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Resilience Intervention for Older, HIV-Infected Women (BRIgHT)

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ClinicalTrials.gov Identifier: NCT03071887
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Christina Psaros, Massachusetts General Hospital

Brief Summary:
The goal of this study is to refine and pilot 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 living with chronic disease. The investigators will adapt the 3RP resiliency intervention to the needs of this population and conduct preliminary testing of the group intervention via an open pilot study.

Condition or disease Intervention/treatment Phase
Resilience, Psychological Behavioral: Relaxation Response Resiliency Program (3RP) Not Applicable

Detailed Description:

Overview.

Participants will be HIV-infected women (N=up to 40) age 50 or over. Women will be recruited from the Boston area. Based on the investigators' qualitative work, the investigators will deliver an adapted version of the 3RP resiliency intervention to groups of 5-8 HIV-infected women age 50 and over. The 3RP intervention will consist of 8-10 weekly sessions of 90 minutes each focused on skills training to build and enhance resilience. The investigators will conduct baseline and post-treatment quantitative assessments, in addition to individual exit interviews to solicit feedback on the intervention. These data will be used to inform the design of a future randomized pilot study.

Study procedures.

Participants (N = up to 40) will be HIV-infected women age 50 or over . Participants will be recruited via study flyers (posted in the infectious disease clinics at local hospitals and in the waiting areas of Boston area community organizations) and provider referral. Once an individual expresses interest in the study, a research assistant will screen that individual to assess study eligibility criteria. Individuals who meet inclusion criteria will be invited to sign informed consent and complete an in-person baseline assessment. Participants will then complete the intervention (described below), a post-treatment assessment, and an individual in-depth exit interview to provide feedback on their experience in the study.

3RP Intervention:

Once enrolled in the study, participants will complete weekly group sessions of the 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is an open pilot of the adapted Relaxation Response Resiliency Program (3RP).
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Developing a Resilience Intervention for Older, HIV-Infected Women
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : April 2018
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
Treatment arm - Relaxation Response Resiliency Program (3RP) (this is an open pilot; the treatment arm is the only arm)
Behavioral: Relaxation Response Resiliency Program (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 3RP intervention currently consists of eight, 90-minute weekly group sessions. The investigators plan to adapt the intervention to address common concerns for older, HIV-infected women, including: stress of managing a chronic long-term, life threatening illness; additional medical comorbidities; pain and fatigue; stigma and social isolation; depression and anxiety; and sexuality concerns.




Primary Outcome Measures :
  1. Feasibility of study procedures [ Time Frame: Approximately 10 weeks after baseline ]
    The investigators will assess feasibility by collecting data on the number of completed treatment sessions.

  2. Acceptability of study procedures [ Time Frame: Approximately 10 weeks after baseline ]
    Acceptability will be assessed using scores on the Client Satisfaction Questionnaire (CSQ-8).



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
  • HIV-infected
  • 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): NCT03071887


Contacts
Contact: Christina Psaros, PhD 617.726.7458 cpsaros@mgh.harvard.edu
Contact: Greer Raggio, PhD, MPH 617.726.7458 graggio@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elsa Sweek, MS    617-643-4566    esweek@mgh.harvard.edu   
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Nina Lin, MD         
Sponsors and Collaborators
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Christina Psaros, PhD Massachusetts General Hospital

Responsible Party: Christina Psaros, Assistant Professor of Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03071887     History of Changes
Other Study ID Numbers: R34AT009170 ( U.S. NIH Grant/Contract )
R34AT009170-01A1 ( U.S. NIH Grant/Contract )
2017P000404 ( Other Identifier: Partners Human Research Committee/IRB )
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No