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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: Recruiting study of Bipolar Disorder, sponsored by VA Office of Research and Development.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

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.

Conditions Studied

Study Locations (1)

Minnesota

  • Minneapolis VA Health Care System, Minneapolis, MN - Minneapolis

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2024-09-10
Est. Completion 2027-09-30
VA Office of Research and Development

1,668 total trials

What NCT06204705 shows while recruiting

NCT06204705 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 331-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (40% lower).

The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 0 interventions.

NCT06204705 reports a single indexed study location in 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.

Similar trials for Bipolar Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06204705's enrollment target sits among peer trials

200 35th of 162 higher than 126 of 162 other Bipolar Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06204705, the US trial registry maintained by the National Library of Medicine. NCT06204705 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.