Trial Outcomes & Findings for Project CARE: An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Open Trial (NCT NCT03825640)
NCT ID: NCT03825640
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
18 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 family 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.
|
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
|
12
|
6
|
|
Overall Study
COMPLETED
|
11
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
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 - Open Trial
Baseline characteristics by cohort
| Measure |
Community Treatment Adherence at Re-Entry (CARE)
n=12 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 family 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.
|
Significant Others (SOs)
n=6 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=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.08 years
STANDARD_DEVIATION 11.33 • n=158 Participants
|
48.67 years
STANDARD_DEVIATION 17.18 • n=157 Participants
|
39.97 years
STANDARD_DEVIATION 12.71 • n=315 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=158 Participants
|
4 Participants
n=157 Participants
|
9 Participants
n=315 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
9 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=158 Participants
|
6 Participants
n=157 Participants
|
17 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=158 Participants
|
4 Participants
n=157 Participants
|
12 Participants
n=315 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=158 Participants
|
6 participants
n=157 Participants
|
18 participants
n=315 Participants
|
PRIMARY outcome
Timeframe: 24 weeks post-releasePopulation: Note: 11 of the 12 participants completed the intervention, but one of those individuals was lost to follow-up at the final assessment. Therefore, the total number of participants analyzed is 10. 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=10 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 family 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.
|
|---|---|
|
Client Satisfaction Questionnaire-8 (CSQ-8)
|
27.90 score on a scale
Standard Deviation 3.07
|
SECONDARY outcome
Timeframe: 24 weeks post-releasePopulation: Note: 11 of the 12 participants completed the intervention, but one of those individuals was lost to follow-up at the final assessment. Therefore, the total number of participants analyzed is 10. 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=10 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 family 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.
|
|---|---|
|
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
|
10.90 score on a scale
Standard Deviation 5.53
|
SECONDARY outcome
Timeframe: 24 weeks post-releasePopulation: Note: 11 of the 12 participants completed the intervention, but one of those individuals was lost to follow-up at the final assessment. Therefore, the total number of participants analyzed is 10. 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=10 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 family 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.
|
|---|---|
|
Altman Self-Rating Scale for Mania (ASRM)
|
3.30 score on a scale
Standard Deviation 4.76
|
Adverse Events
Community Treatment Adherence at Re-Entry (CARE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place