IntelliCare Plus for Depression and Anxiety Disorders
Recruiting in Palo Alto (17 mi)
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.
12345How 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.
678910Eligibility 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.
+2 more
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.
+1 more
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
Participant Groups
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.
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.
IntelliCare Plus is already approved in United States for the following indications:
🇺🇸 Approved in United States as IntelliCare Plus for:
- Depression
- Anxiety
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Jessica Morrow LipschitzBoston, MA
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Who Is Running the Clinical Trial?
Brigham and Women's HospitalLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
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]IntelliCare is a modular platform that includes 12 simple apps targeting specific psychological strategies for common mental health problems.
Uptake and Usage of IntelliCare: A Publicly Available Suite of Mental Health and Well-Being Apps. [2020]Treatments for depression and anxiety have several behavioral and psychological targets and rely on varied strategies. Digital mental health treatments often employ feature-rich approaches addressing several targets and strategies. These treatments, often optimized for desktop computer use, are at odds with the ways people use smartphone applications. Smartphone use tends to focus on singular functions with easy navigation to desired tools. The IntelliCare suite of apps was developed to address the discrepancy between need for diverse behavioral strategies and constraints imposed by typical app use. Each app focuses on one strategy for a limited subset of clinical aims all pertinent to depression and anxiety. This study presents the uptake and usage of apps from the IntelliCare suite following an open deployment on a large app marketplace.
IntelliCare: An Eclectic, Skills-Based App Suite for the Treatment of Depression and Anxiety. [2022]Digital mental health tools have tended to use psychoeducational strategies based on treatment orientations developed and validated outside of digital health. These features do not map well to the brief but frequent ways that people use mobile phones and mobile phone apps today. To address these challenges, we developed a suite of apps for depression and anxiety called IntelliCare, each developed with a focused goal and interactional style. IntelliCare apps prioritize interactive skills training over education and are designed for frequent but short interactions.
Feasibility, engagement, and preliminary clinical outcomes of a digital biodata-driven intervention for anxiety and depression. [2022]The main hypothesis is that a digital, biodata-driven, and personalized program would exhibit high user retention and engagement, followed by more effective management of their depressive and anxiety symptoms.
A randomized controlled trial of an internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression. [2022]Internet-delivered treatments for depression have proved successful, with supported programs offering the potential for improved adherence and outcomes. Internet interventions are particularly interesting in the context of increasing access to interventions, and delivering interventions population-wide.
Management of comorbid anxiety and depression. [2007]The coexistence of anxiety and depression is common and frequently poses diagnostic and treatment challenges in the clinical setting. Although precise diagnosis is important for treatment selection, it is often complicated by the shortcomings of the current classification system. Whereas some patients present with symptoms that meet the diagnostic criteria for both an anxiety disorder and major depression, others may present with "subsyndromal" symptoms of depression and/or anxiety. Epidemiologic data and a rational treatment approach to the patient with mixed anxiety and depression, depressive symptoms coexistent with "syndromal" and "subsyndromal" symptoms of generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and social phobia are discussed, as well as areas of future research to examine coexisting anxiety and depression.
Pharmacotherapeutic options in the treatment of comorbid depression and anxiety. [2019]Although anxiety and mood disorders are listed as separate disorders in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, they frequently coexist. They may be expressed phenotypically as comorbidities or as the provisional entity mixed anxiety-depressive disorder. Patients with both anxiety and depression are more symptomatic, use more health care resources, and have a worse prognosis than those with a single disorder. Recognizing and treating these patients are challenges for physicians because the symptoms of the two disorders often overlap. Administration of effective treatment, comprising both anxiolytic and antidepressant effects, can reduce patient distress and disability, as well as inappropriate utilization of medical services. Medications such as tricyclic antidepressants, selective serotonin reuptake inhibitors, nefazodone, venlafaxine XR (extended release) and mirtazapine, are highly effective in treating comorbid depression and anxiety. These newer agents now represent the pharmacotherapeutic treatments of choice for the comorbid conditions.
Generalized anxiety disorder. [2008]Patients with generalized anxiety disorder experience worry or anxiety and a number of physical and psychologic symptoms. The disorder is frequently difficult to diagnose because of the variety of presentations and the common occurrence of comorbid medical or psychiatric conditions. The lifetime prevalence is approximately 4 to 6 percent in the general population and is more common in women than in men. It is often chronic, and patients with this disorder are more likely to be seen by family physicians than by psychiatrists. Treatment consists of pharmacotherapy and various forms of psychotherapy. The benzodiazepines are used for short-term treatment, but because of the frequently chronic nature of generalized anxiety disorder, they may need to be continued for months to years. Buspirone and antidepressants are also used for the pharmacologic management of patients with generalized anxiety disorder. Patients must receive an appropriate pharmacologic trial with dosage titrated to optimal levels as judged by the control of symptoms and the tolerance of side effects. Psychiatric consultation should be considered for patients who do not respond to an appropriate trial of pharmacotherapy.
Treatment of insomnia associated with clinical depression. [2022]Sleep disturbances are almost always present in patients with depression. Though sleep disturbances generally abate with the resolution of depression, some patients continue to report poor sleep. Since a number of studies have demonstrated that insomnia increases the risk of new-onset depression and recurrence of depression, optimal management of insomnia associated with depression becomes an important clinical goal. Antidepressant agents have variable effects on sleep and in fact, some antidepressants seem to worsen sleep in patients with depression. This article reviews various treatment options in the management of patients presenting with insomnia and depression, including single agents, combination strategies and behavioral interventions.
The Comorbidity of Major Depression and Anxiety Disorders: Recognition and Management in Primary Care. [2022]BACKGROUND: Depressive and anxiety disorders commonly occur together in patients presenting in the primary care setting. Although recognition of individual depressive and anxiety disorders has increased substantially in the past decade, recognition of comorbidity still lags. The current report reviews the epidemiology, clinical implications, and management of comorbidity in the primary care setting. METHOD: Literature was reviewed by 2 methods: (1) a MEDLINE search (1980-2001) using the key words depression, depressivedisorders, and anxietydisorders; comorbidity was also searched with individual anxiety diagnoses; and (2) direct search of psychiatry, primary care, and internal medicine journals over the past 5 years. RESULTS: Between 10% and 20% of adults in any given 12-month period will visit their primary care physician during an anxiety or depressive disorder episode (although typically for a nonpsychiatric complaint); more than 50% of these patients suffer from a comorbid second depressive or anxiety disorder. The presence of depressive/anxiety comorbidity substantially increases medical utilization and is associated with greater chronicity, slower recovery, increased rates of recurrence, and greater psychosocial disability. Typically, long-term treatment is indicated, although far less research is available to guide treatment decisions. Selective serotonin reuptake inhibitor antidepressants are the preferred treatment based on efficacy, safety, and tolerability criteria. Knowledge of their differential clinical and pharmacokinetic profiles can assist in optimizing treatment. CONCLUSION: Increased recognition of the high prevalence and negative psychosocial impact of depression and anxiety disorder comorbidity will lead to more effective treatment. While it is hoped that early and effective intervention will yield long-term benefits, research is needed to confirm this.