The BRIgHT Program: Building Resilience in HIV Together

Mass General Brigham

Status: Completed

Conditions: Resilience, Psychological

Treatments: Behavioral: Adapted 3RP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03673098

5R34AT009170 (U.S. NIH Grant/Contract)

2018P001803

Details and patient eligibility

About

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.

Full description

Overview.

This is the second phase of a two-part study. In the first phase (Protocol ID: R34AT009170), the investigators adapted an existing resiliency intervention, the Relaxation Response Resiliency Program (3RP), to the needs of women ages 50 and over who are living with HIV. The investigators conducted preliminary testing of the refined group intervention via an open pilot study (N=13 enrolled) across two sites, MGH and Boston Medical Center), and conducted individual exit interviews to solicit feedback on the intervention. Based on these qualitative data, as well as qualitative work conducted previously with this population, the goal of this phase of the project is to conduct a small, randomized pilot of the intervention in groups of up to 10 women with HIV (total N=up to 60) to assess feasibility and acceptability of all study procedures.

Study Procedures.

Participants will be women living with HIV (N=up to 60) age 50 or over, who are recruited via flyers and provider referral from Boston area hospitals and health care settings, as well as community organizations serving individuals living with HIV. Once an individual expresses interest in the study, they will be screened by a study staff member, either by phone or in person, in order to assess study eligibility. Eligible and interested individuals will be invited to sign informed consent and complete an in-person baseline assessment. Participants will be randomized to either a 10-week intervention group (adapted 3RP intervention) or a 10-week control group (supportive psychotherapy program). Participants will then complete a post-treatment assessment, an individual in-depth exit interview to provide feedback on their experience in the study, and a 3-month follow-up assessment. Data from this second phase of the study will inform the eventual development of a full-scale randomized controlled trial.

Adapted 3RP Intervention.

Once randomized into the intervention condition, participants will complete 10, 90-minute weekly group sessions of the adapted 3RP intervention. Sessions will focus on developing an understanding of stress sources and physiology, and on developing a regular practice of eliciting the relaxation response (RR) and learning cognitive behavioral and positive psychology skills to enhance resiliency to long-term stress. Participants will be encouraged to practice skills (RR practice, thoughts records to learn adaptive thinking) between group sessions.

Supportive Psychotherapy Control Program.

The control condition will be a supportive therapy program that is matched to the intervention for number and length of sessions. Basic principles of supportive psychotherapy will be followed, and the interventionist will facilitate discussion around what it is like to live with HIV as an aging woman.

Enrollment: 44 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Intervention Group: Adapted 3RP

Experimental group

Description:

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

Treatment:

Behavioral: Adapted 3RP

Control Group: Supportive Psychotherapy

No Intervention group

Description:

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.