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

Sponsor

Actualize Therapy (Industry)

Overall Status

Completed

CT.gov ID

NCT03500536

Collaborator

University of Arkansas (Other)

146

Enrollment

Location

Arms

8.5

Actual Duration (Months)

17.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Anxiety Primary Health Care	Behavioral: IntelliCare	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

146 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Implementing an Innovative Suite of Mobile Applications for Depression and Anxiety

Actual Study Start Date :

Jul 18, 2018

Actual Primary Completion Date :

Apr 4, 2019

Actual Study Completion Date :

Apr 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Waitlist Control 8 weeks of treatment as usual followed by 8 weeks of IntelliCare treatment.
Experimental: Experimental 8 weeks of IntelliCare treatment followed by 8 weeks of treatment as usual.	Behavioral: IntelliCare A suite of mobile apps that use principles of computerized therapy to decrease symptoms of depression.

Arm

Intervention/Treatment

No Intervention: Waitlist Control

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

Experimental: Experimental

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

Behavioral: IntelliCare

A suite of mobile apps that use principles of computerized therapy to decrease symptoms of depression.

Outcome Measures

Primary Outcome Measures

Symptoms of depression [8 weeks]
Using the PHQ-9 screener

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Positive screen on PHQ-9

Exclusion Criteria:

Does not own or use a mobile smart phone

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205

Sponsors and Collaborators

Actualize Therapy
University of Arkansas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pauli Lieponis, Interim Principal Investigator, Actualize Therapy

ClinicalTrials.gov Identifier:

NCT03500536

Other Study ID Numbers:

Main

First Posted:

Apr 18, 2018

Last Update Posted:

Apr 30, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Apr 30, 2019