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NCT06204705 · ClinicalTrials.gov registry record
mHealth Estimate-based Algorithms Signaling Upcoming Recurrence of Episodes in Bipolar Disorders
A clinical trial of Bipolar Disorder, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT06204705 is a study of Bipolar Disorder that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 200 participants, below the 331-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06204705, a study of Bipolar Disorder, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
Veterans with bipolar disorders (BD) experience recurrent and seemingly unpredictable periods of severe impairments in psychosocial functioning, such as participation in social roles and activities. Many effective treatments for BD emphasize early detection of bipolar episodes, in order to make necessary treatment adjustments and prevent psychosocial impairments associated with acute mood episodes. Unfortunately, acute mood episodes in BD are also associated with a decrease in a patient's insight into their own symptoms, which can prevent one's ability to self-report first signs of symptoms and functional declines. Moreover, routine care visits for BD are typically too infrequent to capture and effectively monitor day-to-day changes in a patient's mood and functioning. Objective, low-effort, and continuous methods of tracking symptoms and social participation of Veterans with BD in real-time and in-situ are needed to provide early (i.e., days in advance) warning signs of acute bipolar episodes and functional declines, which in turn would enable well-timed interventions to prevent poor psychosocial outcomes. mHealth refers to the use of mobile and wireless devices as part of patient care and offers many potential opportunities for early detection of and intervention for acute mood states in this population. However, these mHealth approaches have not been investigated in Veterans with BD. In a Small Projects in Rehabilitation Research (SPiRE)-funded pilot study, the investigator team established high feasibility and acceptability of one such innovative passive mHealth approach using a smartphone program, or an app, in a small sample of Veterans with BD to track their smartphone's GPS/location. The pilot study used a priori location context ratings of visited places (e.g., a priori ratings on types of activities usually engaged in at a frequently visited location) to derive unobtrusive measures of social participation (e.g., time spent at work-related locations). The
Conditions Studied
Study Locations (1)
Minnesota
- Minneapolis VA Health Care System, Minneapolis, MN - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-09-10 |
| Est. Completion | 2027-09-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06204705
The ClinicalTrials.gov registry entry for NCT06204705 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 331-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (40% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 0 interventions.
NCT06204705 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06204705 about?
NCT06204705 is a clinical study titled "mHealth Estimate-based Algorithms Signaling Upcoming Recurrence of Episodes in Bipolar Disorders". Veterans with bipolar disorders (BD) experience recurrent and seemingly unpredictable periods of severe impairments in psychosocial functioning, such as participation in social roles and activities. Many effective treatments for BD emphasize early detection of bipolar episodes, in order to make nece...
What is the current status of trial NCT06204705?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2024-09-10. Estimated completion is 2027-09-30.
What conditions does trial NCT06204705 study?
This clinical trial studies the following conditions: Bipolar Disorder.
Who is sponsoring clinical trial NCT06204705?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06204705 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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