Observational Study on Bipolar Disorder Episodes in Veterans
This study is looking at how to better predict upcoming mood episodes in veterans with bipolar disorder (BD). People with BD often have unpredictable periods of severe problems with social activities. While treatments exist, it's hard to catch these episodes early because people might not realize their symptoms are worsening, and doctor visits aren't frequent enough. This study aims to find new ways to detect these changes without relying on a person's self-reporting or frequent clinic visits. Researchers will be tracking how social participation, depression symptoms (using the Modified Hamilton Rating Scale for Depression), and mania symptoms (using the Young Mania Rating Scale) change over 14 weeks. You could be eligible if you are a veteran, 18 or older, and have a confirmed diagnosis of Bipolar I, Bipolar II, or Other Specified Bipolar Disorder.
- Study design
- This is an observational study with a planned enrollment of 200 participants. It is not testing a specific intervention or drug.
- What's involved
- You would have your social participation measured biweekly for 14 weeks, and your depression and mania symptoms measured weekly for 14 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your participation, depression, and mania symptoms will be tracked for 14 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
mHealth Estimate-based Algorithms Signaling Upcoming Recurrence of Episodes in Bipolar Disorders
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Snezana Urosevic, PhD · PRINCIPAL_INVESTIGATOR · Minneapolis VA Health Care System, Minneapolis, MN
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Impaired Social ParticipationBiweekly for 14 weeks
To determine presence of impaired social participation, an average of T scores will be calculated from two scales: PROMIS Satisfaction with Participation in Social Roles and PROMIS Ability to Participate in Social Roles and Activities scales. Averaged T scores less than 40 (1 standard deviation below population mean of 50) will be considered as indicators of impaired social participation. The PROMIS scales will be administered biweekly for the duration of 14 weeks of the follow-up.
- Modified Hamilton Rating Scale for DepressionWeekly for 14 weeks
Modified Hamilton Rating Scale for Depression interviews administered biweekly will assess depression symptoms for each week of the 14-week follow-up to assess presence of clinically significant depression (score of 14 or higher) and/or changes in depression severity.
- Young Mania Rating ScaleWeekly for 14 weeks
Young Mania Rating Scale interviews administered biweekly will assess manic/hypomanic symptoms for each week of the 14-week follow-up period to determine presence of clinically significant hypomania/mania (scores above 12) and changes in hypomania/mania symptom severity.
- PROMIS Ability to Participate in Social Roles and ActivitiesBiweekly for 14 weeks
PROMIS Ability to Participate in Social Roles and Activities is a self-report measure of difficulties with social participation. The raw scores range from 8 to 40 with higher scores indicating greater difficulties with social participation. The raw scores will be transformed into T scores and then average with T score for PROMIS Satisfaction with Participation in Social Roles for each week of the follow-up. These average scores of T score less than 40 will be considered as indicators of impaired social participation during this week.