Machine Learning-Optimized Digital Therapy for Emotional Disorders

Overseen By Anthony Rosellini, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Disqualifiers: Non-English speakers, Under 18

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

1800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve digital mental health treatments for Kaiser Permanente members by using machine learning to recommend the best program for each person. Participants will be placed in one of three online mental health programs and receive ongoing support. The goal is to find out which program works best for different people.

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 focused on digital mental health interventions, so it's likely you can continue your current treatments, but you should confirm with the trial organizers.

Is the Machine Learning-Optimized Digital Therapy for Emotional Disorders generally safe for humans?

Research indicates that digital mental health interventions, including those using the Unified Protocol, are generally safe for humans. A study found that digital interventions can be safe even for individuals with suicidal thoughts, as they showed a decrease in such thoughts during the study. ^{1 2 3 4 5}

How is the Machine Learning-Optimized Digital Therapy for Emotional Disorders treatment different from other treatments for depression?

This treatment is unique because it uses machine learning to predict how well a person will respond to digital interventions, allowing for personalized treatment plans. It combines digital tools like online therapy and virtual reality with traditional methods, making it more accessible and engaging for patients. ^{6 7 8 9 10}

What data supports the effectiveness of this treatment for emotional disorders?

Digital mental health interventions, like internet-based cognitive behavioral therapy (iCBT), have shown effectiveness in reducing symptoms of depression and anxiety. In one study, patients using a digital mental health program experienced a 23% reduction in depression scores, indicating potential benefits for emotional disorders. ^{9 11 12 13 14}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18 or older who have access to an internet-connected device. It's designed for those experiencing emotional disorders like anxiety and depression.

Inclusion Criteria

Have a device that can connect to the internet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (virtual)

Baseline Assessment

Participants complete baseline assessment questionnaires through Qualtrics

Up to 2 weeks

1 visit (virtual)

Treatment

Participants are randomly assigned to one of three digital mental health interventions and receive regular asynchronous support

12 weeks

3 visits (virtual) at 4, 8, and 12 weeks

Follow-up

Participants are monitored for changes in well-being, anxiety, and depression

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Digital Interventions
• Space for depression
• Space for resilience
• The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)

Trial Overview The study tests three digital mental health programs: UP, Space for Depression, and Space for Resilience. Using machine learning, it aims to find out which program works best in a large healthcare setting.

How Is the Trial Designed?

Group I: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) Experimental Treatment 1 Intervention

Digital, transdiagnostic, emotion-focused CBT intervention that consists of five "core" modules or components that have been shown to target temperamental characteristics (i.e., neuroticism) and resulting emotion dysregulation that are believed to underlie all anxiety, depressive, and emotional disorders. The core components of the program are psychoeducation, mindfulness, cognitive flexibility, behavioral strategies to counter emotion-driven behaviors, interoceptive, and emotion exposures.

Group II: Space for Resilience (SFR) Active Control 1 Intervention

Digital program based on positive psychology principles and designed to promote resilience and well-being through a series of seven modules. The core components of the program include psychoeducation, values exploration, building relationships, promoting self-esteem and self-efficacy, and building gratitude and optimism.

Group III: Space from Depression (SFD) Active Control 1 Intervention

Digital CBT program designed to minimize the impact of depressive symptoms. This program emphasizes the use of cognitive behavioral strategies as well as mindfulness through a series of seven structured modules. The core components of the program include psychoeducation around the relationship between thoughts, feelings, and behaviors; cognitive behavioral practices aimed at restructuring negative beliefs; behavioral strategies to improve self-esteem; and mindfulness techniques that focus attention on the present moment.

Digital Interventions is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Digital Mental Health Interventions for:

• Anxiety Disorders
• Depressive Disorders
• Trauma and Stressor-Related Disorders

Approved in United States as Digital Mental Health Interventions for:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Post-Traumatic Stress Disorder

Approved in Canada as Digital Mental Health Interventions for:

• Mood Disorders
• Anxiety Disorders
• Substance Use Disorders

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Silver Cloud Health

Collaborator

Trials

10

Recruited

2,700+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

Published Research Related to This Trial

A digital mental health program providing internet-based cognitive behavioral therapy (iCBT) was successfully implemented in primary care, with 2,228 patients prescribed the program and nearly 49% enrolling, indicating good acceptance among patients.

Patients who engaged with the iCBT program showed significant clinical improvements, with a 23% reduction in depression scores (PHQ-9) and a 26% reduction in anxiety scores (GAD-7), demonstrating the efficacy of digital tools in treating mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. Sharif-Sidi, Z., Shen, C., Wong, W., et al.[2021]

Digital media and electronic health systems can effectively assess and monitor both somatic and psychiatric disorders by collecting real-world data on symptoms, wellbeing, and physiological indicators over time.

For online interventions to be successful, patients require motivation and support from therapists, highlighting the need for mental health professionals to become proficient in using digital tools to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[E-Health in diagnosis and therapy of mental disorders : Will therapists soon become superfluous?] Lüttke, S., Hautzinger, M., Fuhr, K.[2019]

The study developed a set of implementation outcome scales for digital mental health interventions, called iOSDMH, which includes measures for users, providers, and managers, focusing on acceptability, appropriateness, feasibility, satisfaction, and harm.

Psychometric evaluation of the iOSDMH for users showed good reliability and validity, indicating that these scales can effectively assess the implementation of digital mental health programs, which is crucial for optimizing their delivery to those in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation Outcome Scales for Digital Mental Health (iOSDMH): Scale Development and Cross-sectional Study. Sasaki, N., Obikane, E., Vedanthan, R., et al.[2022]

This scoping review analyzed 144 studies on digital mental health (DMH) platforms and interventions, finding that while there is preliminary evidence for their feasibility and usability, the effectiveness remains mostly heterogeneous and limited.

One notable finding was that a specific digital mental health intervention demonstrated significant long-term effectiveness in reducing anxiety and depression in adults, suggesting potential for broader application with targeted engagement strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Use of Digital Mental Health Platforms and Interventions: Scoping Review. Balcombe, L., De Leo, D.[2023]

Internet and mobile-based interventions (IMI) have shown effectiveness in treating various mental health disorders in both inpatient and outpatient settings, based on a review of 14 recent studies.

Despite promising results, the limited number of studies, particularly involving inpatient samples, highlights the need for more collaboration between researchers and clinicians to effectively integrate IMI into routine mental healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital interventions in adult mental healthcare settings: recent evidence and future directions. Dülsen, P., Bendig, E., Küchler, AM., et al.[2021]

A brief online version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders was tested with 19 young adults, showing that 72% attended at least four out of five sessions, indicating good feasibility for this format.

Participants reported that key concepts from the therapy, like understanding emotions and mindfulness, were useful in their daily lives, and there was a significant reduction in anxiety-related life impairment at the 12-week follow-up compared to baseline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a brief, online transdiagnostic psychotherapy for young adults. Dimitropoulos, G., Lindenbach, D., Rowbotham, M., et al.[2023]

Mexican individuals participating in a telehealth program using a unified protocol for anxiety, depression, and trauma showed significant reductions in depression, anxiety, emotional issues, uncertainty intolerance, and psychological distress.

The study highlights that the transdiagnostic unified protocol is effective for training therapists to address a range of emotional and trauma-related disorders, making it a versatile tool in mental health treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online transdiagnostic intervention for emotional, trauma- and stressor-related disorders in the Mexican population: A randomized pilot and feasibility trial. de la Rosa-Gómez, A., Hernández Posadas, A., Valencia, PD., et al.[2023]

In a study of 7,326 adults undergoing psychotherapy for depression and/or anxiety, completing more supplemental video lessons based on the Unified Protocol was associated with greater reductions in symptom severity after 10 weeks.

Participants who completed at least 7 out of 10 video lessons experienced significantly greater improvements in both depression and anxiety symptoms compared to those who did not watch any lessons, suggesting that these videos can enhance the effectiveness of tele-psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utility of completing adjuvant video lessons based on the unified protocol during psychotherapy: A retrospective study using a telehealth platform in routine clinical care. Belanger, HG., Long, LJ., Winsberg, M., et al.[2023]

The Unified Protocol (UP) for treating emotional disorders has shown promising results in a virtual group format, with significant improvements in depression, emotional regulation, and quality of life in a previous pilot study of 7 subjects.

After three months, the positive effects of the UP were maintained, indicating its potential for long-term efficacy in teletherapy settings, although more extensive research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unified Protocol for the transdiagnostic treatment of emotional disorders in virtual and group format in Argentina: three months follow-up of a pilot study Celleri, M., Cremades, CF., Rojas, L., et al.[2023]

In a study involving 301 participants, digital mental health interventions (DMHIs) for depression were found to be safe for individuals with suicidal ideation, as their suicidal thoughts decreased over the 8-week intervention period.

Importantly, the presence of suicidal ideation at the start of the study did not reduce the effectiveness of the depression treatment, indicating that DMHIs can perform well in high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Safety of a General Digital Mental Health Intervention to Effect Symptom Reduction among Individuals with and without Suicidal Ideation: A Secondary Analysis. Meyerhoff, J., Kruzan, KP., Kim, KA., et al.[2023]

A study involving 632 participants demonstrated that machine learning methods can effectively predict changes in symptoms of major depressive disorder and generalized anxiety disorder based on pre-treatment characteristics.

The ability to predict who will benefit from digital psychiatric interventions allows for personalized treatment decisions, potentially directing individuals to either standalone digital therapies or more intensive blended care options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Artificial Intelligence to Predict Change in Depression and Anxiety Symptoms in a Digital Intervention: Evidence from a Transdiagnostic Randomized Controlled Trial. Jacobson, NC., Nemesure, MD.[2023]

The 16-week Feel Program, a digital mental health support initiative, showed a 65% retention rate among 48 adult participants, with high user satisfaction (65% reported very high satisfaction) and significant engagement in activities designed to manage depressive and anxiety symptoms.

Results indicated that 93.5% of participants experienced a decrease in depressive or anxiety symptoms, with 51.6% showing clinically significant improvement, suggesting that higher engagement in the program correlates with better mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, engagement, and preliminary clinical outcomes of a digital biodata-driven intervention for anxiety and depression. Tsirmpas, C., Andrikopoulos, D., Fatouros, P., et al.[2022]

Digital interventions for anxiety disorders show a large pooled effect size of g = 0.80, indicating they are significantly more effective than wait-list or usual care controls, based on a meta-analysis of 47 randomized controlled trials involving 4958 participants.

Specific anxiety disorders, such as panic disorder and social anxiety disorder, also demonstrated moderate to large effect sizes, suggesting that digital interventions can be tailored effectively for different types of anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two decades of digital interventions for anxiety disorders: a systematic review and meta-analysis of treatment effectiveness. Pauley, D., Cuijpers, P., Papola, D., et al.[2023]

The prevalence of depression is high, affecting about 20% of Americans, and access to effective treatments like cognitive behavioral therapy (CBT) is limited, especially for underrepresented groups.

The Entertain Me Well (EMW) platform offers an innovative, engaging online CBT program that tailors content to specific populations, such as rural church members and dialysis patients, aiming to improve treatment accessibility and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Entertain Me Well: An Entertaining, Tailorable, Online Platform Delivering CBT for Depression. Weaver, A., Zhang, A., Xiang, X., et al.[2023]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

[E-Health in diagnosis and therapy of mental disorders : Will therapists soon become superfluous?] [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

Implementation Outcome Scales for Digital Mental Health (iOSDMH): Scale Development and Cross-sectional Study. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of the Use of Digital Mental Health Platforms and Interventions: Scoping Review. [2023]

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

Digital interventions in adult mental healthcare settings: recent evidence and future directions. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a brief, online transdiagnostic psychotherapy for young adults. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Online transdiagnostic intervention for emotional, trauma- and stressor-related disorders in the Mexican population: A randomized pilot and feasibility trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The utility of completing adjuvant video lessons based on the unified protocol during psychotherapy: A retrospective study using a telehealth platform in routine clinical care. [2023]

9. Argentina pubmed.ncbi.nlm.nih.gov

Unified Protocol for the transdiagnostic treatment of emotional disorders in virtual and group format in Argentina: three months follow-up of a pilot study [2023]

10. England pubmed.ncbi.nlm.nih.gov

Exploring the Safety of a General Digital Mental Health Intervention to Effect Symptom Reduction among Individuals with and without Suicidal Ideation: A Secondary Analysis. [2023]

11. Ireland pubmed.ncbi.nlm.nih.gov

Using Artificial Intelligence to Predict Change in Depression and Anxiety Symptoms in a Digital Intervention: Evidence from a Transdiagnostic Randomized Controlled Trial. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility, engagement, and preliminary clinical outcomes of a digital biodata-driven intervention for anxiety and depression. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Two decades of digital interventions for anxiety disorders: a systematic review and meta-analysis of treatment effectiveness. [2023]

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

Entertain Me Well: An Entertaining, Tailorable, Online Platform Delivering CBT for Depression. [2023]