VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
NCT Number: NCT03652948
Using technology to deliver depression interventions is one way could alleviate the public health burden of depression. The study is testing a mobile app intervention program for depression that uses cognitive behavioral skills and mindfulness. This study seeks to obtain feedback on the intervention and refine the intervention and then test the intervention in a larger study. The mobile app intervention called the Meru Health Ascend program consists of the app and therapist support via messaging within the app.
Looking for future studies?
Notify Me40 year–120 year
All sexes
Interventional
Phase 2 / Phase 3
Palo Alto, California, 94304, United States
The Meru Health Ascend program is a guided self-management program that uses a mobile application to deliver content of the intervention. A licensed therapist (Meru Health employed) provides support to participants as needed and reviews practice logs within the app.The 8-week program teaches cognitive behavioral techniques and mindfulness skills with the aim of improving the user's mental health. The platform provides informational videos, skills practices, group discussion, and messaging with the therapist. The Meru Health program enrolls participants in treatment groups that work through the program at the same time and can provide support to on another on the discussion board within the app.
We are conducting two studies in middle aged and older adults with elevated depressive symptoms to evaluate the Meru Health Ascend program. In the first study (study 1), we will examine the feasibility of the intervention in individuals aged 40 years or older with elevated depression symptoms using an iterative case series. Specifically, we will examine the usability of app and materials, dropout and reasons for dropout, and user perceptions of the program.
We will then conduct a proof-of-concept study (study 2) using a nonrandomized pre-post design to examine whether individuals achieve clinically significant reductions in depressive symptoms.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cognitive-behavioral skills, mindfulness
Time frame: Change from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2
The Patient Health Questionnaire 9-item (PHQ-9) is a measure that assesses 9 depressive symptoms with scores ranging from 0 to 27. Higher scores indicate more severe depressive symptomatology.
Time frame: Change from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2
The Generalized Anxiety Disorder 7-item (GAD-7) is a seven item measure of anxiety symptoms with scores ranging from 0 to 21. Higher scores indicate more severe anxiety symptomatology.
Palo Alto Veterans Institute for Research
Other
Evaluation of Meru Health Ascend Mobile Intervention for Depression in Middle Aged and Older Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04837573
Behavior, Behavioral Symptoms
Los Angeles, California, United States
View Trial DetailsNCT05619510
Behavior, Behavioral Symptoms
Baltimore, Maryland, United States
View Trial DetailsNCT04990401
Behavior, Behavioral Symptoms
Dallas, Texas, United States
View Trial DetailsNCT03517878
Acquired Immunodeficiency Syndrome, Alcohol Drinking
Mqanduli, Eastern Cape, South Africa
View Trial Details