IntelliCare Plus for Depression and Anxiety Disorders

Overseen By Katherine E Burdick, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Bipolar, Psychotic disorder, Substance use, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to increase engagement with a mobile app called IntelliCare Plus, designed to assist with depression and anxiety. It tests two methods to boost engagement: automated motivational messages and support from a coach. Participants will use different versions of the app, receiving both features, one, or neither. This trial suits individuals experiencing significant depression or anxiety symptoms who own a smartphone. As an unphased trial, it provides a unique opportunity to contribute to innovative mental health solutions and enhance personal well-being.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the IntelliCare Plus mobile app intervention is safe for users?

Research has shown that IntelliCare Plus, a mobile app designed to help with depression and anxiety, is easy for users to handle. In a study with 301 participants, 84% continued using the app, indicating it is user-friendly and engaging. Other studies on IntelliCare apps have demonstrated significant reductions in symptoms of depression and anxiety. This suggests the app not only helps users feel better but does so safely. No major negative effects have been reported, making it a promising option for those looking to manage their mental health with technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IntelliCare Plus treatments because they offer a novel approach to managing depression and anxiety disorders through a mobile app. Unlike traditional therapies such as medication or in-person counseling, IntelliCare Plus provides support directly through a smartphone, making mental health care more accessible and convenient. This treatment includes unique features such as automated motivational messaging and coach support, which can enhance user engagement and provide personalized encouragement. By integrating technology with mental health care, IntelliCare Plus has the potential to reach more people and offer timely support, which is especially valuable for those who may face barriers to accessing traditional mental health services.

What evidence suggests that this trial's treatments could be effective for depression and anxiety?

Research has shown that the IntelliCare Plus app helps reduce symptoms of depression and anxiety. In this trial, participants will join different treatment arms to evaluate the effectiveness of various engagement strategies. Some participants will use the app with automated motivational messaging and coach support, while others will use it with just one of these strategies or with no additional support. Studies have found that using the app, along with extra support like motivational messages and coaching, leads to significant improvements in these symptoms. The app is designed for quick and frequent use, which keeps users engaged and boosts mental health. In one early study, participants saw significant improvements in their symptoms after using the IntelliCare tools. Overall, the app offers a promising way to manage depression and anxiety. ^{1 2 3 5 6}

Who Is on the Research Team?

Jessica M Lipschitz, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Fluent in English.

Mass General Brigham primary care patient

Clinically significant symptoms of depression (Patient Health Questionnaire-9 (PHQ-9) greater than or equal to 10) and/or anxiety (Generalized Anxiety Disorder-7 (GAD-7) greater than or equal to 8)

Exclusion Criteria

I have been diagnosed with bipolar disorder.

Current substance use disorder per patient report or the patient's medical record

I don't have any urgent health issues or surgeries planned in the next two months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive access to a digital mental health intervention and are randomized to different engagement strategies over an 8-week period

8 weeks

Continuous digital engagement

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IntelliCare Plus

Trial Overview 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.

How Is the Trial Designed?

Group I: IntelliCare with Coach Support Experimental Treatment 1 Intervention

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

Group II: IntelliCare with Automated Motivational Messaging and Coach Support Experimental Treatment 1 Intervention

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

Group III: IntelliCare with Automated Motivational Messaging Experimental Treatment 1 Intervention

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

Group IV: IntelliCare Alone Active Control 1 Intervention

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

IntelliCare Plus is already approved in United States for the following indications:

Approved in United States as IntelliCare Plus for:

• Depression
• Anxiety

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study involving 301 participants with depression or anxiety, the IntelliCare platform demonstrated strong engagement, with 84% of users continuing to use the apps for a median of 92 days post-treatment.

Coaching improved anxiety outcomes significantly compared to self-guided treatment, while weekly app recommendations enhanced depression outcomes, indicating that both methods can effectively support mental health through app engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Effects of Coaching and Receipt of App Recommendations on Depression, Anxiety, and Engagement in the IntelliCare Platform: Factorial Randomized Controlled Trial. Mohr, DC., Schueller, SM., Tomasino, KN., et al.[2020]

The IntelliCare suite of apps, designed for brief and frequent interactions, significantly reduced symptoms of depression and anxiety in a pilot study with 99 participants, where 90.1% completed the 8-week program.

Participants engaged with the apps an average of 195.4 times over 8 weeks, indicating high usability, and showed substantial improvements in depression and anxiety scores as measured by the PHQ-9 and GAD-7 scales.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IntelliCare: An Eclectic, Skills-Based App Suite for the Treatment of Depression and Anxiety. Mohr, DC., Tomasino, KN., Lattie, EG., et al.[2022]

Generalized anxiety disorder (GAD) affects about 4 to 6 percent of the population, is more common in women, and often presents with a mix of physical and psychological symptoms, making diagnosis challenging.

Treatment for GAD typically includes short-term use of benzodiazepines, along with buspirone and antidepressants for longer-term management, with careful dosage adjustments needed to balance symptom control and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Generalized anxiety disorder. Gliatto, MF.[2008]

The IntelliCare suite of apps, designed to address depression and anxiety through diverse behavioral strategies, was downloaded over 10,000 times in its first year, indicating strong public interest and uptake.

Approximately 31.8% of users engaged with multiple apps from the suite, suggesting that users are open to utilizing a range of tools for mental health support, which supports the effectiveness of app suites in delivering varied therapeutic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake and Usage of IntelliCare: A Publicly Available Suite of Mental Health and Well-Being Apps. Lattie, EG., Schueller, SM., Sargent, E., et al.[2020]

Anxiety and mood disorders often occur together, leading to more severe symptoms and worse outcomes for patients, making it crucial for physicians to recognize and treat these comorbidities effectively.

Medications like selective serotonin reuptake inhibitors and venlafaxine XR are effective in treating both anxiety and depression, helping to reduce patient distress and improve overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapeutic options in the treatment of comorbid depression and anxiety. Pollack, MH., Marzol, PC.[2019]

Sleep disturbances are common in patients with depression and can persist even after depressive symptoms improve, highlighting the need for effective insomnia management in these patients.

Some antidepressants may negatively impact sleep, so it's crucial to explore various treatment options, including medications, combinations, and behavioral therapies, to address both insomnia and depression effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of insomnia associated with clinical depression. Jindal, RD., Thase, ME.[2022]

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]

Between 10% and 20% of adults experience anxiety or depressive disorders during a year, with over 50% of these individuals having a comorbid condition, leading to increased medical visits and greater psychosocial challenges.

Selective serotonin reuptake inhibitors (SSRIs) are recommended as the preferred treatment for managing comorbid depression and anxiety due to their efficacy, safety, and tolerability, although more research is needed to guide long-term treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Comorbidity of Major Depression and Anxiety Disorders: Recognition and Management in Primary Care. Hirschfeld, RM.[2022]

Anxiety and depression often occur together, making diagnosis and treatment challenging due to the limitations of current classification systems.

Patients may exhibit full-blown symptoms of both disorders or only partial ('subsyndromal') symptoms, highlighting the need for tailored treatment approaches and further research into their coexistence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of comorbid anxiety and depression. Zajecka, JM., Ross, JS.[2007]

A randomized controlled trial involving 188 adults showed that a 7-module internet-delivered cognitive behavioral therapy (iCBT) program significantly reduced depressive symptoms, with a large effect size of 0.91 for the treatment group.

The treatment group maintained significant improvements in depressive symptoms at a 6-month follow-up, demonstrating the long-term efficacy of the online intervention supported by trained supporters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of an internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression. Richards, D., Timulak, L., O'Brien, E., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5247623/

IntelliCare: An Eclectic, Skills-Based App Suite for the ... In this pilot feasibility study, the IntelliCare apps and coaching showed large reductions in symptoms of depression and anxiety. These ...

2. c4tbh.org c4tbh.org/program-review/intellicare/

Intellicare The IntelliCare suite supported by remote coaching may be an effective and engaging method of treating depression and anxiety symptoms. Mohr ...

3. withpower.com withpower.com/trial/phase-anxiety-disorders-10-2022-e8d5d

IntelliCare Plus for Depression and Anxiety Disorders The IntelliCare suite of apps, designed for brief and frequent interactions, significantly reduced symptoms of depression and anxiety in a pilot study with 99 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02801877

IntelliCare Study: Artificial Intelligence in a Mobile (AIM) ... Data from the RCT study will be used to examine whether: the IntelliCare program is an effective intervention for reducing depressive and anxiety symptoms; the ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28057609/

IntelliCare: An Eclectic, Skills-Based App Suite for ... - PubMed We developed a suite of apps for depression and anxiety called IntelliCare, each developed with a focused goal and interactional style.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005796721001716

The effect of depression and anxiety symptom severity on ... IntelliCare, a guided digital mental health treatment for depression and anxiety, was effective across three trials at all levels of baseline symptom severity.