Meru Health Ascend Mobile Intervention for Depression in Middle Aged and Older Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03652948|
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : September 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Depression Depressive Symptoms||Behavioral: Meru Health Ascend Program||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Study 1: 8 week mobile app based intervention using cognitive behavioral and mindfulness skills Study 2: 12 week mobile app based intervention (8 week intervention+4 weeks focused on sleep and nutrition)|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Meru Health Ascend Mobile Intervention for Depression in Middle Aged and Older Adults|
|Actual Study Start Date :||July 12, 2018|
|Estimated Primary Completion Date :||January 30, 2021|
|Estimated Study Completion Date :||January 30, 2021|
Experimental: Meru Health Ascend Program
The Meru Health Ascend Program is an 8-week mobile application (app) based intervention that teaches cognitive-behavioral and mindfulness skills. The intervention also includes a group discussion board with the other participants in the intervention group and therapist support via chat within the app.
Study 2 is examining a revised version of the Meru Health Ascend Program that is 12 weeks long and incorporates sleep and nutrition information in addition to the 8-week program.
Behavioral: Meru Health Ascend Program
Cognitive-behavioral skills, mindfulness
- change in depressive symptoms [ 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.
- change in anxiety symptoms [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652948
|Contact: Christine E Gould, PhD||650-493-5000 ext email@example.com|
|United States, California|
|VA Palo Alto Health Care System||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Christine Gould, PhD 650-493-5000 ext 68899 firstname.lastname@example.org|
|Principal Investigator: Christine E Gould, PhD|
|Principal Investigator:||Christine E Gould, PhD||VA Palo Alto Health Care System|