Trial Outcomes & Findings for Intervention for Comorbid Substance Use and Bipolar Disorders (NCT NCT04202393)
NCT ID: NCT04202393
Last Updated: 2026-08-13
Results Overview
The Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) assesses depressive symptom severity. Total scores range from 0 to 27 and higher scores indicated higher symptom severity.
COMPLETED
NA
178 participants
6 months
2026-08-13
Participant Flow
Between February 2020 November 2024, chart screens were completed for inpatient and partial hospital admissions at a local psychiatric hospital. Based on initial eligibility criteria, patients were approached on the units. Study staff described the study and, if the patient was interested, completed an informed consent process.
After consent, participants completed a baseline assessment to confirm eligibility before random assignment. Two participants who were randomly assigned were not included in the data because they were randomized in error and were subsequently determined not to be eligible to participate. It was discovered that one had previously participated in a study with a similar intervention and another had previously participated in this study. The final intent-to-treat sample was 176.
Participant milestones
| Measure |
Integrated Treatment Adherence Program (ITAP)
A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
|
Safety Assessment and Follow-up Evaluation (SAFE)
Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
85
|
|
Overall Study
COMPLETED
|
47
|
45
|
|
Overall Study
NOT COMPLETED
|
44
|
40
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intervention for Comorbid Substance Use and Bipolar Disorders
Baseline characteristics by cohort
| Measure |
Integrated Treatment Adherence Program (ITAP)
n=91 Participants
A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
|
Safety Assessment and Follow-up Evaluation (SAFE)
n=85 Participants
Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.2088 years
STANDARD_DEVIATION 12.15320 • n=1 Participants
|
39.4 years
STANDARD_DEVIATION 10.86519 • n=1 Participants
|
38.7841 years
STANDARD_DEVIATION 11.53177 • n=1 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=1 Participants
|
38 Participants
n=1 Participants
|
79 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=1 Participants
|
47 Participants
n=1 Participants
|
97 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
4 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
10 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=1 Participants
|
64 Participants
n=1 Participants
|
131 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=1 Participants
|
12 Participants
n=1 Participants
|
23 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=1 Participants
|
8 Participants
n=1 Participants
|
21 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=1 Participants
|
77 Participants
n=1 Participants
|
154 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
|
19.0 total score
STANDARD_DEVIATION 5.8 • n=1 Participants
|
20.2 total score
STANDARD_DEVIATION 5.3 • n=1 Participants
|
19.5 total score
STANDARD_DEVIATION 5.6 • n=1 Participants
|
|
The Clinician-Administered Rating Scale for Mania (CARS-M)
|
20.9 total score
STANDARD_DEVIATION 9.8 • n=1 Participants
|
20.2 total score
STANDARD_DEVIATION 10.1 • n=1 Participants
|
20.6 total score
STANDARD_DEVIATION 9.9 • n=1 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) assesses depressive symptom severity. Total scores range from 0 to 27 and higher scores indicated higher symptom severity.
Outcome measures
| Measure |
Integrated Treatment Adherence Program (ITAP)
n=62 Participants
A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
|
Safety Assessment and Follow-up Evaluation (SAFE)
n=59 Participants
Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
|
|---|---|---|
|
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
|
11.35 total score
Standard Deviation 6.22
|
13.35 total score
Standard Deviation 7.19
|
PRIMARY outcome
Timeframe: 6 monthsThe Clinician-Administered Rating Scale for Mania (CARS-M) assesses mania symptom severity. Total scores range from 0 to 50 and higher scores indicated higher symptom severity.
Outcome measures
| Measure |
Integrated Treatment Adherence Program (ITAP)
n=62 Participants
A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
|
Safety Assessment and Follow-up Evaluation (SAFE)
n=59 Participants
Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
|
|---|---|---|
|
Clinician-Administered Rating Scale for Mania (CARS-M)
|
8.30 total score
Standard Deviation 8.15
|
10.38 total score
Standard Deviation 9.22
|
Adverse Events
Integrated Treatment Adherence Program (ITAP)
Safety Assessment and Follow-up Evaluation (SAFE)
Serious adverse events
| Measure |
Integrated Treatment Adherence Program (ITAP)
n=91 participants at risk
A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization.
|
Safety Assessment and Follow-up Evaluation (SAFE)
n=85 participants at risk
Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization.
|
|---|---|---|
|
Social circumstances
Rehospitalization
|
48.4%
44/91 • from enrollment until end of follow-up, up to 9 months
|
55.3%
47/85 • from enrollment until end of follow-up, up to 9 months
|
|
Social circumstances
Suicide Attempt
|
16.5%
15/91 • from enrollment until end of follow-up, up to 9 months
|
23.5%
20/85 • from enrollment until end of follow-up, up to 9 months
|
|
General disorders
Unintentional Overdose
|
5.5%
5/91 • from enrollment until end of follow-up, up to 9 months
|
10.6%
9/85 • from enrollment until end of follow-up, up to 9 months
|
|
Social circumstances
Incarceration
|
3.3%
3/91 • from enrollment until end of follow-up, up to 9 months
|
1.2%
1/85 • from enrollment until end of follow-up, up to 9 months
|
Other adverse events
Adverse event data not reported
Additional Information
Brandon Gaudiano, Research Psychologist
Butler Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place