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

NCT ID: NCT03500536

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-18

Study Completion Date

2019-04-04

Brief Summary

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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.

Detailed Description

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Conditions

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Depression Anxiety Primary Health Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Waitlist Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental

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

Group Type EXPERIMENTAL

IntelliCare

Intervention Type BEHAVIORAL

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

Interventions

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IntelliCare

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Positive screen on PHQ-9

Exclusion Criteria

* Does not own or use a mobile smart phone
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role collaborator

Actualize Therapy

INDUSTRY

Sponsor Role lead

Responsible Party

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Pauli Lieponis

Interim Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32432695 (View on PubMed)

Other Identifiers

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Main

Identifier Type: -

Identifier Source: org_study_id