What side effects are associated with this type of intervention?

Common treatments for depression include antidepressants such as SSRIs (e.g., fluoxetine, sertraline), SNRIs (e.g., venlafaxine, duloxetine), tricyclics (e.g., amitriptyline), and MAOIs. Known side effects of these medications can include nausea, weight gain, sexual dysfunction, insomnia, dry mouth, blurred vision, constipation, and dizziness. Digital mental health interventions, such as cognitive-behavioral therapy (CBT) delivered online, generally have fewer physical side effects but may require high user engagement and can sometimes lead to initial increases in anxiety or distress as patients confront challenging thoughts and behaviors.

What prior FDA approvals exist?

The FDA has approved several classes of antidepressants for the treatment of depression, including SSRIs (e.g., fluoxetine, sertraline), SNRIs (e.g., venlafaxine, duloxetine), and tricyclic antidepressants. These medications have been shown to be effective in clinical trials, often compared to placebo. Recent advancements in digital mental health programs, such as those being studied using machine learning to develop precision treatment rules, aim to optimize the delivery and effectiveness of these treatments. By leveraging data from clinical settings, these digital interventions can provide personalized treatment recommendations, potentially improving outcomes for patients with depression.

What other types of research exist?

Promising novel alternatives to Digital Mental Health Programs for depression patients in 2024 include: 1) Telemedicine-based Cognitive Behavioral Therapy (CBT), which has shown similar efficacy to face-to-face CBT and can overcome access barriers. 2) Mobile phone-based interventions, which offer flexibility and real-time support. 3) Acceptance and Commitment Therapy (ACT) delivered via telehealth, which has been effective in various settings. 4) Mindfulness-based interventions, including apps and online programs, which have demonstrated benefits for mental health. 5) Group behavior therapy programs conducted virtually, providing peer support and structured therapy.

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Machine Learning-Optimized Digital Therapy for Emotional Disorders

N/A

Recruiting

Research Sponsored by Boston University Charles River Campus

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves digital interventions rather than medications, traditional side effects are not expected. However, users may experience discomfort or distress related to the content of the mental health interventions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline well-being at week 12

Secondary study objectives

Change from baseline anxiety at week 12

Mental Depression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)Experimental Treatment1 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 Control1 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 Control1 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression include pharmacological interventions like SSRIs and SNRIs, which adjust neurotransmitter levels to enhance mood, and psychotherapeutic approaches such as Cognitive Behavioral Therapy (CBT) and Interpersonal Psychotherapy (IPT), which aim to modify negative thought patterns and improve interpersonal relationships. Digital mental health programs often incorporate these psychotherapeutic methods into online platforms, making them more accessible. Understanding these mechanisms helps in personalizing treatment, thereby potentially increasing effectiveness and patient engagement.

Are all psychotherapies equally effective in the treatment of adult depression? The lack of statistical power of comparative outcome studies.Addressing the challenges of a cross-national investigation: lessons from the Pittsburgh-Pisa study of treatment-relevant phenotypes of unipolar depression.Psychosocial treatments of psychological symptoms in dementia: a systematic review of reports meeting quality standards.