40 Participants NeededMy employer runs this trial

Digital Stepped-Care for Depression

NN
ML
Overseen ByMcKay Lucas
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital approach to treating depression by comparing three methods: a self-help app called Moodivate (Behavioral Activation Therapy App), telehealth sessions with a counselor, and a combination of both. The trial aims to assess the ease of adherence to these treatments and their effectiveness in improving mood. Individuals with long-standing depression symptoms who use a smartphone may be suitable candidates, particularly if they are open to apps and online therapy. Conducted in South Carolina, this study helps researchers identify better ways to support people with depression. As an unphased trial, it offers a unique opportunity to explore innovative treatments for depression and contribute to advancing mental health care.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both treatments in this trial are safe. The Moodivate app, tested in several studies, greatly improves depression symptoms without serious side effects. Users track their mood and activities with the app, aiding in depression management.

For the telehealth-delivered Behavioral Activation, studies have demonstrated its safety and positive reception. Participants reported high satisfaction, and it effectively reduces depression symptoms. These studies have identified no major safety issues.

Both treatments employ Behavioral Activation, a proven method for treating depression, making them safe options for managing depressive symptoms.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for depression because they incorporate digital tools that enhance access and flexibility. Unlike traditional face-to-face therapy, the Moodivate app allows users to engage in Behavioral Activation therapy on their phones, enabling daily self-guided activities that help improve mood. The Digitally-Enhanced Stepped Care approach takes this a step further by passively monitoring app engagement to decide if more intensive standard care is needed, offering a tailored treatment pathway. Meanwhile, the Telebehavioral Health option delivers therapy sessions via telehealth, providing the benefits of direct interaction with a therapist without the need for in-person visits. These digital approaches offer promising alternatives that could make managing depression more accessible and personalized.

What evidence suggests that this trial's treatments could be effective for depression?

Studies have shown that Behavioral Activation therapy, such as the Moodivate app, effectively reduces depression symptoms. Users of the app were three times more likely to experience meaningful improvements in their depression. One study found that participants had significant reductions in their depression scores after using the app. In this trial, participants may use the Moodivate app alone or as part of a Digitally-Enhanced Stepped Care approach. Research has also shown that Behavioral Activation therapy delivered through telehealth effectively reduces depression symptoms, with patients experiencing fewer symptoms after several sessions. Participants in this trial may also receive Behavioral Activation therapy through telehealth. Both the app and telehealth methods offer promising ways to manage depression effectively.12356

Who Is on the Research Team?

JD

Jennifer Dahne, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults (18+) with significant depression symptoms who own a smartphone, are willing to use a depression treatment app and participate in telehealth therapy, have access to email or text messaging, and can speak English.

Inclusion Criteria

* elevated depression symptoms (score of \>=10 on the PHQ-9)
I am 18 years old or older.
* owns an iOS or Android smartphone
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
Remote screening

Treatment

Participants receive a digitally enhanced stepped-care approach for depression treatment, involving the Moodivate app and potential telebehavioral health sessions

12 weeks
Weekly app engagement and telehealth sessions as needed

Follow-up

Participants are monitored for changes in depression severity using PHQ-9 scores

4 weeks
Questionnaire measures at weeks 1, 2, 4, 6, 8, and 12

What Are the Treatments Tested in This Trial?

Interventions

  • Behavioral Activation Therapy App (Moodivate)
  • Telehealth Delivered Behavioral Activation

Trial Overview

The study compares three approaches: starting with a self-guided depression app and stepping up to online therapy if needed; online therapy only; or using the app alone. Participants are randomly assigned to one of these groups.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Moodivate OnlyExperimental Treatment1 Intervention
Group II: Digitally-Enhanced Stepped CareExperimental Treatment1 Intervention
Group III: Telebehavioral HealthActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

Citations

Moodivate: A self-help behavioral activation mobile app for ...

There is an ample evidence base supporting the efficacy of BATD in the treatment of depression. Across studies, it is associated with reductions in depressive ...

A behavioral activation mobile application for depression ...

The participants showed significant reductions from baseline to post-treatment in depressive symptoms (BDI-II: -5.95, HDRS-17: -7.23, PHQ-8: -3.44) and anxiety ...

Having a “therapist in your pocket” curbs depression ...

App users were also 3 times more likely to achieve a clinically meaningful improvement in their depression and 2.3 times more likely to attain ...

Pilot Randomized Trial of a Self-Help Behavioral Activation ...

Nearly 70% of Moodivate participants continued to use the app 1 month after trial enrollment and 50% at the end of the 8-week follow-up period. A generalized ...

5.

behavioralactivationtech.com

behavioralactivationtech.com/apps/moodivate

Moodivate - an app to manage your depression

Moodivate is a self-help Behavioral Activation mobile app that delivers all Behavioral Activation treatment components. It is ideal for individuals who have ...

Mental Health Coach: Moodivate - App Store - Apple

Moodivate is a self-help app based on Behavioral Activation (BA), a clinically proven treatment for depression. confirmed by over 15 studies ...