Bipolar Disorder, Substance Use Disorders
Conditions
Brief summary
This trial aims to evaluate the effectiveness of a novel intervention for patients with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. Half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care.
Interventions
BEHAVIORALIntegrated Treatment Adherence Program (ITAP)
Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.
Enhanced assessment and evaluation with clinician feedback.
Sponsors
Butler Hospital
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * Diagnosis of a bipolar-spectrum disorder * Diagnosis of a substance use disorder * Taking at least one mood-stabilizing medication Exclusion: * Unable to speak and read English * Younger than age 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) | 6 months | 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. |
| Clinician-Administered Rating Scale for Mania (CARS-M) | 6 months | The 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrandon Gaudiano, PhD
Butler Hospital
PRINCIPAL_INVESTIGATORIvan Miller, PhD
Butler Hospital
Participant flow
Recruitment details
Between October 2020 and 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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38.2088 years STANDARD_DEVIATION 12.1532 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) | 19.5 total score STANDARD_DEVIATION 5.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 23 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 67 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 50 Participants |
| The Clinician-Administered Rating Scale for Mania (CARS-M) | 20.6 total score STANDARD_DEVIATION 9.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 91 | 1 / 85 |
| other Total, other adverse events | 0 / 91 | 0 / 85 |
| serious Total, serious adverse events | 67 / 91 | 77 / 85 |
Outcome results
None listed