N/A
Completed N=50
Effectiveness of Two Self Assessment Tools: KIOS-Bipolar or eMoods
Source: ClinicalTrials.gov NCT02418910 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Comparison of Two Brief Assessment Measures: KIOS Bipolar or eMOODs — 43 Participants
Summary
The goal of this project is to complete the development of a patient-centered software system and mobile app to assist in managing bipolar disorder. In Phase I, the investigators developed a novel computational tool known as KIOS. Based on concepts from nonlinear systems (chaos) theory, KIOS tracks multiple interacting symptoms to determine the precise state of a BD patient. Once the patient's state is identified and the trajectory of the patient is established, KIOS produces advice specific to the patient's condition to help manage the course of the disease. To demonstrate the usability of the software, KIOS was converted to an online tool with mobile access. Twenty bipolar patients evaluated KIOS in a twelve week field trial. No technical problems with the software were observed and results showed that patients had significantly more reductions in symptom severity than increases. The development of this innovative tool to help patients self- manage BD has the potential to have a profound impact on public health and achieve significant commercial success.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Two Brief Assessment Measures: KIOS Bipolar or eMOODs |
43 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female outpatients 18 years of age or older
- Bipolar I or II disorder as assessed by MINI 6.0
- In psychiatric outpatient treatment at UTHSCSA, University of Louisville, or Lindner Center of Hope, Mason Ohio
- Currently taking mood stabilizer or second generation antipsychotic for 4 weeks or longer
- Ability to access Kios-Bipolar or eMoods (via computer, smartphone or tablet)
Exclusion Criteria
- Unwilling or unable to comply with study requirements
- Renal impairment (serum creatinine >1.5 mg/dl
- If on thyroid medication must be euthyroid for at least 1 month
- Drug/alcohol dependence within the past 30 days
Data sourced from ClinicalTrials.gov (NCT02418910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.