Digital Behavioral Activation for Depression

(GetActivE Trial)

Recruiting at 1 trial location

Overseen By Morgan Rose, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Mania, Psychosis, Developmental disability

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a digital tool combined with health coaching can improve mood and reduce suicidal thoughts in teens with depression. Participants will either use the Vira app with support from a health coach to encourage positive activities or use the EARS app for activity monitoring. The study seeks teens aged 12-18 who frequently experience depression and loss of interest in activities, are fluent in English, and are willing to download and use the app on their smartphones. As an unphased trial, this study provides a unique opportunity for teens to contribute to innovative research that could enhance mental health support tools.

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 seems focused on using a digital app and health coaching to help with depression.

What prior data suggests that this digital intervention is safe for youth?

Research has shown that digital tools, like the one tested in this trial, are generally safe for people with depression. Studies have found that these mobile health (mHealth) methods can effectively reduce depression symptoms without major safety issues.

For example, mHealth tools, which use mobile apps to assist with mental health, have successfully lowered depression symptoms. They often pair app use with some human support, such as a health coach, to guide users. This combination appears effective and is usually well-received by users.

Significant negative effects from these digital tools have not been reported. This is encouraging for the safety of the GET ActivE treatment under study. It is important to note that these tools are designed to be supportive and empowering, which likely contributes to their overall safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about GET ActivE for depression because it integrates cutting-edge mobile technology with personalized health coaching. Unlike traditional treatments like medication or in-person therapy, GET ActivE uses the Vira app to track user activity and mood in real-time, delivering tailored behavioral interventions right when they’re needed. This approach not only actively involves patients in their own care but also provides timely support to boost mood and activity levels, potentially leading to faster and more sustainable improvements.

What evidence suggests that this digital intervention could be effective for depression?

Research has shown that digital programs like GET ActivE, which participants in this trial may receive, can help reduce depression symptoms. Improvements have been observed as soon as two months after starting these programs. These digital tools encourage engagement in positive activities, boosting mood and enjoyment. One fully automated program even reduced the loss of enjoyment in just one month. By using the Vira app along with health coaching, GET ActivE aims to help teens combat depression by encouraging participation in enjoyable activities. Meanwhile, participants in the Activity Monitoring Alone arm will use the EARS app to track activity data, which will be summarized and sent to them for review. ^{1 6 7 8 9}

Who Is on the Research Team?

Jamie Zelazny, PhD, MPH, RN

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for at-risk youth dealing with depression and anhedonia, which means they struggle to feel pleasure in normally enjoyable activities. Participants should be interested in using a digital app and engaging with health coaches to manage their symptoms. Specific eligibility criteria are not provided, but typically these would include age range, mental health status, and willingness to use technology.

Inclusion Criteria

Willing to download the app on their smartphones

English language fluency and literacy level sufficient to engage in study protocol

I often find little pleasure or interest in doing things.

Exclusion Criteria

Evidence of mania, psychosis, or developmental disability precluding comprehension of study procedures per EHR review and phone screen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with the Vira app and health coaching to increase activity and improve mood

12 weeks

Weekly follow-ups with health coach

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up assessments at 1, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• GET ActivE

Trial Overview The study tests whether a mobile app called Vira combined with health coaching (GET ActivE) can increase enjoyment of life among teens with depression compared to just using another app called EARS. The GET ActivE intervention includes daily interactions with the Vira app and regular conversations with a health coach aimed at improving well-being.

How Is the Trial Designed?

Group I: GET ActivE Experimental Treatment 1 Intervention

GET ActivE intervention uses the Vira mobile application and a health coach, integrating mobile sensing, self-report assessment, and just-in-time nudges and notifications from a health coach to increase patient activity and promote positive mood cycles. A health coach reinforces Behavioral Activation (BA) principles and encourages engagement with activities by composing and triggering appropriate intervention nudges and messages (by text, phone call, video call, chat, email, etc.) specific to activity patterns and mood ratings highlighted on the Vira app. The health coach reviews the patient's data from the Vira practitioner dashboard and will follow up with patients at least weekly (and caregivers periodically) to reinforce behaviors that are consistent with BA and personally relevant based on the participant's own mobile sensing data and mood ratings.

Group II: Activity Monitoring Alone Active Control 1 Intervention

Participants who are eligible for the GET Active Study and are randomly assigned to Treatment As Usual will be asked to download a mobile sensing activity monitoring app called the Effortless Assessment of Risk States (EARS) app which will derive activity data. The activity data will be collated to yield weekly summary measures that will be sent via short messaging services (SMS) text messaging to participants randomized to the control condition for viewing.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

This study will evaluate the effectiveness of an 8-week smartphone-based behavioral activation intervention for major depressive disorders, involving 120 participants split into treatment and control groups.

The intervention aims to integrate technology into mental health care, allowing therapists to monitor patient activities through a smartphone app, potentially enhancing treatment accessibility and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation-based guided self-help treatment administered through a smartphone application: study protocol for a randomized controlled trial. Ly, KH., Carlbring, P., Andersson, G.[2022]

Internet-based behavioral activation (iBA) significantly reduces depressive symptoms compared to inactive control groups, with a moderate effect size based on a systematic review of 12 randomized controlled trials involving 3274 participants.

iBA also leads to reductions in anxiety and improvements in quality of life and activation, although no significant effects on depressive symptoms were observed at the 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based Behavioral Activation for Depression: Systematic Review and Meta-Analysis. Alber, CS., Krämer, LV., Rosar, SM., et al.[2023]

In a study of 313 patients with major depressive disorder, internet-based behavioral activation significantly reduced depressive symptoms by increasing engagement in enjoyable activities, with a measurable effect observed after 4 weeks.

The findings suggest that clinicians and patients should expect a 4-week period for activation levels to improve before seeing a notable reduction in depression symptoms, which typically occurs around 6 weeks into the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Explaining the Efficacy of an Internet-Based Behavioral Activation Intervention for Major Depression: A Mechanistic Study of a Randomized-Controlled Trial. Fu, Z., Burger, H., Arjadi, R., et al.[2022]

Digital interventions for depression have a significant medium effect size (g = .52) compared to control conditions, based on a systematic review of 83 studies involving 15,530 participants.

Interventions with human therapeutic guidance are more effective (g = .63) than self-help interventions (g = .34), and there is no significant difference in outcomes between digital interventions and traditional face-to-face therapy, suggesting that digital options can be a viable alternative for treating depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital interventions for the treatment of depression: A meta-analytic review. Moshe, I., Terhorst, Y., Philippi, P., et al.[2021]

Postmarketing safety evaluations of antidepressant drugs can benefit from data collected through systems like the FDA Adverse Event Reporting System and electronic medical records, which provide more extensive information than premarketing trials.

The study assesses the strengths and limitations of these data sources for pharmacovigilance, highlighting the need for consistent results and integration of evidence to improve drug safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients. Duan, R., Zhang, X., Du, J., et al.[2021]

In a study involving 218 patients with moderately severe to severe depression, participation in the therapist-supported Meru Health Program led to a significant reduction in depressive symptoms, with an average decrease of 8.30 points on the PHQ-9 scale, indicating strong efficacy.

Approximately 34% of patients with moderately severe symptoms and 29.9% of those with severe symptoms showed a response to the intervention, achieving at least a 50% reduction in their PHQ-9 scores, suggesting that the program may be effective for those with more severe depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significant reduction in depressive symptoms among patients with moderately-severe to severe depressive symptoms after participation in a therapist-supported, evidence-based mobile health program delivered via a smartphone app. Forman-Hoffman, VL., Nelson, BW., Ranta, K., et al.[2021]

Behavioral activation (BA) combined with nutrition counseling showed significant reductions in depression scores and body weight among 14 obese patients with major depressive disorder over a 12-week period, with 10 participants achieving full remission.

The study suggests that BA may be a promising approach for treating both obesity and depression, highlighting the need for further research through randomized controlled trials to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial investigation of behavioral activation therapy for co-morbid major depressive disorder and obesity. Pagoto, S., Bodenlos, JS., Schneider, KL., et al.[2011]

The Behavioral Apptivation mobile application was developed to support Brief Behavioral Activation Treatment for Depression (BATD), which is a well-supported psychotherapy for treating depression.

Initial pilot testing of the app in a small open-label trial showed feasibility for use alongside individual BATD therapy, suggesting it could enhance clinical practice for treating depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Preliminary Feasibility Study of a Brief Behavioral Activation Mobile Application (Behavioral Apptivation) to Be Used in Conjunction With Ongoing Therapy. Dahne, J., Kustanowitz, J., Lejuez, CW.[2020]

Citations

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Effectiveness of Digital Behavioral Activation Interventions for ... Digital BA interventions significantly reduced depressive symptoms at 2 months (P<.001, I²=0%), 3 months (P=.001, I²=51%), and 6 months (P=.009, I² ...

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meta-analysis of digital interventions for depression on ... Prior meta-analyses show that digital interventions for depression can effectively reduce primary symptoms. However, it remains unclear whether these ...

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A Pilot Randomized Controlled Trial (the DoBAt Study) Effective and scalable interventions to address adolescent depression are urgently needed. This study evaluated the feasibility, ...

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An online group behavioral activation therapy for major ... A ten-session online group BAT program significantly reduced depressive symptoms in this pre-post trial. •Online group BAT increased behavioral activation ...

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A Behavioral Activation Digital Intervention Incorporating ... The Kuamsha app is a feasible and acceptable treatment for depression among adolescents in rural South Africa.

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Efficacy, Safety, and Evaluation Criteria of mHealth ... This review suggests that mHealth interventions can be effective in reducing depressive symptoms, with hybrid interventions achieving the best results.

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Assessing the Efficacy and Safety of a Digital Therapeutic ... This protocol describes a virtual randomized controlled trial designed to evaluate the efficacy and safety of a self-guided, mobile app–based implementation of ...

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Randomized controlled study of a digital data driven ... This 16-week prospective, decentralized, randomized, waitlist-controlled study investigated the effectiveness of a digital data-driven therapeutic.