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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH121220 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Determine if depression, which persists after depression treatment at 26 weeks, is associated with increased innate inflammation in a prospective cohort of HIV-infected Ugandans receiving SSRIs in which group psychotherapy is initiated.
Depression in HIV is a complex co-morbidity with both social factors such as stigma as well as biologic components. Disruptions in neurotransmitters such as serotonin and catecholamines are known to cause depression. Inflammation caused by diseases such as stroke, diabetes, and HIV is associated with higher rates of depression. HIV causes inflammation throughout the body, but since the virus can cross the blood-brain-barrier, HIV can replicate in and target the brain causing neuroinflammation which predisposes depression. However the pathophysiology of the role of inflammation in comorbid depression and HIV is poorly understood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | The first 100 participants with HIV and depression will receive standard of care including SSRI therapy. |
|
| Standard of Care + Group Support Psychotherapy | Experimental | The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy. |
|
| Standard of Care (Non-Depressed) | Active Comparator | 100 participants with HIV and without depression will receive standard of care therapy for HIV and no depression treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Pyschotherapy | Behavioral | Group psychotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Health Questionnaire (PHQ)-9 | The Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity. a score of 0-27 is possible. We aren't reporting subscales. A score of 5+ will screen positive for mild depression, and a score of 10+ is considered a positive to screen for moderate-severe depression. change between baseline and 3 months | 3 months |
| Change in Patient Health Questionnaire (PHQ)-9 | The Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity. a score of 0-27 is possible. We aren't reporting subscales. A score of 5+ will screen positive for mild depression, and a score of 10+ is considered a positive to screen for moderate-severe depression. change between baseline and 6 months | 6 months |
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Inclusion Criteria:
For the depressed patient arm,
For the non-depressed patient arm,
Exclusion Criteria:
- No additional exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Lofgren, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Diseases Institute | Kampala | Uganda |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | The first 100 participants with HIV and depression will receive standard of care including SSRI therapy. Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs). HIV Standard of Care: Standard clinical care for HIV |
| FG001 | Standard of Care + Group Support Psychotherapy | The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy. Group Pyschotherapy: Group psychotherapy Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs). HIV Standard of Care: Standard clinical care for HIV |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | The first 100 participants with HIV and depression will receive standard of care including SSRI therapy. Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs). HIV Standard of Care: Standard clinical care for HIV |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Patient Health Questionnaire (PHQ)-9 | The Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity. a score of 0-27 is possible. We aren't reporting subscales. A score of 5+ will screen positive for mild depression, and a score of 10+ is considered a positive to screen for moderate-severe depression. change between baseline and 3 months | Posted | Mean | Inter-Quartile Range | units on a scale | 3 months |
|
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Adverse events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | The first 100 participants with HIV and depression will receive standard of care including SSRI therapy. Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs). HIV Standard of Care: Standard clinical care for HIV |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Lofgren | University of Minnesota | 612-624-9996 | Lofg0020@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2019 | Dec 9, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 27, 2020 | Dec 9, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Depression Standard of Care |
| Other |
Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs). |
|
| HIV Standard of Care | Other | Standard clinical care for HIV |
|
| Standard of Care + Group Support Psychotherapy |
The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy. Group Pyschotherapy: Group psychotherapy Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs). HIV Standard of Care: Standard clinical care for HIV |
| BG002 | Total | Total of all reporting groups |
| YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Standard of Care + Group Support Psychotherapy | The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy. Group Pyschotherapy: Group psychotherapy Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs). HIV Standard of Care: Standard clinical care for HIV |
|
|
| Primary | Change in Patient Health Questionnaire (PHQ)-9 | The Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity. a score of 0-27 is possible. We aren't reporting subscales. A score of 5+ will screen positive for mild depression, and a score of 10+ is considered a positive to screen for moderate-severe depression. change between baseline and 6 months | Posted | Mean | Inter-Quartile Range | units on a scale | 6 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard of Care + Group Support Psychotherapy | The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy. Group Pyschotherapy: Group psychotherapy Depression Standard of Care: Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs). HIV Standard of Care: Standard clinical care for HIV | 0 | 0 | 0 | 0 | 0 | 0 |
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