Improving Mental Health Among the LGBTQ+ Community
Primary Purpose
Anxiety, Depression
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acceptance-Based Behavior Therapy (ABBT)
Treatment-as-Usual (TAU)
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Depression, LGBTQ+, COVID-19, Brief intervention, Social support, Acceptance-based behavior therapy
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
Sites / Locations
- Brown UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Acceptance-Based Behavior Therapy (ABBT)
Treatment-as-Usual (TAU)
Arm Description
The 2-session ABBT will be delivered remotely or in-person, depending on preference.
Control participants will receive the currently recommended best practices of care at the recruitment site.
Outcomes
Primary Outcome Measures
Hamilton Anxiety Rating Scale (HAM-A)
The interviewer-rated HAM-A is a measure of anxiety symptom severity.
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
The interviewer-rated QIDS-C is a measure of depressive symptom severity.
Secondary Outcome Measures
Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is a self-report measure of anxiety severity.
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a self-report measure of depression severity.
Full Information
NCT ID
NCT05540067
First Posted
September 12, 2022
Last Updated
January 30, 2023
Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05540067
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
Anxiety, Depression, LGBTQ+, COVID-19, Brief intervention, Social support, Acceptance-based behavior therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is a 2-arm RCT.
Masking
Outcomes Assessor
Masking Description
Blinded raters will conduct interviewer-rated assessments of anxiety and depression (primary outcomes)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acceptance-Based Behavior Therapy (ABBT)
Arm Type
Experimental
Arm Description
The 2-session ABBT will be delivered remotely or in-person, depending on preference.
Arm Title
Treatment-as-Usual (TAU)
Arm Type
Other
Arm Description
Control participants will receive the currently recommended best practices of care at the recruitment site.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance-Based Behavior Therapy (ABBT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment-as-Usual (TAU)
Intervention Description
TAU includes brief mental health screening, consultation with providers, and referrals to psychotherapy and/or psychiatric medication.
Primary Outcome Measure Information:
Title
Hamilton Anxiety Rating Scale (HAM-A)
Description
The interviewer-rated HAM-A is a measure of anxiety symptom severity.
Time Frame
39 weeks
Title
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
Description
The interviewer-rated QIDS-C is a measure of depressive symptom severity.
Time Frame
39 weeks
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
The GAD-7 is a self-report measure of anxiety severity.
Time Frame
39 weeks
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
The PHQ-9 is a self-report measure of depression severity.
Time Frame
39 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ethan Moitra, Ph.D.
Phone
(401) 444-1949
Email
ethan_moitra@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ethan Moitra, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ethan Moitra
Phone
401-444-1949
Email
ethan_moitra@brown.edu
First Name & Middle Initial & Last Name & Degree
Ethan Moitra, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators will share data via The National Institute of Mental Health Data Archive (NDA).
IPD Sharing 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.
IPD Sharing Access Criteria
Request to access the data will be evaluated by the MPIs to ensure that they meet reasonable standards of scientific integrity.
IPD Sharing URL
http://nda.nih.gov/
Learn more about this trial
Improving Mental Health Among the LGBTQ+ Community
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