS). This 5 item measure uses a 0-4 rating scale and sums across the items for a maximum score of 20. The higher the score, the greater the presence of anxiety symptoms.
Outcome measures
| Measure |
Online EQuIP
n=60 Participants
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
|
Self-Monitoring
n=60 Participants
Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
Self-monitoring control: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
|
|---|---|---|
|
Change in Anxiety Symptoms
Baseline
|
9.12 score on a scale
Standard Error 0.39
|
8.97 score on a scale
Standard Error 0.44
|
|
Change in Anxiety Symptoms
4-month post-baseline
|
7.32 score on a scale
Standard Error 0.53
|
7.45 score on a scale
Standard Error 0.51
|
|
Change in Anxiety Symptoms
8-month post-baseline
|
7.25 score on a scale
Standard Error 0.52
|
7.52 score on a scale
Standard Error 0.60
|
PRIMARY outcome
Timeframe: Baseline, 4 months, 8 monthsPopulation: The decrease in participants from baseline to post-baseline assessments reflect withdrawals, participants lost to follow-up, and participants dismissed from the study.
Alcohol use in participants will be assessed using the Alcohol Use Disorders Identification (AUDIT) instrument. Any alcohol use over the past 3 months will be measured through the first item of the instrument ("How often, during the last 3 months did you have a drink containing alcohol?") with the creation of a binary variable (1 = any alcohol use, 0 = no alcohol use).
Outcome measures
| Measure |
Online EQuIP
n=60 Participants
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
|
Self-Monitoring
n=60 Participants
Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
Self-monitoring control: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
|
|---|---|---|
|
Number of Participants Reporting Any Alcohol Use
Baseline
|
42 Participants
|
41 Participants
|
|
Number of Participants Reporting Any Alcohol Use
4-month post-baseline
|
28 Participants
|
36 Participants
|
|
Number of Participants Reporting Any Alcohol Use
8-month post-baseline
|
34 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 months, 8 monthsPopulation: The decrease in participants from baseline to post-baseline assessments reflect withdrawals, participants lost to follow-up, and participants dismissed from the study.
Suicidal ideation will be measured using the Suicidal Ideation Attributes Scale (SIDAS). Any suicidal ideation was assessed through the first item of this scale ("In the past month, how often have you had thoughts about suicide?") with the creation of a binary variable (1 = any suicidal ideation, 0 = no suicidal ideation).
Outcome measures
| Measure |
Online EQuIP
n=60 Participants
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
|
Self-Monitoring
n=60 Participants
Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
Self-monitoring control: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
|
|---|---|---|
|
Number of Participants Reporting Any Suicidal Ideation
4-month post-baseline
|
25 Participants
|
24 Participants
|
|
Number of Participants Reporting Any Suicidal Ideation
Baseline
|
37 Participants
|
35 Participants
|
|
Number of Participants Reporting Any Suicidal Ideation
8-month post-baseline
|
28 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 months, 8 monthsPopulation: The decrease in participants from baseline to post-baseline assessments reflect withdrawals, participants lost to follow-up, and participants dismissed from the study.
Sexual risk behavior is defined as: condomless anal or vaginal/frontal sex \[not counting the sole use of prosthetics\] in the absence of PrEP, with any HIV+ partner \[except primary HIV+ partners with a known undetectable viral load\] or status-unknown partner. A binary variable of any sexual risk behavior was constructed from reports of past-90 day sexual behavior (1 = any sexual risk behavior, 0 = no sexual risk behavior).
Outcome measures
| Measure |
Online EQuIP
n=60 Participants
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
|
Self-Monitoring
n=60 Participants
Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
Self-monitoring control: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
|
|---|---|---|
|
Number of Participants Reporting Any Sexual Risk Behavior
Baseline
|
4 Participants
|
3 Participants
|
|
Number of Participants Reporting Any Sexual Risk Behavior
4-month post-baseline
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Any Sexual Risk Behavior
8-month post-baseline
|
4 Participants
|
3 Participants
|
Adverse Events
Online EQuIP
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Self-Monitoring
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Online EQuIP
n=60 participants at risk
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
|
Self-Monitoring
n=60 participants at risk
Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
Self-monitoring control: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
|
|---|---|---|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/60 • Adverse events were monitored from baseline through completion of the final follow-up assessment at 8 months.
|
1.7%
1/60 • Number of events 1 • Adverse events were monitored from baseline through completion of the final follow-up assessment at 8 months.
|
Other adverse events
| Measure |
Online EQuIP
n=60 participants at risk
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
|
Self-Monitoring
n=60 participants at risk
Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
Self-monitoring control: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
|
|---|---|---|
|
Psychiatric disorders
Active Suicidality
|
1.7%
1/60 • Number of events 1 • Adverse events were monitored from baseline through completion of the final follow-up assessment at 8 months.
|
0.00%
0/60 • Adverse events were monitored from baseline through completion of the final follow-up assessment at 8 months.
|
Additional Information
Dr. Danielle Chiaramonte
Yale University School of Public Health
Phone: 646-429-9407
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place