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Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar

Primary Purpose

Bipolar Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
The Monsenso system with feedback
The Monsenso system without feedback
CAG Bipola and mood monitoring only
Sponsored by
Mental Health Services in the Capital Region, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • None

Sites / Locations

  • Psychiatric Center Copenhagen, RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Monsenso with feedback

Monsenso without feedback

Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Daily self-reported mood instability via Monsenso
Mood measured daily via smartphones on a scale form -3 to +3.

Secondary Outcome Measures

Risk of psychiatric hospitalization
Data on hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status.
Cumulated duration of psychiatric hospitalization
Data on hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status.
Quality of life according to WHO Quality of Life-BREF
Scored between 0-100. Higher scores indicate higher quality of life. Patient evaluated
Patient-evaluated depressive symptoms according to the Major Depressive Inventory
Higher scores indicate higher severity of depressive symptoms. Patient evaluated.
Patient-evaluated manic symptoms according to the Altman Self-rating Scale for Mania
Higher scores indicate higher severity of manic symptoms. Patient evaluated.
Perceived stress according to Cohen's Perceived stress scale
Patient evaluated. Scores between 0-40. Higher score indicate higher perceived stress.
Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder
Patient evaluated. Higher scores indicate higher satisfaction with treatment.
Adherence to the Danish national guidelines of medical treatment of bipolar disorder according to use of the three main maintenance mood stabilizers for bipolar disorder: lithium, lamotrigine or quetiapine and the use of antidepressants
Adherence to medication will be an additional outcome measure in arms 1 and 2 of the RCT based on daily self-monitoring of medication via the Monsenso system.

Full Information

First Posted
January 3, 2020
Last Updated
June 6, 2023
Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Maria Faurholt-Jepsen, MD, DMSc, The Mental Health Services in the Capital Region of Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04230421
Brief Title
Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar
Official Title
Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar RCT
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Maria Faurholt-Jepsen, MD, DMSc, The Mental Health Services in the Capital Region of Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Bipolar disorder is a complex illness with a complex treatment that differs during manic, depressed, and remitted states, frequently leaving patients with decreased quality of life and impaired psychosocial function. IT solutions have during recent years emerged as a possible way to optimize treatment, but the effects of digital health interventions are rarely investigated scientifically in health care services. This is an application from the entire Mental Health Services, Capital Region of Denmark including all psychiatric centers in the region. The Smart Bipolar randomized controlled trial is a pragmatic trial aiming to investigate the effects of smartphone-based add-on treatment in large-scale clinical practice (N= 200 patients). Findings from the study will have a great impact on future IT monitoring and treatment in bipolar disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monsenso with feedback
Arm Type
Experimental
Arm Description
Daily smartphone-based monitoring and treatment using the Monsenso system with a clinical feedback loop feedback.
Arm Title
Monsenso without feedback
Arm Type
Active Comparator
Arm Description
Daily smartphone-based monitoring and treatment using the Monsenso system WITHOUT a clinical feedback loop feedback.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
CAG Bipolar treatment alone and daily mood monitoring using only the mood monitoring part of the Monsenso system.
Intervention Type
Device
Intervention Name(s)
The Monsenso system with feedback
Intervention Description
See description under intervention
Intervention Type
Device
Intervention Name(s)
The Monsenso system without feedback
Intervention Description
See description under intervention
Intervention Type
Device
Intervention Name(s)
CAG Bipola and mood monitoring only
Intervention Description
See description under intervention
Primary Outcome Measure Information:
Title
Daily self-reported mood instability via Monsenso
Description
Mood measured daily via smartphones on a scale form -3 to +3.
Time Frame
During the entire study period of 6 months per participant
Secondary Outcome Measure Information:
Title
Risk of psychiatric hospitalization
Description
Data on hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status.
Time Frame
During the entire study period of 6 months per participant
Title
Cumulated duration of psychiatric hospitalization
Description
Data on hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status.
Time Frame
During the entire study period of 6 months per participant
Title
Quality of life according to WHO Quality of Life-BREF
Description
Scored between 0-100. Higher scores indicate higher quality of life. Patient evaluated
Time Frame
Baseline and 6 months
Title
Patient-evaluated depressive symptoms according to the Major Depressive Inventory
Description
Higher scores indicate higher severity of depressive symptoms. Patient evaluated.
Time Frame
Baseline and 6 months
Title
Patient-evaluated manic symptoms according to the Altman Self-rating Scale for Mania
Description
Higher scores indicate higher severity of manic symptoms. Patient evaluated.
Time Frame
Baseline and 6 months
Title
Perceived stress according to Cohen's Perceived stress scale
Description
Patient evaluated. Scores between 0-40. Higher score indicate higher perceived stress.
Time Frame
Baseline and 6 months
Title
Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder
Description
Patient evaluated. Higher scores indicate higher satisfaction with treatment.
Time Frame
Baseline and 6 months
Title
Adherence to the Danish national guidelines of medical treatment of bipolar disorder according to use of the three main maintenance mood stabilizers for bipolar disorder: lithium, lamotrigine or quetiapine and the use of antidepressants
Description
Adherence to medication will be an additional outcome measure in arms 1 and 2 of the RCT based on daily self-monitoring of medication via the Monsenso system.
Time Frame
During the entire study period of 6 months
Other Pre-specified Outcome Measures:
Title
Patient-reported smartphone-based symptoms
Description
Patietns-reported smartphone-based symptoms such as stress, anxiety, activity, sleep, mixed mood, adherence to medication and adherence to patient-reported smartphone-based monitoring
Time Frame
During the entire study period of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Vedel Kessing, Prof., MD, DMSc
Phone
+4538647073
Email
lars.vedel.kessing@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Faurholt-Jepsen, MD, DMSc
Phone
+4538647073
Email
maria.faurholtjepsen@regionh.dk
Facility Information:
Facility Name
Psychiatric Center Copenhagen, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Faurholt-Jepsen
First Name & Middle Initial & Last Name & Degree
Lars Vedel Kessing

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar

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