Integrating a Suite of Mental Health Apps for Depression in a Healthcare Setting

The purpose of this study is to evaluate the implementation of IntelliCare as a frontline intervention within health care settings.

Study Overview

• Status: Recruiting
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: IntelliCare

Detailed Description

This study will evaluate the implementation of IntelliCare in two settings: Primary care in the McLeod Health system, serving a rural population where mental healthcare workers are scarce, and Northwestern Medicine's Department of Psychiatry, which currently has a 9-month waitlist for psychological services.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Mohr, PhD; Phone Number: 3125031403; Email: d-mohr@northwestern.edu
• Study Contact Backup: Name: Andrea Graham, PhD; Phone Number: 312-503-5266; Email: andrea.graham@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Not yet recruiting
      • Northwestern Medicine Dept of Psychiatry
      • Contact: Jeff Rado, MD; Phone Number: 312-695-5060; Email: jeffrey.rado@nm.org
  • South Carolina
    • Florence, South Carolina, United States, 29506
      • Recruiting
      • MacLeod HealthCare
      • Contact: Brittany Rainwater, PsyD; Phone Number: 843-777-2826; Email: brittany.rainwater@mcleodhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient who have been identified as depressed or anxious by a care provider in one of the participating healthcare organizations.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: IntelliCare; 8 weeks of IntelliCare	Behavioral: IntelliCare; A mobile intervention that use principles of computerized therapy to decrease symptoms of depression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach	1. Number of eligible patients during trial period; 2) number offered IntelliCare; 3) number initiating IntelliCare; 4) number completing IntelliCare	5 months
Cost	Cost of delivering IntelliCare per patient	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Patient Health Questionnaire-9 (PHQ-9); higher scores indicate greater symptom severity	Administered weekly over 8 weeks

Collaborators and Investigators

• Sponsor: Adaptive Health, Inc
• Investigators: Principal Investigator: Carolyn MacIver, Adaptive Health, Inc

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: R44MH114725-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No