The BRIgHT Program: Building Resilience in HIV Together
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|ClinicalTrials.gov Identifier: NCT03673098|
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : May 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Resilience, Psychological||Behavioral: Adapted 3RP||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Intervention: 10 weekly sessions of the adapted Relaxation Response Resiliency Program (3RP) Control: 10 weekly sessions of a supportive psychotherapy program|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Developing a Resilience Intervention for Older, HIV-Infected Women|
|Actual Study Start Date :||November 5, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: Intervention Group: Adapted 3RP
The intervention condition will consist of the 10-week adapted 3RP intervention.
Behavioral: Adapted 3RP
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).
No Intervention: Control Group: Supportive Psychotherapy
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.
- Feasibility of study procedures, as assessed by number of individuals screened, eligible, and enrolled; and number of assessments and sessions completed [ Time Frame: Assessed approximately 10 weeks after baseline ]Investigators will assess feasibility of study procedures by tracking the number of potential participants screened and eligible, the number of eligible participants enrolled, and the number of treatment, assessment, and make-up sessions completed by all enrolled participants. These metrics will be assessed together in order to provide a comprehensive understanding of the feasibility of this study.
- Feasibility of study procedures, as assessed by time required to complete study procedures [ Time Frame: Assessed approximately 10 weeks after baseline ]Investigators will assess feasibility of study procedures by tracking the time it takes to screen and enroll participants, as well as the time it takes for participants to complete each assessment. These metrics will be assessed together in order to provide a comprehensive understanding of the feasibility of this study.
- Feasibility of study procedures, as assessed by reasons for declining enrollment/participation [ Time Frame: Assessed approximately 10 weeks after baseline ]Investigators will assess feasibility of study procedures by tracking reasons for declining enrollment and for prematurely leaving the trial. These metrics will be assessed together in order to provide a comprehensive understanding of the feasibility of this study.
- Acceptability of study procedures, as assessed by the Client Satisfaction Questionnaire [ Time Frame: Assessed approximately 10 weeks after baseline ]Investigators will assess acceptability at the post-treatment visit and the 3-month follow-up 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. Investigators will also ask participants at both of these visits about their perceptions of the burden of the study assessment battery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673098
|Contact: Christina Psaros, PhDemail@example.com|
|Contact: Georgia Goodman, BSfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Christina Psaros, PhD 617-726-7458 email@example.com|
|Principal Investigator:||Christina Christina, PhD||Massachusetts General Hospital|