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

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CARE
Treatment As Usual
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rhode Island Department of Corrections
  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Community treatment Adherence at Re-Entry (CARE)

Treatment As Usual (TAU)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Client Satisfaction Questionnaire-8 (CSQ-8)
Intervention feasibility and acceptability; Total satisfaction scores range from 8 (low) to 32 (high)

Secondary Outcome Measures

Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
depressive symptom severity; Total depressive symptom severity scores range from 0 (none) to 27 (very severe)
Altman Self-Rating Scale for Mania (ASRM)
manic symptom severity; Total manic symptom severity scores range from 0 (none) to 20 (severe)

Full Information

First Posted
February 12, 2020
Last Updated
February 8, 2023
Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04269772
Brief Title
Project CARE: An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Pilot RCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
August 10, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community treatment Adherence at Re-Entry (CARE)
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual (TAU)
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CARE
Intervention Description
Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.
Intervention Type
Other
Intervention Name(s)
Treatment As Usual
Intervention Description
Treatment as usual, unrestricted, as provided by prison and community providers.
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire-8 (CSQ-8)
Description
Intervention feasibility and acceptability; Total satisfaction scores range from 8 (low) to 32 (high)
Time Frame
24 weeks post-release
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
Description
depressive symptom severity; Total depressive symptom severity scores range from 0 (none) to 27 (very severe)
Time Frame
24 weeks post-release
Title
Altman Self-Rating Scale for Mania (ASRM)
Description
manic symptom severity; Total manic symptom severity scores range from 0 (none) to 20 (severe)
Time Frame
24 weeks post-release

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Weinstock, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Department of Corrections
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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