Effectiveness of Two Self Assessment Tools: KIOS-Bipolar or eMoods

Completed

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT02418910

Run by

The University of Texas Health Science Center at San Antonio

People needed

50

Starts

2015-10-01

Expected to finish

2017-04-01

Last updated by the study team

2019-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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