NCT03071887: BRIgHT

Resilience Intervention for Older, HIV-Infected Women

Completed NA Results posted Last updated 28 October 2019

What this trial tests

NA trial testing Relaxation Response Resiliency Program (3RP) in Resilience, Psychological in 13 participants. Completed in 27 August 2018.

Timeline

27 November 2017

Primary endpoint
27 August 2018

27 August 2018

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	13
Start date	27 November 2017
Primary completion	27 August 2018
Estimated completion	27 August 2018
Sites	2 locations across United States

Drugs / interventions tested

• Relaxation Response Resiliency Program (3RP)

Conditions studied

• Resilience, Psychological — all drugs for Resilience, Psychological →

Sponsor

Massachusetts General Hospital

Who can join

50 and older, female only, with Resilience, Psychological. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Completing Treatment Sessions Primary · Approximately 10 weeks after baseline

The investigators will assess feasibility by collecting data on the number of completed treatment sessions.

Attended at least half of group sessions

Group	Value	95% CI
Treatment: Relaxation Response Resiliency Program (3RP)	4

Attended fewer than half of group sessions

Group	Value	95% CI
Treatment: Relaxation Response Resiliency Program (3RP)	9

Participant Satisfaction With Study Procedures Primary · Approximately 10 weeks after baseline

Acceptability will be assessed using scores on the Client Satisfaction Questionnaire (CSQ-8). Response options as follows, "Very satisfied", "Mostly satisfied", "Indifferent or mildly dissatisfied", and "Quite dissatisfied".

Very satisfied

Group	Value	95% CI
Treatment: Relaxation Response Resiliency Program (3RP)	6

Mostly satisfied

Group	Value	95% CI
Treatment: Relaxation Response Resiliency Program (3RP)	1

Sponsor's own description

The goal of this study is to refine and pilot 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 living with chronic disease. The investigators will adapt the 3RP resiliency intervention to the needs of this population and conduct preliminary testing of the group intervention via an open pilot study.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mental Health, Social Connectedness, and Fear During the COVID-19 Pandemic: A Qualitative Perspective from Older Women with HIV.
   Stanton AM, Goodman GR, Blyler A, Kirakosian N, et al · · 2023 · cited 10× · PMID 36538139 · DOI 10.1007/s10461-022-03950-9
2. Adapting, testing, and refining a resilience intervention for older women with HIV: An open pilot study.
   Psaros C, Stanton AM, Goodman GR, Raggio G, et al · · 2023 · cited 5× · PMID 35787146 · DOI 10.1080/08952841.2022.2094163