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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05274620
• Other study ID #: R44MH114725-05
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: July 2022
• Source: Adaptive Health, Inc
• Contact: David Mohr, PhD
• Phone: 3125031403
• Email: d-mohr[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Disorder

Intervention

Behavioral:
• IntelliCare
A mobile intervention that use principles of computerized therapy to decrease symptoms of depression

Locations

Country	Name	City	State
United States	Northwestern Medicine Dept of Psychiatry	Chicago	Illinois
United States	MacLeod HealthCare	Florence	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Adaptive Health, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach	1. Number of eligible patients during trial period; 2) number offered IntelliCare; 3) number initiating IntelliCare; 4) number completing IntelliCare	5 months
Primary	Cost	Cost of delivering IntelliCare per patient	7 months
Secondary	Depression	Patient Health Questionnaire-9 (PHQ-9); higher scores indicate greater symptom severity	Administered weekly over 8 weeks