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
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

March 29, 2021

Last Update Submit

October 17, 2023

Conditions

Keywords

Sister CircleBlack Women

Outcome Measures

Primary Outcomes (2)

  • Recruitment, completion, and retention rates of participants

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

    16 weeks

  • 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 Outcomes (3)

  • Changes in Perceived Stress Scale (PSS) from baseline at 8 weeks and 16 weeks

    baseline, 8 weeks, 16 weeks

  • Changes in Positive and Negative Affect Schedule (PANAS) Scale from baseline at 8 weeks and 16 weeks

    baseline, 8 weeks, 16 weeks

  • Changes in Acceptance and Action Questionnaire II (AAQ-II) from baseline at 8 weeks and 16 weeks

    baseline, 8 weeks, 16 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

Study Officials

  • Kia Skrine Jeffers, PhD, RN, PHN

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

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

October 19, 2023

Record last verified: 2023-10

Locations