Improving Mental Health Among the LGBTQ+ Community

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05540067
• Other study ID #: 2022003397
• Secondary ID: RF1MH132348
• Status: Recruiting
• Phase: Phase 2
• Start date: January 25, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: January 2023
• Source: Brown University
• Contact: Ethan Moitra, Ph.D.
• Phone: (401) 444-1949
• Email: ethan_moitra[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 31, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

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

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Anxiety Rating Scale (HAM-A)	The interviewer-rated HAM-A is a measure of anxiety symptom severity.	39 weeks
Primary	Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)	The interviewer-rated QIDS-C is a measure of depressive symptom severity.	39 weeks
Secondary	Generalized Anxiety Disorder-7 (GAD-7)	The GAD-7 is a self-report measure of anxiety severity.	39 weeks
Secondary	Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 is a self-report measure of depression severity.	39 weeks