Clinical trial NCT03033420: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Affective Disorders
Unipolar Depression
Bipolar Disorder
Keywords: Unipolar disorder
Bipolar disorder
Randomized controlled trial
Smartphone
Re-admission
CBT
Lead sponsor: Psychiatric Centre Rigshospitalet
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
First posted: 2017-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of re-admissions
timeFrame: 6 months trial period
measure: Duration of re-admissions
timeFrame: 6 months trial period
Secondary outcomes:
measure: Severity of depressive symptoms
timeFrame: 6 months trial period
measure: Severity of manic symptoms
timeFrame: 6 months trial period
measure: Psychosocial functioning
timeFrame: 6 months trial period
measure: Number of affective episodes
timeFrame: 6 months trial period
Other outcomes:
measure: Perceived stress
timeFrame: 6 months trial period
measure: Quality of life
timeFrame: 6 months trial period
measure: Self-rated manic symptoms
timeFrame: 6 months trial period
measure: Self-rated depressive symptoms
timeFrame: 6 months trial period
measure: Self-rated depressive symptoms
timeFrame: 6 months trial period
measure: Recovery
timeFrame: 6 months trial period
measure: Empowerment
timeFrame: 6 months trial period
measure: Adherence to medication
timeFrame: 6 months trial period
measure: Well-being
timeFrame: 6 months trial period
measure: Rumination
timeFrame: 6 months trial period
measure: Worrying
timeFrame: 6 months trial period
measure: Satisfaction
timeFrame: 6 months trial period
Locations:
city: Copenhagen
country: Denmark
facility: Psychiatric Center Copenhagen, Rigshospitalet
Study officials:
affiliation: Psychiatric Center Copenhagen, Denmark
name: Maria Faurholt-Jepsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Faurholt-Jepsen M, Frost M, Martiny K, Tuxen N, Rosenberg N, Busk J, Winther O, Bardram JE, Kessing LV. 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 protocol for two randomized controlled trials. Trials. 2017 Jun 15;18(1):277. doi: 10.1186/s13063-017-2015-3.