Reducing the Rate and Duration of Re-ADMISsions Among Patients With Unipolar Disorder and Bipolar Disorder Using Smartphone-based Monitoring and Treatment - The RADMIS Trials

Study Overview
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Brief Summary
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Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality due to mental and substance use disorders, and burden society with the highest health care costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric hospitalization is a major burden. Smartphones comprise an innovative and unique platform for monitoring and treatment of depression and mania. The RADMIS trials use a randomized controlled single-blind parallel-group design. Patients with unipolar or bipolar disorder discharged from psychiatric hospitals in The Capital Region of Denmark are invited to participate. Patients are at discharge from the psychiatric hospitals randomized, separately according to psychiatric diagnosis (thus, the RADMIS trial consists of two separate trials according to diagnosis, bipolar disorder or unipolar disorder), to: 1) a smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules (intervention group) or 2) treatment-as-usual (control group) for a 6-months trial period. The trial is started in March 2017. The outcomes are 1) differences in the number and duration of re-admissions between the intervention group and the control group (primary), 2) differences in severity of depressive and manic symptoms (manic symptoms only for patients with bipolar disorder); differences in psychosocial functioning; and differences in number of affective episodes between the intervention group and the control group (secondary), and 3) differences in perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms (only for patients with bipolar disorder), recovery, empowerment, adherence to medication, well-being, ruminations, worrying, and satisfaction between the intervention group and the control group (tertiary).

Detailed Description
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Background Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality due to mental and substance use disorders, and burden society with the highest health care costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric hospitalization are a major burden. Smartphones comprise an innovative and unique platform for monitoring and treatment of depression and mania. No prior trial has investigated whether the use of a smartphone-based system can prevent re-admission among patients discharged from hospital. Methods The RADMIS trials use a randomized controlled single-blind parallel-group design. Patients with unipolar disorder and patients with bipolar disorder are invited to participate in each their trial when discharged from psychiatric hospitals in The Capital Region of Denmark following an affective episode and randomized to either 1) a smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules (intervention group) or 2) standard treatment (control group) for a 6-months trial period. The trial is started in March 2017. The outcomes are 1) differences in the number and duration of re-admissions between the intervention group and the control group (primary), 2) differences in severity of depressive and manic symptoms (manic symptoms only for patients with bipolar disorder); differences in psychosocial functioning; and differences in number of affective episodes between the intervention group and the control group (secondary), and 3) differences in perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms (only for patients with bipolar disorder), recovery, empowerment, adherence to medication, well-being, ruminations, worrying, and satisfaction between the intervention group and the control group (tertiary). Analysis Recruitment is ongoing. Discussion If the smartphone-based monitoring system is proved effective in reducing the rate and duration of re-admissions there will be basis for using a system of this kind in the treatment of unipolar and bipolar disorder in general and in a larger scale.

Official Title
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Reducing the Rate and Duration of Re-ADMISsions Among Patients With Unipolar Disorder and Bipolar Disorder Using Smartphone-based Monitoring and Treatment - The RADMIS Trials

Conditions
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Affective Disorders, Unipolar Depression, Bipolar Disorder

Intervention / Treatment
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* Device: A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unipolar disorder or bipolar disorder diagnoses according to ICD-10 Patients who are discharged from a psychiatric hospital in The Capital Region of Denmark following an affective episode (depression or mania) Exclusion Criteria: Pregnancy A lack of Danish language skills

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules | Device: A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules<br>* A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules<br>* Other names: Monsenso;|
| No Intervention: Control group<br>Treatment-as-usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of re-admissions | Differences in the number of re-admissions between the intervention group and the control group. Data will be collected from Danish registers. | 6 months trial period | 
| Duration of re-admissions | Differences in the duration of re-admissions between the intervention group and the control group. | 6 months trial period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of depressive symptoms | Differences in the severity of depressive (The Hamilton Depression Rating Scale) symptoms between the intervention group and the control group. | 6 months trial period | 
| Severity of manic symptoms | Differences in the severity of manic (The Young Mania Rating Scale) symptoms between the intervention group and the control group. | 6 months trial period | 
| Psychosocial functioning | Differences in psychosocial functioning (The Psychosocial Functioning Assessment Short Test - FAST) between the intervention group and the control group. | 6 months trial period | 
| Number of affective episodes | Differences in the number of affective episodes between the intervention group and the control group. | 6 months trial period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unipolar disorder, Bipolar disorder, Randomized controlled trial, Smartphone, Re-admission, CBT