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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071887
Recruitment Status : Completed
First Posted : March 7, 2017
Results First Posted : September 20, 2019
Last Update Posted : October 28, 2019
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 women living with HIV (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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
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
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : August 27, 2018

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. Number of Participants Completing Treatment Sessions [ Time Frame: Approximately 10 weeks after baseline ]
    The investigators will assess feasibility by collecting data on the number of completed treatment sessions.

  2. Participant Satisfaction With Study Procedures [ Time Frame: Approximately 10 weeks after baseline ]
    Acceptability will be assessed using scores on the Client Satisfaction Questionnaire (CSQ-8). Response options as follows, "Very satisfied", "Mostly satisfied", "Indifferent or mildly dissatisfied", and "Quite dissatisfied".



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Christina Psaros, PhD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Christina Psaros, Massachusetts General Hospital:
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Responsible Party: Christina Psaros, Assistant Professor of Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03071887    
Other Study ID Numbers: 2017P000404
R34AT009170 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2017    Key Record Dates
Results First Posted: September 20, 2019
Last Update Posted: October 28, 2019
Last Verified: October 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