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.
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
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Kia Skrine Jeffers, PhD, RN, PHN
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor-investigator, Kia Skrine Jeffers, PhD, RN, PHN, University of California, Los Angeles
- Investigators
- Kia Skrine Jeffers, PhD, RN, PHN, Principal investigator, University of California, Los Angeles
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