App-Based Program for Anxiety and Depression

Overseen By Ulrich Kirk, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern Denmark

Must be taking: Anxiety, Depression medications

Disqualifiers: Schizophrenia, Psychosis, Bipolar, others

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

Compensation: Varies

Number of Visits: 2

Duration: 3 weeks

168 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that if you are on medication for anxiety or depression, you must have been on a stable dose for at least 4 weeks before starting. If you meet this condition, you can continue your current medications.

What data supports the effectiveness of the App-Based Program for Anxiety and Depression treatment?

Research shows that digital programs, including mobile apps, can significantly improve symptoms of anxiety and depression. Studies have found that these tools, which often use cognitive behavioral therapy (CBT), help manage these conditions effectively by increasing user engagement and providing personalized support. ^{1 2 3 4 5}

Is the app-based program for anxiety and depression safe for humans?

Safety data for behavioral health interventions like the app-based program is limited, as adverse events are often not fully monitored or reported. However, serious adverse events such as suicide attempts and psychiatric hospitalizations are typically monitored, while temporary increases in anxiety may occur but are considered a normal part of therapy. ^{6 7 8 9 10}

How is the App-Based Program for Anxiety and Depression different from other treatments for these conditions?

This app-based program is unique because it uses a digital, biodata-driven approach to personalize treatment for anxiety and depression, potentially increasing user engagement and effectiveness. Unlike traditional therapies, it offers a convenient, self-guided experience that can be accessed anytime, making it more accessible and flexible for users. ^{1 11 12 13 14}

What is the purpose of this trial?

Generalized anxiety disorder is a mental health disorder characterized by feelings of tension and worry with physical symptoms including increased blood pressure. Approximately 20% of US adults reported an anxiety disorder in the past year and an estimated 31% of US adults reported anxiety at some time in their lives. Anxiety can be experienced throughout one's life and levels of anxiety can increase with stressful life events, physical health conditions, and medication use. Chronic, untreated anxiety has been linked to headaches, dizziness, depression, high blood pressure, heart disease, digestive disorders, and a worsened immune system - greatly impacting one's overall quality of life (QOL). Anxiety and depression are highly comorbid, with approximately 50-60% of those with anxiety symptoms also experiencing depression symptoms. Experiencing these disorders and symptoms comorbidly may further worsen one's mental health and overall QOL. Untreated, chronic depression can heighten symptoms of depression leading to increased risk of heart disease, sleep disruptions, weight gain/loss, a weakened immune system, physical pains, and suicide attempts. Anxiety and depression are commonly treated using various psychotherapeutic techniques including cognitive behavioral therapy (CBT) and acceptance and commitment therapy techniques administered by a licensed therapist. However, therapy has many barriers to treatment including insurance not covering treatments, overall treatment cost, unsure where to seek treatment/no access to a therapist, and therapy being unavailable and inconvenient due to scheduling during the workday. As such, app-based mental health tools have increased in popularity to improve access and affordability to effective mental health treatments. The purpose of the study is to examine the effectiveness of a guided anxiety/depression app-based program by Headspace, which uses CBT with mindfulness to improve anxiety and depression symptoms in a population with elevated baseline anxiety and/or depression. The study will employ a 2-arm app-based intervention involving 1 active intervention and a waitlist control for a duration of 3 weeks, followed by a 3-week follow-up assessment.

Research Team

Ulrich Kirk, PhD

Principal Investigator

University of Southern Denmark

Eligibility Criteria

This trial is for adults with elevated anxiety or depression. Participants should have symptoms of these conditions but not be currently receiving treatment. It's not specified who can't join, so generally those with other mental health treatments or conflicting conditions may be excluded.

Inclusion Criteria

Based in the U.S.

I have been on a stable dose of anxiety or depression medication for at least 4 weeks.

Access to a smartphone device, as the intervention will be delivered via a smartphone application

Exclusion Criteria

I do not have severe mental health issues, serious physical health concerns requiring surgery soon, a prognosis of less than 6 months, or am not pregnant.

Risks associated with suicidal ideation and risk of self-harm

I have not been on a stable dose of medication for anxiety or depression for at least 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Treatment

Participants engage in a 3-week app-based intervention or waitlist control

3 weeks

Weekly virtual check-ins

Follow-up

Participants complete a follow-up assessment 3 weeks after the intervention

3 weeks

1 visit (virtual)

Treatment Details

Interventions

• Anxiety/Depression Program

Trial Overview The study tests a guided app-based program by Headspace that combines cognitive behavioral therapy (CBT) and mindfulness to treat anxiety and depression. Participants will either use the app or be on a waitlist for comparison over a period of 3 weeks, followed by another 3-week assessment.

Participant Groups

Group I: Waitlist Experimental Treatment 1 Intervention

Group II: Anxiety/Depression Program Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Southern Denmark

Lead Sponsor

Trials

574

Recruited

4,459,000+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

Findings from Research

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 digital mental health program providing internet-based cognitive behavioral therapy (iCBT) was successfully implemented in primary care, with 2,228 patients prescribed the program and nearly 49% enrolling, indicating good acceptance among patients.

Patients who engaged with the iCBT program showed significant clinical improvements, with a 23% reduction in depression scores (PHQ-9) and a 26% reduction in anxiety scores (GAD-7), demonstrating the efficacy of digital tools in treating mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. Sharif-Sidi, Z., Shen, C., Wong, W., et al.[2021]

A systematic review of 22 studies over the past decade found that mobile applications significantly improve symptoms of depression and anxiety, demonstrating their effectiveness as a digital treatment tool.

Mobile apps promote patient empowerment and health literacy, suggesting they can enhance self-management of mental health conditions, but further research is needed to fully integrate them into healthcare practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technological prescription: evaluation of the effectiveness of mobile applications to improve depression and anxiety. Systematic review. Planas, R., Yuguero, O.[2021]

The study involving 594 patients showed that implementing computerized outcome feedback (OF) technology in therapy for depression and anxiety did not significantly change clinical outcomes, as measured by PHQ-9 and GAD-7 scores, compared to traditional methods.

However, the use of OF led to a significant reduction in the average duration and cost of treatment, suggesting that OF can enhance the efficiency of stepped care psychological services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the efficiency of psychological treatment using outcome feedback technology. Delgadillo, J., Overend, K., Lucock, M., et al.[2018]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

In a study of 260 chronically depressed patients, those receiving Cognitive Behavioral Analysis System of Psychotherapy (CBASP) reported more severe adverse events compared to those receiving supportive psychotherapy, particularly in personal and occupational life.

However, CBASP was associated with fewer adverse events related to suicidal thoughts, suggesting that while it may lead to some temporary challenges, it can be a safer option in terms of suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression. Meister, R., Lanio, J., Fangmeier, T., et al.[2021]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

The EVAD tool was developed to evaluate and classify the severity of adverse events in psychotherapeutic clinical trials, filling a gap in the existing frameworks for such evaluations.

Content validation showed strong agreement among experts, with perfect scores for relevance and high scores for clarity and coherence, indicating that EVAD is a reliable and meaningful tool for assessing adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and content validity of EVAD: A novel tool for evaluating and classifying the severity of adverse events for psychotherapeutic clinical trials. Mejía-Castrejón, J., Sierra-Madero, JG., Belaunzarán-Zamudio, PF., et al.[2023]

A systematic review of 115 psychotherapy study protocols revealed that while 77 protocols explicitly addressed harm, there was a lack of standardization in how harm was conceptualized and assessed, particularly regarding adverse events.

The review highlighted that although serious adverse events were defined consistently, the definitions and considerations for adverse events varied widely, suggesting a need for more standardized approaches in clinical research to effectively monitor and report harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

A systematic review identified eight studies of internet-based programs for treating anxiety and depression in children and adolescents, with most interventions based on cognitive behavior therapy.

Six out of eight studies reported reductions in symptoms of anxiety and/or depression after the interventions, indicating early support for the effectiveness of these online programs, although more rigorous research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of internet-based prevention and treatment programs for anxiety and depression in children and adolescents. Calear, AL., Christensen, H.[2022]

A review of 3,278 mobile apps for anxiety disorders in Brazil found that only 71 met the eligibility criteria, with most apps focusing on education, self-assessment, and meditation, but only 43.66% were rated as having acceptable quality according to the Mobile App Rating Scale (MARS).

There was a notable discrepancy between user star ratings and the quality assessed by MARS, indicating that users should be cautious when selecting these apps for managing anxiety disorders, as many apps were classified as low quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of mobile applications focused on the care of patients with anxiety disorders: A systematic review in app stores in Brazil. Souza do Nascimento, V., Teotonio Rodrigues, A., Rotta, I., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Addressing depression and behavioral health needs through a digital program at scale. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Technological prescription: evaluation of the effectiveness of mobile applications to improve depression and anxiety. Systematic review. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Improving the efficiency of psychological treatment using outcome feedback technology. [2018]

5. Canada pubmed.ncbi.nlm.nih.gov

Specifying the Efficacy of Digital Therapeutic Tools for Depression and Anxiety: Retrospective, 2-Cohort, Real-World Analysis. [2023]

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

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

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

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

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

Development and content validity of EVAD: A novel tool for evaluating and classifying the severity of adverse events for psychotherapeutic clinical trials. [2023]

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

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. [2023]

11. Australia pubmed.ncbi.nlm.nih.gov

Review of internet-based prevention and treatment programs for anxiety and depression in children and adolescents. [2022]

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

Multimedia Field Test Thinking About Exposures? There's an App for That! [2020]

13. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of mobile applications focused on the care of patients with anxiety disorders: A systematic review in app stores in Brazil. [2023]

14. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Phone-Based App for Use During Cognitive Behavioral Therapy for Adolescents With Anxiety (MindClimb): User-Centered Design and Usability Study. [2021]