CURRENT STUDIES

Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health Interventions (OPTIMA)

Digital mental health treatments are a cost-effective and efficient approach to expanding the accessibility and impact of psychological treatments; however, little guidance exists for selecting the most effective program for a given individual. In the proposed study, we will examine the use of three digital mental health treatments and develop treatment recommendations that can be used to select a digital program that is most likely to be the optimal treatment for each user. About 1800 participants will take part in this research study led by researchers at Boston University. The results of this study are expected to improve the delivery of digital mental health treatments within large healthcare systems.

The research study aims to examine the overall effects and engagement patterns of several different digital mental health treatments and to determine whether it is possible to match people with the digital treatment they are most likely to benefit from. Researchers at Boston University (BU) are conducting this study in collaboration with Kaiser Permanente and SilverCloud Health researchers. Kaiser Permanente has given permission for the research team at BU to offer Kaiser members an opportunity to learn more about the study through the SilverCloud Health platform for this voluntary project.

Participants who take part in this research study will be in this research study for approximately three months. Participants will use a digital treatment and complete self-report questionnaires during this time. Participants in this study will receive one of three digital treatments administered through SilverCloud Health’s online platform. The digital version of The Unified Protocol, Space for Resilience, and Space from Depression on the SilverCloud Health Services by Amwell.

Participants will have access to a treatment program for 12 weeks and can work through it at their own pace. While completing the program, they will also receive feedback from a SilverCloud Health coach/ supporter. More specifically, they will receive weekly asynchronous written messages (called “reviews”) from the supporter based on their work within the program. Participants will also be able to ask the supporter questions about the program.

Find more information at: https://clinicaltrials.gov/study/NCT05567640?term=todd%20farchione&rank=4

Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression

The efficacy of the Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) combined with commercial FDA-approved Continuous Glucose Monitoring (CGM) will be tested in comparison to CGM only in a randomized controlled clinical trial. The central hypothesis is that the addition of the UP-CBT intervention will yield clinically significant improvements in anxiety and depressive symptom severity and glycemic control relative to CGM alone. We will recruit 94 adults (age 18-64) with suboptimally controlled type 1 diabetes and an anxiety or depressive disorder from a national population for an entirely virtual 12-month study over five years, with targeted recruitment of racial/ethnic minorities. In addition to standard measurement of hemoglobin A1c (HbA1c) for glycemic control and validated patient-reported outcome (PRO) surveys, the study integrates momentary psychological and behavioral data via smartphone-based ecological momentary assessment (EMA) with CGM data to assess day-to-day changes in affect, self-management, and glycemia over the course of the trial.

Qualitative information will be collected from people with Type 1 Diabetes (T1D) ages 35-64 to solicit suggestions and inform future study decisions. We will create 2-4 focus groups to ask their impressions about our current study and to explore key factors like establishing adult care and attending medical appointments, disease self-management, and adjusting to chronic disease. We will compare interview responses from participant groups who have high vs. low social needs and poor vs. good glycemic control.

Find more information at: https://clinicaltrials.gov/study/NCT05734313

Flourishing and Virtue in Cognitive-Behavioral Therapy for Anxiety and Depressive Disorders

Research shows that positive emotions can buffer against the effects of stress as well as contribute to overall well-being and functioning. People with emotional disorders, such as anxiety and depressive disorders, often report lower levels of positive emotions. However, to date, most existing treatment approaches for emotional disorders focus on decreasing negative emotions, without explicitly targeting positive emotions.

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is a transdiagnostic, cognitive-behavioral therapy that has been shown to be effective for treating emotional disorders, including anxiety and depressive disorders. The UP targets negative emotions and helps people decrease their avoidance of emotions. The UP helps people respond to their emotions in ways that are more helpful to them and in line with their goals. In its current form, the UP does not explicitly target positive emotions, but some research suggests that individuals treated with the UP and other cognitive-behavioral treatments experience some improvement in positive affect across treatment. 

In the current study funded by the John Templeton Foundation, we created a modified version of the digital UP (UP+) delivered entirely on an online platform that includes exercises specifically designed to enhance positive emotions. The digital UP+ was then evaluated in a small sample of participants to examine acceptability and feasibility, and this information was used to continue to refine the protocol. Finally, we are conducting a randomized controlled trial to assess the efficacy of the digital UP+ compared to the standard digital UP. Participants diagnosed with anxiety and/or depressive disorders are randomized to either receive the digital UP or the digital UP+ and will be assessed on a range of outcomes, including positive and negative affect, psychological symptoms, and functional outcomes. 

Find more information at: https://clinicaltrials.gov/study/NCT05120232?term=todd%20farchione&rank=2

Study for Alcohol Reduction 2 (StAR2)

Almost 18 million US adults have alcohol use disorders (AUD), with one third of these individuals also diagnosed with anxiety disorders (AXD). The coexistence of AUD and AXD imposes a high burden via healthcare costs and lost productivity. To date, existing treatment approaches for addressing AUD/AXD comorbidity have been only modestly effective and there is a lack of adequate research to guide treatment decisions.  

The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has shown efficacy in treating emotional disorders. The efficacy of the UP to facilitate abstinence from alcohol consumption in individuals with comorbid AUD/AXD has also been examined, with results from this study indicating a reduction from baseline in drinks consumed per day. However, further evaluation of the UP for managing AUD/AXD is warranted.  

In this NIH-funded clinical trial, we will further assess the UP’s effectiveness in reducing alcohol consumption in patients with comorbid AUD/AXD. Participants will be randomized to one of two conditions: 1) treatment with the UP or 2) treatment with therapist-guided Take Control (TC; a therapist-directed alcohol reduction program). In addition, in a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be used to examine the effects of the UP on changes in brain activity in areas important to regulation of emotional and reward processes implicated in excessive alcohol consumption. 

Find more information at: https://clinicaltrials.gov/study/NCT03230006?term=todd%20farchione&rank=1