NCT04230421

Brief Summary

The Smart Bipolar RCT is a pragmatic RCT aiming to investigate effects of smartphone-based add on treatment in large scale clinical practice (N= 200 patients).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress98%
Mar 2021Jul 2026

First Submitted

Initial submission to the registry

January 3, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

4.3 years

First QC Date

January 3, 2020

Last Update Submit

June 6, 2023

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Daily self-reported mood instability via Monsenso

    Mood measured daily via smartphones on a scale form -3 to +3.

    During the entire study period of 6 months per participant

Secondary Outcomes (8)

  • Risk of psychiatric hospitalization

    During the entire study period of 6 months per participant

  • Cumulated duration of psychiatric hospitalization

    During the entire study period of 6 months per participant

  • Quality of life according to WHO Quality of Life-BREF

    Baseline and 6 months

  • Patient-evaluated depressive symptoms according to the Major Depressive Inventory

    Baseline and 6 months

  • Patient-evaluated manic symptoms according to the Altman Self-rating Scale for Mania

    Baseline and 6 months

  • +3 more secondary outcomes

Other Outcomes (1)

  • Patient-reported smartphone-based symptoms

    During the entire study period of 6 months

Study Arms (3)

Monsenso with feedback

EXPERIMENTAL

Daily smartphone-based monitoring and treatment using the Monsenso system with a clinical feedback loop feedback.

Device: The Monsenso system with feedback

Monsenso without feedback

ACTIVE COMPARATOR

Daily smartphone-based monitoring and treatment using the Monsenso system WITHOUT a clinical feedback loop feedback.

Device: The Monsenso system without feedback

Control

ACTIVE COMPARATOR

CAG Bipolar treatment alone and daily mood monitoring using only the mood monitoring part of the Monsenso system.

Device: CAG Bipola and mood monitoring only

Interventions

The Monsenso system with feedbackDEVICE

See description under intervention

Monsenso with feedback
The Monsenso system without feedbackDEVICE

See description under intervention

Monsenso without feedback
CAG Bipola and mood monitoring onlyDEVICE

See description under intervention

Control

Eligibility Criteria

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

You may qualify if:

  • All patients in CAG Bipolar, i.e., with a main diagnosis of bipolar disorder in the five large centers, in the Mental Health Services, Capital Region of Denmark (Psychiatric Center Copenhagen, Psychiatric Center Hilleroed, Psychiatric Center Amager, Psychiatric Center Glostrup and Psychiatric Center Ballerup)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Center Copenhagen, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (1)

  • Faurholt-Jepsen M, Kyster NB, Dyreholt MS, Christensen EM, Bondo-Kozuch P, Lerche AS, Smidt B, Knorr U, Brondmark K, Cardoso AB, Mathiesen A, Sjaelland R, Norbak-Emig H, Sponsor LL, Mardosas D, Sarauw-Nielsen IP, Bukh JD, Heller TV, Frost M, Iversen N, Bardram JE, Busk J, Vinberg M, Kessing LV. The effect of smartphone-based monitoring and treatment including clinical feedback versus smartphone-based monitoring without clinical feedback in bipolar disorder: the SmartBipolar trial-a study protocol for a randomized controlled parallel-group trial. Trials. 2023 Sep 12;24(1):583. doi: 10.1186/s13063-023-07625-1.

    PMID: 37700334DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Central Study Contacts

Lars Vedel Kessing, Prof., MD, DMSc

CONTACT

+4538647073lars.vedel.kessing@regionh.dk

Maria Faurholt-Jepsen, MD, DMSc

CONTACT

+4538647073maria.faurholtjepsen@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof., Principal Investigator

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 18, 2020

Study Start

March 1, 2021

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

June 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)