N/A
Completed N=34
Project CARE: An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Pilot RCT
Source: ClinicalTrials.gov NCT04269772 ↗Enrolled (actual)
34
Serious AEs
10.0%
Results posted
Jan 2026
Primary outcomePrimary: Client Satisfaction Questionnaire-8 (CSQ-8) — 28.00; 26.20 score on a scale
Summary
The aim of this program of research is to develop and pilot the CARE (Community treatment Adherence at Re-Entry) program, an adjunctive intervention for incarcerated individuals with bipolar disorder (BD) transitioning from prison to the community.
The purpose of this proposed project is to establish the feasibility, acceptability, and preliminary effects of this newly developed intervention on symptom outcomes in a small pilot randomized controlled feasibility trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Client Satisfaction Questionnaire-8 (CSQ-8) |
28.00; 26.20 | — |
| SECONDARY Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) |
7.38; 7.64 | — |
| SECONDARY Altman Self-Rating Scale for Mania (ASRM) |
1.13; 1.82 | — |
Eligibility Criteria
Inclusion Criteria
- DSM-5 diagnosis of bipolar I, bipolar II, or bipolar disorder not elsewhere classified
- Anticipated prison release within 4-10 weeks
- Expected release to locations anywhere in RI or to locations in other states within a 30 mile radius of Providence
- Aged 18 or older
- Willingness to sign an informed consent document that describes study procedures
Exclusion Criteria
- Presence of current psychiatric symptoms severe enough to warrant separation from the general prison population
- Cognitive impairment sufficient to prevent successful completion of the baseline interview
- Inability to understand English sufficiently well to understand the consent form or assessment instruments when they are read aloud
Data sourced from ClinicalTrials.gov (NCT04269772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.