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

• Sponsor: Adaptive Health, Inc (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05274620
• Collaborator: (none)
• Enrollment: 240
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 16
• Patients Per Site: 120
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Depression; Anxiety	Behavioral: IntelliCare	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Integrating a Suite of Mental Health Apps for Depression in a Healthcare Setting
• Actual Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Aug 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Reach [5 months]

   1. Number of eligible patients during trial period; 2) number offered IntelliCare; 3) number initiating IntelliCare; 4) number completing IntelliCare

2. Cost [7 months]

   Cost of delivering IntelliCare per patient

Secondary Outcome Measures

1. Depression [Administered weekly over 8 weeks]

   Patient Health Questionnaire-9 (PHQ-9); higher scores indicate greater symptom severity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Medicine Dept of Psychiatry	Chicago	Illinois	United States	60611
2	MacLeod HealthCare	Florence	South Carolina	United States	29506

Sponsors and Collaborators

• Adaptive Health, Inc

Investigators

• Principal Investigator: Carolyn MacIver, Adaptive Health, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adaptive Health, Inc
• ClinicalTrials.gov Identifier: NCT05274620
• Other Study ID Numbers: R44MH114725-05
• First Posted: Mar 10, 2022
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Jul 20, 2022