Back to resultsIntegrating a Suite of Mental Health Apps for Depression in a Healthcare Setting
Primary Purpose
Depression, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IntelliCare
Sponsored by
About this trial
This is an interventional health services research trial for Depression
Eligibility Criteria
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
Sites / Locations
- Northwestern Medicine Dept of Psychiatry
- MacLeod HealthCareRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
IntelliCare
Arm Description
8 weeks of IntelliCare
Outcomes
Primary Outcome Measures
Reach
1. Number of eligible patients during trial period; 2) number offered IntelliCare; 3) number initiating IntelliCare; 4) number completing IntelliCare
Cost
Cost of delivering IntelliCare per patient
Secondary Outcome Measures
Depression
Patient Health Questionnaire-9 (PHQ-9); higher scores indicate greater symptom severity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05274620
Brief Title
Integrating a Suite of Mental Health Apps for Depression in a Healthcare Setting
Official Title
Integrating a Suite of Mental Health Apps for Depression in a Healthcare Setting
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adaptive Health, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the implementation of IntelliCare as a frontline intervention within health care settings.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IntelliCare
Arm Type
Other
Arm Description
8 weeks of IntelliCare
Intervention Type
Behavioral
Intervention Name(s)
IntelliCare
Intervention Description
A mobile intervention that use principles of computerized therapy to decrease symptoms of depression
Primary Outcome Measure Information:
Title
Reach
Description
1. Number of eligible patients during trial period; 2) number offered IntelliCare; 3) number initiating IntelliCare; 4) number completing IntelliCare
Time Frame
5 months
Title
Cost
Description
Cost of delivering IntelliCare per patient
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Depression
Description
Patient Health Questionnaire-9 (PHQ-9); higher scores indicate greater symptom severity
Time Frame
Administered weekly over 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Mohr, PhD
Phone
3125031403
Email
d-mohr@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Graham, PhD
Phone
312-503-5266
Email
andrea.graham@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn MacIver
Organizational Affiliation
Adaptive Health, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medicine Dept of Psychiatry
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Rado, MD
Phone
312-695-5060
Email
jeffrey.rado@nm.org
Facility Name
MacLeod HealthCare
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Rainwater, PsyD
Phone
843-777-2826
Email
brittany.rainwater@mcleodhealth.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Integrating a Suite of Mental Health Apps for Depression in a Healthcare Setting
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