Clincosm LogoSign in Get a demo

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

Sponsor
Kia Skrine Jeffers, PhD, RN, PHN (Other)
Overall Status
Recruiting
CT.gov ID
NCT04837573
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
15.9
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Sister Circle protocol
 N/A

Study Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Recruitment, completion, and retention rates of participants [16 weeks]

    80 percent recruitment, 80 percent completion, and 75 percent retention

  2. Assess Acceptability according to the Theoretical Framework of Acceptability [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 [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 [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 [baseline, 8 weeks, 16 weeks]

    Exploratory description of effect sizes

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of California, Los Angeles Los Angeles California United States 90095

Sponsors and Collaborators

  • Kia Skrine Jeffers, PhD, RN, PHN

Investigators

  • Principal Investigator: Kia Skrine Jeffers, PhD, RN, PHN, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Apr 8, 2021
Last Update Posted:
Jun 8, 2022
Last Verified:
Jun 1, 2022
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, Assistant Professor, University of California, Los Angeles
Sister Circle
Black Women
Additional relevant MeSH terms:
Depression

Study Results

No Results Posted as of Jun 8, 2022