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

P

Psychiatric Centre Rigshospitalet

Status

Completed

Conditions

Bipolar Disorder
Unipolar Depression
Affective Disorders

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03033420
RADMIS

Details and patient eligibility

About

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).

Full description

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Intervention group
Experimental group
Description:
A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
Treatment:
Device: A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
Control group
No Intervention group
Description:
Treatment-as-usual

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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