Clinical trial NCT05540067: Improving Mental Health Among the LGBTQ+ Community
Official title: Improving Mental Health Among the LGBTQ+ Community Impacted by the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Anxiety
Depression
Keywords: Anxiety
Depression
LGBTQ+
COVID-19
Brief intervention
Social support
Acceptance-based behavior therapy
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-09-14
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a 2-arm RCT.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: 39 weeks
measure: Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
timeFrame: 39 weeks
Secondary outcomes:
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 39 weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 39 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Ethan Moitra, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: