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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04837573
Recruitment Status : Not yet recruiting
First Posted : April 8, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Kia Skrine Jeffers, PhD, RN, PHN, University of California, Los Angeles

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Depression Behavioral: Sister Circle protocol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Feasibility and Acceptability of a Therapeutically-Grounded Virtual Sister Circle Intervention for Black Women With Depressive Symptoms
Estimated Study Start Date : October 15, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment, completion, and retention rates of participants [ Time Frame: 16 weeks ]
    80 percent recruitment, 80 percent completion, and 75 percent retention

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identified females
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837573


Contacts
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Contact: Kia Skrine Jeffers, PhD, RN, PHN 310-267-0483 kiajeffers@ucla.edu

Sponsors and Collaborators
Kia Skrine Jeffers, PhD, RN, PHN
Investigators
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Principal Investigator: Kia Skrine Jeffers, PhD, RN, PHN University of California, Los Angeles
More Information
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Responsible Party: Kia Skrine Jeffers, PhD, RN, PHN, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04837573    
Other Study ID Numbers: 21-002949
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kia Skrine Jeffers, PhD, RN, PHN, University of California, Los Angeles:
Sister Circle
Black Women
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms