The BRIgHT Program: Building Resilience in HIV Together

NCT03673098 | Completed Results DMC

• 2 other identifiers: 2018P0018035R34AT009170
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Resilience, Psychological

Keywords

Resilience; Women; HIV/AIDS

Outcome Measures

Primary Outcomes (10)

• Feasibility of Study Procedures, as Assessed by Number of Individuals Screened and Eligible for Participation in the Study

  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.

  Assessed at screening (pre-baseline)

• Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals.

  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.

  Assessed up to 6 months post-baseline

• Feasibility of Study Procedures, as Assessed by Time Required for Screening and Enrollment

  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.

  Assessed after completion of all baseline assessments

• Feasibility of Study Procedures, as Assessed by Time Required to Complete Study Procedures

  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.

  Assessed up to 6 months post-baseline

• Feasibility as Assessed by Reasons for Declining Enrollment

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

  Assessed at screening (pre-baseline)

• Feasibility as Assessed by Reasons for Enrolling But Not Taking Part in Group Sessions

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

  Assessed up to 3 months post-baseline

• Feasibility as Assessed by Reasons for Withdrawing From the Study

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

  Assessed up to 6 months post-baseline

• Feasibility as Assessed by Participants Lost to Follow-Up

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

  Assessed up to 6 months post-baseline

• Acceptability of Study Procedures, as Assessed by the Client Satisfaction Questionnaire

  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.

  Assessed up to 6 months post-baseline

• Acceptability of Study Procedures, as Assessed by the Perception of Study Assessments Questionnaire

  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.

  Assessed up to 6 months post-baseline

Study Arms (2)

Intervention Group: Adapted 3RP

EXPERIMENTAL

The intervention condition will consist of the 10-week adapted 3RP intervention.

Behavioral: Adapted 3RP

Control Group: Supportive Psychotherapy

NO INTERVENTION

The control condition will be a 10-week supportive therapy program. Visits include supportive psychotherapy to address stressful or difficult topics related to aging as a woman living with HIV. The program was developed to approximate the most frequent mental health counseling provided to adults with HIV at the community level.

Interventions

Adapted 3RP BEHAVIORAL

The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The adapted 3RP intervention consists of 10, 90-minute weekly group sessions. Content specific to older women living with HIV, including self-compassion exercises, was added to the intervention in the first phase of this study (open pilot).

Intervention Group: Adapted 3RP

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: The investigators will recruit biologically born women who endorse a female gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• biologically born women who endorse a female identity
• living with HIV/AIDS
• age 50 or older
• English-speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Christina Psaros
• Organization: Massachusetts General Hospital

cpsaros@mgh.harvard.edu

617-726-7458

Study Officials

• Christina Christina, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Model Details: Intervention: 10 weekly sessions of the adapted Relaxation Response Resiliency Program (3RP) Control: 10 weekly sessions of a supportive psychotherapy program

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 17, 2018
• Study Start: November 5, 2018
• Primary Completion: March 8, 2021
• Study Completion: April 14, 2021
• Last Updated: May 13, 2022
• Results First Posted: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)