Clinical trial NCT03652948: Meru Health Ascend Mobile Intervention for Depression in Middle Aged and Older Adults
Official title: Evaluation of Meru Health Ascend Mobile Intervention for Depression in Middle Aged and Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Depression
Depressive Symptoms
Keywords: mobile app
middle age adults
older adults
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: Meru Health, Inc.
name: Stanford University
First posted: 2018-08-29
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Owns a smart phone, resides in California, PHQ-9 score greater than or equal to 10, stable dose of medication (if taking psychotropic), able to read and understand English.

Exclusion Criteria:

* Psychotic disorder, possible cognitive impairment, evidence of problematic drinking behavior, active suicide ideation with a plan, active psychological treatment, bipolar disorder (study 2 only)

Primary outcomes:
measure: change in depressive symptoms
timeFrame: Change from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2
Secondary outcomes:
measure: change in anxiety symptoms
timeFrame: Change from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: VA Palo Alto Health Care System
name: Christine E Gould, PhD
role: PRINCIPAL_INVESTIGATOR
References: