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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03825640
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Brown University

Tracking Information
First Submitted Date  ICMJE January 30, 2019
First Posted Date  ICMJE January 31, 2019
Last Update Posted Date February 13, 2020
Actual Study Start Date  ICMJE January 14, 2019
Actual Primary Completion Date January 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
Client Satisfaction Questionnaire-8 (CSQ-8) [ Time Frame: 24 weeks post-release ]
Intervention feasibility and acceptability
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) [ Time Frame: 24 weeks post-release ]
    depressive symptom severity
  • Altman Self-Rating Scale for Mania (ASRM) [ Time Frame: 24 weeks post-release ]
    manic symptom severity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project CARE: An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Open Trial
Official Title  ICMJE Project CARE (Community Treatment Adherence at Re-Entry): An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Open Trial
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE Behavioral: CARE
Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.
Study Arms  ICMJE 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.

Intervention: Behavioral: CARE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 15, 2020
Actual Primary Completion Date January 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03825640
Other Study ID Numbers  ICMJE 1806002090
R34MH117198 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Lauren Weinstock, PhD Brown University
PRS Account Brown University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP