Trial Outcomes & Findings for Feasibility & Acceptability of a Virtual Sister Circle Intervention for Black Women With Depressive Symptoms (NCT NCT04837573)

Last Updated: 2026-06-05

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

12 weeks

Results posted on

2026-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 Intervention, Weeks 1-6 During Weeks 1-6, Group 1 receives the Intervention and Group 2 receives no treatment. Sister Circle protocol: The intervention is an 6-week, therapeutically-informed protocol.	Group 2 Intervention, Weeks 7-12 During Weeks 7-12, Group 2 receives the Intervention and Group 1 receives no treatment. Sister Circle protocol: The intervention is an 6-week, therapeutically-informed protocol.
Overall Study STARTED	15	15
Overall Study COMPLETED	14	8
Overall Study NOT COMPLETED	1	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 Intervention, Weeks 1-6 During Weeks 1-6, Group 1 receives the Intervention and Group 2 receives no treatment. Sister Circle protocol: The intervention is an 6-week, therapeutically-informed protocol.	Group 2 Intervention, Weeks 7-12 During Weeks 7-12, Group 2 receives the Intervention and Group 1 receives no treatment. Sister Circle protocol: The intervention is an 6-week, therapeutically-informed protocol.
Overall Study Lost to Follow-up	1	4
Overall Study Not available to meet at scheduled time	0	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 Intervention, Weeks 1-6 n=15 Participants During Weeks 1-6, Group 1 receives the Intervention and Group 2 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol.	Group 2 Intervention, Weeks 7-12 n=15 Participants During Weeks 7-12, Group 2 receives the Intervention and Group 1 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=20 Participants	15 Participants n=20 Participants	30 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Sex: Female, Male Female	15 Participants n=20 Participants	15 Participants n=20 Participants	30 Participants n=40 Participants
Sex: Female, Male Male	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	15 Participants n=20 Participants	15 Participants n=20 Participants	30 Participants n=40 Participants
Race (NIH/OMB) White	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	Group 1 Intervention, Weeks 1-6 n=15 Participants During Weeks 1-6, Group 1 receives the Intervention and Group 2 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol.	Group 2 Intervention, Weeks 7-12 n=15 Participants During Weeks 7-12, Group 2 receives the Intervention and Group 1 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol.
Completion and Retention Rates of Participants as Measures of Feasibility Completion	79 percentage of participants	88 percentage of participants
Completion and Retention Rates of Participants as Measures of Feasibility Retention	93 percentage of participants	73 percentage of participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Group 1 Intervention, Weeks 1-6 n=10 Participants During Weeks 1-6, Group 1 receives the Intervention and Group 2 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol.	Group 2 Intervention, Weeks 7-12 n=5 Participants During Weeks 7-12, Group 2 receives the Intervention and Group 1 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol.
Number of Participants Who Reported Acceptability According to the Theoretical Framework of Acceptability	10 Participants	5 Participants

PRIMARY outcome

Timeframe: 6 weeks

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

Recruitment: # enrolled/# eligible

Outcome measures

Outcome measures
Measure	Group 1 Intervention, Weeks 1-6 n=43 Participants During Weeks 1-6, Group 1 receives the Intervention and Group 2 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol.	Group 2 Intervention, Weeks 7-12 During Weeks 7-12, Group 2 receives the Intervention and Group 1 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol.
Proportion of Eligible Potential Participants That Enrolled in the Study, as a Measure of Feasibility	69.8 percentage of potential participants	—

SECONDARY outcome

Timeframe: Baseline to 6 weeks

Population: Participants who completed baseline and Week 6 surveys were included in this analysis. At Week 6, Group 1 has completed the intervention, and Group 2 has not yet participated in the intervention period.

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).

Outcome measures

Outcome measures
Measure	Group 1 Intervention, Weeks 1-6 n=13 Participants During Weeks 1-6, Group 1 receives the Intervention and Group 2 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol.	Group 2 Intervention, Weeks 7-12 n=10 Participants During Weeks 7-12, Group 2 receives the Intervention and Group 1 receives no treatment. Sister Circle protocol: The intervention is a 6-week, therapeutically-informed protocol.
Changes in Psychological Flexibility (Baseline to 6 Weeks)	-5.3 score on a scale Interval -21.0 to 3.0	-0.5 score on a scale Interval -20.0 to 7.0

Adverse Events

Group 1 Intervention, Weeks 1-6

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 Intervention, Weeks 7-12

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carol M. Mangione, MD, MSHS

University of California, Los Angeles

Phone: 310-794-2298

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place