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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04269772
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Brown University

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: CARE Other: Treatment As Usual 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 of 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 pilot randomized controlled trial (n=40) of the CARE intervention compared to treatment as usual for prisoners with BD around the time of community re-entry. 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., update, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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 - Pilot RCT
Actual Study Start Date : January 21, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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 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.

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.
Other: Treatment As Usual
Treatment as usual, unrestricted, as provided by prison and community providers.

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)

Information from the National Library of Medicine

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

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 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04269772

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Contact: Lauren Weinstock, PhD 401-455-6304
Contact: Hannah Graves, ScM 401-444-1953

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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   
Contact: Hannah Graves, ScM    401-444-1953   
Sponsors and Collaborators
Brown University
National Institute of Mental Health (NIMH)
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Principal Investigator: Lauren Weinstock, PhD Brown University
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Responsible Party: Brown University Identifier: NCT04269772    
Other Study ID Numbers: 1806002090-RCT
R34MH117198 ( U.S. NIH Grant/Contract )
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders