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

Overview

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).

Full Title of Study: “Effects of Smartphone-based Treatment for Bipolar Disorder – the Smart Bipolar RCT”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: July 1, 2025

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.

Interventions

• Device: The Monsenso system with feedback
  • See description under intervention
• Device: The Monsenso system without feedback
  • See description under intervention
• Device: CAG Bipola and mood monitoring only
  • See description under intervention

Arms, Groups and Cohorts

• Experimental: Monsenso with feedback
  • Daily smartphone-based monitoring and treatment using the Monsenso system with a clinical feedback loop feedback.
• Active Comparator: Monsenso without feedback
  • Daily smartphone-based monitoring and treatment using the Monsenso system WITHOUT a clinical feedback loop feedback.
• Active Comparator: Control
  • CAG Bipolar treatment alone and daily mood monitoring using only the mood monitoring part of the Monsenso system.

Clinical Trial Outcome Measures

Primary Measures

• Daily self-reported mood instability via Monsenso
  • Time Frame: During the entire study period of 6 months per participant
  • Mood measured daily via smartphones on a scale form -3 to +3.

Secondary Measures

• Risk of psychiatric hospitalization
  • Time Frame: During the entire study period of 6 months per participant
  • 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
  • Time Frame: During the entire study period of 6 months per participant
  • 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
  • Time Frame: Baseline and 6 months
  • Scored between 0-100. Higher scores indicate higher quality of life. Patient evaluated
• Patient-evaluated depressive symptoms according to the Major Depressive Inventory
  • Time Frame: Baseline and 6 months
  • Higher scores indicate higher severity of depressive symptoms. Patient evaluated.
• Patient-evaluated manic symptoms according to the Altman Self-rating Scale for Mania
  • Time Frame: Baseline and 6 months
  • Higher scores indicate higher severity of manic symptoms. Patient evaluated.
• Perceived stress according to Cohen’s Perceived stress scale
  • Time Frame: Baseline and 6 months
  • 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
  • Time Frame: Baseline and 6 months
  • 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
  • Time Frame: During the entire study period of 6 months
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Mental Health Services in the Capital Region, Denmark
• Collaborator
  • Maria Faurholt-Jepsen, MD, DMSc
• Provider of Information About this Clinical Study
  • Principal Investigator: Lars Vedel Kessing, Prof., Principal Investigator – Mental Health Services in the Capital Region, Denmark
• Overall Contact(s)
  • Lars Vedel Kessing, Prof., MD, DMSc, +4538647073, lars.vedel.kessing@regionh.dk