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

240 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Acceptance-Based Behavior Therapy (ABBT) for mental health in the LGBTQ+ community?

Research shows that Acceptance-Based Behavior Therapy (ABBT) can help improve medication adherence in people with HIV by addressing avoidance behaviors. Additionally, Acceptance and Commitment Therapy (ACT), a similar approach, has been effective for anxiety and depression, suggesting ABBT may also be beneficial for mental health issues in the LGBTQ+ community. ^{1 2 3 4 5}

Is Acceptance-Based Behavior Therapy (ABBT) safe for humans?

Research on Acceptance-Based Behavior Therapy (ABBT) and its related forms, like Acceptance and Commitment Therapy (ACT), suggests that these therapies are generally safe for humans. They have been used in various studies for conditions like anxiety, depression, and HIV medication adherence, with no significant safety concerns reported. ^{1 2 4 6 7}

How is Acceptance-Based Behavior Therapy (ABBT) unique for mental health in the LGBTQ+ community?

Acceptance-Based Behavior Therapy (ABBT) is unique because it focuses on improving social support and reducing mental health symptoms by promoting acceptance and commitment to personal values, which is particularly beneficial for LGBTQ+ individuals who may experience heightened anxiety and depression due to minority stress and social isolation. ^{8 9 10 11 12}

Research Team

Ethan Moitra, PhD

Principal Investigator

Brown University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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) 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 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]

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-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]

References

1. England pubmed.ncbi.nlm.nih.gov

Acceptance-based behavior therapy to promote HIV medication adherence. [2011]

2. Netherlands 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. [2021]

3. United States 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. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy as a Treatment for Anxiety and Depression: A Review. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy Informed Behavioral Health Interventions Delivered by Non-Mental Health Professionals: A Systematic Review. [2023]

6. India 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Mindfulness and acceptance-based behavioral therapies for anxiety disorders. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ+ persons: Study protocol. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Implementing Attachment-Based Family Therapy for Depressed and Suicidal Adolescents and Young Adults in LGBTQ+ Services. [2022]

10. England 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Toward Formulating Evidence-Based Principles of LGB-Affirmative Psychotherapy. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Moderators of LGBQ-affirmative cognitive behavioral therapy: ESTEEM is especially effective among Black and Latino sexual minority men. [2023]