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.
12345Is 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.
12467How 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.
89101112Eligibility 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+
I am 18 years old or older.
Self-reported ≥ mild anxiety and/or depressive symptoms, based on the GAD-7 and PHQ-9
+2 more
Exclusion Criteria
Not applicable.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Treatment-as-Usual (TAU)Experimental Treatment1 Intervention
Control participants will receive the currently recommended best practices of care at the recruitment site.
Group II: Acceptance-Based Behavior Therapy (ABBT)Experimental Treatment1 Intervention
The 2-session ABBT will be delivered remotely or in-person, depending on preference.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brown UniversityProvidence, RI
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Who Is Running the Clinical Trial?
Brown UniversityLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Acceptance-based behavior therapy to promote HIV medication adherence. [2011]A significant number of adults with HIV in the USA do not maintain adherence to highly active antiretroviral therapy (HAART) at adequate levels. Although traditional cognitive behavioral interventions have shown promise in promoting HAART adherence, acceptance-based behavior therapy (ABBT) may be particularly useful in this population. ABBT has the potential to overcome common avoidance-based barriers associated with poor adherence, including denial of various illness-related factors and avoidance of stigmatization. We describe the rationale for promoting psychological and behavioral acceptance in HIV-positive populations; outline an ABBT to promote HAART adherence targeting primary care patients from urban, minority, low socioeconomic backgrounds; and report preliminary qualitative observations of treatment feasibility and acceptability.
Effect of acceptance-based behavior therapy on severity of symptoms, worry and quality of life in women with generalized anxiety disorder. [2021]Acceptance-based behavior therapy (ABBT) is a new psychotherapy for generalized anxiety disorder (GAD). The current study intended to compare severity of symptoms, worry and quality of life of GAD female patients between ABBT and control.
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]Previous studies have demonstrated that acceptance and commitment therapy (ACT) is effective for depression and may be useful for complex transdiagnostic clients.
Acceptance and Commitment Therapy as a Treatment for Anxiety and Depression: A Review. [2018]Acceptance and commitment therapy (ACT) is a modern form of cognitive behavioral therapy based on a distinct philosophy and basic science of cognition. This article reviews the core features of ACT's theoretic model of psychopathology and treatment and its therapeutic approach. It provides a systematic review of randomized controlled trials (RCTs) evaluating ACT for depression and anxiety disorders. Summarizing 36 RCTs, ACT appears to be more efficacious than waitlist conditions and treatment-as-usual, with largely equivalent effects relative to traditional cognitive behavioral therapy. Evidence indicates that ACT treatment outcomes are mediated through increases in psychological flexibility, its theorized process of change.
Acceptance and Commitment Therapy Informed Behavioral Health Interventions Delivered by Non-Mental Health Professionals: A Systematic Review. [2023]Acceptance and Commitment Therapy (ACT) is a third-wave behavioral and cognitive therapy that increases psychological flexibility through mindfulness, acceptance, and value-driven behavior change. ACT has been successfully used to inform a variety of health interventions. Using non-therapists to deliver ACT-based behavioral health interventions offers an opportunity to provide cost efficient and integrated care, particularly among underserved populations experiencing barriers to mental health care, such as inadequate insurance, mental health stigma, and provider shortages. This systematic review aims to: 1) identify ACT-informed behavioral health interventions delivered by laypeople and 2) review the specific characteristics of each intervention including number and duration of sessions, delivery modality, interventionist training, and intervention outcomes.
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]Acceptance-based behavior therapy (ABBT) was developed based on the theory that generalized anxiety disorder (GAD) is maintained through a reactive and fused relationship with internal experiences and a tendency toward experiential avoidance and behavioral restriction. ABBT specifically targets these elements. Here, we aimed to compare ABBT to the applied relaxation (AR), which is the most utilized psychological therapy for GAD.
Mindfulness and acceptance-based behavioral therapies for anxiety disorders. [2021]This article presents a brief conceptual overview of acceptance-based behavioral therapies (ABBTs) for anxiety disorders, followed by a review and summary of the recent efficacy studies of ABBTs for anxiety and comorbid disorders. We discuss clinical implications, including the importance of targeting reactivity and experiential avoidance in interventions for anxiety disorders through the use of mindfulness and other acceptance-based strategies, as well the encouragement of engagement in meaningful activities or valued action. We also address future directions for research, such as expanding research to include more randomized control trials comparing ABBTs for specific anxiety disorders to other active treatments, examining mechanisms of change, exploring adaptations in different care-delivery contexts, as well as determining the applicability of these approaches to clients from marginalized or non-dominant statuses.
A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ+ persons: Study protocol. [2023]During the COVID-19 pandemic, public health measures limited social interactions as an effective and protective intervention for all. For many, however, this social isolation exacerbated mental health symptoms. People who identify as lesbian, gay, bisexual, transgender, and queer (LGBTQ+) were already at elevated risk of anxiety and depression, relative to cisgender and heterosexual populations, and pandemic-related social isolation likely heightened these disparities. In our prior work with sexual and gender minorities, we developed and established feasibility and acceptability of a novel acceptance-based behavioral therapy (ABBT) intervention for HIV treatment. ABBT showed promise in improving social support and reducing mental health symptoms. 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 improve social support for LGBTQ+ persons living with anxiety and depression.
Implementing Attachment-Based Family Therapy for Depressed and Suicidal Adolescents and Young Adults in LGBTQ+ Services. [2022]Background: Suicide is a serious public health problem for LGBTQ+ adolescents and young adults. Attachment-based family therapy (ABFT) is one of the few suicide treatment models that has been tested with this population. The challenge remains in how to implement ABFT into the ecology of LGBTQ+ service settings. Aims: In this study, we tested the feasibility, acceptability, and preliminary effectiveness of ABFT in LGBTQ+ community settings. Method: Ten participants were enrolled in 16 weeks of ABFT across three LGBTQ+ organizations. Feasibility (treatment completion) and acceptability (Working Alliance Inventory [WAI]; opinions about treatment [OAT]) were measured for youth and caregivers. Depression and suicide outcomes were assessed for nine participants. Results: ABFT was demonstrated to be both feasible and acceptable. All participants completed treatment, and there were no dropouts. Adolescents/young adults and their caregivers reported high WAI and adequate OAT scores throughout treatment. There was a significant decrease in suicidal ideation (β = -12.16, t(10) = -3.14, p < .01). Decreases in depression, however, were not significant (β = -1.83, t(9.11) = -0.88, p = .40). Limitations: The small sample limits our ability to estimate treatment effectiveness. A larger effectiveness trial is warranted. Conclusion: ABFT is a promising treatment for LGBTQ+ service settings.
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]LGBTQ-affirmative cognitive-behavioral therapy (CBT) addresses the adverse impacts of minority stress. However, this treatment has rarely been tested in randomized controlled trials with LGBTQ youth and never using an asynchronous online platform for broad reach. This study examined the feasibility, acceptability, preliminary efficacy, and multi-level stigma moderators of LGBTQ-affirmative internet-based CBT (ICBT).
Toward Formulating Evidence-Based Principles of LGB-Affirmative Psychotherapy. [2020]In this commentary, we review eight potential LGB-affirmative psychotherapy principles for improving minority stress coping among sexual minority clients. We illustrate these principles with examples from both Mandel's (2014) treatment approach and our clinical research team's recent attempt to create and test the efficacy of a treatment employing these principles in an ongoing randomized controlled trial. These principles are grounded in empirical research regarding the mechanisms through which minority stress compromises the mental health of sexual minority individuals and are supported by clinical expert consensus. The specific principles that we review include: 1) normalizing the mental health impact of minority stress, 2) facilitating emotion awareness, regulation, and acceptance, 3) decreasing avoidance, 4) restructuring minority stress cognitions, 5) empowering sexual minority clients to communicate assertively, 6) validating sexual minority individuals' unique strengths, 7) building supportive relationships, and 8) affirming healthy, rewarding expressions of sexuality. We believe that Mandel's skillful approach to helping her hybrid client Adam cope with minority stressors, such as internalized homophobia, and associated mental health problems such as substance abuse and depression, to form a healthy identity as a gay man represents an exemplary demonstration of these principles in action.
Moderators of LGBQ-affirmative cognitive behavioral therapy: ESTEEM is especially effective among Black and Latino sexual minority men. [2023]Lesbian, gay, bisexual, and queer (LGBQ)-affirmative cognitive behavioral therapy (CBT) focused on minority stress processes can address gay and bisexual men's transdiagnostic mental and behavioral health concerns. Identifying moderators of treatment outcomes may inform the mechanisms of LGBQ-affirmative CBT and subpopulations who may derive particular benefit.