NCT04837573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 14, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2023

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

June 5, 2026

Completed
Last Updated

June 5, 2026

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

March 29, 2021

Results QC Date

May 31, 2024

Last Update Submit

May 11, 2026

Conditions

Keywords

Sister CircleBlack Women

Outcome Measures

Primary Outcomes (3)

  • Completion and Retention Rates of Participants as Measures of Feasibility

    Completion: # of participants who attended 4+ sessions/ # participants available to attend 4+ sessions Retention: # retained/ # enrolled

    12 weeks

  • Number of Participants Who Reported Acceptability According to the Theoretical Framework of Acceptability

    Qualitative assessment of Acceptability. The interview guide was organized according to the 7 constructs of the Theoretical Framework of Acceptability. Participants reported whether the intervention was an acceptable fit with their personal value of becoming more whole, and with their collective value of addressing their depressive symptoms and experiences in a trusted space.

    12 weeks

  • Proportion of Eligible Potential Participants That Enrolled in the Study, as a Measure of Feasibility

    Recruitment: # enrolled/# eligible

    6 weeks

Secondary Outcomes (1)

  • Changes in Psychological Flexibility (Baseline to 6 Weeks)

    Baseline to 6 weeks

Study Arms (2)

Group 1 Intervention, Weeks 1-8

EXPERIMENTAL

During Weeks 1-8, Group 1 receives the Intervention and Group 2 receives no treatment.

Behavioral: Sister Circle protocol

Group 2 Intervention, Weeks 9-16

ACTIVE COMPARATOR

During Weeks 9-16, Group 2 receives the Intervention and Group 1 receives no treatment.

Behavioral: Sister Circle protocol

Interventions

The intervention is an 8-week, therapeutically-informed protocol.

Group 1 Intervention, Weeks 1-8Group 2 Intervention, Weeks 9-16

Eligibility Criteria

Age40 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identified females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Have a diagnosis of bipolar, but is not taking medication for the condition
  • Experiencing psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Carol M. Mangione, MD, MSHS
Organization
University of California, Los Angeles

Study Officials

  • Kia Skrine Jeffers, PhD, RN, PHN

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 8, 2021

Study Start

September 14, 2022

Primary Completion

April 2, 2023

Study Completion

April 2, 2023

Last Updated

June 5, 2026

Results First Posted

June 5, 2026

Record last verified: 2024-05

Locations