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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder
• Intervention / Treatment: Device: The Monsenso system with feedback; Device: The Monsenso system without feedback; Device: CAG Bipola and mood monitoring only

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lars Vedel Kessing, Prof., MD, DMSc; Phone Number: +4538647073; Email: lars.vedel.kessing@regionh.dk
• Study Contact Backup: Name: Maria Faurholt-Jepsen, MD, DMSc; Phone Number: +4538647073; Email: maria.faurholtjepsen@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Psychiatric Center Copenhagen, Rigshospitalet
    • Contact: Maria Faurholt-Jepsen
    • Contact: Lars Vedel Kessing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monsenso with feedback; Daily smartphone-based monitoring and treatment using the Monsenso system with a clinical feedback loop feedback.	Device: The Monsenso system with feedback; See description under intervention
Active Comparator: Monsenso without feedback; Daily smartphone-based monitoring and treatment using the Monsenso system WITHOUT a clinical feedback loop feedback.	Device: The Monsenso system without feedback; See description under intervention
Active Comparator: Control; 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; See description under intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the entire study period of 6 months per participant
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.	During the entire study period of 6 months per participant
Quality of life according to WHO Quality of Life-BREF	Scored between 0-100. Higher scores indicate higher quality of life. Patient evaluated	Baseline and 6 months
Patient-evaluated depressive symptoms according to the Major Depressive Inventory	Higher scores indicate higher severity of depressive symptoms. Patient evaluated.	Baseline and 6 months
Patient-evaluated manic symptoms according to the Altman Self-rating Scale for Mania	Higher scores indicate higher severity of manic symptoms. Patient evaluated.	Baseline and 6 months
Perceived stress according to Cohen's Perceived stress scale	Patient evaluated. Scores between 0-40. Higher score indicate higher perceived stress.	Baseline and 6 months
Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder	Patient evaluated. Higher scores indicate higher satisfaction with treatment.	Baseline and 6 months
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.	During the entire study period of 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported smartphone-based symptoms	Patietns-reported smartphone-based symptoms such as stress, anxiety, activity, sleep, mixed mood, adherence to medication and adherence to patient-reported smartphone-based monitoring	During the entire study period of 6 months

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Bipolar Disorder
• Other Study ID Numbers: H-19067259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No