- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04837573
Feasibility & Acceptability of a Virtual Sister Circle Intervention for Black Women With Depressive Symptoms
October 17, 2023 updated by: Kia Skrine Jeffers, PhD, RN, PHN
Evaluating the Feasibility and Acceptability of a Therapeutically-Grounded Virtual Sister Circle Intervention for Black Women With Depressive Symptoms
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- University of California, Los Angeles
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1 Intervention, Weeks 1-8
During Weeks 1-8, Group 1 receives the Intervention and Group 2 receives no treatment.
|
The intervention is an 8-week, therapeutically-informed protocol.
|
Active Comparator: Group 2 Intervention, Weeks 9-16
During Weeks 9-16, Group 2 receives the Intervention and Group 1 receives no treatment.
|
The intervention is an 8-week, therapeutically-informed protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment, completion, and retention rates of participants
Time Frame: 16 weeks
|
80 percent recruitment, 80 percent completion, and 75 percent retention
|
16 weeks
|
Assess Acceptability according to the Theoretical Framework of Acceptability
Time Frame: 16 weeks
|
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
Time Frame: baseline, 8 weeks, 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
Time Frame: baseline, 8 weeks, 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
Time Frame: baseline, 8 weeks, 16 weeks
|
Exploratory description of effect sizes
|
baseline, 8 weeks, 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kia Skrine Jeffers, PhD, RN, PHN, University of California, Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2022
Primary Completion (Actual)
April 2, 2023
Study Completion (Actual)
April 2, 2023
Study Registration Dates
First Submitted
March 29, 2021
First Submitted That Met QC Criteria
April 5, 2021
First Posted (Actual)
April 8, 2021
Study Record Updates
Last Update Posted (Actual)
October 19, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-002949
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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