Digital Therapeutic for Depression and Anxiety
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a digital treatment called HPDT-DA-013 for individuals with Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD). Participants will use this digital tool for 8-10 weeks to determine its effectiveness in reducing symptoms of depression and anxiety. The study will also conduct monthly check-ins for a year to monitor long-term effects. Suitable candidates for this trial are adults living in the U.S. who have easy access to a smartphone or computer and have been diagnosed with MDD or GAD. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance mental health treatments.
Do I have to stop taking my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this digital therapeutic is safe for participants with MDD or GAD?
Research has shown that digital treatments like HPDT-DA-013 are usually easy to use. These treatments employ software to help manage and treat health conditions. Studies have found that they safely and effectively address issues like depression and anxiety.
For HPDT-DA-013, existing studies have focused on its safety and effectiveness in treating Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD). So far, no major reports of serious side effects have emerged, suggesting it is likely safe for participants.
Since this trial does not specify a phase, it is important to note that treatments entering certain phases have usually demonstrated a basic level of safety in earlier research. This suggests that HPDT-DA-013 has likely already undergone some safety testing.12345Why are researchers excited about this trial?
Unlike the traditional approaches for treating Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD), which commonly involve medications like SSRIs or cognitive behavioral therapy, HPDT-DA-013 is a digital therapeutic. This treatment is unique because it leverages digital technology to provide an innovative and potentially more accessible way to manage symptoms. Researchers are excited about this treatment because it could offer a non-pharmacological option that is less invasive and may have fewer side effects. Additionally, the flexibility of a digital platform means it could be tailored to each individual’s needs, providing a personalized approach to mental health care.
What evidence suggests that this digital therapeutic is effective for Major Depressive Disorder or Generalized Anxiety Disorder?
Research shows that HPDT-DA-013, a digital treatment under study in this trial, may help manage symptoms of Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD). Digital treatments like HPDT-DA-013 use tested software to deliver therapy via a smartphone or computer. Studies have found that these treatments can effectively reduce symptoms of depression and anxiety by guiding users through therapeutic exercises and activities. Although the specific results for HPDT-DA-013 are still under investigation, similar digital treatments have demonstrated positive effects in improving mood and reducing anxiety. This suggests that HPDT-DA-013 could be a helpful option for individuals dealing with MDD or GAD.13467
Who Is on the Research Team?
Roger Vilardaga, Ph.D.
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the HPDT-DA-013 digital therapeutic for 8-10 weeks, completing PHQ-9 and GAD-7 assessments, as well as safety and medication use questionnaires
Follow-up
Participants are monitored monthly for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HPDT-DA-013
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Use HPDT-DA-013 digital therapeutic for a period of 8-10 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Happify Inc.
Lead Sponsor
Citations
Digital Therapeutic for Major Depressive Disorder (MDD ...
Participants access HPDT-DA-013 on their smart device or computer and complete treatment over a period of 8-10 weeks. During the treatment period, participants ...
Digital therapeutics in the clinic - PMC
Digital therapeutics deliver interventions directly to patients using an evidence‐based, clinically evaluated software to treat, manage, or prevent diseases.
Digital Therapeutic for Major Depressive Disorder (MDD) ...
This trial tests a digital therapeutic program for adults with depression or anxiety. Participants use the program on their devices for a few months, ...
Digital Therapeutic for Major Depressive Disorder (MDD ...
Study Description. This study aims to assess the safety and efficacy of HPDT-DA-013 digital therapeutic in adults ages 22 years and older ...
NCT05016050: A trial that was reported late by Happify Inc.
Full data ; A Real-World Evidence, Single-Arm, Open-Label Study Evaluating the Safety and Efficacy of HPDT-DA-013 Digital Therapeutic in the Treatment of Major ...
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ctv.veeva.com
ctv.veeva.com/study/digital-therapeutic-for-major-depressive-disorder-mdd-and-generalized-anxiety-disorder-gadDigital Therapeutic for Major Depressive Disorder (MDD) and ...
This study aims to assess the safety and efficacy of HPDT-DA ... After 8-10 weeks, participants will complete end-of-treatment assessments, and ...
7.
d148x66490prkv.cloudfront.net
d148x66490prkv.cloudfront.net/hmpeducation/2024-11/Understanding%20and%20Utilizing%20Digital%20Therapeutics%20in%20MDD.pdfUnderstanding and Utilizing Digital Therapeutics in MDD
Required to demonstrate evidence of clinical effectiveness, patient safety, that are reviewed and authorized by a regulatory body. Digital Therapeutic (DTx).
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