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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-2019-027 | Other Identifier | Providence VA Medical Center |
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| Name | Class |
|---|---|
| Providence VA Medical Center | FED |
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This trial aims to evaluate the effectiveness of a novel intervention for Veterans 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.
This randomized controlled trial will evaluate the effectiveness of a psychosocial intervention designed to improve treatment adherence in Veterans with comorbid bipolar disorder and substance use disorders (BP-SUD) following a psychiatric hospitalization. Participants will be randomized to either the specialized psychosocial intervention or an enhanced safety monitoring program, both as adjuncts to VA treatment as usual. Veterans with BP-SUD will be recruited from the Providence VAMC inpatient psychiatric unit and assessed at baseline and at 3 (mid-treatment), 6 (post-treatment), and 9-month post-discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrated Treatment Adherence Program for Veterans (ITAP-VA) | 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 for Veterans (ITAP-VA) | Behavioral | Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning. |
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| Measure | Description | Time Frame |
|---|---|---|
| Brief Adherence Rating Scale (BARS) | The Brief Adherence Rating Scale (BARS) assesses the percentage of missed medication doses over the past month. The total adherence score ranges from 0% to 100% and higher scores indicate greater adherence. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Metrik, PhD | Providence VA Medical Center, Providence, RI | Principal Investigator |
| Brandon A Gaudiano, PhD | Providence VA Medical Center, Providence, RI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence VA Medical Center, Providence, RI | Providence | Rhode Island | 02908-4734 | United States |
After all data have been collected and the results of the studies published, de-identified data will be made available to other qualified researchers on request. The request will be evaluated by the PI and the Co-Investigators to ensure that it meets reasonable standards of scientific integrity.
After all data have been collected and the results of the studies published, de-identified data will be made available to other qualified researchers on request.
The request will be evaluated by the PI and the Co-Investigators to ensure that it meets reasonable standards of scientific integrity.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 4, 2024 | Oct 16, 2025 |
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| Safety Assessment and Follow-up Evaluation (SAFE) | Behavioral | Measurement-based care assessment and evaluation. |
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| ICF_000.pdf |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D019966 | Substance-Related Disorders |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
| D015438 | Health Behavior |
| D001519 | Behavior |
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