ABBT for Mental Health in LGBTQ+ Community

Overseen By Ethan Moitra, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Brown University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the mental health of individuals who identify as LGBTQ+ by testing a brief therapy called Acceptance-Based Behavior Therapy (ABBT). It will compare ABBT to the usual care currently received. The goal is to determine if ABBT can increase social support and alleviate anxiety or depression. Individuals who identify as LGBTQ+ and have mild anxiety or depression symptoms may be suitable for this study. As a Phase 2 trial, this research focuses on assessing the effectiveness of ABBT in an initial, smaller group, offering participants an opportunity to contribute to significant advancements in mental health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, as there are no exclusion criteria related to medication use.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Acceptance-Based Behavior Therapy (ABBT) is generally easy for participants to handle. Studies have found that ABBT can improve mental health by increasing social support and reducing symptoms. Although these studies primarily focused on ABBT's effectiveness, participants did not report any major safety issues.

ABBT, a type of talk therapy, does not involve medication, reducing the risk of physical side effects. This makes it a relatively safe option for many people. Discussing any concerns with a healthcare provider is always important, but current research suggests that ABBT is a safe way to improve mental health. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for mental health in the LGBTQ+ community?

Researchers are excited about Acceptance-Based Behavior Therapy (ABBT) for mental health in the LGBTQ+ community because it offers a unique approach compared to traditional therapies like Cognitive Behavioral Therapy (CBT) or medication. ABBT focuses on helping individuals accept their thoughts and feelings rather than trying to change them, which can be particularly empowering for those facing stigma and discrimination. This therapy is also flexible, with options for remote or in-person sessions, making it more accessible to people who may not have easy access to traditional mental health resources. By targeting acceptance and mindfulness, ABBT aims to provide a supportive environment that resonates with the unique experiences of the LGBTQ+ community.

What evidence suggests that this trial's treatments could be effective for improving mental health in the LGBTQ+ community?

This trial will compare Acceptance-Based Behavior Therapy (ABBT) with Treatment-as-Usual (TAU) for mental health in the LGBTQ+ community. Studies have shown that ABBT can improve mental health by reducing stress and anxiety through acceptance of thoughts and feelings. Previous trials demonstrated that ABBT boosts overall well-being and social support for LGBTQ+ individuals. Additionally, ABBT helps people with HIV adhere to their treatments by addressing avoidance behaviors. These findings suggest that ABBT could be a promising way to enhance mental health in diverse groups. ^{2 3 4 6 7}

Who Is on the Research Team?

Ethan Moitra, PhD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who identify as LGBTQ+ and are experiencing mild or greater anxiety and/or depression. Participants must be seeking any clinical care at the recruitment clinic.

Inclusion Criteria

Identify as LGBTQ+

Self-reported ≥ mild anxiety and/or depressive symptoms, based on the GAD-7 and PHQ-9

Ability to speak and read English

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 2-session Acceptance-Based Behavioral Therapy (ABBT) delivered remotely or in-person, or Treatment-as-Usual (TAU)

2 weeks

2 visits (remote or in-person)

Follow-up

Participants are monitored for anxiety and depressive symptoms using various scales

39 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance-Based Behavior Therapy (ABBT)
• Treatment-as-Usual (TAU)

Trial Overview The study compares usual treatment methods with a brief Acceptance-Based Behavior Therapy (ABBT) to see if ABBT can better improve mental health by increasing social support among LGBTQ+ individuals.

How Is the Trial Designed?

Group I: Treatment-as-Usual (TAU) Experimental Treatment 1 Intervention

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

Group II: Acceptance-Based Behavior Therapy (ABBT) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a randomized clinical trial involving 18 women with generalized anxiety disorder (GAD), Acceptance-based behavior therapy (ABBT) significantly reduced the severity of GAD symptoms and improved quality of life compared to a control group that did not receive psychotherapy.

While ABBT led to a decrease in worry severity, this change was not statistically significant when compared to the control group, indicating that while ABBT is effective for symptom relief, its impact on worry may require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of acceptance-based behavior therapy on severity of symptoms, worry and quality of life in women with generalized anxiety disorder. Zargar, F., Asgharnejad Farid, AA., Atef-Vahid, MK., et al.[2021]

Acceptance-based behavior therapy (ABBT) may be more effective than traditional cognitive behavioral interventions in improving adherence to highly active antiretroviral therapy (HAART) among adults with HIV, particularly by addressing avoidance behaviors related to stigma and denial.

The study outlines an ABBT approach tailored for urban, minority, low socioeconomic patients, and preliminary observations suggest that this treatment is feasible and acceptable for promoting HAART adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance-based behavior therapy to promote HIV medication adherence. Moitra, E., Herbert, JD., Forman, EM.[2011]

Acceptance-based behavior therapy (ABBT) and applied relaxation (AR) were found to have similar effects on patients with generalized anxiety disorder (GAD) in terms of acceptance of internal experiences, engagement in meaningful activities, and quality of life, based on a study involving 18 patients over 12 weeks.

Both therapies were administered alongside routine drug treatments, indicating that ABBT can be considered an effective alternative to the commonly used AR therapy for managing GAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the effectiveness of acceptance-based behavior therapy and applied relaxation on acceptance of internal experiences, engagement in valued actions and quality of life in generalized anxiety disorder. Zargar, F., Farid, AA., Atef-Vahid, MK., et al.[2022]

Acceptance and Commitment Therapy (ACT) has been shown to be more effective than waitlist conditions and standard treatment for depression and anxiety, based on a systematic review of 36 randomized controlled trials.

The effectiveness of ACT is linked to its ability to enhance psychological flexibility, which is a key mechanism in its approach to treating mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy as a Treatment for Anxiety and Depression: A Review. Twohig, MP., Levin, ME.[2018]

Acceptance-based behavioral therapies (ABBTs) effectively target anxiety disorders by focusing on reducing reactivity and experiential avoidance, using mindfulness and acceptance strategies to promote engagement in meaningful activities.

Future research should include more randomized control trials comparing ABBTs to other treatments, investigate the mechanisms behind their effectiveness, and explore their applicability to diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and acceptance-based behavioral therapies for anxiety disorders. Roemer, L., Williston, SK., Eustis, EH., et al.[2021]

A randomized controlled trial involving 240 LGBTQ+ adults aims to evaluate the efficacy of a novel acceptance-based behavioral therapy (ABBT) in improving social support and reducing anxiety and depression compared to standard treatment.

ABBT is designed to be an identity-affirming intervention that may enhance mental health outcomes for LGBTQ+ individuals, particularly in the context of increased mental health challenges due to social isolation during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ+ persons: Study protocol. Moitra, E., Brick, LA., Cancilliere, MK., et al.[2023]

Attachment-based family therapy (ABFT) was found to be feasible and acceptable for LGBTQ+ adolescents and young adults, with all 10 participants completing the 16-week treatment without dropouts.

The therapy significantly reduced suicidal ideation among participants, indicating its potential effectiveness in addressing suicide risk in this population, although changes in depression levels were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Attachment-Based Family Therapy for Depressed and Suicidal Adolescents and Young Adults in LGBTQ+ Services. Russon, J., Morrissey, J., Dellinger, J., et al.[2022]

LGBTQ-affirmative internet-based cognitive-behavioral therapy (ICBT) was found to be feasible and acceptable for 120 LGBTQ youth, with participants completing an average of 6.08 sessions and reporting positive engagement with the treatment.

While overall outcomes showed small and non-significant differences, ICBT was particularly effective in reducing psychological distress for participants living in areas with high anti-LGBTQ bias, suggesting that the therapy may be especially beneficial for those facing greater stigma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided LGBTQ-affirmative internet cognitive-behavioral therapy for sexual minority youth's mental health: A randomized controlled trial of a minority stress treatment approach. Pachankis, JE., Soulliard, ZA., Layland, EK., et al.[2023]

The commentary outlines eight LGB-affirmative psychotherapy principles aimed at improving coping strategies for sexual minority clients facing minority stress, which is linked to mental health issues.

These principles, supported by empirical research and clinical consensus, include normalizing the impact of minority stress and empowering clients, and are being tested for efficacy in an ongoing randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward Formulating Evidence-Based Principles of LGB-Affirmative Psychotherapy. Proujansky, RA., Pachankis, JE.[2020]

In a clinical trial involving 254 gay and bisexual men, the LGBQ-affirmative cognitive behavioral therapy (CBT) called ESTEEM significantly reduced mental health comorbidities, particularly for Black and Latino participants, compared to control treatments.

Racial/ethnic minority identification was a key moderator of treatment efficacy, with Black and Latino participants showing greater improvements in anxiety and substance use issues, suggesting that ESTEEM may be especially beneficial for these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderators of LGBQ-affirmative cognitive behavioral therapy: ESTEEM is especially effective among Black and Latino sexual minority men. Keefe, JR., Rodriguez-Seijas, C., Jackson, SD., et al.[2023]

Acceptance and Commitment Therapy (ACT) showed significant improvements in global mental health, depression, cognitive fusion, and values in complex clients treated by both psychologists and non-psychologists in a National Health Service setting.

The positive effects of ACT were partially maintained at a 3-month follow-up, indicating its potential long-term benefits, and outcomes were similar regardless of the therapist's professional background.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of Acceptance and Commitment Therapy Delivered by Psychologists and Non-Psychologists in an NHS Community Adult Mental Health Service: a Preliminary Analysis. Richardson, T., Bell, L., Bolderston, H., et al.[2018]

Acceptance and Commitment Therapy (ACT) can be effectively delivered by non-therapists, such as healthcare workers and teachers, providing a cost-efficient way to improve mental health care access for underserved populations.

The systematic review identified 19 unique ACT-informed interventions that showed positive outcomes, including increased pain tolerance, improved acceptance, and reduced psychological distress, indicating that these interventions can effectively enhance psychological flexibility and health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy Informed Behavioral Health Interventions Delivered by Non-Mental Health Professionals: A Systematic Review. Arnold, T., Haubrick, KK., Klasko-Foster, LB., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37146874/

A randomized trial of acceptance-based behavioral therapy to ... In the current study, we investigate the efficacy of ABBT, compared to a treatment-as-usual control condition, in a full-scale randomized ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423001349

A randomized trial of acceptance-based behavioral therapy ... In the current study, we investigate the efficacy of ABBT, compared to a treatment-as-usual control condition, in a full-scale randomized controlled trial to ...

3. rehabiljournal.com rehabiljournal.com/articles/commentary-on-the-termination-of-a-randomized-trial-of-acceptance-based-behavioral-therapy-to-improve-mental-health-outcomes-for-lgbtq-persons.html

Commentary on the Termination of a Randomized Trial ... A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ plus persons: Study protocol. Contemp Clin ...

4. withpower.com withpower.com/trial/phase-2-depression-10-2022-4d544

ABBT for Mental Health in LGBTQ+ Community Research shows that Acceptance-Based Behavior Therapy (ABBT) can help improve medication adherence in people with HIV by addressing avoidance behaviors.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S221214472200059X

A call for ACTion: A systematic review of empirical ... This systematic review aimed to describe how ACT has been used to help LGBTQI+ individuals improve wellbeing and PF, and how it was tailored to suit LGBTQI+ ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10155421/

A randomized trial of acceptance-based behavioral therapy to ... ABBT showed promise in improving social support and reducing mental health symptoms. In the current study, we investigate the efficacy of ABBT, ...

7. researchgate.net researchgate.net/publication/392572406_Commentary_on_the_Termination_of_a_Randomized_Trial_of_Acceptance-based_Behavioral_Therapy_to_Improve_Mental_Health_Outcomes_for_LGBTQ_persons

Commentary on the Termination of a Randomized Trial ... ABBT showed promise in improving social support and reducing mental health symptoms. In the current study, we investigate the efficacy of ABBT, ...