Bipolar DisorderNCT04269772
Project CARE: An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Pilot RCT
A study testing CARE and Treatment As Usual in people with Bipolar Disorder, run by Brown University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- CARE and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jan 2020to 2 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rhode Island Department of Corrections
Cranston, Rhode Island, 02920
Brown University
Providence, Rhode Island, 02912
About this study
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
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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- CARE, Treatment As Usual
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAREBehavioural
Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.
Treatment As UsualOther
Treatment as usual, unrestricted, as provided by prison and community providers.
| Study group | Role | What they receive |
|---|---|---|
| Community treatment Adherence at Re-Entry (CARE) | Experimental | 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. Receives: Behavioral: CARE |
| Treatment As Usual (TAU) | Other | 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. Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire-8 (CSQ-8)
Intervention feasibility and acceptability. Total Client Satisfaction Questionnaire-8 (CSQ-8) scores range from 8 to 32 with higher scores indicating higher levels of satisfaction.
Measured: 24 weeks post-release
Secondary outcomes (2)
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
Depressive symptom severity. Total QIDS-SR depressive symptom severity scores range from 0 to 27 with higher scores indicating more severe depressive symptoms.
Measured: 24 weeks post-release
Altman Self-Rating Scale for Mania (ASRM)
Manic 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.
Measured: 24 weeks post-release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start21 Jan 2020
- Primary completion10 Aug 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Lauren Weinstock, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269772
- Sponsor's protocol ID
- 1806002090-RCT
- Other IDs
- R34MH117198
- Status last verified
- Feb 2023
- First submitted
- 12 Feb 2020
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04269772
- Acronym / sponsor ID
- 1806002090-RCT
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community treatment Adherence at Re-Entry (CARE) | Experimental | Behavioral: CARECARE 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) | Other | Other: Treatment As UsualTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAREHybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community. | Behavioural | Community treatment Adherence at Re-Entry (CARE) |
| Treatment As UsualTreatment as usual, unrestricted, as provided by prison and community providers. | Other | Treatment As Usual (TAU) |
Primary outcome
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: 24 weeks post-release
Intervention feasibility and acceptability. Total Client Satisfaction Questionnaire-8 (CSQ-8) scores range from 8 to 32 with higher scores indicating higher levels of satisfaction.
2 secondary outcomes
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
Time frame: 24 weeks post-release
Altman Self-Rating Scale for Mania (ASRM)
Time frame: 24 weeks post-release
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Weinstock, PhD principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARE and Treatment As Usual in people with Bipolar Disorder, run by Brown University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire-8 (CSQ-8) (time frame: 24 weeks post-release). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.