App-Based CBT for Anxiety and Depression

Recruiting at 3 trial locations

Overseen By Erum Nadeem, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Current mental health treatment, Mania, Psychosis, Suicidal ideation, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests SilverCloud, an app-based therapy program guided by a therapist, for adolescents with significant mental health symptoms in school-based health centers. The app helps users change negative thoughts and behaviors with therapist support.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment SilverCloud for anxiety and depression?

Research shows that digital tools like internet-based cognitive behavioral therapy (iCBT) can help improve mental health conditions such as anxiety and depression. In one study, patients using a digital mental health program showed a 23% reduction in depression scores, indicating that such treatments can be effective. ^{1 2 3 4 5}

Is app-based CBT safe for humans?

Research on digital cognitive-behavioral therapy (CBT) apps, including those for anxiety and depression, suggests they are generally safe for humans. Studies have shown high acceptability and usability, with no significant safety concerns reported. ^{6 7 8 9 10}

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

SilverCloud is unique because it offers cognitive behavioral therapy (CBT) through an app, allowing users to access therapy at home and at their own pace, which can enhance convenience and reduce stigma compared to traditional in-person therapy. ^{1 9 11 12 13}

Research Team

Anna Van Meter, PhD

Principal Investigator

NYU Langone Health

Erum Nadeem, PhD

Principal Investigator

Rutgers University

Eligibility Criteria

This trial is for high school students in grades 9-11 who are experiencing symptoms of depression or anxiety, have a score of 10+ on GAD-7 or PHQ-9, and can speak/read English. They must be enrolled in their school's health center to participate.

Inclusion Criteria

For phase I open trial: Speak/read English. The current investigational version of SilverCloud that will be used in this study is only available in English

I am currently in 9th, 10th, or 11th grade.

For phase I open trial: Enrolled in the SBHC at the high school

Exclusion Criteria

For RCT: Does not use a smartphone

For RCT: Current suicidal ideation with intent. Participants who have a suicide plan and intent to act on it will be referred to the SBHC suicide risk protocol and will not be eligible until their suicidal thoughts have abated

For phase I open trial: Current suicidal ideation with intent. Participants who have a suicide plan and intent to act on it will be referred to the SBHC suicide risk protocol and will not be eligible until their suicidal thoughts have abated

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open Trial

An open trial of SilverCloud is conducted to determine preliminary efficacy and inform program refinements

8 weeks

Weekly virtual check-ins

Randomized Controlled Trial

Participants are randomized to receive SilverCloud or treatment as usual (TAU) to assess efficacy

8 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SilverCloud

Trial Overview The study tests SilverCloud, an app-based CBT program guided by clinicians, against the usual treatment methods. It aims to see if it's effective and practical as a mental health intervention for vulnerable youth in schools.

Participant Groups

Group I: SilverCloud Experimental Treatment 1 Intervention

Adolescents who seek or are referred for mental health services and screen positive for significant mental health symptoms randomized to receive SilverCloud.

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

Adolescents who seek or are referred for mental health services and screen positive for significant mental health symptoms randomized to receive psychotherapy.

SilverCloud is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as SilverCloud for:

• Anxiety
• Depression
• Low Mood

Approved in United States as SilverCloud for:

• Anxiety
• Depression
• Low Mood

Approved in United Kingdom as SilverCloud for:

• Anxiety
• Depression
• Low Mood
• ADHD Support

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

A computer-aided self-help clinic effectively increased the number of anxious and depressed patients treated per clinician while reducing the time each patient spent with a clinician, without compromising treatment effectiveness.

Patients showed improvement using one of four computer-aided cognitive behavior therapy (CBT) systems for various anxiety and mood disorders, highlighting the potential for these systems to enhance accessibility and reduce stigma associated with mental health treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-aided CBT self-help for anxiety and depressive disorders: experience of a London clinic and future directions. Gega, L., Marks, I., Mataix-Cols, D.[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]

In a pilot study involving 100 patients using the Blues Begone computerized CBT program for depression and anxiety, 58 patients completed the program, showing promising engagement with the treatment.

Of those who completed the program, 72% achieved reliable improvement, and 62% experienced both reliable and clinically significant change, suggesting that Blues Begone could be an effective home-based treatment option with minimal human support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open trial in the NHS of Blues Begone: a new home based computerized CBT program. Purves, DG., Bennett, M., Wellman, N.[2019]

Digital media and electronic health systems can effectively assess and monitor both somatic and psychiatric disorders by collecting real-world data on symptoms, wellbeing, and physiological indicators over time.

For online interventions to be successful, patients require motivation and support from therapists, highlighting the need for mental health professionals to become proficient in using digital tools to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[E-Health in diagnosis and therapy of mental disorders : Will therapists soon become superfluous?] Lüttke, S., Hautzinger, M., Fuhr, K.[2019]

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]

A study involving 70 college students showed that using a conversational agent (Woebot) for 2 weeks significantly reduced symptoms of depression compared to an information-only control group, indicating its efficacy in delivering cognitive-behavioral therapy (CBT).

Participants engaged with the Woebot an average of 12 times, demonstrating good feasibility and acceptability, with feedback suggesting that the interaction process was more important to users than the content itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Cognitive Behavior Therapy to Young Adults With Symptoms of Depression and Anxiety Using a Fully Automated Conversational Agent (Woebot): A Randomized Controlled Trial. Fitzpatrick, KK., Darcy, A., Vierhile, M.[2020]

The eHealth CF-CBT program, a digital mental health intervention for adults with cystic fibrosis, showed high feasibility and acceptability, with all 10 participants completing the 8-session program successfully.

Preliminary results indicated significant improvements in anxiety (90% of participants), depression (90% of participants), and perceived stress (80% of participants), suggesting that this intervention could be effective for managing mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot of a therapist-guided digital mental health intervention (eHealth CF-CBT) for adults with cystic fibrosis. Verkleij, M., Georgiopoulos, AM., Barendrecht, H., et al.[2023]

A coach-enhanced digital cognitive-behavioral intervention (dCBI) was prescribed to 506 adolescents and young adults, with 278 enrolling and showing significant engagement, as 58% actively used the app and 63% communicated with their coach.

The dCBI app led to significant reductions in anxiety and depression symptoms at both 1 and 3 months, demonstrating its effectiveness and feasibility as a routine part of pediatric care for emotional distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Digital Cognitive-Behavioral Intervention for Depression and Anxiety Among Adolescents and Young Adults. Szigethy, EM., Silfee, V., Marroquin, MA., et al.[2023]

A smartphone-based digital CBT intervention called 'Daylight™' was found to be feasible and safe for treating Generalized Anxiety Disorder (GAD) in a study of 21 adults, with high engagement and satisfaction reported by participants.

The intervention showed promising efficacy, with 70% of participants no longer experiencing clinically significant GAD symptoms and significant reductions in depressive symptoms and sleep difficulties after the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of a digital CBT intervention for symptoms of Generalized Anxiety Disorder: A randomized multiple-baseline study. Miller, CB., Gu, J., Henry, AL., et al.[2021]

A randomized controlled trial with 30 military personnel showed that using a mobile health (mHealth) application alongside cognitive behavioral therapy (CBT) significantly improved compliance and reduced symptoms of depression, anxiety, stress, and anger compared to traditional CBT alone, where 50% of participants dropped out.

The study highlights the potential of integrating data-driven mobile applications with mental health treatments to enhance therapy adherence in high-risk populations like military personnel, paving the way for more personalized and effective mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated stress detection using mobile application and wearable sensors improves symptoms of mental health disorders in military personnel. Winslow, BD., Kwasinski, R., Hullfish, J., et al.[2022]

The study demonstrated that SilverCloud therapy is feasible and effective for individuals with moderate to severe anxiety and/or depression, as indicated by significant improvements in GAD-7, PHQ-9, and WHO-5 scores from pre- to post-therapy.

Participants showed notable improvements in their mental health, suggesting that SilverCloud can be a valuable intervention for those facing anxiety and depression linked to social, behavioral, or economic factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SilverCloud mental health feasibility study: who will it benefit the most? Bartholmae, MM., Karpov, MV., Dod, RD., et al.[2023]

The SAM app, used by over 105,000 registered users, shows that most users experience a significant reduction in anxiety levels shortly after starting to use the app, although some may experience a bounce-back effect later.

Distinct user engagement patterns were identified, with a small group achieving long-term anxiety reduction over 12-110 days, suggesting that even minimal engagement with the app can lead to positive outcomes in anxiety management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interaction and Engagement with an Anxiety Management App: Analysis Using Large-Scale Behavioral Data. Matthews, P., Topham, P., Caleb-Solly, P.[2023]

A mobile application designed to enhance perceived control over anxiety significantly reduced salivary cortisol levels in patients undergoing endodontic treatment, indicating its effectiveness in managing anxiety.

In a study of 46 patients, those using the application showed significant reductions in cortisol levels at all stages of treatment, while the control group showed no changes, highlighting the app's potential as a useful tool for anxiety management in dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the effectiveness of a mobile application in the management of dental anxiety: A randomised controlled trial. Nalci, G., Alaçam, T., Altunkaynak, B.[2022]

References

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

Computer-aided CBT self-help for anxiety and depressive disorders: experience of a London clinic and future directions. [2022]

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

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

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

An open trial in the NHS of Blues Begone: a new home based computerized CBT program. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[E-Health in diagnosis and therapy of mental disorders : Will therapists soon become superfluous?] [2019]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Canada pubmed.ncbi.nlm.nih.gov

Delivering Cognitive Behavior Therapy to Young Adults With Symptoms of Depression and Anxiety Using a Fully Automated Conversational Agent (Woebot): A Randomized Controlled Trial. [2020]

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

Pilot of a therapist-guided digital mental health intervention (eHealth CF-CBT) for adults with cystic fibrosis. [2023]

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

A Digital Cognitive-Behavioral Intervention for Depression and Anxiety Among Adolescents and Young Adults. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of a digital CBT intervention for symptoms of Generalized Anxiety Disorder: A randomized multiple-baseline study. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Automated stress detection using mobile application and wearable sensors improves symptoms of mental health disorders in military personnel. [2022]

11. Poland pubmed.ncbi.nlm.nih.gov

SilverCloud mental health feasibility study: who will it benefit the most? [2023]

12. Canada pubmed.ncbi.nlm.nih.gov

Interaction and Engagement with an Anxiety Management App: Analysis Using Large-Scale Behavioral Data. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Evaluation of the effectiveness of a mobile application in the management of dental anxiety: A randomised controlled trial. [2022]