N/A
N=120
A Trial of Online LGBTQ-affirmative Cognitive Behavioral Therapy to Reduce Depression and Associated Health Risks Among Young Adults
LGBTQ · Sexual Behavior
Bottom Line
View on ClinicalTrials.gov: NCT04408469 ↗Enrolled (actual)
120
Serious AEs
0.8%
Results posted
May 2024
Primary outcome: Primary: Change in Distress — 1.43; 1.57; 1.22; 1.34 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Online EQuIP (Behavioral); Self-monitoring control (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Distress |
1.43; 1.57; 1.22; 1.34; 1.07; 1.21 | — |
| PRIMARY Change in Depression |
14.17; 15.41; 12.68; 13.45; 12.44; 13.38 | — |
| PRIMARY Change in Depression Severity |
7.20; 8.40; 6.07; 6.98; 6.15; 6.63 | — |
| PRIMARY Change in Anxiety Symptoms |
9.12; 8.97; 7.32; 7.45; 7.25; 7.52 | — |
| PRIMARY Number of Participants Reporting Any Alcohol Use |
42; 41; 28; 36; 34; 34 | — |
| PRIMARY Number of Participants Reporting Any Suicidal Ideation |
37; 35; 25; 24; 28; 25 | — |
| PRIMARY Number of Participants Reporting Any Sexual Risk Behavior |
4; 3; 2; 4; 4; 3 | — |
Summary
This study is to test the efficacy of an online CBT intervention (EQuIP) that addresses the pathways through which minority stress compromises LGBTQ young adults' co-occurring mental (e.g., depression) and behavioral (e.g., substance use, condomless anal sex) health problems. This purpose of this study is to determine if the treatment is efficacious when delivered online and if its efficacy exceeds that of the self-monitoring control.
Eligibility Criteria
Inclusion Criteria
- identify as lesbian, bisexual, gay, or another sexual minority identity (e.g., pansexual, demisexual)
- past-week symptoms of depression or anxiety using the Brief Symptom Inventory-4 cutoff of 2.5 on either the depression subscale or anxiety subscale
- weekly access to internet on a laptop, desktop, or tablet device
- ability to read, write, and speak in English
- provision of informed consent.
Exclusion Criteria
- current active suicidality or homicidality (defined as active intent or concrete plan, as opposed to passive suicidal ideation)
- evidence of active untreated mania, psychosis, or gross cognitive impairment - current enrollment in an intervention study
- current enrollment in intensive mental health treatment (i.e., receiving mental health treatment more than once per month or 8 or more sessions of CBT within the past year.
Data sourced from ClinicalTrials.gov (NCT04408469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.