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

Sponsor

Psychiatric Centre Rigshospitalet (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03033420

Collaborator

Technical University of Denmark (Other)

400

Enrollment

Location

Arms

47.5

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Affective Disorders Unipolar Depression Bipolar Disorder	Device: A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 15, 2017

Actual Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

May 1, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intervention group

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

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

Other Names:

Monsenso

No Intervention: Control group

Treatment-as-usual

Outcome Measures

Primary Outcome Measures

Number of re-admissions [6 months trial period]
Differences in the number of re-admissions between the intervention group and the control group. Data will be collected from Danish registers.
Duration of re-admissions [6 months trial period]
Differences in the duration of re-admissions between the intervention group and the control group.

Secondary Outcome Measures

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

Other Outcome Measures

Perceived stress [6 months trial period]
Differences in perceived stress (The Cohen's Perceived stress scale) between the intervention group and the control group.
Quality of life [6 months trial period]
Differences in quality of life (The WHO Quality of Life-BREF) between the intervention group and the control group.
Self-rated manic symptoms [6 months trial period]
Differences in self-rated manic symptoms (The Altman Self Rating scale for Mania) between the intervention group and the control group.
Self-rated depressive symptoms [6 months trial period]
Differences in self-rated depressive symptoms (The Becks Depressive Inventory) between the intervention group and the control group.
Self-rated depressive symptoms [6 months trial period]
Differences in self-rated depressive symptoms (The Hamilton Depression Self-rating Scale 6-item) between the intervention group and the control group.
Recovery [6 months trial period]
Differences in recovery (The Recovery Assessment Scale) between the intervention group and the control group.
Empowerment [6 months trial period]
Differences in empowerment (Rogers empowerment scale) between the intervention group and the control group.
Adherence to medication [6 months trial period]
Differences in adherence to medication (The Medicine Adherence Rating Scale) between the intervention group and the control group.
Well-being [6 months trial period]
Differences in well-being according (The WHO (five) well-being index) between the intervention group and the control group.
Rumination [6 months trial period]
Differences in rumination (The Rumination Response Scale) between the intervention group and the control group.
Worrying [6 months trial period]
Differences in worrying (The Penn State Worry Questionnaire) between the intervention group and the control group.
Satisfaction [6 months trial period]
Differences in satisfaction (The Verona Satisfaction Scale-Affective Disorder) between the intervention group and the control group.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)