Depressive SymptomsNCT04837573

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

A study testing Sister Circle protocol in people with Depressive Symptoms and Depression, run by Kia Skrine Jeffers, PhD, RN, PHN at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and older, women only
Conditions the study is for: Depressive Symptoms, Depression
What is being tested?: Sister Circle protocol
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 14 Sep 2022to 2 Apr 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, Los Angeles
Los Angeles, California, 90095

Other trials in United States

About this study

Official title: 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.

Conditions: Depressive Symptoms, Depression
Being tested: Sister Circle protocol
Keywords: Sister Circle, Black Women
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04837573
Study group	Role	What they receive
Group 1 Intervention, Weeks 1-8	Experimental	During Weeks 1-8, Group 1 receives the Intervention and Group 2 receives no treatment. Receives: 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. Receives: Behavioral: Sister Circle protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 12 weeks
Proportion of Eligible Potential Participants That Enrolled in the Study, as a Measure of Feasibility
Recruitment: # enrolled/# eligible
Measured: 6 weeks

Secondary outcomes (1)

Changes in Psychological Flexibility (Baseline to 6 Weeks)
Changes in psychological flexibility scores from baseline to 6 weeks using the Acceptance and Action Questionnaire II (AAQ-II). Scores range from 7-49. Lower scores indicate greater psychological flexibility (better outcome).
Measured: Baseline to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 20222 Apr 2023

First posted8 Apr 2021
Study start14 Sep 2022
Primary completion2 Apr 2023
Study completion2 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Depressive SymptomsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04837573
Sponsor's protocol ID: 21-002949
Other IDs: P30-AG02168, UL1TR001881
Status last verified: May 2024
First submitted: 29 Mar 2021
Last updated: 5 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Feasibility and Acceptability of a Therapeutically-Grounded Virtual Sister Circle Intervention for Black Women With Depressive Symptoms
ClinicalTrials.gov ID: NCT04837573
Acronym / sponsor ID: 21-002949
Conditions: Depressive Symptoms, Depression
Keywords: Sister Circle, Black Women
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Kia Skrine Jeffers, PhD, RN, PHNUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), National Center for Advancing Translational Sciences (NCATS)
Study start: 14 Sep 2022 (actual)
Primary completion: 2 Apr 2023 (actual)
Study completion: 2 Apr 2023 (actual)
First posted: 8 Apr 2021 (actual)
Results: Posted 5 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1 Intervention, Weeks 1-8	Experimental	Behavioral: Sister Circle protocolDuring Weeks 1-8, Group 1 receives the Intervention and Group 2 receives no treatment.
Group 2 Intervention, Weeks 9-16	Active comparator	Behavioral: Sister Circle protocolDuring Weeks 9-16, Group 2 receives the Intervention and Group 1 receives no treatment.

Who may qualify

Ages: 40 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Identify as Black or African American
Identify as female
Age 40 years and older
Community-dwelling
Self-report of experiencing depressive symptoms

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sister Circle protocolThe intervention is an 8-week, therapeutically-informed protocol.	Behavioural	Group 1 Intervention, Weeks 1-8, Group 2 Intervention, Weeks 9-16

Primary outcome

Completion and Retention Rates of Participants as Measures of Feasibility
Time frame: 12 weeks
Completion: # of participants who attended 4+ sessions/ # participants available to attend 4+ sessions Retention: # retained/ # enrolled
Number of Participants Who Reported Acceptability According to the Theoretical Framework of Acceptability
Time frame: 12 weeks
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.
Proportion of Eligible Potential Participants That Enrolled in the Study, as a Measure of Feasibility
Time frame: 6 weeks
Recruitment: # enrolled/# eligible

1 secondary outcome

Changes in Psychological Flexibility (Baseline to 6 Weeks)
Time frame: Baseline to 6 weeks

Results and safety

Results posted to the registry on 5 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 Intervention, Weeks 1-6	15	14
Group 2 Intervention, Weeks 7-12	15	8

Primary outcome: Completion and Retention Rates of Participants as Measures of Feasibility

Time frame: 12 weeks. Number. Unit: percentage of participants

Measure	Group 1 Intervention, Weeks 1-6 n = 15	Group 2 Intervention, Weeks 7-12 n = 15
Completion	79	88
Retention	93	73

Population analysed: Completion rates were calculated for participants who were able to meet during the time the sessions were held. Retention rates were calculated for all enrolled participants.

Primary outcome: Number of Participants Who Reported Acceptability According to the Theoretical Framework of Acceptability

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Group 1 Intervention, Weeks 1-6 n = 10	Group 2 Intervention, Weeks 7-12 n = 5
Value	10	5

Population analysed: 15 women participated in their respective focus groups during Weeks 6 and 12. The remaining 7 participants who completed the intervention did not attend, therefore their qualitative "acceptability" data could not be collected or analyzed.

Primary outcome: Proportion of Eligible Potential Participants That Enrolled in the Study, as a Measure of Feasibility

Time frame: 6 weeks. Number. Unit: percentage of potential participants

Measure	Total Recruitment n = 43
Value	69.8

Population analysed: Individuals who completed the eligibility determination form and were eligible to participate

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 Intervention, Weeks 1-6	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Group 2 Intervention, Weeks 7-12	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kia Skrine Jeffers, PhD, RN, PHN principal investigator

University of California, Los Angeles

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sister Circle protocol in people with Depressive Symptoms and Depression, run by Kia Skrine Jeffers, PhD, RN, PHN at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion and Retention Rates of Participants as Measures of Feasibility (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04837573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.