NCT03673098

The BRIgHT Program: Building Resilience in HIV Together

Completed NA Results posted Last updated 13 May 2022

What this trial tests

NA trial testing Adapted 3RP in Resilience, Psychological in 44 participants. Completed in 14 April 2021.

Timeline

5 November 2018

Primary endpoint
8 March 2021

14 April 2021

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	44
Start date	5 November 2018
Primary completion	8 March 2021
Estimated completion	14 April 2021
Sites	1 location across United States

Drugs / interventions tested

• Adapted 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.

Feasibility of Study Procedures, as Assessed by Number of Individuals Screened and Eligible for Participation in the Study Primary · Assessed at screening (pre-baseline)

Investigators assessed feasibility of study procedures by tracking the number of potential participants screened and eligible for participation. These metrics were assessed together with the number of eligible individuals enrolled, and the number of assessments completed in order to provide a comprehensive understanding of the feasibility of this study.

Group	Value	95% CI
Total Recruitment Population	61
Total Recruitment Population	3
Total Recruitment Population	1

Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals. Primary · Assessed up to 6 months post-baseline

Investigators assessed feasibility of study procedures by tracking the number of eligible participants enrolled, and the number of treatment, assessment, and make-up sessions completed by all enrolled participants. These metrics were assessed together with the number of individuals screened and eligible in order to provide a comprehensive understanding of the feasibility of this study.

Participated in group sessions

Group	Value	95% CI
Intervention Group: Adapted 3RP	20
Control Group: Supportive Psychotherapy	21

Attended at least 70% of group sessions

Group	Value	95% CI
Intervention Group: Adapted 3RP	15
Control Group: Supportive Psychotherapy	15

Completed post-treatment assessment

Group	Value	95% CI
Intervention Group: Adapted 3RP	16
Control Group: Supportive Psychotherapy	18

Completed qualitative exit interview

Group	Value	95% CI
Intervention Group: Adapted 3RP	15
Control Group: Supportive Psychotherapy	18

Completed 3-month follow-up assessment

Group	Value	95% CI
Intervention Group: Adapted 3RP	13
Control Group: Supportive Psychotherapy	17

Completed COVID-19 quantitative assessment

Group	Value	95% CI
Intervention Group: Adapted 3RP	13
Control Group: Supportive Psychotherapy	15

Completed COVID-19 qualitative interview

Group	Value	95% CI
Intervention Group: Adapted 3RP	10
Control Group: Supportive Psychotherapy	14

Feasibility of Study Procedures, as Assessed by Time Required for Screening and Enrollment Primary · Assessed after completion of all baseline assessments

Investigators assessed feasibility of study procedures by tracking the time it takes to screen and enroll participants, as measured by the number of months it took to recruit, screen, and schedule a baseline assessment for all 44 participants, compared to the number of months we estimated it would take to enroll our target number of participants at the outset of the study (11 months). These metrics were assessed in order to provide a comprehensive understanding of the feasibility of this study.

Planned duration of screening and enrollment

Group	Value	95% CI
Overall	11

Actual duration of screening and enrollment

Group	Value	95% CI
Overall	21

Feasibility of Study Procedures, as Assessed by Time Required to Complete Study Procedures Primary · Assessed up to 6 months post-baseline

Investigators assessed feasibility of study procedures by tracking the time it takes for participants to complete each assessment. These metrics were assessed in order to provide a comprehensive understanding of the feasibility of this study.

Baseline assessment

Group	Value	95% CI
Intervention Group: Adapted 3RP	94.9	36 – 203
Control Group: Supportive Psychotherapy	94.6	39 – 184
Overall	94.8	36 – 203

Post-treatment assessment

Group	Value	95% CI
Intervention Group: Adapted 3RP	86.7	33 – 165
Control Group: Supportive Psychotherapy	84.3	33 – 160
Overall	85.4	33 – 165

3-month follow-up assessment

Group	Value	95% CI
Intervention Group: Adapted 3RP	93.2	45 – 278
Control Group: Supportive Psychotherapy	70.3	29 – 138
Overall	80.9	29 – 278

Feasibility as Assessed by Reasons for Declining Enrollment Primary · Assessed at screening (pre-baseline)

Includes the number of individuals who were eligible (N=61), but declined to enroll and those reasons for declining.

Group	Value	95% CI
Overall	2
Overall	1
Overall	14

Feasibility as Assessed by Reasons for Enrolling But Not Taking Part in Group Sessions Primary · Assessed up to 3 months post-baseline

Includes the number of individuals who enrolled, but did not take part in group sessions (N=2) and the reasons for not participating.

Group	Value	95% CI
Intervention Group: Adapted 3RP	1
Control Group: Supportive Psychotherapy	0
Overall	1
Intervention Group: Adapted 3RP	1
Control Group: Supportive Psychotherapy	0
Overall	1

Feasibility as Assessed by Reasons for Withdrawing From the Study Primary · Assessed up to 6 months post-baseline

Includes the number of individuals who withdrew from the study, despite participating in group sessions (N=7), and the reasons for withdrawing.

Group	Value	95% CI
Intervention Group: Adapted 3RP	1
Control Group: Supportive Psychotherapy	0
Overall	1
Intervention Group: Adapted 3RP	2
Control Group: Supportive Psychotherapy	0
Overall	2
Intervention Group: Adapted 3RP	0
Control Group: Supportive Psychotherapy	1
Overall	1
Intervention Group: Adapted 3RP	1
Control Group: Supportive Psychotherapy	0
Overall	1

Feasibility as Assessed by Participants Lost to Follow-Up Primary · Assessed up to 6 months post-baseline

Includes the number of individuals who were lost to follow-up and unable to be traced (N=5).

Group	Value	95% CI
Intervention Group: Adapted 3RP	2
Control Group: Supportive Psychotherapy	3
Overall	5

Acceptability of Study Procedures, as Assessed by the Client Satisfaction Questionnaire Primary · Assessed up to 6 months post-baseline

Investigators assessed acceptability at the post-treatment visit using the eight-item Client Satisfaction Questionnaire (CSQ-8), a measure of how much an individual values a treatment. Items are summed to create an overall score; scores range from 8 to 32, with higher scores indicating higher satisfaction. Excellent acceptability was defined a priori as CSQ-8 scores between 26 and 32, and good acceptability was defined a priori as CSQ-8 scores between 20 and 25.

Group	Value	95% CI
Intervention Group: Adapted 3RP	20.6	± 4.3
Control Group: Supportive Psychotherapy	20.3	± 3.5
Overall	20.4	± 3.8

Acceptability of Study Procedures, as Assessed by the Perception of Study Assessments Questionnaire Primary · Assessed up to 6 months post-baseline

Investigators assessed acceptability at the post-treatment visit by asking participants about their perceptions of the burden of the study assessment battery on a scale from 1 ("no/minimal burden") to 10 ("too much of a burden"). Items are summed to create an overall score; scores range from 1 to 10, with lower scores indicating higher satisfaction.

Group	Value	95% CI
Intervention Group: Adapted 3RP	11
Control Group: Supportive Psychotherapy	9
Overall	20
Intervention Group: Adapted 3RP	1
Control Group: Supportive Psychotherapy	6
Overall	7
Intervention Group: Adapted 3RP	2
Control Group: Supportive Psychotherapy	2
Overall	4
Intervention Group: Adapted 3RP	1
Control Group: Supportive Psychotherapy	1
Overall	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 6 months post-baseline. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Group: Adapted 3RP

Serious: 1/23 (4%)

Deaths: 0/23

Control Group: Supportive Psychotherapy

Serious: 0/21 (0%)

Deaths: 0/21

Serious adverse events (1 terms)

Reaction	System	Intervention Group: Adapte…	Control Group: Supportive …
Admission to Emergency Department, Unrelated to Study	Psychiatric disorders	—	—

Most-reported serious reactions: Admission to Emergency Department, Unrelated to Study.

Data from ClinicalTrials.gov NCT03673098 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A resiliency intervention adapted for older women with HIV: Results from a pilot randomized controlled trial in the northeastern US.
   Psaros C, Stanton AM, Goodman GR, Blyler A, et al · · 2025 · PMID 38761072 · DOI 10.1177/13591053241253050