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

Part of paid clinical trials in Cranston, Rhode Island.

Sponsor
Brown University
Study ID
NCT04269772
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CARE — BEHAVIORAL
    Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.
  • Treatment As Usual — OTHER
    Treatment as usual, unrestricted, as provided by prison and community providers.

Study Details

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.

Key Dates

Start date
Jan 21, 2020
Status verified
Feb 2023
Primary completion
Aug 10, 2022
Completion
Nov 2, 2022

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Community treatment Adherence at Re-Entry (CARE)
    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 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.
  • Other: Treatment As Usual (TAU)
    Treatment As Usual (TAU) consists of unrestricted treatment provided by prison and community providers, as part of routine care in the criminal justice re-entry context. Study staff will provide no additional treatment in this arm.

Primary Outcome Measure

Client Satisfaction Questionnaire-8 (CSQ-8) [ Time Frame: 24 weeks post-release ]

Locations (2)

FacilityCityStateZIPSite coordinators
Rhode Island Department of CorrectionsCranstonRhode Island02920-
Brown UniversityProvidenceRhode Island02912-

Find similar trials in Cranston, RI

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
Rhode Island Department of Corrections· Cranston, RIBrown University· Providence, RI

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