NCT04583891 is a NA clinical trial of IntelliCare in Depression, Anxiety, sponsored by University of Virginia.

Who is sponsoring NCT04583891?

NCT04583891 is sponsored by University of Virginia.

What drugs are being tested in NCT04583891?

Interventions in NCT04583891: IntelliCare, Psychoeducation, Coaching.

What condition does NCT04583891 study?

NCT04583891 studies Depression, Anxiety, Engagement, Patient.

Is NCT04583891 still recruiting?

NCT04583891 is currently completed. Last updated 10 November 2025.

Are results published for NCT04583891?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-11-10 · How we verify

NCT04583891

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design

Completed NA Results posted Last updated 10 November 2025

What this trial tests

NA trial testing IntelliCare in Depression, Anxiety in 313 participants. Completed in 16 January 2024.

Timeline

27 September 2021

Primary endpoint
16 January 2024

16 January 2024

Quick facts

Lead sponsor	University of Virginia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	313
Start date	27 September 2021
Primary completion	16 January 2024
Estimated completion	16 January 2024
Sites	1 location across United States

Drugs / interventions tested

IntelliCare
Psychoeducation
Coaching

Conditions studied

Depression, Anxiety — all drugs for Depression, Anxiety →
Engagement, Patient — all drugs for Engagement, Patient →

Sponsor

University of Virginia

Who can join

18 and older, female only, with Depression, Anxiety or Engagement, Patient. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Health Questionnaire-8 Primary · Baseline

8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	12.1	± 4.6
IntelliCare - Low Engager, No Coaching	11.8	± 4.1
IntelliCare - Low Engager, Coaching	12.5	± 4.5
Patient Education	12.7	± 4.4

Patient Health Questionnaire-8 Primary · Post 8 weeks

8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	8.1	± 5.1
IntelliCare - Low Engager, No Coaching	10.5	± 5.8
IntelliCare - Low Engager, Coaching	7.2	± 4.4
Patient Education	9.4	± 4.9

Patient Health Questionnaire-8 Primary · 6 month follow up

8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	7.2	± 4.9
IntelliCare - Low Engager, No Coaching	7.4	± 4.3
IntelliCare - Low Engager, Coaching	7.2	± 5.1
Patient Education	8.8	± 5.5

Patient Health Questionnaire-8 Primary · 12 month follow up

8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	6.7	± 4.9
IntelliCare - Low Engager, No Coaching	7.4	± 3.9
IntelliCare - Low Engager, Coaching	6.6	± 5.6
Patient Education	8.3	± 5.9

Generalized Anxiety Disorder-7 Primary · Baseline

7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	11.4	± 4.0
IntelliCare - Low Engager, No Coaching	12.2	± 5.0
IntelliCare - Low Engager, Coaching	12.4	± 5.2
Patient Education	12.6	± 4.7

Generalized Anxiety Disorder-7 Primary · Post 8 weeks

7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	6.9	± 4.6
IntelliCare - Low Engager, No Coaching	7.6	± 4.5
IntelliCare - Low Engager, Coaching	7.7	± 5.1
Patient Education	8.9	± 5.5

Generalized Anxiety Disorder-7 Primary · 6 month follow up

7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	6.3	± 5.0
IntelliCare - Low Engager, No Coaching	7.0	± 4.6
IntelliCare - Low Engager, Coaching	7.3	± 5.7
Patient Education	8.0	± 5.5

Generalized Anxiety Disorder-7 Primary · 12 month follow up

7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	5.7	± 5.1
IntelliCare - Low Engager, No Coaching	6.0	± 4.2
IntelliCare - Low Engager, Coaching	7.2	± 5.6
Patient Education	7.5	± 5.8

App Engagement From App Sessions Secondary · Frequency of unique app sessions from Baseline through 8 weeks

Frequency of unique app sessions from Baseline through 8 weeks based on median number of app sessions

Week 1

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	12	8.5 – 15.5
IntelliCare - Low Engager, No Coaching	6	3.5 – 8.5
IntelliCare - Low Engager, Coaching	7	5 – 9
Patient Education	2	1 – 3

Week 2

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	9	5 – 13
IntelliCare - Low Engager, No Coaching	4	2 – 6
IntelliCare - Low Engager, Coaching	4.5	2 – 7
Patient Education	0	0 – 1

Week 3

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	8	4.5 – 11.5
IntelliCare - Low Engager, No Coaching	2.5	1 – 4
IntelliCare - Low Engager, Coaching	5	2.5 – 7.5
Patient Education	0	0 – 0

Week 4

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	7	3.5 – 10.5
IntelliCare - Low Engager, No Coaching	1	0 – 4
IntelliCare - Low Engager, Coaching	5	2 – 8
Patient Education	0	0 – 0

Week 5

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	6	3 – 9
IntelliCare - Low Engager, No Coaching	2	0.5 – 3.5
IntelliCare - Low Engager, Coaching	3.5	1.5 – 5.5
Patient Education	0	0 – 0

Week 6

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	5	2.5 – 7.5
IntelliCare - Low Engager, No Coaching	1	0 – 3
IntelliCare - Low Engager, Coaching	4	2 – 6
Patient Education	0	0 – 0

Week 7

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	5	2 – 8
IntelliCare - Low Engager, No Coaching	0.5	0 – 4
IntelliCare - Low Engager, Coaching	4.5	2.5 – 6.5
Patient Education	0	0 – 0

Week 8

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	4	0.5 – 7.5
IntelliCare - Low Engager, No Coaching	0.5	0 – 3
IntelliCare - Low Engager, Coaching	3.5	1.5 – 5.5
Patient Education	0	0 – 0

36-Item Short Form Survey - Physical Health Secondary · Baseline

The SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	35.5	± 40.9
IntelliCare - Low Engager, No Coaching	41.4	± 36.9
IntelliCare - Low Engager, Coaching	39.7	± 42.2
Patient Education	35.7	± 39.4

36-Item Short Form Survey - Physical Health Secondary · 8 week

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	44.7	± 41.9
IntelliCare - Low Engager, No Coaching	45.8	± 36.6
IntelliCare - Low Engager, Coaching	53.8	± 41.5
Patient Education	44.5	± 40.2

36-Item Short Form Survey - Physical Health Secondary · 6 months

Group	Value	95% CI
IntelliCare - High Engager, No Coaching	60.3	± 42.1
IntelliCare - Low Engager, No Coaching	51.5	± 41.0
IntelliCare - Low Engager, Coaching	56.5	± 45.2
Patient Education	49.0	± 40.1

Sponsor's own description

The overarching goals of this project are to provide the first rigorous test of a scalable and publicly accessible mobile health intervention (IntelliCare) to address emotional distress in women with breast cancer, and to test the impact of human coaching as a way to increase engagement with digital health interventions to improve outcomes. To achieve these goals, an innovative experimental study design, known as a Sequential, Multiple Assignment, Randomized Trial (SMART), will be used to test the effects of the IntelliCare apps on symptoms of depression and anxiety, as well as the added value of human support to improve participant engagement. 313 breast cancer survivors diagnosed within the past 5 years and who screen positive for elevated symptoms of depression and/or anxiety will be recruited. Participants will initially be randomized to receive the IntelliCare apps or app-delivered patient education (control) for 8 weeks, and the impact of the IntelliCare apps on reducing symptoms of depression and anxiety in breast cancer survivors relative to control will be tested (Aim 1). We will monitor the app usage data of participants who receive the IntelliCare apps. Those who are high-engagers will continue to use the apps with no change. Those who are low-to-moderate engagers will be rerandomized after 1 week to either receive added coaching vs. not (i.e., no change) in addition to the apps. The hypothesis is that added coaching to address barriers to app usage will lead to greater engagement with the apps (Aim 2), for low-to-moderate engagers. Finally, semi-structured exit interviews will be conducted with participants that receive the IntelliCare apps and coaching. Interviews will capture survivors' perceptions about the extent to which, and how, tailoring the apps and coaching specifically for breast cancer survivors may improve intervention outcomes and engagement (Aim 3).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Prospective associations between sleep quality and sexual satisfaction in distressed breast cancer survivors: Secondary analysis from the Apps Reaching Cancer Survivors randomized trial.
Shaffer KM, Daniel KE, Wiseman KP, Ritterband LM, et al · · 2025 · cited 1× · PMID 40966187 · DOI 10.1002/cncr.70093

Verify or expand the search:

Other trials of IntelliCare

Trials testing the same drug.

NCT05525689 — Evaluating Technology Enabled Services in Perinatal Depression · NA · completed
NCT05274620 — Integrating a Suite of Mental Health Apps for Depression in a Healthcare Setting · NA · completed
NCT04499729 — Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation · NA · terminated
NCT03500536 — Understanding the Efficacy of Mobile Apps as Intervention for Depression in Adults When Deployed as Part of Primary Care · NA · completed

Other recruiting trials for Depression, Anxiety

Currently open trials in the same condition.

NCT07278466 — The COMParing App Support Strategies Study · NA · recruiting
NCT07280481 — Weekly Dynamics of Psychopathological and Symptom Networks During Mindfulness-Based Interventions for Emotional Distress · NA · recruiting
NCT07014852 — Integrating Inuit Knowledge Principles in Multi-Level Mental Health Clinical Trials · EARLY_PHASE1 · recruiting
NCT07186816 — SUpport From PEeRs to Expand Access Study - Community · NA · recruiting
NCT07091032 — Building Connections · NA · recruiting

Other University of Virginia trials

Trials by the same sponsor.

NCT05880355 — Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI · EARLY_PHASE1 · not yet recruiting
NCT07405645 — Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy · NA · recruiting
NCT07146685 — Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study · Phase 4 · not yet recruiting
NCT07298941 — Resilience Enhancement Following Sleep Treatment · Phase 2 · recruiting
NCT07036315 — Meaning in Music-Based Pain Modulation · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04583891 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Virginia
Last refreshed: 10 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04583891.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04583891

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of IntelliCare

Other recruiting trials for Depression, Anxiety

Other University of Virginia trials

Verify against primary sources