An interventional study of Adapted 3RP in Resilience, Psychological, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-05-13.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
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.
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.
Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention condition will consist of the 10-week adapted 3RP intervention.
Behavioral: Adapted 3RP
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.
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).
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.
Time frame: Assessed at screening (pre-baseline)
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.
Time frame: Assessed up to 6 months post-baseline
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.
Time frame: Assessed after completion of all baseline assessments
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.
Time frame: Assessed up to 6 months post-baseline
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.
Time frame: Assessed at screening (pre-baseline)
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.
Time frame: Assessed up to 3 months post-baseline
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.
Time frame: Assessed up to 6 months post-baseline
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).
Time frame: Assessed up to 6 months post-baseline
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.
Time frame: Assessed up to 6 months post-baseline
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.
Time frame: Assessed up to 6 months post-baseline
Participants were recruited from Boston-area hospitals and healthcare settings between October 2018 and July 2020. The first participant was enrolled on November 5, 2018 and the last participant was enrolled in July 10, 2020.
| Milestone | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy |
|---|---|---|
| Started | 23 | 21 |
| Completed | 13 | 17 |
| Not completed | 10 | 4 |
| Withdrew: Lost to follow-up | 2 | 3 |
| Withdrew: Withdrawal by subject | 6 | 1 |
| Withdrew: Could not participate due to scheduling conflicts or health issues | 2 | 0 |
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.
| Participants | Total Recruitment Population |
|---|---|
| Eligible | 61 |
| Ineligible: Not a cisgender woman | 3 |
| Ineligible: Not living with HIV | 1 |
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.
| Participants | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy |
|---|---|---|
| Participated in group sessions | 20 | 21 |
| Attended at least 70% of group sessions | 15 | 15 |
| Completed post-treatment assessment | 16 | 18 |
| Completed qualitative exit interview | 15 | 18 |
| Completed 3-month follow-up assessment | 13 | 17 |
| Completed COVID-19 quantitative assessment | 13 | 15 |
| Completed COVID-19 qualitative interview | 10 | 14 |
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.
| months | Overall |
|---|---|
| Planned duration of screening and enrollment | 11 |
| Actual duration of screening and enrollment | 21 |
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.
| minutes | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy | Overall |
|---|---|---|---|
| Baseline assessment | 94.9 (36 to 203) | 94.6 (39 to 184) | 94.8 (36 to 203) |
| Post-treatment assessment | 86.7 (33 to 165) | 84.3 (33 to 160) | 85.4 (33 to 165) |
| 3-month follow-up assessment | 93.2 (45 to 278) | 70.3 (29 to 138) | 80.9 (29 to 278) |
Includes the number of individuals who were eligible (N=61), but declined to enroll and those reasons for declining.
| Participants | Overall |
|---|---|
| Scheduling conflicts | 2 |
| Lack of interest | 1 |
| Reason unknown | 14 |
Includes the number of individuals who enrolled, but did not take part in group sessions (N=2) and the reasons for not participating.
| Participants | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy | Overall |
|---|---|---|---|
| Scheduling conflicts | 1 | 0 | 1 |
| Health issues | 1 | 0 | 1 |
Includes the number of individuals who withdrew from the study, despite participating in group sessions (N=7), and the reasons for withdrawing.
| Participants | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy | Overall |
|---|---|---|---|
| Scheduling conflicts | 1 | 0 | 1 |
| Health issues | 2 | 0 | 2 |
| Lack of privacy | 0 | 1 | 1 |
| Reimbursement issues | 1 | 0 | 1 |
| Reasons unknown | 2 | 0 | 2 |
Includes the number of individuals who were lost to follow-up and unable to be traced (N=5).
| Participants | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy | Overall |
|---|---|---|---|
| Feasibility as Assessed by Participants Lost to Follow-Up | 2 | 3 | 5 |
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.
| score on a scale | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy | Overall |
|---|---|---|---|
| Acceptability of Study Procedures, as Assessed by the Client Satisfaction Questionnaire | 20.6 ± 4.3 | 20.3 ± 3.5 | 20.4 ± 3.8 |
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.
| Participants | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy | Overall |
|---|---|---|---|
| "No/minimal burden" (score = 1) | 11 | 9 | 20 |
| Between "No/minimal burden" and "Moderate burden" (score = 2-4) | 1 | 6 | 7 |
| Between "Moderate burden" and "Too much of a burden" (score = 5-9) | 2 | 2 | 4 |
| "Too much of a burden" (score = 10) | 1 | 1 | 2 |
Collected over Up to 6 months post-baseline. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group: Adapted 3RP | 0/23 (0%) | 1/23 (4.3%) | 0/23 (0%) |
| Control Group: Supportive Psychotherapy | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Event | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy |
|---|---|---|
| Admission to Emergency Department, Unrelated to StudyPsychiatric disorders | 1/23 | 0/21 |
| Age, Continuous(years) | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy | Total |
|---|---|---|---|
| Mean | 57.6 (50 to 73) | 59.2 (50 to 71) | 58 (50 to 73) |
| Sex: Female, Male(Participants) | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy | Total |
|---|---|---|---|
| Female | 23 | 21 | 44 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 21 | 20 | 41 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 14 | 10 | 24 |
| White | 5 | 8 | 13 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy | Total |
|---|---|---|---|
| United States | 23 | 21 | 44 |
| Education Level(Participants) | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy | Total |
|---|---|---|---|
| No formal education | 0 | 0 | 0 |
| Eighth grade or lower | 3 | 0 | 3 |
| Some high school | 3 | 3 | 6 |
| High school graduate or GED | 5 | 9 | 14 |
| Some college/Associate degree/technical school | 10 | 5 | 15 |
| College graduate (BA/BS) | 0 | 1 | 1 |
| Some graduate school | 1 | 1 | 2 |
| Master's degree | 1 | 1 | 2 |
| Doctorate/Medical degree/Law degree | 0 | 0 | 0 |
| Not Reported | 0 | 1 | 1 |
| Employment Status(Participants) | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy | Total |
|---|---|---|---|
| Full-time employed | 5 | 4 | 9 |
| Part-time Employed | 2 | 4 | 6 |
| Full-time or part-time in school | 0 | 0 | 0 |
| Neither employed nor in school/ Retired | 8 | 3 | 11 |
| On disability | 6 | 9 | 15 |
| Other | 2 | 1 | 3 |
| Annual Income(Participants) | Intervention Group: Adapted 3RP | Control Group: Supportive Psychotherapy | Total |
|---|---|---|---|
| $10,000 or less | 5 | 6 | 11 |
| $10,001 to $20,000 | 9 | 8 | 17 |
| $20,001 to $40,000 | 3 | 1 | 4 |
| $40,001 to $60,000 | 3 | 4 | 7 |
| $60,001 to $80,000 | 0 | 1 | 1 |
| Over $80,000 | 2 | 1 | 3 |
| Not Reported | 1 | 0 | 1 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts General Hospital