MDD Clinical Trial
Official title:
Can Mental Health Apps Work in the Real World? A Feasibility Pilot Study.
Over two million people in the US download health apps onto their smartphones and tablets, with the intent of improving their quality of life. Despite widespread use of these apps, there is relatively little information regarding app user access (do users download health apps and use them more than once), app user engagement (do users follow the app protocols) and app impact on mood, cognition and daily functioning. Our long-term goal is to conduct a future randomized controlled trial investigating access, engagement and impact of two types of mental health apps, apps based on evidence-based therapeutic principles (i.e.: Problem Solving Therapy) and apps based on cognitive neuroscience principles of depression (i.e.: a cognitive training game called Evolution) and compare both to an information only app. Our intent is to conduct this study entirely on mobile devices, in order to investigate access, engagement, and impact in an ecologically valid manner. The purpose of this pilot study is to test the feasibility of conducting our future randomized controlled trial comparing three mobile mental health apps for the management of depressed mood, improvement of cognitive control, and improvement in activities of daily living in people aged 18 and older. Recruitment, consent, randomization, app use and outcome assessment will be conducted entirely on mobile devices. We will recruit 150 people through four different recruitment avenues to determine which avenue results in the most representative sample of our target population (people 18 and older who have symptoms of depression that are interfering with their quality of life). We will also determine the number we need to recruit to have a final sample of 150 people willing to be randomized between the 3 apps and complete an 12-week study of app impact on mood, cognition and function. This pilot will provide information on the completeness of data from a study conducted in this manner, and uncover any other challenges we may face by using mobile devices for data collection, and if we will find differential drop out between app type (e.g.: will more people stop using of the information only app prematurely?). Although we will not have sufficient statistical power to answer questions about comparative effectiveness between the apps, we plan to explore relationships between sample demographics, app use, and improvement in cognitive control on improvements in mood and function.
Participants will be recruited nationally from a variety of on-line sources. Participants will complete a breif on-line survey and then randomized to one of three mobile apps for depression. Participants are expected to use the apps for 4 weeks, complete daily ratings of mood, as well as complete 4 comprehensive assessments on their smart devices at weeks 1, 4, 8 and 12. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04482296 -
Effect of Zinc Supplementation on Depression in SSRI-treated Major Depressive Disorder Patients
|
N/A | |
| Recruiting |
NCT04071886 -
Effect of Short-Term Mindfulness-Based Training For Major Depression Disorder: An Eye-Tracking Study
|
N/A | |
| Completed |
NCT04076644 -
Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder
|
N/A | |
| Completed |
NCT05528315 -
SAD/MAD of ABX-002-1902 Investigating the Safety, Pharmacokinetics/Pharmacodynamics of in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT05437588 -
Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
|
N/A | |
| Recruiting |
NCT06095778 -
rTMS Therapy for Treatment-Resistant Depression With Different Targets Guided by pBFS
|
N/A | |
| Active, not recruiting |
NCT05657691 -
Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD)
|
Phase 2 | |
| Completed |
NCT02013609 -
Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment
|
Phase 3 | |
| Completed |
NCT02339285 -
Transcranial Alternating Current Stimulation for Major Depressive Disorder
|
N/A | |
| Recruiting |
NCT03971305 -
A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK(+) ALCL
|
||
| Recruiting |
NCT05169346 -
Neurofeedback to Treat Depression
|
N/A | |
| Completed |
NCT01344733 -
A Non Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient With Major Depressive Disorder (MDD)
|
N/A | |
| Completed |
NCT04268316 -
Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder
|
N/A | |
| Active, not recruiting |
NCT01557946 -
Glutamatergic and GABAergic Mediators of Antidepressant Response in Major Depression
|
Phase 2 | |
| Recruiting |
NCT01501812 -
Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders
|
N/A | |
| Completed |
NCT04880460 -
Effect of Magnesium Supplementation in Selective Serotonin Reuptake Inhibitors Treated Major Depressive Disorder Patients
|
Phase 2 | |
| Completed |
NCT04226352 -
Three Dosing Regimens of Dextromethorphan (DXM) Reportedly Used in Major Depressive Disorder
|
Phase 1 | |
| Recruiting |
NCT03754712 -
Effect of Vitamin D Administration Along With SSRIs in Patients With Major Depressive Disorder
|
N/A | |
| Recruiting |
NCT02669030 -
A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia
|
Phase 4 | |
| Completed |
NCT03994081 -
Mechanism of Action of tACS for the Treatment of MDD
|
N/A |