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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
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Christina Psaros, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Resilience, Psychological Behavioral: Adapted 3RP Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The investigators will recruit biologically born women who endorse a female gender identity.
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Christina Psaros, PhD 617-726-7458 cpsaros@mgh.harvard.edu
Contact: Georgia Goodman, BS 617-726-3679 ggoodman@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Christina Psaros, PhD    617-726-7458    cpsaros@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Christina Christina, PhD Massachusetts General Hospital

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Responsible Party: Christina Psaros, Assistant Professor of Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03673098     History of Changes
Other Study ID Numbers: 5R34AT009170-02 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christina Psaros, Massachusetts General Hospital:
Resilience
Women
HIV/AIDS