Bipolar Disorder Clinical Trial
— RADMISOfficial 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
NCT number | NCT03033420 |
Other study ID # | RADMIS |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2017 |
Est. completion date | May 1, 2021 |
Verified date | September 2022 |
Source | Psychiatric Centre Rigshospitalet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 200 |
Est. completion date | May 1, 2021 |
Est. primary completion date | March 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Psychiatric Center Copenhagen, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Psychiatric Centre Rigshospitalet | Technical University of Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Perceived stress | Differences in perceived stress (The Cohen's Perceived stress scale) between the intervention group and the control group. | 6 months trial period | |
Other | Quality of life | Differences in quality of life (The WHO Quality of Life-BREF) between the intervention group and the control group. | 6 months trial period | |
Other | Self-rated manic symptoms | Differences in self-rated manic symptoms (The Altman Self Rating scale for Mania) between the intervention group and the control group. | 6 months trial period | |
Other | Self-rated depressive symptoms | Differences in self-rated depressive symptoms (The Becks Depressive Inventory) between the intervention group and the control group. | 6 months trial period | |
Other | Self-rated depressive symptoms | Differences in self-rated depressive symptoms (The Hamilton Depression Self-rating Scale 6-item) between the intervention group and the control group. | 6 months trial period | |
Other | Recovery | Differences in recovery (The Recovery Assessment Scale) between the intervention group and the control group. | 6 months trial period | |
Other | Empowerment | Differences in empowerment (Rogers empowerment scale) between the intervention group and the control group. | 6 months trial period | |
Other | Adherence to medication | Differences in adherence to medication (The Medicine Adherence Rating Scale) between the intervention group and the control group. | 6 months trial period | |
Other | Well-being | Differences in well-being according (The WHO (five) well-being index) between the intervention group and the control group. | 6 months trial period | |
Other | Rumination | Differences in rumination (The Rumination Response Scale) between the intervention group and the control group. | 6 months trial period | |
Other | Worrying | Differences in worrying (The Penn State Worry Questionnaire) between the intervention group and the control group. | 6 months trial period | |
Other | Satisfaction | Differences in satisfaction (The Verona Satisfaction Scale-Affective Disorder) between the intervention group and the control group. | 6 months trial period | |
Primary | 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 | |
Primary | Duration of re-admissions | Differences in the duration of re-admissions between the intervention group and the control group. | 6 months trial period | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Number of affective episodes | Differences in the number of affective episodes between the intervention group and the control group. | 6 months trial period |
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