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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT009170 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Treatment arm - Relaxation Response Resiliency Program (3RP) (this is an open pilot; the treatment arm is the only arm) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relaxation Response Resiliency Program (3RP) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Completing Treatment Sessions | The investigators will assess feasibility by collecting data on the number of completed treatment sessions. | Approximately 10 weeks after baseline |
| Participant Satisfaction With Study Procedures | 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". | Approximately 10 weeks after baseline |
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Inclusion Criteria:
Exclusion Criteria:
The investigators will recruit biologically born women who endorse a female gender identity.
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| Name | Affiliation | Role |
|---|---|---|
| Christina Psaros, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Boston Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36538139 | Derived | Stanton AM, Goodman GR, Blyler A, Kirakosian N, Labbe AK, Robbins GK, Park ER, Psaros C. Mental Health, Social Connectedness, and Fear During the COVID-19 Pandemic: A Qualitative Perspective from Older Women with HIV. AIDS Behav. 2023 Jul;27(7):2176-2189. doi: 10.1007/s10461-022-03950-9. Epub 2022 Dec 20. |
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The three open pilot groups and qualitative exit interviews were conducted between December 2017 and July 2018 through community outreach, flyers, and referrals from healthcare providers at the Infectious Disease units of two Boston-area hospitals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment: 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 adapted 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment: 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 adapted 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Completing Treatment Sessions | The investigators will assess feasibility by collecting data on the number of completed treatment sessions. | Posted | Count of Participants | Participants | Approximately 10 weeks after baseline |
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Adverse event data were collected over the 8 months study enrollment and participation (December 2017 through August 2018).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment: 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 adapted 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christina Psaros | Massachusetts General Hospital | 617.726.7458 | cpsaros@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2019 | Aug 15, 2019 | Prot_SAP_000.pdf |
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This is an open pilot of the adapted Relaxation Response Resiliency Program (3RP).
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| Boston |
| Massachusetts |
| 02118 |
| United States |
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| Primary | Participant Satisfaction With Study Procedures | 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". | Posted | Count of Participants | Participants | Approximately 10 weeks after baseline |
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| 0 |
| 13 |
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