Resilience, Psychological Clinical Trial
Official title:
Developing a Resilience Intervention for Older, HIV-Infected Women
Verified date | May 2022 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | April 14, 2021 |
Est. primary completion date | March 8, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of Study Procedures, as Assessed by Number of Individuals Screened and Eligible for Participation in the Study | Investigators assessed feasibility of study procedures by tracking the number of potential participants screened and eligible for participation. These metrics were assessed together with the number of eligible individuals enrolled, and the number of assessments completed in order to provide a comprehensive understanding of the feasibility of this study. | Assessed at screening (pre-baseline) | |
Primary | Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals. | Investigators assessed feasibility of study procedures by tracking the number of eligible participants enrolled, and the number of treatment, assessment, and make-up sessions completed by all enrolled participants. These metrics were assessed together with the number of individuals screened and eligible in order to provide a comprehensive understanding of the feasibility of this study. | Assessed up to 6 months post-baseline | |
Primary | Feasibility of Study Procedures, as Assessed by Time Required for Screening and Enrollment | Investigators assessed feasibility of study procedures by tracking the time it takes to screen and enroll participants, as measured by the number of months it took to recruit, screen, and schedule a baseline assessment for all 44 participants, compared to the number of months we estimated it would take to enroll our target number of participants at the outset of the study (11 months). These metrics were assessed in order to provide a comprehensive understanding of the feasibility of this study. | Assessed after completion of all baseline assessments | |
Primary | Feasibility of Study Procedures, as Assessed by Time Required to Complete Study Procedures | Investigators assessed feasibility of study procedures by tracking the time it takes for participants to complete each assessment. These metrics were assessed in order to provide a comprehensive understanding of the feasibility of this study. | Assessed up to 6 months post-baseline | |
Primary | Feasibility as Assessed by Reasons for Declining Enrollment | Includes the number of individuals who were eligible (N=61), but declined to enroll and those reasons for declining. | Assessed at screening (pre-baseline) | |
Primary | Feasibility as Assessed by Reasons for Enrolling But Not Taking Part in Group Sessions | Includes the number of individuals who enrolled, but did not take part in group sessions (N=2) and the reasons for not participating. | Assessed up to 3 months post-baseline | |
Primary | Feasibility as Assessed by Reasons for Withdrawing From the Study | Includes the number of individuals who withdrew from the study, despite participating in group sessions (N=7), and the reasons for withdrawing. | Assessed up to 6 months post-baseline | |
Primary | Feasibility as Assessed by Participants Lost to Follow-Up | Includes the number of individuals who were lost to follow-up and unable to be traced (N=5). | Assessed up to 6 months post-baseline | |
Primary | Acceptability of Study Procedures, as Assessed by the Client Satisfaction Questionnaire | Investigators assessed acceptability at the post-treatment 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. Excellent acceptability was defined a priori as CSQ-8 scores between 26 and 32, and good acceptability was defined a priori as CSQ-8 scores between 20 and 25. | Assessed up to 6 months post-baseline | |
Primary | Acceptability of Study Procedures, as Assessed by the Perception of Study Assessments Questionnaire | Investigators assessed acceptability at the post-treatment visit by asking participants about their perceptions of the burden of the study assessment battery on a scale from 1 ("no/minimal burden") to 10 ("too much of a burden"). Items are summed to create an overall score; scores range from 1 to 10, with lower scores indicating higher satisfaction. | Assessed up to 6 months post-baseline |
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