N/A
N=44
The BRIgHT Program: Building Resilience in HIV Together
Resilience, Psychological
Bottom Line
View on ClinicalTrials.gov: NCT03673098 ↗Enrolled (actual)
44
Serious AEs
2.3%
Results posted
May 2022
Primary outcome: Primary: Feasibility of Study Procedures, as Assessed by Number of Individuals Screened and Eligible for Participation in the Study — 61; 3; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Adapted 3RP (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Study Procedures, as Assessed by Number of Individuals Screened and Eligible for Participation in the Study |
61; 3; 1 | — |
| PRIMARY Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals. |
20; 21; 15; 15; 16; 18 | — |
| PRIMARY Feasibility of Study Procedures, as Assessed by Time Required for Screening and Enrollment |
11; 21 | — |
| PRIMARY Feasibility of Study Procedures, as Assessed by Time Required to Complete Study Procedures |
94.9; 94.6; 94.8; 86.7; 84.3; 85.4 | — |
| PRIMARY Feasibility as Assessed by Reasons for Declining Enrollment |
2; 1; 14 | — |
| PRIMARY Feasibility as Assessed by Reasons for Enrolling But Not Taking Part in Group Sessions |
1; 0; 1; 1; 0; 1 | — |
| PRIMARY Feasibility as Assessed by Reasons for Withdrawing From the Study |
1; 0; 1; 2; 0; 2 | — |
| PRIMARY Feasibility as Assessed by Participants Lost to Follow-Up |
2; 3; 5 | — |
| PRIMARY Acceptability of Study Procedures, as Assessed by the Client Satisfaction Questionnaire |
20.6; 20.3; 20.4 | — |
| PRIMARY Acceptability of Study Procedures, as Assessed by the Perception of Study Assessments Questionnaire |
11; 9; 20; 1; 6; 7 | — |
Summary
This is the second phase of a two-part study. In the first phase (Protocol ID: R34AT009170), the investigators refined and piloted the Relaxation Response Resiliency (3RP) intervention for women age 50 and over who are living with HIV, a group especially burdened by stressors related both to aging and to living with chronic disease. In this part of the study, the investigators will use data from the first phase to further adapt the intervention manual, and test the final product via a small randomized controlled trial in the same population.
Eligibility Criteria
Inclusion Criteria
- biologically born women who endorse a female identity
- living with HIV/AIDS
- age 50 or older
- English-speaking
Exclusion Criteria
- presence of an active (i.e. untreated) and interfering psychiatric disorder (e.g., bipolar disorder, schizophrenia, substance abuse)
- have participated in a structured cognitive behavioral therapy and/or a mind-body intervention in the past year
Data sourced from ClinicalTrials.gov (NCT03673098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.