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Understanding the Efficacy of Mobile Apps as Intervention for Depression in Adults When Deployed as Part of Primary Care.

Primary Purpose

Depression, Anxiety, Primary Health Care

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IntelliCare
Sponsored by
Actualize Therapy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Positive screen on PHQ-9

Exclusion Criteria:

  • Does not own or use a mobile smart phone

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Waitlist Control

Experimental

Arm Description

8 weeks of treatment as usual followed by 8 weeks of IntelliCare treatment.

8 weeks of IntelliCare treatment followed by 8 weeks of treatment as usual.

Outcomes

Primary Outcome Measures

Symptoms of depression
Using the PHQ-9 screener

Secondary Outcome Measures

Full Information

First Posted
April 10, 2018
Last Updated
April 26, 2019
Sponsor
Actualize Therapy
Collaborators
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT03500536
Brief Title
Understanding the Efficacy of Mobile Apps as Intervention for Depression in Adults When Deployed as Part of Primary Care.
Official Title
Implementing an Innovative Suite of Mobile Applications for Depression and Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
April 4, 2019 (Actual)
Study Completion Date
April 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Actualize Therapy
Collaborators
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The clinical study is meant to optimize the mobile intervention, to develop a robust implementation plan for the mobile intervention within primary care, and to conduct an effectiveness trial, randomizing 128 participants in order to understand effect on severity of depression and anxiety symptoms, cost-effectiveness, and usability of mobile apps.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Primary Health Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
8 weeks of treatment as usual followed by 8 weeks of IntelliCare treatment.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
8 weeks of IntelliCare treatment followed by 8 weeks of treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
IntelliCare
Intervention Description
A suite of mobile apps that use principles of computerized therapy to decrease symptoms of depression.
Primary Outcome Measure Information:
Title
Symptoms of depression
Description
Using the PHQ-9 screener
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Positive screen on PHQ-9 Exclusion Criteria: Does not own or use a mobile smart phone
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32432695
Citation
Graham AK, Greene CJ, Kwasny MJ, Kaiser SM, Lieponis P, Powell T, Mohr DC. Coached Mobile App Platform for the Treatment of Depression and Anxiety Among Primary Care Patients: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Sep 1;77(9):906-914. doi: 10.1001/jamapsychiatry.2020.1011.
Results Reference
derived

Learn more about this trial

Understanding the Efficacy of Mobile Apps as Intervention for Depression in Adults When Deployed as Part of Primary Care.

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