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

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

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

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=99 Participants
22.03 years
STANDARD_DEVIATION 3.51 • n=107 Participants
21.93 years
STANDARD_DEVIATION 3.25 • n=206 Participants
Sex/Gender, Customized
Gender identity · Cisgender woman
22 Participants
n=99 Participants
29 Participants
n=107 Participants
51 Participants
n=206 Participants
Sex/Gender, Customized
Gender identity · Cisgender man
10 Participants
n=99 Participants
5 Participants
n=107 Participants
15 Participants
n=206 Participants
Sex/Gender, Customized
Gender identity · Transgender woman
3 Participants
n=99 Participants
2 Participants
n=107 Participants
5 Participants
n=206 Participants
Sex/Gender, Customized
Gender identity · Transgender man
3 Participants
n=99 Participants
8 Participants
n=107 Participants
11 Participants
n=206 Participants
Sex/Gender, Customized
Gender identity · Nonbinary (e.g., genderqueer, agender, gender fluid)
17 Participants
n=99 Participants
12 Participants
n=107 Participants
29 Participants
n=206 Participants
Sex/Gender, Customized
Gender identity · Other
5 Participants
n=99 Participants
4 Participants
n=107 Participants
9 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants
n=99 Participants
11 Participants
n=107 Participants
22 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
49 Participants
n=99 Participants
49 Participants
n=107 Participants
98 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race/Ethnicity, Customized
Race/ethnicity · American Indian or Alaskan Native
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race/Ethnicity, Customized
Race/ethnicity · Asian
12 Participants
n=99 Participants
8 Participants
n=107 Participants
20 Participants
n=206 Participants
Race/Ethnicity, Customized
Race/ethnicity · Black/African American
1 Participants
n=99 Participants
2 Participants
n=107 Participants
3 Participants
n=206 Participants
Race/Ethnicity, Customized
Race/ethnicity · Native Hawaiian/Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race/Ethnicity, Customized
Race/ethnicity · White, Hispanic/Latinx
6 Participants
n=99 Participants
7 Participants
n=107 Participants
13 Participants
n=206 Participants
Race/Ethnicity, Customized
Race/ethnicity · White, Non-Hispanic/Latinx
29 Participants
n=99 Participants
30 Participants
n=107 Participants
59 Participants
n=206 Participants
Race/Ethnicity, Customized
Race/ethnicity · Multiracial/Multiple Races
9 Participants
n=99 Participants
11 Participants
n=107 Participants
20 Participants
n=206 Participants
Race/Ethnicity, Customized
Race/ethnicity · Other
3 Participants
n=99 Participants
1 Participants
n=107 Participants
4 Participants
n=206 Participants
Sexual Orientation
Asexual
3 Participants
n=99 Participants
3 Participants
n=107 Participants
6 Participants
n=206 Participants
Sexual Orientation
Bisexual
21 Participants
n=99 Participants
20 Participants
n=107 Participants
41 Participants
n=206 Participants
Sexual Orientation
Gay
11 Participants
n=99 Participants
8 Participants
n=107 Participants
19 Participants
n=206 Participants
Sexual Orientation
Lesbian
6 Participants
n=99 Participants
14 Participants
n=107 Participants
20 Participants
n=206 Participants
Sexual Orientation
Pansexual
4 Participants
n=99 Participants
4 Participants
n=107 Participants
8 Participants
n=206 Participants
Sexual Orientation
Queer
11 Participants
n=99 Participants
10 Participants
n=107 Participants
21 Participants
n=206 Participants
Sexual Orientation
Other
4 Participants
n=99 Participants
1 Participants
n=107 Participants
5 Participants
n=206 Participants
Sex Assigned at Birth
Female
42 Participants
n=99 Participants
49 Participants
n=107 Participants
91 Participants
n=206 Participants
Sex Assigned at Birth
Male
17 Participants
n=99 Participants
10 Participants
n=107 Participants
27 Participants
n=206 Participants
Sex Assigned at Birth
Intersex
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Education Degree
Less than high school
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Education Degree
Some high school
9 Participants
n=99 Participants
12 Participants
n=107 Participants
21 Participants
n=206 Participants
Education Degree
High school diploma or GED
4 Participants
n=99 Participants
9 Participants
n=107 Participants
13 Participants
n=206 Participants
Education Degree
Some college
24 Participants
n=99 Participants
17 Participants
n=107 Participants
41 Participants
n=206 Participants
Education Degree
Associate's degree
1 Participants
n=99 Participants
2 Participants
n=107 Participants
3 Participants
n=206 Participants
Education Degree
4-year college degree
16 Participants
n=99 Participants
16 Participants
n=107 Participants
32 Participants
n=206 Participants
Education Degree
Some graduate school
4 Participants
n=99 Participants
2 Participants
n=107 Participants
6 Participants
n=206 Participants
Education Degree
Advanced graduate school degree
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
U.S. Region
Midwest
11 Participants
n=99 Participants
10 Participants
n=107 Participants
21 Participants
n=206 Participants
U.S. Region
Northeast
9 Participants
n=99 Participants
13 Participants
n=107 Participants
22 Participants
n=206 Participants
U.S. Region
South
28 Participants
n=99 Participants
25 Participants
n=107 Participants
53 Participants
n=206 Participants
U.S. Region
West
12 Participants
n=99 Participants
12 Participants
n=107 Participants
24 Participants
n=206 Participants
Difficulty Meeting Basic Needs
Not very hard
32 Participants
n=99 Participants
33 Participants
n=107 Participants
65 Participants
n=206 Participants
Difficulty Meeting Basic Needs
Somewhat hard
26 Participants
n=99 Participants
18 Participants
n=107 Participants
44 Participants
n=206 Participants
Difficulty Meeting Basic Needs
Very hard
2 Participants
n=99 Participants
9 Participants
n=107 Participants
11 Participants
n=206 Participants
Financial Worry
3.23 score on a scale
STANDARD_DEVIATION 1.01 • n=99 Participants
3.23 score on a scale
STANDARD_DEVIATION 1.17 • n=107 Participants
3.23 score on a scale
STANDARD_DEVIATION 1.09 • n=206 Participants

PRIMARY outcome

Timeframe: Baseline, 4 months, 8 months

Population: 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

Outcome measures
Measure
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
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.
Change in Distress
Baseline
1.57 score on a scale
Standard Error 0.09
1.43 score on a scale
Standard Error 0.07
Change in Distress
4-month Post-baseline
1.34 score on a scale
Standard Error 0.11
1.22 score on a scale
Standard Error 0.11
Change in Distress
8-month Post-baseline
1.21 score on a scale
Standard Error 0.09
1.07 score on a scale
Standard Error 0.10

PRIMARY outcome

Timeframe: Baseline, 4 months, 8 months

Population: 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

Outcome measures
Measure
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
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.
Change in Depression
Baseline
15.41 score on a scale
Standard Error 0.47
14.17 score on a scale
Standard Error 0.36
Change in Depression
4-month post-baseline
13.45 score on a scale
Standard Error 0.50
12.68 score on a scale
Standard Error 0.57
Change in Depression
8-month post-baseline
13.38 score on a scale
Standard Error 0.50
12.44 score on a scale
Standard Error 0.48

PRIMARY outcome

Timeframe: Baseline, 4 months, 8 months

Population: 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

Outcome measures
Measure
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
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.
Change in Depression Severity
Baseline
8.40 score on a scale
Standard Error 0.58
7.20 score on a scale
Standard Error 0.54
Change in Depression Severity
4-month post-baseline
6.98 score on a scale
Standard Error 0.58
6.07 score on a scale
Standard Error 0.73
Change in Depression Severity
8-month post-baseline
6.63 score on a scale
Standard Error 0.73
6.15 score on a scale
Standard Error 0.74

PRIMARY outcome

Timeframe: Baseline, 4 months, 8 months

Population: 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

Outcome measures
Measure
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
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.
Change in Anxiety Symptoms
Baseline
8.97 score on a scale
Standard Error 0.44
9.12 score on a scale
Standard Error 0.39
Change in Anxiety Symptoms
4-month post-baseline
7.45 score on a scale
Standard Error 0.51
7.32 score on a scale
Standard Error 0.53
Change in Anxiety Symptoms
8-month post-baseline
7.52 score on a scale
Standard Error 0.60
7.25 score on a scale
Standard Error 0.52

PRIMARY outcome

Timeframe: Baseline, 4 months, 8 months

Population: 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

Outcome measures
Measure
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
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.
Number of Participants Reporting Any Alcohol Use
Baseline
41 Participants
42 Participants
Number of Participants Reporting Any Alcohol Use
4-month post-baseline
36 Participants
28 Participants
Number of Participants Reporting Any Alcohol Use
8-month post-baseline
34 Participants
34 Participants

PRIMARY outcome

Timeframe: Baseline, 4 months, 8 months

Population: 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

Outcome measures
Measure
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
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.
Number of Participants Reporting Any Suicidal Ideation
Baseline
35 Participants
37 Participants
Number of Participants Reporting Any Suicidal Ideation
4-month post-baseline
24 Participants
25 Participants
Number of Participants Reporting Any Suicidal Ideation
8-month post-baseline
25 Participants
28 Participants

PRIMARY outcome

Timeframe: Baseline, 4 months, 8 months

Population: 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

Outcome measures
Measure
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
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.
Number of Participants Reporting Any Sexual Risk Behavior
Baseline
3 Participants
4 Participants
Number of Participants Reporting Any Sexual Risk Behavior
4-month post-baseline
4 Participants
2 Participants
Number of Participants Reporting Any Sexual Risk Behavior
8-month post-baseline
3 Participants
4 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

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

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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place