What is the mechanism of action of this treatment?

Common treatments for depression, such as behavioral activation and personalized support, work by engaging patients in activities that enhance their mood and reduce depressive symptoms. Behavioral activation, facilitated through regular motivational prompts, helps patients stay engaged and motivated by increasing positive interactions with their environment. Personalized guidance and support from a coach provide tailored advice and emotional support, aiding patients in navigating their treatment and maintaining adherence. These approaches are crucial for depression patients as they address both behavioral and emotional aspects, promoting sustained engagement and improving overall treatment outcomes.

What side effects are associated with this type of intervention?

Behavioral activation and coach support are common non-pharmacological treatments for depression. Behavioral activation, which encourages engagement in positive activities, may initially increase anxiety or stress as patients face previously avoided tasks. Coach support, offering personalized guidance, can lead to emotional discomfort as patients work through personal issues. Both treatments are generally well-tolerated and have minimal side effects compared to pharmacological options.

What prior FDA approvals exist?

The FDA has approved several treatments for depression, primarily focusing on pharmacotherapy, such as SSRIs (e.g., fluoxetine, sertraline) and SNRIs (e.g., duloxetine, venlafaxine). While the FDA has not specifically approved digital interventions like Automated Motivational Push Messaging or Coach Support, these approaches align with evidence-based psychotherapies such as Cognitive Behavioral Therapy (CBT) and other supportive therapies. These psychotherapies have been shown to be effective in treating depression and are often recommended as part of a comprehensive treatment plan.

What other types of research exist?

Promising novel alternatives for depression treatment in 2024 include: 1) Digital Cognitive Behavioral Therapy (CBT) platforms, which offer structured, interactive therapy sessions online. 2) Virtual Reality (VR) therapy, providing immersive environments for exposure therapy and relaxation techniques. 3) Ecological Momentary Interventions (EMIs), delivering real-time, context-aware therapeutic prompts based on patient behavior and environment. 4) Peer support networks facilitated through social media or specialized apps, enabling community-based support and shared experiences.

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Behavioral Intervention

IntelliCare Plus for Depression and Anxiety Disorders

N/A

Recruiting

Led By Jessica M Lipschitz, PhD

Research Sponsored by Brigham and Women's Hospital

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 for 3 hours after each decision point, over the 8-week intervention period

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two methods to increase engagement with a mental health app for people with depression or anxiety. One method uses automated motivational messages, and the other uses support from a coach. The goal is to see if these methods help patients use the app more often and improve their mental health.

Who is the study for?

This trial is for Mass General Brigham primary care patients aged 18-75 with significant symptoms of depression or anxiety, who own a smartphone. It's not for those with bipolar I/II, psychotic disorders, unstable medical conditions that could interfere with participation, or current substance use disorder.

What is being tested?

The study tests how to boost patient involvement in using the IntelliCare Plus app for treating depression and/or anxiety. It compares two methods: automated motivational messages and coach support to see which one increases engagement more effectively.

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 stress from regular app usage or emotional responses to content.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for 3 hours after each decision point, over the 8-week intervention period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for 3 hours after each decision point, over the 8-week intervention period

This trial's timeline: 3 weeks for screening, Varies for treatment, and for 3 hours after each decision point, over the 8-week intervention period for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Intervention Engagement Within 3 Hours Following a Decision Point - Proximal (Short-Term)

Minutes of Intervention Use - Distal (Long-Term)

Secondary study objectives

Anxiety Disorders

Change in Patient Health Questionnaire-8 (PHQ-8) Self-Report Scale Score - Distal (Long-Term)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: IntelliCare with Coach SupportExperimental Treatment1 Intervention

IntelliCare Plus mobile application intervention with one engagement strategy, coach support.

Group II: IntelliCare with Automated Motivational Messaging and Coach SupportExperimental Treatment1 Intervention

IntelliCare Plus mobile application intervention with two engagement strategies, automated motivational messaging and coach support.

Group III: IntelliCare with Automated Motivational MessagingExperimental Treatment1 Intervention

IntelliCare Plus mobile application intervention with one engagement strategy, automated motivational messaging.

Group IV: IntelliCare AloneActive Control1 Intervention

IntelliCare Plus mobile application intervention with no additional engagement strategy applied.

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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, such as behavioral activation and personalized support, work by engaging patients in activities that enhance their mood and reduce depressive symptoms. Behavioral activation, facilitated through regular motivational prompts, helps patients stay engaged and motivated by increasing positive interactions with their environment. Personalized guidance and support from a coach provide tailored advice and emotional support, aiding patients in navigating their treatment and maintaining adherence. These approaches are crucial for depression patients as they address both behavioral and emotional aspects, promoting sustained engagement and improving overall treatment outcomes.

Barriers and facilitators for the implementation of blended psychotherapy for depression: A qualitative pilot study of therapists' perspective.