IntelliCare Plus for Depression and Anxiety Disorders

Overseen By Jessica M Lipschitz, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brigham and Women's Hospital

Disqualifiers: Bipolar, Psychotic disorder, Substance use, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment IntelliCare Plus for depression and anxiety disorders?

Research shows that the IntelliCare platform, which includes a suite of apps, is designed to help with depression and anxiety by focusing on specific psychological strategies. These apps are made for frequent, short interactions, which can help people manage their symptoms effectively. ^{1 2 3 4 5}

How is the IntelliCare Plus treatment different from other treatments for depression and anxiety?

IntelliCare Plus is unique because it is a digital platform that offers a suite of mobile apps designed to help manage depression and anxiety, providing a flexible and accessible alternative to traditional medication or therapy. This approach allows users to engage with various therapeutic tools and techniques at their own pace, potentially improving adherence and outcomes. ^{6 7 8 9 10}

Research Team

Jessica M Lipschitz, PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

I am between 18 and 75 years old.

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.

Trial Timeline

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

Treatment Details

Interventions

• IntelliCare Plus (Behavioral Intervention)

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.

Participant Groups

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.

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. Canada 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. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Uptake and Usage of IntelliCare: A Publicly Available Suite of Mental Health and Well-Being Apps. [2020]

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

IntelliCare: An Eclectic, Skills-Based App Suite for the Treatment of Depression and Anxiety. [2022]

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

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

5. England 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. [2022]

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

Management of comorbid anxiety and depression. [2007]

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

Pharmacotherapeutic options in the treatment of comorbid depression and anxiety. [2019]

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

Generalized anxiety disorder. [2008]

9. England pubmed.ncbi.nlm.nih.gov

Treatment of insomnia associated with clinical depression. [2022]

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

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