Improving Mental Health Among the LGBTQ+ Community

October 22, 2025 updated by: Brown University

Improving Mental Health Among the LGBTQ+ Community Impacted by the COVID-19 Pandemic

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acceptance-Based Behavior Therapy (ABBT)
The 2-session ABBT will be delivered remotely or in-person, depending on preference.
Behavioral: 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.
Other: Treatment-as-Usual (TAU)
Control participants will receive the currently recommended best practices of care at the recruitment site.
Other: Treatment-as-Usual (TAU)
TAU includes brief mental health screening, consultation with providers, and referrals to psychotherapy and/or psychiatric medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: 39 weeks
The interviewer-rated HAM-A is a measure of anxiety symptom severity.
39 weeks
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
Time Frame: 39 weeks
The interviewer-rated QIDS-C is a measure of depressive symptom severity.
39 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 39 weeks
The GAD-7 is a self-report measure of anxiety severity.
39 weeks
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 39 weeks
The PHQ-9 is a self-report measure of depression severity.
39 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Ethan Moitra, Ph.D., Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Estimated)

October 23, 2025

Last Update Submitted That Met QC Criteria

October 22, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022003397
  • RF1MH132348 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will share data via The National Institute of Mental Health Data Archive (NDA).

IPD Sharing Time Frame

Data will be uploaded to NDA semi-annually. Consistent with NIMH guidelines, there will be no specific time limit regarding how long IPD are available.

IPD Sharing Access Criteria

Request to access the data will be evaluated by the MPIs to ensure that they meet reasonable standards of scientific integrity.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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