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

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.

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.