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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH122870 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrated Treatment Adherence Program (ITAP) | Experimental | A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization. |
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| Safety Assessment and Follow-up Evaluation (SAFE) | Active Comparator | Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated Treatment Adherence Program (ITAP) | Behavioral | Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning. |
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| Measure | Description | Time Frame |
|---|---|---|
| Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) | 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. | 6 months |
| Clinician-Administered Rating Scale for Mania (CARS-M) | 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. | 6 months |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon Gaudiano, PhD | Butler Hospital | Principal Investigator |
| Ivan Miller, PhD | Butler Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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| Safety Assessment and Follow-up Evaluation (SAFE) | Behavioral | Enhanced assessment and evaluation with clinician feedback. |
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