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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

This Phase II study has the specific aim of evaluation of KIOS-Bipolar in a randomized, open 52 week effectiveness study of 120 bipolar subjects in current treatment at three socioeconomically diverse academic health science centers. Concurrent with this clinical effectiveness study, the research team, funded by the same NIH grant,will refine prototype software and integrate data security and establish quality standards into the KIOS-Bipolar system.

The clinical trial will:

Assess sensitivity of K-B assessed improvement or worsening by comparison with assessment by BISS-Self and BISS-42.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Comparison of Two Brief Assessment Measures: KIOS Bipolar or eMOODs

Time frame: 52 weeks

measure is the count of participants with KIOS or eMOOD assessments completed on time, completed only with follow-up prompts, and the number of weeks not submitted.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

Biomedical Development Corporation

Registry information

Official study title

Comparative Effectiveness of Two Self Assessment Tools: KIOS-Bipolar or eMoods: A Randomized, Open 52 Week Study for Persons With Bipolar Disorder

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Apr 17, 2015
Registry last updated: Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed