CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
CARE +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 5
  • DSM-5 diagnosis of bipolar I, bipolar II, or bipolar disorder not elsewhere classified
  • Anticipated prison release within 4-10 weeks
  • Expected release to Rhode Island or locations within 30 miles of Providence in other states
  • Age 18 or older
Key exclusion· 3
  • Current psychiatric symptoms severe enough to warrant separation from general prison population
  • Cognitive impairment preventing successful completion of baseline interview
  • Insufficient English proficiency to understand consent form or assessment instruments

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04269772
NCT04269772N/ACompleted

Project CARE (Community Treatment Adherence at Re-Entry): An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Pilot RCT

Brown University·interventional·Posted Feb 17, 2020·Updated Jan 28, 2026

In Brief

A clinical study evaluating CARE and Treatment As Usual for Bipolar Disorder. Completed, enrolled 34 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 17, 2020
Enrollment StartJan 21, 2020
Primary CompletionAug 10, 2022
Study CompletionNov 2, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.4 years ago

Interventions

CAREbehavioral

Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.

Treatment As Usualother

Treatment as usual, unrestricted, as provided by prison and community providers.