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

NCT04269772 | Completed Results DMC

• 2 other identifiers: 1806002090-RCTR34MH117198
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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 in a small pilot randomized controlled feasibility trial.

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 (2)

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 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

Treatment As Usual (TAU)

OTHER

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.

Other: Treatment As Usual

Interventions

CARE BEHAVIORAL

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)

Treatment As Usual OTHER

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

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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

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

Sponsors & Collaborators

• Brown University: lead
• National Institute of Mental Health (NIMH): collaborator

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

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Limitations and Caveats

Recruitment began 01/20/20 but was paused 03/12/20 due to COVID-related prison lockdowns. In consultation w/ RIDOC admin and Brown University IRB, an additional recruitment method was approved in which the prison provided referrals of individuals just released from prison, for approach by phone for post-release study enrollment; referral-based recruitment began 10/05/20.The study received permission to resume in-person recruitment in the prison on 09/18/21, per the original recruitment protocol.

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: January 21, 2020
• Primary Completion: August 10, 2022
• Study Completion: November 2, 2022
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2023-02

Locations

US (2)