NCT03500536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 18, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2019

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

April 10, 2018

Last Update Submit

April 26, 2019

Conditions

DepressionAnxietyPrimary Health Care

Outcome Measures

Primary Outcomes (1)

  • Symptoms of depression

    Using the PHQ-9 screener

    8 weeks

Study Arms (2)

Waitlist Control

NO INTERVENTION

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

Interventions

IntelliCareBEHAVIORAL

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

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive screen on PHQ-9

You may not qualify if:

  • Does not own or use a mobile smart phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

  • 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.

    PMID: 32432695DERIVED

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interim Principal Investigator

Study Record Dates

First Submitted

April 10, 2018

First Posted

April 18, 2018

Study Start

July 18, 2018

Primary Completion

April 4, 2019

Study Completion

April 4, 2019

Last Updated

April 30, 2019

Record last verified: 2019-04

Locations

US(1)