Feasibility & Acceptability of a Virtual Sister Circle Intervention for Black Women With Depressive Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating the Feasibility and Acceptability of a Therapeutically-Grounded Virtual Sister Circle Intervention for Black Women With Depressive Symptoms

Conditions
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Depressive Symptoms, Depression

Intervention / Treatment
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* Behavioral: Sister Circle protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Identify as Black or African American Identify as female Age 40 years and older Community-dwelling Self-report of experiencing depressive symptoms Ability to commit to the 8-week intervention Access to Zoom Speak and read English Exclusion Criteria: Have a diagnosis of bipolar, but is not taking medication for the condition Experiencing psychosis

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 Intervention, Weeks 1-8<br>During Weeks 1-8, Group 1 receives the Intervention and Group 2 receives no treatment. | Behavioral: Sister Circle protocol<br>* The intervention is an 8-week, therapeutically-informed protocol.<br>|
| Active Comparator: Group 2 Intervention, Weeks 9-16<br>During Weeks 9-16, Group 2 receives the Intervention and Group 1 receives no treatment. | Behavioral: Sister Circle protocol<br>* The intervention is an 8-week, therapeutically-informed protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment, completion, and retention rates of participants | 80 percent recruitment, 80 percent completion, and 75 percent retention | 16 weeks | 
| Assess Acceptability according to the Theoretical Framework of Acceptability | Qualitative assessment of Acceptability. The interview guide will be organized according to the constructs of the Theoretical Framework of Acceptability. Methodological conventions of qualitative description will be used to analyze the data. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Perceived Stress Scale (PSS) from baseline at 8 weeks and 16 weeks | Exploratory description of effect sizes | baseline, 8 weeks, 16 weeks | 
| Changes in Positive and Negative Affect Schedule (PANAS) Scale from baseline at 8 weeks and 16 weeks | Exploratory description of effect sizes | baseline, 8 weeks, 16 weeks | 
| Changes in Acceptance and Action Questionnaire II (AAQ-II) from baseline at 8 weeks and 16 weeks | Exploratory description of effect sizes | baseline, 8 weeks, 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sister Circle, Black Women