Improving Mental Health Among the LGBTQ+ Community

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-25

Study Completion Date

2026-08-31

Brief Summary

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

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.

Related Clinical Trials

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

Affirmative Family and Individual Psychotherapy for Sexual and Gender Minority Adults and Their Nonaccepting Parents

NCT05766592

Mental Health Issue Parent-Child Relations

RECRUITING PHASE3

Creating Welcoming Faith Communities for People With Serious Mental Illnesses

NCT06336980

Other

RECRUITING NA

Leveraging Telepsychology and Behavioral Economics to Increase Fidelity to CBT

NCT06601062

Implementation Science

ENROLLING_BY_INVITATION NA

Optimizing Implementation Coaching to Support Successful EBP Delivery

NCT05799794

Anxiety Depression Mental Health Issue

COMPLETED NA

Researching the Effectiveness of Acceptance-Based Coping During Hospitalization

NCT02336581

Psychosis Schizophrenia

COMPLETED NA

Detailed Description

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

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.

Conditions

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

Anxiety Depression

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

This is a 2-arm RCT.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Blinded raters will conduct interviewer-rated assessments of anxiety and depression (primary outcomes)

Study Groups

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

Acceptance-Based Behavior Therapy (ABBT)

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

Group Type EXPERIMENTAL

Acceptance-Based Behavior Therapy (ABBT)

Intervention Type BEHAVIORAL

In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified challenges related to the COVID-19 pandemic, mental health, and social support. Interventionists will help participants identify potential challenges to acceptance. At the second session, participants will practice acceptance-based coping skills and a social support behavioral plan will be developed. These discussions will help the participant clarify how best to align their values with decisions on how to manage their mental health and social support in the context of the COVID-19 pandemic.

Treatment-as-Usual (TAU)

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

Group Type OTHER

Treatment-as-Usual (TAU)

Intervention Type OTHER

TAU includes brief mental health screening, consultation with providers, and referrals to psychotherapy and/or psychiatric medication.

Interventions

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

Acceptance-Based Behavior Therapy (ABBT)

In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified challenges related to the COVID-19 pandemic, mental health, and social support. Interventionists will help participants identify potential challenges to acceptance. At the second session, participants will practice acceptance-based coping skills and a social support behavioral plan will be developed. These discussions will help the participant clarify how best to align their values with decisions on how to manage their mental health and social support in the context of the COVID-19 pandemic.

Intervention Type BEHAVIORAL

Treatment-as-Usual (TAU)

TAU includes brief mental health screening, consultation with providers, and referrals to psychotherapy and/or psychiatric medication.

Intervention Type OTHER

Eligibility Criteria

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

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