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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03825640
Enrollment
18
Registered
2019-01-31
Start date
2019-01-14
Completion date
2020-01-15
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

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.

Interventions

BEHAVIORALCARE

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

Sponsors

Brown University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 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.

Design outcomes

Primary

MeasureTime frameDescription
Client Satisfaction Questionnaire-8 (CSQ-8)24 weeks post-releaseIntervention feasibility and acceptability. Total Client Satisfaction Questionnaire-8 (CSQ-8) scores range from 8 to 32 with higher scores indicating higher levels of satisfaction.

Secondary

MeasureTime frameDescription
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)24 weeks post-releaseDepressive symptom severity. Total QIDS-SR depressive symptom severity scores range from 0 to 27 with higher scores indicating more severe depressive symptoms.
Altman Self-Rating Scale for Mania (ASRM)24 weeks post-releaseManic symptom severity. Total Altman Self-Rating Scale for Mania (ASRM) manic symptom severity scores range from 0 to 20 with higher scores indicating more severe symptoms of mania.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLauren Weinstock, PhD

Brown University

Baseline characteristics

Characteristic
Age, Continuous48.67 years
STANDARD_DEVIATION 17.18
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
12 Participants
Region of Enrollment
United States
18 participants
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
7 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 12
other
Total, other adverse events
0 / 12
serious
Total, serious adverse events
0 / 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026