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

Trial Summary

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 data supports the effectiveness of the treatment GET ActivE for depression?

Research shows that digital interventions, like the GET ActivE treatment, can effectively reduce depression symptoms. Studies have found that digital tools, especially those with therapist support, lead to significant improvements in people with moderate to severe depression. ^{1 2 3 4 5}

Is Digital Behavioral Activation for Depression safe for humans?

Behavioral Activation (BA) has been studied for depression and related conditions, and while specific safety data for Digital Behavioral Activation is limited, BA generally appears safe for humans. It has been used to promote health behaviors and reduce depressive symptoms without significant safety concerns reported in the studies reviewed. ^{6 7 8 9 10}

How is the treatment GET ActivE for depression different from other treatments?

GET ActivE is unique because it uses digital behavioral activation, which involves increasing engagement in meaningful activities through a smartphone or internet platform, making it more accessible and cost-effective compared to traditional in-person therapy. ^{10 11 12 13 14}

What is the purpose of this trial?

The study will adapt and deploy a digital Behavioral Activation app with mobile sensing, supported by health coaches, that encourages youth to engage in positive activities. The study has the potential to offer a low-cost and scalable behavioral intervention that may decrease risk of suicide among at-risk youth. This research will examine specifically whether an intervention involving an app called Vira, combined with health coaching (GET ActivE) can improve enjoyment for teens coping with depression. Research participants will be randomly assigned to one of two study intervention. One study intervention involves a) downloading an app called Vira and engaging by responding to a daily question, and b) participating in a conversation via text, phone, or messages through an appt with a health coach. The health coach will use the Vira app and principles from evidence-based therapy and behavior change to provide users with insights to sustain well-being and better manage risk factors for suicidal thoughts and behaviors such as depressed mood and behavioral withdrawal. The second study intervention involves downloading an app called EARS and responding to a daily question.

Research Team

Jamie Zelazny, PhD, MPH, RN

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Personalized digital intervention for depression based on social rhythm principles adds significantly to outpatient treatment. [2023]

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

Digital interventions for the treatment of depression: A meta-analytic review. [2021]

4. Canada pubmed.ncbi.nlm.nih.gov

Use of a Mobile App to Augment Psychotherapy in a Community Psychiatric Clinic: Feasibility and Fidelity Trial. [2020]

5. Netherlands 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. [2021]

6. England 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The risks of adverse events with venlafaxine and mirtazapine versus 'active placebo', placebo, or no intervention for adults with major depressive disorder: a protocol for two separate systematic reviews with meta-analysis and Trial Sequential Analysis. [2023]

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

Adverse event methods were heterogeneous and insufficiently reported in randomized trials on persistent depressive disorder. [2018]

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

Initial investigation of behavioral activation therapy for co-morbid major depressive disorder and obesity. [2011]

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

Behavioral Activation, Depression, and Promotion of Health Behaviors: A Scoping Review. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Behavioral activation-based guided self-help treatment administered through a smartphone application: study protocol for a randomized controlled trial. [2022]

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

Internet-Based Behavioral Activation for Depression: Systematic Review and Meta-Analysis. [2023]

13. Germany 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. [2022]

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

Reward Network Modulation as a Mechanism of Change in Behavioral Activation. [2020]