Trial results for Project CARE, an open trial investigating an integrated treatment adherence program for Bipolar Disorder, were posted on ClinicalTrials.gov on 2026-01-28, with 18 participants enrolled.
Background
Bipolar Disorder is a mental health condition characterized by significant mood shifts, including manic/hypomanic and depressive episodes. Managing Bipolar Disorder can be particularly challenging for individuals transitioning from incarceration back into the community, where continuity of care and adherence to treatment regimens are critical for preventing relapse and promoting stability. The Project CARE (Community treatment Adherence at Re-Entry) program was developed as an adjunctive intervention to support incarcerated individuals with Bipolar Disorder during this transition, aiming to improve treatment adherence and symptom outcomes.
Trial design
This completed study, designated as Phase NA, enrolled 18 participants diagnosed with Bipolar Disorder. The trial investigated the Project CARE program, an adjunctive intervention designed for incarcerated individuals with bipolar disorder transitioning from prison to the community. The primary purpose of this project was to establish the feasibility, acceptability, and preliminary effects of this newly developed intervention on symptom outcomes.
Key results
The trial reported several key measurements related to client satisfaction and symptom outcomes:
- Client Satisfaction Questionnaire-8 (CSQ-8) (score on a scale):
- A mean score of 27.90 (Standard Deviation 3.07) was observed for the Community Treatment Adherence at Re-Entry (CARE) group.
- Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) (score on a scale):
- A mean score of 10.90 (Standard Deviation 5.53) was observed for the Community Treatment Adherence at Re-Entry (CARE) group.
- Altman Self-Rating Scale for Mania (ASRM) (score on a scale):
- A mean score of 3.30 (Standard Deviation 4.76) was observed for the Community Treatment Adherence at Re-Entry (CARE) group.
What this means
The posted results provide preliminary data on client satisfaction, depressive symptoms, and manic symptoms among individuals with Bipolar Disorder participating in the Project CARE program during their transition from prison to the community. As an open trial focused on feasibility and acceptability, these measurements offer initial insights into the program's potential impact on symptom outcomes in this specific, vulnerable population. The data contributes to understanding the initial effects of an integrated treatment adherence program, laying groundwork for future research.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03825640, titled "Project CARE: An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Open Trial", were posted on 2026-01-28 on clinicaltrials.gov.