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

Yale University

Status: Completed

Conditions: Suicidality; Minority Stress; HIV; Depression; Substance Abuse

Treatments: Other: Control; Behavioral: Expressive Writing (EW) Intervention; Behavioral: Self-Affirmation (SA) Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03751020

1512016952

1R21MH113860-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 108 patients

Sex: All

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 3 patient groups, including a placebo group

Expressive Writing (EW)

Experimental group

Description:

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

Treatment:

Behavioral: Expressive Writing (EW) Intervention

Self-Affirmation (SA)

Experimental group

Description:

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.

Treatment:

Behavioral: Self-Affirmation (SA) Intervention

Control

Placebo Comparator group

Description:

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.

Treatment:

Other: Control