N/A N=108 Randomized Double-blind Prevention

Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults

Depression · Suicidality · Substance Abuse · HIV · Minority Stress

Bottom Line

View on ClinicalTrials.gov: NCT03751020 ↗

Enrolled (actual)

108

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Change in Depression. — 24.75; 25.17; 29.06; 21.03 units on a scale — p=<0.01

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Expressive Writing (EW) Intervention (Behavioral); Self-Affirmation (SA) Intervention (Behavioral); Control (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Depression.	24.75; 25.17; 29.06; 21.03; 17.42; 21.73	<0.01 sig
PRIMARY Change in Psychological Distress.	2.31; 2.22; 2.63; 1.84; 1.82; 2.08	0.03 sig
PRIMARY Change in Anxiety.	21.72; 20.28; 26.94; 14.73; 13.54; 19.47	0.07
PRIMARY Change in Suicidality - Suicidal Ideation.	6.05; 4.19; 9.42; 2.36; 1.21; 2.70	0.73
PRIMARY Change in Alcohol Use.	5.08; 4.25; 5.97; 4.67; 3.70; 3.73	0.10
PRIMARY Change in Drug Use.	0.39; 0.31; 1.47; 0.36; 0.67; 0.57	0.76
PRIMARY Suicidal Intent	4; 4; 9; 0; 0; 1	—
PRIMARY Attempted Suicide	1; 0; 1; 0; 0; 0	—
SECONDARY Self Injury.	0.61; 1.36; 0.94; 0.12; 0.21; 0.07	—
SECONDARY Rumination	12.39; 12.97; 13.03; 11.58; 11.67; 12.10	—
SECONDARY Perceived Support	5.11; 5.35; 4.89; 5.10; 5.34; 5.03	—
SECONDARY Hopelessness	7.00; 5.14; 7.44; 6.93; 4.88; 7.80	—
SECONDARY Lesbian, Gay, Bisexual (LGB) Identity	22.44; 18.47; 20.11; 19.91; 17.33; 18.27	—
SECONDARY Change in Cortisol	10.12; 8.28; 10.91; 10.37; 6.18; 12.21	—
SECONDARY Change in Stress	30.25; 29.53; 31.61; 27.03; 24.70; 26.73	—
SECONDARY Change in Impulsiveness Total Score	53.75; 51.03; 54.31; 52.35; 52.76; 54.06	—
SECONDARY Change in Impulsiveness- Attentional	16.36; 16.44; 16.33; 15.79; 15.64; 16.70	—
SECONDARY Change in Impulsiveness- Motor	20.78; 20.78; 21.39; 15.71; 20.52; 21.23	—
SECONDARY Change in Impulsiveness- Non-Planning	17.00; 16.80; 16.58; 15.71; 16.61; 16.13	—
SECONDARY Change in Risk Taking	—	—
SECONDARY Change in Minority Stress (Rejection)	14.47; 12.33; 14.94; 12.92; 10.95; 12.99	—
SECONDARY Change in Parental Attitudes	2.85; 2.59; 2.61; 2.71; 2.60; 2.36	—
SECONDARY Change in Outness	4.46; 5.32; 5.05; 4.55; 5.13; 4.94	—
SECONDARY Change in Internalized Homophobia	1.42; 1.38; 1.58; 1.27; 1.27; 1.56	—
SECONDARY Change in Discrimination - 9 Items (Part 1)	19.75; 19.22; 21.14; 18.61; 17.88; 20.47	—
SECONDARY Change in Discrimination - Item 1 (Part 2)	0.78; 0.89; 1.19; 0.67; 1.00; 0.97	—
SECONDARY Change in Discrimination - Item 2 (Part 2)	1.03; 1.42; 1.53; 1.00; 1.24; 1.30	—
SECONDARY Change in Victimization	1.47; 1.33; 2.56; 0.30; 0.24; 0.67	—
SECONDARY Change in Religious Affiliation	2.70; 3.05; 2.78; 2.78; 2.79; 2.71	—
SECONDARY Change in Religious Strain	29.08; 27.11; 32.75; 27.52; 26.52; 31.40	—

Summary

The purpose of this study is to test the feasibility of writing interventions specifically designed for lesbian, gay, and bisexual (LGB) emerging adults (ages 18-29) that are aimed at improving the outcomes: depression, suicidality, substance abuse and HIV risk behaviors.

Eligibility Criteria

Inclusion Criteria

Self-identify as lesbian, gay, or bisexual
Live in Washington county, Tennessee (TN), or any of its 6 contiguous counties in northeastern TN
Have personal Internet access
Hair at least 2cm in length

Exclusion Criteria

Failure to meet inclusion criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03751020). 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.