Improving Mental Health Among the LGBTQ+ Community

Sponsor
Brown University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05540067
Collaborator
National Institute of Mental Health (NIMH) (NIH)
240
1
2
34
7.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Acceptance-Based Behavior Therapy (ABBT)
  • Other: Treatment-as-Usual (TAU)
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a 2-arm RCT.This is a 2-arm RCT.
Masking:
Single (Outcomes Assessor)
Masking Description:
Blinded raters will conduct interviewer-rated assessments of anxiety and depression (primary outcomes)
Primary Purpose:
Treatment
Official Title:
Improving Mental Health Among the LGBTQ+ Community Impacted by the COVID-19 Pandemic
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Aug 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acceptance-Based Behavior Therapy (ABBT)

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

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)

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

Other: Treatment-as-Usual (TAU)
TAU includes brief mental health screening, consultation with providers, and referrals to psychotherapy and/or psychiatric medication.

Outcome Measures

Primary Outcome Measures

  1. Hamilton Anxiety Rating Scale (HAM-A) [39 weeks]

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

  2. Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) [39 weeks]

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

Secondary Outcome Measures

  1. Generalized Anxiety Disorder-7 (GAD-7) [39 weeks]

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

  2. Patient Health Questionnaire-9 (PHQ-9) [39 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brown University Providence Rhode Island United States 02912

Sponsors and Collaborators

  • Brown University
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Ethan Moitra, Ph.D., Brown University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brown University
ClinicalTrials.gov Identifier:
NCT05540067
Other Study ID Numbers:
  • 2022003397
  • RF1MH132348
First Posted:
Sep 14, 2022
Last Update Posted:
Sep 14, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Brown University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2022