Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04269772 |
| Other study ID # |
1806002090-RCT |
| Secondary ID |
R34MH117198 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 21, 2020 |
| Est. completion date |
November 2, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Brown University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
