Meru Health Ascend Mobile Intervention for Depression in Middle Aged and Older Adults

NCT03652948 | Completed Phase 2

• 1 other identifier: GOU0003
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Depressive Symptoms

Keywords

mobile app; middle age adults; older adults

Outcome Measures

Primary Outcomes (1)

• change in depressive symptoms

  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 from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2

Secondary Outcomes (1)

• change in anxiety symptoms

  Change from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2

Study Arms (1)

Meru Health Ascend Program

EXPERIMENTAL

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

Interventions

Meru Health Ascend Program BEHAVIORAL

Cognitive-behavioral skills, mindfulness

Meru Health Ascend Program

Eligibility Criteria

• Age: 40 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• Meru Health, Inc.: collaborator
• Stanford University: collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Christine E Gould, PhD

  VA Palo Alto Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 29, 2018
• Study Start: July 12, 2018
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)