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| ID | Type | Description | Link |
|---|---|---|---|
| P30-AG02168 | Other Grant/Funding Number | NIA | |
| UL1TR001881 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The purpose of this study is to evaluate the feasibility and acceptability of a protocol for middle- and older-aged Black women with depressive symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Intervention, Weeks 1-8 | Experimental | During Weeks 1-8, Group 1 receives the Intervention and Group 2 receives no treatment. |
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| Group 2 Intervention, Weeks 9-16 | Active Comparator | During Weeks 9-16, Group 2 receives the Intervention and Group 1 receives no treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sister Circle protocol | Behavioral | The intervention is an 8-week, therapeutically-informed protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Completion and Retention Rates of Participants as Measures of Feasibility | Completion: # of participants who attended 4+ sessions/ # participants available to attend 4+ sessions Retention: # retained/ # enrolled | 12 weeks |
| Number of Participants Who Reported Acceptability According to the Theoretical Framework of Acceptability | Qualitative assessment of Acceptability. The interview guide was organized according to the 7 constructs of the Theoretical Framework of Acceptability. Participants reported whether the intervention was an acceptable fit with their personal value of becoming more whole, and with their collective value of addressing their depressive symptoms and experiences in a trusted space. | 12 weeks |
| Proportion of Eligible Potential Participants That Enrolled in the Study, as a Measure of Feasibility | Recruitment: # enrolled/# eligible | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Psychological Flexibility (Baseline to 6 Weeks) | Changes in psychological flexibility scores from baseline to 6 weeks using the Acceptance and Action Questionnaire II (AAQ-II). Scores range from 7-49. Lower scores indicate greater psychological flexibility (better outcome). | Baseline to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Self-identified females
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| Name | Affiliation | Role |
|---|---|---|
| Kia Skrine Jeffers, PhD, RN, PHN | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Intervention, Weeks 1-6 | During Weeks 1-6, Group 1 receives the Intervention and Group 2 receives no treatment. Sister Circle protocol: The intervention is an 6-week, therapeutically-informed protocol. |
| FG001 | Group 2 Intervention, Weeks 7-12 | During Weeks 7-12, Group 2 receives the Intervention and Group 1 receives no treatment. Sister Circle protocol: The intervention is an 6-week, therapeutically-informed protocol. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Intervention, Weeks 1-6 | During Weeks 1-6, Group 1 receives the Intervention and Group 2 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol. |
| BG001 | Group 2 Intervention, Weeks 7-12 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Completion and Retention Rates of Participants as Measures of Feasibility | Completion: # of participants who attended 4+ sessions/ # participants available to attend 4+ sessions Retention: # retained/ # enrolled | Completion rates were calculated for participants who were able to meet during the time the sessions were held. Retention rates were calculated for all enrolled participants. | Posted | Number | percentage of participants | 12 weeks |
|
12 weeks
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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 | Group 1 Intervention, Weeks 1-6 | During Weeks 1-6, Group 1 receives the Intervention and Group 2 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carol M. Mangione, MD, MSHS | University of California, Los Angeles | 310-794-2298 | cmmagione@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 1, 2022 | May 31, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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During Weeks 7-12, Group 2 receives the Intervention and Group 1 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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During Weeks 7-12, Group 2 receives the Intervention and Group 1 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol. |
|
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| Primary | Number of Participants Who Reported Acceptability According to the Theoretical Framework of Acceptability | Qualitative assessment of Acceptability. The interview guide was organized according to the 7 constructs of the Theoretical Framework of Acceptability. Participants reported whether the intervention was an acceptable fit with their personal value of becoming more whole, and with their collective value of addressing their depressive symptoms and experiences in a trusted space. | 15 women participated in their respective focus groups during Weeks 6 and 12. The remaining 7 participants who completed the intervention did not attend, therefore their qualitative "acceptability" data could not be collected or analyzed. | Posted | Count of Participants | Participants | 12 weeks |
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| Primary | Proportion of Eligible Potential Participants That Enrolled in the Study, as a Measure of Feasibility | Recruitment: # enrolled/# eligible | Individuals who completed the eligibility determination form and were eligible to participate | Posted | Number | percentage of potential participants | 6 weeks |
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|
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| Secondary | Changes in Psychological Flexibility (Baseline to 6 Weeks) | Changes in psychological flexibility scores from baseline to 6 weeks using the Acceptance and Action Questionnaire II (AAQ-II). Scores range from 7-49. Lower scores indicate greater psychological flexibility (better outcome). | Participants who completed baseline and Week 6 surveys were included in this analysis. At Week 6, Group 1 has completed the intervention, and Group 2 has not yet participated in the intervention period. | Posted | Mean | Full Range | score on a scale | Baseline to 6 weeks |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Group 2 Intervention, Weeks 7-12 | During Weeks 7-12, Group 2 receives the Intervention and Group 1 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol. | 0 | 15 | 0 | 15 | 0 | 15 |
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