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Active, Not Recruiting

NCT Number: NCT05540067

Improving Mental Health Among the LGBTQ+ Community

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brown University

Providence, Rhode Island, 02912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acceptance-Based Behavior Therapy (ABBT)

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)

Other

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

Primary outcomes

  1. Hamilton Anxiety Rating Scale (HAM-A)

    Time frame: 39 weeks

    The interviewer-rated HAM-A is a measure of anxiety symptom severity.

  2. 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.

Secondary outcomes

  1. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 39 weeks

    The GAD-7 is a self-report measure of anxiety severity.

  2. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 39 weeks

    The PHQ-9 is a self-report measure of depression severity.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2022
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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