Improving Mental Health Among the LGBTQ+ Community

Phase 2

Recruiting

• Conditions: Depression; Anxiety
• Interventions: Other: Treatment-as-Usual (TAU); Behavioral: Acceptance-Based Behavior Therapy (ABBT)

• Registration Number: NCT05540067
• Lead Sponsor: Brown University

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.

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 Timeline

• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-14
• Study Start: 2023-01-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment-as-Usual (TAU)	Treatment-as-Usual (TAU)	Control participants will receive the currently recommended best practices of care at the recruitment site.
Acceptance-Based Behavior Therapy (ABBT)	Acceptance-Based Behavior Therapy (ABBT)	The 2-session ABBT will be delivered remotely or in-person, depending on preference.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 (PHQ-9)	39 weeks	The PHQ-9 is a self-report measure of depression severity.
Generalized Anxiety Disorder-7 (GAD-7)	39 weeks	The GAD-7 is a self-report measure of anxiety severity.

Trial Locations

Locations (1)

Brown University; 🇺🇸 Providence, Rhode Island, United States