Trial results for Project CARE, an integrated treatment adherence program for Bipolar Disorder, were posted on ClinicalTrials.gov on 2026-01-28, involving 34 participants.
Background
Bipolar Disorder is a chronic mental health condition characterized by significant mood swings. Effective management often relies on consistent treatment adherence, which can be particularly challenging for individuals transitioning from incarceration to the community. Project CARE was designed as an adjunctive intervention to support treatment adherence for this specific population, aiming to improve symptom outcomes during a critical re-entry period.
Trial design
This completed pilot randomized controlled feasibility trial, designated as Phase NA, enrolled 34 participants with Bipolar Disorder. The study aimed to establish the feasibility, acceptability, and preliminary effects of the Community Treatment Adherence at Re-Entry (CARE) program, an adjunctive intervention for incarcerated individuals with bipolar disorder transitioning from prison to the community. The intervention was compared against Treatment As Usual (TAU).
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):
- For the Community Treatment Adherence at Re-Entry (CARE) group, a mean score of 28.00 (Standard Deviation 6.57) was observed.
- For the Treatment As Usual (TAU) group, a mean score of 26.20 (Standard Deviation 5.16) was observed.
- Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) (score on a scale):
- For the Community Treatment Adherence at Re-Entry (CARE) group, a mean score of 7.38 (Standard Deviation 6.61) was observed.
- For the Treatment As Usual (TAU) group, a mean score of 7.64 (Standard Deviation 5.82) was observed.
- Altman Self-Rating Scale for Mania (ASRM) (score on a scale):
- For the Community Treatment Adherence at Re-Entry (CARE) group, a mean score of 1.13 (Standard Deviation 2.10) was observed.
- For the Treatment As Usual (TAU) group, a mean score of 1.82 (Standard Deviation 2.44) was observed.
What this means
The posted results provide preliminary data on client satisfaction and symptom outcomes for individuals with Bipolar Disorder transitioning from prison. The Project CARE intervention group showed a slightly higher mean client satisfaction score (28.00 vs. 26.20 for TAU) and slightly lower mean scores on both the Quick Inventory of Depressive Symptomatology - Self-Report (7.38 vs. 7.64 for TAU) and the Altman Self-Rating Scale for Mania (1.13 vs. 1.82 for TAU) compared to the Treatment As Usual group. As a pilot study, these findings contribute to understanding the feasibility and preliminary effects of such an integrated adherence program, laying groundwork for potential larger-scale investigations.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04269772, titled "Project CARE: An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Pilot RCT", were posted on 2026-01-28 on clinicaltrials.gov.