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.
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
The clinical trial will:
1. Assess aggregate time spent in seven primary clinical states of BD (remitted;
subsyndromal depression, mania or mixed state; and syndromal depression, mania or mixed
2. Assess the weekly completion of KIOS-Bipolar and eMoods.
3. Determine indices of patient satisfaction with the format, ease of use, time required
and patient motivation for continuing use of the patient tools both during the trial
and following completion.
4. Determine patient satisfaction with the clinical information on BD illness trajectory
and recommendations to facilitate good health and effective interventions. Note that
eMoods does not provide this element of information, therefore no comparative data will
be feasible for this one objective.
5. Assess patient scored life function indices (Life Function Questionnaire (LFQ) over the
52 week period of the study.
6. Assess the relationship between the 8 symptom items in K-B with relevant items rated
both by clinicians and as self-assessments by patients at four time points (week 0, 8,
16 and 52) in the study. These are times at which clinical care visits will routinely
occur, and therefore will not add either to extra burden on the participants, or extra
contact time with staff. Subjects randomized to eMoods will be similarly scheduled,
with the correlations limited to those feasible with the eMoods product.
Self-assessments with the 29 item BISS-Self are routinely obtained as part of regular
treatment visits. For subjects in this study the trained BISS rater will be blind to
the tool assigned.
The clinician administered scale will be the 42 item Bipolar Inventory of Symptoms
Scale (BISS), however comparisons will be limited to the symptom areas represented in
both K-B and eMoods, e.g., depression and mania subscales; depression, mania,
irritability and anxiety domains. The BISS Self (BISS-S) is a 29 item scale covering
similar symptoms to the BISS, but answered as yes/no, rather than the 0-4 range of the
BISS. The MINI is a structured diagnostic interview providing current and lifetime
psychiatric diagnoses, requiring approximately 20 minutes.
7. Estimate the utility of ancillary features of Kios-Bipolar or eMoods. These features
include capability to submit to the investigative staff displays of symptom
trajectories for the patient's medical record and visual displays of selected aspects
of the patient's illness/wellness. No transmission of data to treating clinical staff
will occur as component of this study.
8. Assess sensitivity of K-B assessed improvement or worsening by comparison with
assessment by BISS-Self and BISS-42.
1. Male or female outpatients 18 years of age or older
2. Bipolar I or II disorder as assessed by MINI 6.0
3. In psychiatric outpatient treatment at UTHSCSA, University of Louisville, or Lindner
Center of Hope, Mason Ohio
4. Currently taking mood stabilizer or second generation antipsychotic for 4 weeks or
5. Ability to access Kios-Bipolar or eMoods (via computer, smartphone or tablet)
1. Unwilling or unable to comply with study requirements
2. Renal impairment (serum creatinine >1.5 mg/dl
3. If on thyroid medication must be euthyroid for at least 1 month
4. Drug/alcohol dependence within the past 30 days