NCT03825640

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
6 years until next milestone

Results Posted

Study results publicly available

January 28, 2026

Completed
Last Updated

January 28, 2026

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

January 30, 2019

Results QC Date

December 8, 2025

Last Update Submit

January 12, 2026

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Client Satisfaction Questionnaire-8 (CSQ-8)

    Intervention feasibility and acceptability. Total Client Satisfaction Questionnaire-8 (CSQ-8) scores range from 8 to 32 with higher scores indicating higher levels of satisfaction.

    24 weeks post-release

Secondary Outcomes (2)

  • Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)

    24 weeks post-release

  • Altman Self-Rating Scale for Mania (ASRM)

    24 weeks post-release

Study Arms (1)

Community treatment Adherence at Re-Entry (CARE)

EXPERIMENTAL

CARE will begin within the 2 months before prison release, and will continue for 6 months after re-entry. CARE will be comprised of: a) 3 individual sessions with the CARE counselor; b) 1 optional family/significant other (SO) session; and c) 11 brief (15-20 min) follow-up telephone contacts with prisoners and their SO over the first 6 months post-release. The CARE intervention will incorporate motivational strategies from existing interventions (e.g., Acceptance and Commitment Therapy) in order to clarify values and goals to enhance motivation for community treatment engagement and behavior change. CARE will also integrate bipolar disorder psychoeducation and strategies from existing family models of intervention for BD (e.g., McMaster Model of Family Functioning) that are designed to improve family communication, social support, and problem-solving around BD illness management over this vulnerable transition period.

Behavioral: CARE

Interventions

CAREBEHAVIORAL

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

Community treatment Adherence at Re-Entry (CARE)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 within 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

You may not qualify if:

  • 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 sufficiently well to understand the consent form or assessment instruments when they are read aloud.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rhode Island Department of Corrections

Cranston, Rhode Island, 02920, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Results Point of Contact

Title
Dr. Lauren Weinstock
Organization
Brown University
Lauren_Weinstock@brown.edu
401-863-1147

Study Officials

  • Lauren Weinstock, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2019

First Posted

January 31, 2019

Study Start

January 14, 2019

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

January 28, 2026

Results First Posted

January 28, 2026

Record last verified: 2020-02

Locations

US(2)