Clinical trial NCT03751020: Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults
Official title: Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Suicidality
Substance Abuse
HIV
Minority Stress
Keywords: Expressive Writing
Minority Stress
Lesbian Gay Bisexual
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-11-23
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This study is considered the third part ("Phase 3") of a larger study where parts one and two were designed to utilize elicitation focus groups to develop effective intervention materials (Phase 1) and then refine the developed materials through structured interviews (Phase 2). Phase 3 will test feasibility and assess early signs of efficacy of writing interventions. To do this, participants will be randomized to one of three arms (one arm will serve as control). Those that choose to participate will be asked to complete outcome measures (depressive symptoms, suicidality, use of alcohol and illicit drugs, HIV risk behavior) and measures of proposed mediators (self-reported and biological stress, behavioral and emotional self-regulation) and moderators (e.g., social support, identity centrality) at baseline, post-intervention, and three-month follow-up. In addition, structured interviews with 15 intervention participants will be used to refine study procedures as the investigators scale up this intervention for a future randomized controlled trial (RCT).

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

Primary outcomes:
measure: Change in Depression.
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Psychological Distress.
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Anxiety.
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Suicidality - Suicidal Ideation.
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Alcohol Use.
timeFrame: Baseline, Post Intervention, 3 Months
measure: Change in Drug Use.
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Suicidal Intent
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Attempted Suicide
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
Secondary outcomes:
measure: Self Injury.
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Rumination
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Perceived Support
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Hopelessness
timeFrame: Baseline, Post Intervention, 3 Months
measure: Lesbian, Gay, Bisexual (LGB) Identity
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Cortisol
timeFrame: 1 and 4 months post baseline.
measure: Change in Stress
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Impulsiveness Total Score
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Impulsiveness- Attentional
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Impulsiveness- Motor
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Impulsiveness- Non-Planning
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Risk Taking
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Minority Stress (Rejection)
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Parental Attitudes
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Outness
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Internalized Homophobia
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Discrimination - 9 Items (Part 1)
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Discrimination - Item 1 (Part 2)
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Discrimination - Item 2 (Part 2)
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Victimization
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Religious Affiliation
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
measure: Change in Religious Strain
timeFrame: Baseline, Post Intervention (day 5), and 3 Months.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Worcester
country: United States
facility: College of the Holy Cross
state: Massachusetts
city: Johnson City
country: United States
facility: East Tennessee State University
state: Tennessee
Study officials:
affiliation: Yale University
name: John Pachankis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pachankis JE, Williams SL, Behari K, Job S, McConocha EM, Chaudoir SR. Brief online interventions for LGBTQ young adult mental and behavioral health: A randomized controlled trial in a high-stigma, low-resource context. J Consult Clin Psychol. 2020 May;88(5):429-444. doi: 10.1037/ccp0000497.