Trial Outcomes & Findings for Project CARE: An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Pilot RCT (NCT NCT04269772)
NCT ID: NCT04269772
Last Updated: 2026-01-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
24 weeks post-release
Results posted on
2026-01-28
Participant Flow
Participant milestones
| Measure |
Community Treatment Adherence at Re-Entry (CARE)
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.
CARE: Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.
|
Treatment As Usual (TAU)
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.
Treatment As Usual: Treatment as usual, unrestricted, as provided by prison and community providers.
|
Significant Others (SOs)
Significant Others (SOs) are enrolled to support the participant in their study treatment (CARE). SOs only participate in family sessions and brief phone sessions (as described in the CARE arm). SO enrollment is optional.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
4
|
|
Overall Study
COMPLETED
|
14
|
15
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Project CARE: An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Pilot RCT
Baseline characteristics by cohort
| Measure |
Community Treatment Adherence at Re-Entry (CARE)
n=15 Participants
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.
CARE: Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.
|
Treatment As Usual (TAU)
n=15 Participants
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.
Treatment As Usual: Treatment as usual, unrestricted, as provided by prison and community providers.
|
Significant Others (SOs)
n=4 Participants
Significant Others (SOs) are enrolled to support the participant in their study treatment (CARE). SOs only participate in family sessions and brief phone sessions (as described in the CARE arm). SO enrollment is optional.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.07 years
STANDARD_DEVIATION 9.45 • n=158 Participants
|
37.00 years
STANDARD_DEVIATION 9.99 • n=157 Participants
|
44.25 years
STANDARD_DEVIATION 17.75 • n=315 Participants
|
37.44 years
STANDARD_DEVIATION 10.75 • n=153 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
4 Participants
n=315 Participants
|
14 Participants
n=153 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=158 Participants
|
10 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
20 Participants
n=153 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
5 Participants
n=153 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=158 Participants
|
14 Participants
n=157 Participants
|
3 Participants
n=315 Participants
|
29 Participants
n=153 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
2 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
1 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
5 Participants
n=153 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=158 Participants
|
10 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
19 Participants
n=153 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
4 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
3 Participants
n=153 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=158 Participants
|
15 participants
n=157 Participants
|
4 participants
n=315 Participants
|
34 participants
n=153 Participants
|
PRIMARY outcome
Timeframe: 24 weeks post-releasePopulation: Note: Out of the 14 participants that completed the study in the CARE arm, only 8 completed the CSQ-8 at the 24 week follow-up (6 did not complete it). Out of the 15 participants that completed the TAU arm, only 10 completed the CSQ-8 at the 24 week follow-up (5 did not complete it). Additionally, Outcome Measure data was not collected for SOs.
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.
Outcome measures
| Measure |
Community Treatment Adherence at Re-Entry (CARE)
n=8 Participants
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.
CARE: Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.
|
Treatment As Usual (TAU)
n=10 Participants
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.
Treatment As Usual: Treatment as usual, unrestricted, as provided by prison and community providers.
|
|---|---|---|
|
Client Satisfaction Questionnaire-8 (CSQ-8)
|
28.00 score on a scale
Standard Deviation 6.57
|
26.20 score on a scale
Standard Deviation 5.16
|
SECONDARY outcome
Timeframe: 24 weeks post-releasePopulation: Note: Out of the 14 participants that completed the study in the CARE arm, only 8 completed the QIDS-SR at the 24 week follow-up (6 did not complete it). Out of the 15 participants that completed the TAU arm, only 11 completed the QIDS-SR at the 24 week follow-up (4 did not complete it). Additionally, Outcome Measure data was not collected for SOs.
Depressive symptom severity. Total QIDS-SR depressive symptom severity scores range from 0 to 27 with higher scores indicating more severe depressive symptoms.
Outcome measures
| Measure |
Community Treatment Adherence at Re-Entry (CARE)
n=8 Participants
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.
CARE: Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.
|
Treatment As Usual (TAU)
n=11 Participants
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.
Treatment As Usual: Treatment as usual, unrestricted, as provided by prison and community providers.
|
|---|---|---|
|
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
|
7.38 score on a scale
Standard Deviation 6.61
|
7.64 score on a scale
Standard Deviation 5.82
|
SECONDARY outcome
Timeframe: 24 weeks post-releasePopulation: Note: Out of the 14 participants that completed the study in the CARE arm, only 8 completed the ASRM at the 24 week follow-up (6 did not complete it). Out of the 15 participants that completed the TAU arm, only 11 completed the ASRM at the 24 week follow-up (4 did not complete it). Additionally, Outcome Measure data was not collected for SOs.
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.
Outcome measures
| Measure |
Community Treatment Adherence at Re-Entry (CARE)
n=8 Participants
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.
CARE: Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.
|
Treatment As Usual (TAU)
n=11 Participants
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.
Treatment As Usual: Treatment as usual, unrestricted, as provided by prison and community providers.
|
|---|---|---|
|
Altman Self-Rating Scale for Mania (ASRM)
|
1.13 score on a scale
Standard Deviation 2.10
|
1.82 score on a scale
Standard Deviation 2.44
|
Adverse Events
Community Treatment Adherence at Re-Entry (CARE)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment As Usual (TAU)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Community Treatment Adherence at Re-Entry (CARE)
n=15 participants at risk
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.
CARE: Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.
|
Treatment As Usual (TAU)
n=15 participants at risk
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.
Treatment As Usual: Treatment as usual, unrestricted, as provided by prison and community providers.
|
|---|---|---|
|
Psychiatric disorders
Inpatient Hopsitalization
|
6.7%
1/15 • Number of events 1 • Assessed from consent through 24 weeks post-release, up to 38 weeks
Adverse Event data was only collected from the main study participants. It was not collected from SOs.
|
6.7%
1/15 • Number of events 1 • Assessed from consent through 24 weeks post-release, up to 38 weeks
Adverse Event data was only collected from the main study participants. It was not collected from SOs.
|
|
Psychiatric disorders
Suicide Attempt
|
6.7%
1/15 • Number of events 1 • Assessed from consent through 24 weeks post-release, up to 38 weeks
Adverse Event data was only collected from the main study participants. It was not collected from SOs.
|
0.00%
0/15 • Assessed from consent through 24 weeks post-release, up to 38 weeks
Adverse Event data was only collected from the main study participants. It was not collected from SOs.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place