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

• ClinicalTrials.gov Identifier: NCT03825640
• Recruitment Status: Recruiting
• First Posted: January 31, 2019
• Last Update Posted: February 1, 2019
• Sponsor: Brown University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Brown University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bipolar Disorder	Behavioral: CARE	Not Applicable

Detailed Description:

Bipolar disorder (BD) is a serious, disabling, and highly recurrent illness that is disproportionately represented in the criminal justice system. BD increases risk for several adverse outcomes for prisoners, including mood instability, suicide attempts, substance use relapse, and high rates of repeat incarceration. Despite these serious negative consequences, up to 70% of prisoners with BD do not receive mental health treatment upon prison release. Lack of engagement in ongoing mental health treatment for BD upon community re-entry represents one potent factor that perpetuates risk for adverse outcomes, and consequences of untreated BD (e.g., impulsivity, substance use) may greatly exacerbate difficulties in establishing stable living conditions (e.g., adequate housing, legal employment) at community re-entry. Thus, there is a critical need for interventions to facilitate engagement with treatment for BD during this vulnerable transition.

To that end, the primary aim of this study is to develop and establish the feasibility and acceptability of the Community treatment Adherence at Re-Entry (CARE) program. CARE is an innovative intervention that will combine evidence-based cognitive-behavioral, family, and telephone outreach strategies to promote treatment engagement and improve clinical outcomes for prisoners with BD during the period of community re-entry. CARE will include 3 individual and 1 family session, followed by 11 brief telephone contacts for up to 6 months post-release. Given its moderate intensity, adjunctive nature, use of community mental health counselors, and use of telephone administration for post-release follow-up, CARE has been designed with an eye toward community implementation. Its proposed mechanisms of action (i.e., increasing values-action consistency, enhancing social supports, and linkage to community treatment services) are further well matched to the practical and clinical needs of re-entering individuals.

The aim of this research is to conduct a small open trial (n=12) of the CARE intervention. Assessments will occur at baseline, immediately pre-release, 4 weeks post-release, and 24 weeks post-release (post-treatment). This study will examine the feasibility and acceptability of CARE (e.g., uptake, adherence to, and completion of the CARE intervention, satisfaction with the intervention, understanding of intervention principles) and of this research design. This study will also examine treatment effects (within relevant confidence intervals) on outcomes (e.g., mood symptoms). Change in potential mechanisms (i.e., values-action consistency derived from intervention principles) will be examined.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 12 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Project CARE (Community Treatment Adherence at Re-Entry): An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Open Trial
• Actual Study Start Date: January 14, 2019
• Estimated Primary Completion Date: January 2020
• Estimated Study Completion Date: August 2021

Arms and Interventions

Arm

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. Client Satisfaction Questionnaire-8 (CSQ-8) [ Time Frame: 24 weeks post-release ]
   Intervention feasibility and acceptability; Total satisfaction scores range from 8 (low) to 32 (high)

Secondary Outcome Measures :

1. Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) [ Time Frame: 24 weeks post-release ]
   depressive symptom severity; Total depressive symptom severity scores range from 0 (none) to 27 (very severe)
2. Altman Self-Rating Scale for Mania (ASRM) [ Time Frame: 24 weeks post-release ]
   manic symptom severity; Total manic symptom severity scores range from 0 (none) to 20 (severe)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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

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

Contacts and Locations

Contacts

Contact: Lauren Weinstock, PhD; 401-455-6304; Lauren_Weinstock@brown.edu

Contact: Hannah Graves, ScM; 401-444-1953; Hannah_Graves@brown.edu

Locations

United States, Rhode Island

Rhode Island Department of Corrections; Recruiting

Cranston, Rhode Island, United States, 02920

Contact: Jeff Renzi

Brown University; Recruiting

Providence, Rhode Island, United States, 02912

Contact: Lauren Weinstock, PhD 401-455-6304 Lauren_Weinstock@brown.edu

Contact: Hannah Graves, ScM 401-444-1953 Hannah_Graves@brown.edu

Sponsors and Collaborators

Brown University

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Lauren Weinstock, PhD; Brown University

More Information

• Responsible Party: Brown University
• ClinicalTrials.gov Identifier: NCT03825640
• Other Study ID Numbers: 1806002090; R34MH117198 ( U.S. NIH Grant/Contract )
• First Posted: January 31, 2019
• Last Update Posted: February 1, 2019
• Last Verified: January 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Bipolar Disorder; Bipolar and Related Disorders; Mental Disorders