AnxietyPhase 2NCT05540067
Improving Mental Health Among the LGBTQ+ Community
A Phase 2 study testing Acceptance-Based Behavior Therapy (ABBT) and Treatment-as-Usual (TAU) in people with Anxiety and Depression, run by Brown University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Acceptance-Based Behavior Therapy (ABBT) and Treatment-as-Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2023to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Mental Health Among the LGBTQ+ Community Impacted by the COVID-19 Pandemic
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.
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- Acceptance-Based Behavior Therapy (ABBT), Treatment-as-Usual (TAU)
- Keywords
- Anxiety, Depression, LGBTQ+, COVID-19, Brief intervention, Social support, Acceptance-based behavior therapy
- Medical subject headings
- Anxiety Disorders, Depression, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance-Based Behavior Therapy (ABBT)Behavioural
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.
TAU includes brief mental health screening, consultation with providers, and referrals to psychotherapy and/or psychiatric medication.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance-Based Behavior Therapy (ABBT) | Experimental | The 2-session ABBT will be delivered remotely or in-person, depending on preference. Receives: Behavioral: Acceptance-Based Behavior Therapy (ABBT) |
| Treatment-as-Usual (TAU) | Other | Control participants will receive the currently recommended best practices of care at the recruitment site. Receives: Other: Treatment-as-Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Scale (HAM-A)
The interviewer-rated HAM-A is a measure of anxiety symptom severity.
Measured: 39 weeks
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
The interviewer-rated QIDS-C is a measure of depressive symptom severity.
Measured: 39 weeks
Secondary outcomes (2)
Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is a self-report measure of anxiety severity.
Measured: 39 weeks
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a self-report measure of depression severity.
Measured: 39 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start25 Jan 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 2-arm RCT.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ethan Moitra, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540067
- Sponsor's protocol ID
- 2022003397
- Other IDs
- RF1MH132348
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share data via The National Institute of Mental Health Data Archive (NDA).
Publications
Moitra E, Brick LA, Cancilliere MK, Elwy AR, Erbe AM, Fenn N, Nunn AS, Salhaney P, Chan PA. A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ+ persons: Study protocol. Contemp Clin Trials. 2023 Jul;130:107211. doi: 10.1016/j.cct.2023.107211. Epub 2023 May 3.
PubMed 37146874
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mental Health Among the LGBTQ+ Community Impacted by the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05540067
- Acronym / sponsor ID
- 2022003397
- Conditions
- Anxiety, Depression
- Keywords
- Anxiety, Depression, LGBTQ+, COVID-19, Brief intervention, Social support, Acceptance-based behavior therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 2-arm RCT.
| Arm | Type | Receives |
|---|---|---|
| Acceptance-Based Behavior Therapy (ABBT) | Experimental | Behavioral: Acceptance-Based Behavior Therapy (ABBT)The 2-session ABBT will be delivered remotely or in-person, depending on preference. |
| Treatment-as-Usual (TAU) | Other | Other: Treatment-as-Usual (TAU)Control participants will receive the currently recommended best practices of care at the recruitment site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Acceptance-Based Behavior Therapy (ABBT) |
| Treatment-as-Usual (TAU)TAU includes brief mental health screening, consultation with providers, and referrals to psychotherapy and/or psychiatric medication. | Other | Treatment-as-Usual (TAU) |
Primary outcome
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 39 weeks
The interviewer-rated HAM-A is a measure of anxiety symptom severity.
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
Time frame: 39 weeks
The interviewer-rated QIDS-C is a measure of depressive symptom severity.
2 secondary outcomes
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 39 weeks
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 39 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 37146874Moitra E, Brick LA, Cancilliere MK, Elwy AR, Erbe AM, Fenn N, Nunn AS, Salhaney P, Chan PA. A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ+ persons: Study protocol. Contemp Clin Trials. 2023 Jul;130:107211. doi: 10.1016/j.cct.2023.107211. Epub 2023 May 3.
- Individual participant dataSharing planned: Yes. The investigators will share data via The National Institute of Mental Health Data Archive (NDA).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethan Moitra, Ph.D. principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acceptance-Based Behavior Therapy (ABBT) and Treatment-as-Usual (TAU) in people with Anxiety and Depression, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (HAM-A) (time frame: 39 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05540067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.