Commentary on the Termination of a Randomized Trial of Acceptance-based Behavioral Therapy to Improve Mental Health Outcomes for LGBTQ+ persons

Ethan Moitra

Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence RI, USA

Recent governmental actions in the United States (U.S.) have led to unexpected, premature terminations of many federally funded research studies. One was my study, “A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ+ persons¹”, a 3-year project that only had six months of data collection remaining. It was terminated due to a perceived focus on “transgender issues,” a topic said to no longer be a priority of our funding agency, the National Institute of Mental Health. Numerous publications discuss the questionable legality of these terminations, as well as their impact on marginalized communities, including people who identify as transgender and non-binary. In this commentary, I will highlight the implications of this termination as they relate to the scientific advancement of mental health treatments, including the ramifications on future scientific lines of inquiry.

The project was awarded with funds specifically earmarked to examine impacts of the COVID-19 pandemic on mental health, in response to the declared public health emergency issued by the Secretary of Health and Human Services (PAR-22-113). Our primary aim was to determine the effectiveness of a brief, acceptance-based counseling intervention to reduce anxiety and depressive symptoms among people who identify as lesbian, gay, bisexual, transgender, and queer+ (LGBTQ+) adults. This group reports significantly higher rates of mental illness compared to cisgender and heterosexual populations in the U.S². In our grant application, we successfully made the case that the pandemic significantly disrupted everyone’s social connections, sometimes leading to loneliness and social isolation, both of which are important contributors to mental health^3-5. Pre-pandemic, LGBTQ+ persons had high rates of loneliness and social isolation, particularly due to stigmatization and other minority stresses⁶, and the pandemic likely exacerbated these vulnerabilities⁷. Thus, people who identify as LGBTQ+ were an ideal group in which to initially test strategies to buffer the effects of the pandemic, focusing on social support, as a pathway to improved mental health. Moreover, irrespective of the pandemic, clinical interventions to enhance social support could be a fruitful approach to improving mental health for anyone coping with anxiety, depression, loneliness, and social isolation.

We proposed to use an acceptance-based behavior therapy (ABBT) intervention, which was rooted in Acceptance and Commitment Therapy (ACT). ACT is a well-established, empirically-supported approach that has shown promise in numerous health conditions^8-10. In this study, we hypothesized that ABBT would be a good fit for our population and their mental health needs. ABBT helps individuals overcome problematic forms of avoidance, particularly avoidance of uncomfortable internal states and the situations that trigger such states¹¹. Acceptance-based approaches rely heavily on metaphors and experiential exercises. In our 2-session ABBT, we discussed participants’ experiences with the pandemic, coping with mental health symptoms, and the impact of other stressors. The conversations varied, including some participants who reported being relatively unaffected by the pandemic. However, all participants reported that their anxiety and depressive symptoms caused problems in their lives.

In our first counseling session, we presented the “Quicksand” metaphor, in which struggling with life’s challenges is compared to struggling with quicksand: the more we try to resist and push away from uncomfortable feelings, the stronger they become. Our intention was to give participants an alternative coping approach that reduced ineffective struggling, thereby allowing them to commit more attention and energy to their values, particularly related to social connections. We then proceeded in the first and second sessions to discuss types of social support, the participant’s social support needs, and which supports they offer to other people. Finally, consistent with behaviorally based interventions, we helped participants set social support goals, including enhancing current supports or developing new ones.

At the time of the study’s termination, we recruited our goal of n=240 LGBTQ+ adults. Half were randomized to ABBT and the other half received treatment-as-usual (TAU) at our clinical recruitment site. At termination of the grant, all ABBT counseling sessions were already complete. In fact, data collection was complete for approximately 75% of the sample. We have baseline data on all 240 participants and sizeable data at 3-month (n=223), 6-month (n=195), and 9-month (n=179) post-baseline. But the remaining n=61 had 3-, 6-, and 9-month follow-ups to complete. Based on our statistical power analysis, it is possible that we can answer our primary question of whether ABBT leads to significantly more improvements in anxiety and depressive symptoms, relative to TAU. We plan to conduct these analyses regardless of the termination. These results will add to the literature on acceptance-based interventions. Additionally, if the intervention is found to be effective, it could lead to further study of ways to implement ABBT in busy medical clinics, where we tested our intervention. Unfortunately, we are less confident in our statistical ability to address our secondary aims.

Our secondary aims were to examine mediators and moderators of ABBT treatment effects. We hypothesized that compared to TAU, ABBT would improve social support, which would mediate outcomes. Also, we hypothesized that the effects of ABBT on mental health would be moderated by DSM-5¹² diagnosis (anxiety or mood disorder vs. no psychiatric disorder). For decades, researchers have emphasized the importance of studying mediators and moderators of treatment effects¹³. At first glance, these factors might appear somewhat analytical or technical, but they can be even more valuable than demonstrating the effectiveness of a single intervention. Indeed, identification of mediators and moderators inform clinical treatment decision-making and are essential drivers of research innovation.

Mediators identify why and how treatments have effects. In our ABBT treatment, improved mental health outcomes could result from a variety of factors, including changes in experiential avoidance, a key process of acceptance-based approaches¹⁴. However, given our ABBT’s focus, we centered our mediational hypothesis on social support. We suggested that ABBT would lead to improved anxiety and mood symptoms because it helped people strengthen their perceived social support. Understanding mechanisms of action is a valuable pursuit in clinical intervention research because it provides causal insights into how a treatment works. Once we know how a treatment works, the scientific field can develop new and innovative interventions, leveraging demonstrated meditators of change, to yield larger effect sizes and benefits. In our example, active therapeutic ingredients, such as ABBT’s discussion of social supports and related goals, could lead to future interventions that amplify these techniques to improve outcomes. As noted by Kraemer and colleagues¹³, the result is more potent and efficient treatments. Unfortunately, due to our early termination, we are not confident that we will have sufficient data to examine mediation.

Moderators relate to whom and under what conditions an intervention works. Given that our ABBT is a brief, 2-session intervention, we did not expect it to be as impactful for people with more severe mental health symptoms stemming from diagnosable clinical disorders, compared to participants with mild symptoms. Indeed, our intention with ABBT was to develop a brief, strengths-based approach that could be a first line of intervention in busy clinical settings. For some people, two counseling sessions might be enough; for others, referral to longer or more intensive mental health care might be needed. As such, we planned to examine differential effects of ABBT based on participants’ anxiety and depressive disorder diagnoses. At baseline, all participants underwent a brief diagnostic interview in which trained raters probed for the presence of Agoraphobia, Generalized Anxiety Disorder, Major Depressive Episode/Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Panic Disorder with Agoraphobia, and Social Anxiety Disorder. According to our baseline data, 69 participants (28.7% of the sample) did not meet criteria for any mental health disorder diagnosis. For those that did meet criteria, the mean number of diagnoses was 1.6 (SD=1.4). The most common diagnoses were Generalized Anxiety Disorder (n=121; 50.4%) and Major Depressive Episode/Disorder (n=86; 35.8%). Using these diagnostic data as pre-randomization moderators, we planned to examine ABBT to determine if its effects varied according to participants’ diagnoses. Result would inform future provision of ABBT, assuming it was effective, by determining who might specifically benefit from the intervention. Clinically, this information could be useful for selecting which treatment to offer each patient. This approach is consistent with the mental health field’s growing pursuit of precision medicine¹⁵, in which a variety of patient characteristics (e.g., diagnosis, genetic profile, dimensional symptom presentation) are collected to guide treatment decisions. Again, due to our premature termination, we might not have sufficient data to examine ABBT moderation.

Overall, the early termination of this study, as with many others, is a challenge that affects research teams and their study participants. After completing 2.5 years of a 3-year project, results of the work will be, at best, qualified and severely limited, and at worse, nonexistent. Thus, premature terminations not only limits scientific findings, potentially wasting U.S. taxpayer funds, but also stifle the advancement of scientific inquiry by undermining analyses that could lead to future research directions.

Conflicts of Interest:

The authors declare no relevant financial or non-financial interests.

Source of Funding:

None.

Acknowledgements:

None.

References

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