Improving Mental Health Among the LGBTQ+ Community

Brown University

Status and phase: Active, not recruiting; Phase 2

Conditions: Depression; Anxiety

Treatments: Behavioral: Acceptance-Based Behavior Therapy (ABBT); Other: Treatment-as-Usual (TAU)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05540067

2022003397

RF1MH132348 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The overall aim of this program of research is to improve the mental health of people who identify as LGBTQ+ by increasing their social support through a brief intervention. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, brief acceptance-based behavioral therapy (ABBT). To achieve the specific aims, the investigators will conduct a fully-powered, randomized clinical trial (n=240) with two treatment arms: treatment-as-usual (TAU) vs. ABBT.

Full description

During the COVID-19 pandemic, up to 81% of adults in the United States experienced worsening mental health. A major cause was the social isolation triggered by the pandemic due to quarantining, loss of family or friends, and loss of work. For individuals who lost social connections or were unable to adapt to maintain their connections, social support decreased and loneliness worsened, putting them at much higher risk for anxiety and depressive symptoms.

Importantly, people who identify as LGBTQ+ have been particularly affected by the social isolation caused by the pandemic and were already at much higher risk of social isolation, loneliness, and mental illness, including suicidality, before the pandemic. The objective of this R01 fully-powered trial is to examine the effectiveness of a brief acceptance-based behavioral telehealth intervention (ABBT) to improve mental health during the COVID-19 pandemic by strengthening social support among LGBTQ+ individuals.

The aims of this proposal are: (1) to examine the effectiveness of ABBT in reducing mental health morbidity by conducting a fully-powered, RCT (n=240) of ABBT vs. Treatment-as-Usual; and, (2) to examine potential mediators and moderators of ABBT treatment effects. Primary outcomes will be anxiety and depressive symptoms.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Present to recruitment clinic for any type of clinical care
• Identify as LGBTQ+
• Self-reported ≥ mild anxiety and/or depressive symptoms, based on the GAD-7 and PHQ-9
• 18 years or older
• Ability to speak and read English

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Acceptance-Based Behavior Therapy (ABBT)

Experimental group

Description:

The 2-session ABBT will be delivered remotely or in-person, depending on preference.

Treatment:

Behavioral: Acceptance-Based Behavior Therapy (ABBT)

Treatment-as-Usual (TAU)

Other group

Description:

Control participants will receive the currently recommended best practices of care at the recruitment site.

Treatment:

Other: Treatment-as-Usual (TAU)