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

Study Summary

This trial is testing how well two different strategies- automated messages and coach support- improve patient engagement with a mobile app intervention for depression and anxiety.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Minutes of Intervention Use - Distal (Long-Term)

Secondary outcome measures

Anxiety Disorders

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

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.

Do I qualify?Apply below to find out

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.

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Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,622 Previous Clinical Trials

11,468,668 Total Patients Enrolled

28 Trials studying Depression

115,877 Patients Enrolled for Depression

National Institute of Mental Health (NIMH)NIH

2,799 Previous Clinical Trials

2,661,088 Total Patients Enrolled

672 Trials studying Depression

253,267 Patients Enrolled for Depression

Jessica M Lipschitz, PhDPrincipal InvestigatorBrigham and Women's Hospital

1 Previous Clinical Trials

12 Total Patients Enrolled

1 Trials studying Depression

12 Patients Enrolled for Depression

Media Library

IntelliCare Plus (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05555875 — N/A

Depression Research Study Groups: IntelliCare with Automated Motivational Messaging and Coach Support, IntelliCare with Automated Motivational Messaging, IntelliCare with Coach Support, IntelliCare Alone

Depression Clinical Trial 2023: IntelliCare Plus Highlights & Side Effects. Trial Name: NCT05555875 — N/A

IntelliCare Plus (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05555875 — N/A

Depression Patient Testimony for trial: Trial Name: NCT05555875 — N/A

~33 spots leftby Mar 2025

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