Improving Mental Health Among the LGBTQ+ Community

NCT05540067 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: 2022003397RF1MH132348
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Depression

Keywords

Anxiety; Depression; LGBTQ+; COVID-19; Brief intervention; Social support; Acceptance-based behavior therapy

Outcome Measures

Primary Outcomes (2)

• Hamilton Anxiety Rating Scale (HAM-A)

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

  39 weeks

• Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)

  The interviewer-rated QIDS-C is a measure of depressive symptom severity.

  39 weeks

Secondary Outcomes (2)

• Generalized Anxiety Disorder-7 (GAD-7)

  39 weeks

• Patient Health Questionnaire-9 (PHQ-9)

  39 weeks

Study Arms (2)

Acceptance-Based Behavior Therapy (ABBT)

EXPERIMENTAL

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

Behavioral: Acceptance-Based Behavior Therapy (ABBT)

Treatment-as-Usual (TAU)

OTHER

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

Other: Treatment-as-Usual (TAU)

Interventions

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.

Acceptance-Based Behavior Therapy (ABBT)

Treatment-as-Usual (TAU) OTHER

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

Treatment-as-Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older
• Ability to speak and read English

You may not qualify if:

• None

Sponsors & Collaborators

• Brown University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

Related Publications (1)

• Moitra E, Brick LA, Cancilliere MK, Elwy AR, Erbe AM, Fenn N, Nunn AS, Salhaney P, Chan PA. A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ+ persons: Study protocol. Contemp Clin Trials. 2023 Jul;130:107211. doi: 10.1016/j.cct.2023.107211. Epub 2023 May 3.

  PMID: 37146874 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; COVID-19

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ethan Moitra, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded raters will conduct interviewer-rated assessments of anxiety and depression (primary outcomes)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 2-arm RCT.

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: January 25, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• 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.
• Access Criteria: Request to access the data will be evaluated by the MPIs to ensure that they meet reasonable standards of scientific integrity.

Locations

US (1)