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

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ClinicalTrials.gov Identifier: NCT04230421
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : February 24, 2021
Sponsor:
Collaborators:
Maria Faurholt-Jepsen, MD, DMSc
The Mental Health Services in the Capital Region of Denmark
Information provided by (Responsible Party):
Lars Vedel Kessing, Mental Health Services in the Capital Region, Denmark

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= 1000 patients).

Condition or disease Intervention/treatment Phase
Bipolar Disorder Device: The Monsenso system with feedback Device: The Monsenso system without feedback Device: CAG Bipola and mood monitoring only Not Applicable

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 has 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= 1000 patients). Findings from the study will have great impact on future IT monitoring and treatment in bipolar disorder.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Smartphone-based Treatment for Bipolar Disorder - the Smart Bipolar RCT
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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




Primary Outcome Measures :
  1. Daily self-reported mood instability via Monsenso [ Time Frame: During the entire study peirod of 6 months per participant ]
    Mood measured daily via smartphones on a scale form -3 to +3.


Secondary Outcome Measures :
  1. Risk of 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.

  2. The Hamilton Depression Scale-17 items [ Time Frame: Baseline and 6 months ]
    Severity of clinician evaluated depressive symptoms. Range from 0-52. Higher score means higher severity of depressive symptoms.

  3. The Young Mania Rating Scale [ Time Frame: Baseline and 6 months ]
    Severity of clinician evaluated manic symptoms. Range 0-60. Higher score means higher severity of manic symptoms.

  4. The Functional Assessment Short Test [ Time Frame: Baseline and 6 months ]
    Clinician evaluated Psychosocial Functioning. Higher score means higher impairment of functioning.

  5. 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

  6. Recovery according to Recovery Assessment Scale [ Time Frame: Baseline and 6 months ]
    Patient evaluated. Higher scores indicate higher level of recovery.

  7. Empowerment according to Rogers empowerment scale [ Time Frame: Baseline and 6 months ]
    Patient evaluated. Higher scores indicate higher empowerment.

  8. General well-being according to the WHO (Five) well-being index [ Time Frame: Baseline and 6 months ]
    Patient evaluated. Scores between 0-25. Higher score indicate higher well being.

  9. 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.

  10. 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.

  11. Satisfaction with care according to scores on the Danish nation-wide patient satisfaction questionnaire [ Time Frame: Baseline and 6 months ]
    Patient evaluated. Higher scores indicate higher satisfaction with treatment.

  12. 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.

  13. Clinicians' satisfaction with their work at start and end of the RCT [ Time Frame: Baseline and 6 months ]
    Clinician evaluated

  14. The number of ambulatory patient visits and other contacts [ Time Frame: During the entire study period of 6 months ]
    Are recorded (divided on physician, nurse, psychologist, social advisor, other therapists).

  15. The duration of ambulatory patient visits and other contacts [ Time Frame: During the entire study period of 6 months ]
    Are recorded (divided on physician, nurse, psychologist, social advisor, other therapists).

  16. Long-term outcome: Risk of hospitalization [ Time Frame: 3, 5 and 10 years ]
    Register-based data

  17. Long-term outcome: Cumulated duration of hospitalization [ Time Frame: 3, 5 and 10 years ]
    Register-based data

  18. Long-term outcome: Prescribed medication [ Time Frame: 3, 5 and 10 years ]
    Register-based data

  19. Long-term outcome: Psychosocial measures (sickdays) [ Time Frame: 3, 5 and 10 years ]
    Register-based data

  20. Long-term outcome: Somatic comorbidity [ Time Frame: 3, 5 and 10 years ]
    Register-based data

  21. Long-term outcome: Rate of suicide [ Time Frame: 3, 5 and 10 years ]
    Register-based data

  22. Long-term outcome: Death due to natural causes [ Time Frame: 3, 5 and 10 years ]
    Register-based data

  23. Cumulated duratio of hospitalization [ Time Frame: During the entire study peirod of 6 months per participant ]
    Data on cumulated duration of 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230421


Contacts
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Contact: Lars Vedel Kessing, Prof., MD, DMSc +4538647073 lars.vedel.kessing@regionh.dk
Contact: Maria Faurholt-Jepsen, MD, DMSc +4538647073 maria.faurholtjepsen@regionh.dk

Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
Maria Faurholt-Jepsen, MD, DMSc
The Mental Health Services in the Capital Region of Denmark
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Responsible Party: Lars Vedel Kessing, Prof., Principal Investigator, Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT04230421    
Other Study ID Numbers: H-19067259
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders