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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04837573
Other study ID # 21-002949
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2022
Est. completion date April 2, 2023

Study information

Verified date October 2023
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 2, 2023
Est. primary completion date April 2, 2023
Accepts healthy volunteers No
Gender Female
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sister Circle protocol
The intervention is an 8-week, therapeutically-informed protocol.

Locations

Country Name City State
United States University of California, Los Angeles Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Kia Skrine Jeffers, PhD, RN, PHN

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment, completion, and retention rates of participants 80 percent recruitment, 80 percent completion, and 75 percent retention 16 weeks
Primary 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 Changes in Perceived Stress Scale (PSS) from baseline at 8 weeks and 16 weeks Exploratory description of effect sizes baseline, 8 weeks, 16 weeks
Secondary 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
Secondary 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
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