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

  • United States
    • 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.
Behavioral: Sister Circle protocol
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.
Behavioral: Sister Circle protocol
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

Kia Skrine Jeffers, PhD, RN, PHN

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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