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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-27

Study Completion Date

2019-06-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimizing PrEP Adherence for Young Men Who Have Sex With Men

NCT03493555

Pre-Exposure Prophylaxis

COMPLETED NA

Youth Empowerment and Safety Intervention

NCT07214233

Suicide Self-Injurious Behavior

RECRUITING NA

Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men

NCT06205368

HIV Infections STI HIV Pre-exposure Prophylaxis

ACTIVE_NOT_RECRUITING NA

Pre-Exposure Prophylaxis in YMSM

NCT01033942

HIV

COMPLETED PHASE2

A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk

NCT02929069

HIV Acquired Immunodeficiency Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Suicidality Substance Abuse HIV Minority Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Expressive Writing (EW)

Expressive Writing (EW) prompts individuals to write about personally stressful events, potentially enabling cognitive processing of unresolved, psychological and physiological stressors.

Group Type EXPERIMENTAL

Expressive Writing (EW) Intervention

Intervention Type BEHAVIORAL

The EW intervention will utilize the procedures piloted earlier with gay and bisexual male college students in urban and rural regions of the US. In this condition, participants will be instructed to write for 20 minutes across three consecutive days in a free-form manner about the most stressful or traumatic LGB-related event that they have encountered.

Self-Affirmation (SA)

Self-Affirmation (SA) interventions prompt individuals to write advice to a (hypothetical) similarly stigmatized person regarding how best to cope with stigma-related stress. By affirming one's own stigmatized identity through the process of helping another similarly stigmatized person.

Group Type EXPERIMENTAL

Self-Affirmation (SA) Intervention

Intervention Type BEHAVIORAL

The SA intervention will ask participants to read a brief description, over the course of 3 consecutive days, of a (hypothetical) LGB youth who is facing minority stress. Each day's description will contain a different LGB youth facing a different stigma-related stressor derived from Phase 1 and 2 interviews. Participants will then be asked to write a letter for 20 minutes to advise the LGB youth how best to cope with minority stress drawing on their personal experiences.

Control

Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days. This control matches the time and activity of the EW and SA arms and has been implemented across dozens of EW and SA studies.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Expressive Writing (EW) Intervention

The EW intervention will utilize the procedures piloted earlier with gay and bisexual male college students in urban and rural regions of the US. In this condition, participants will be instructed to write for 20 minutes across three consecutive days in a free-form manner about the most stressful or traumatic LGB-related event that they have encountered.

Intervention Type BEHAVIORAL

Self-Affirmation (SA) Intervention

The SA intervention will ask participants to read a brief description, over the course of 3 consecutive days, of a (hypothetical) LGB youth who is facing minority stress. Each day's description will contain a different LGB youth facing a different stigma-related stressor derived from Phase 1 and 2 interviews. Participants will then be asked to write a letter for 20 minutes to advise the LGB youth how best to cope with minority stress drawing on their personal experiences.

Intervention Type BEHAVIORAL

Control

Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days. This control matches the time and activity of the EW and SA arms and has been implemented across dozens of EW and SA studies.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes