Resilience, PsychologicalNCT03673098
The BRIgHT Program: Building Resilience in HIV Together
A study testing Adapted 3RP in people with Resilience, Psychological, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Resilience, Psychological
- What is being tested?
- Adapted 3RP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2018to 14 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- biologically born women who endorse a female identity
- living with HIV/AIDS
- age 50 or older
- English-speaking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Developing a Resilience Intervention for Older, HIV-Infected Women
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.
Read the detailed description
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.
- Conditions
- Resilience, Psychological
- Being tested
- Adapted 3RP
- Keywords
- Resilience, Women, HIV/AIDS
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted 3RPBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Adapted 3RP | Experimental | The intervention condition will consist of the 10-week adapted 3RP intervention. Receives: Behavioral: Adapted 3RP |
| Control Group: Supportive Psychotherapy | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Assessed up to 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start5 Nov 2018
- Primary completion8 Mar 2021
- Study completion14 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Resilience, PsychologicalStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention: 10 weekly sessions of the adapted Relaxation Response Resiliency Program (3RP) Control: 10 weekly sessions of a supportive psychotherapy program
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Christina Psaros, Massachusetts General Hospital
- Investigators
- Christina Christina, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673098
- Sponsor's protocol ID
- 2018P001803
- Other IDs
- 5R34AT009170
- Status last verified
- May 2022
- First submitted
- 4 Sep 2018
- Last updated
- 13 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Resilience Intervention for Older, HIV-Infected Women
- ClinicalTrials.gov ID
- NCT03673098
- Acronym / sponsor ID
- 2018P001803
- Conditions
- Resilience, Psychological
- Keywords
- Resilience, Women, HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 14 Apr 2021 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Posted 13 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention: 10 weekly sessions of the adapted Relaxation Response Resiliency Program (3RP) Control: 10 weekly sessions of a supportive psychotherapy program
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Adapted 3RP | Experimental | Behavioral: Adapted 3RPThe intervention condition will consist of the 10-week adapted 3RP intervention. |
| Control Group: Supportive Psychotherapy | No intervention | –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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- biologically born women who endorse a female identity
- living with HIV/AIDS
- age 50 or older
- English-speaking
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted 3RPThe 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). | Behavioural | Intervention Group: Adapted 3RP |
Primary outcome
Feasibility of Study Procedures, as Assessed by Number of Individuals Screened and Eligible for Participation in the Study
Time frame: Assessed at screening (pre-baseline)
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.
Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals.
Time frame: Assessed up to 6 months post-baseline
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.
Feasibility of Study Procedures, as Assessed by Time Required for Screening and Enrollment
Time frame: Assessed after completion of all baseline assessments
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.
Feasibility of Study Procedures, as Assessed by Time Required to Complete Study Procedures
Time frame: Assessed up to 6 months post-baseline
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.
Feasibility as Assessed by Reasons for Declining Enrollment
Time frame: Assessed at screening (pre-baseline)
Includes the number of individuals who were eligible (N=61), but declined to enroll and those reasons for declining.
Feasibility as Assessed by Reasons for Enrolling But Not Taking Part in Group Sessions
Time frame: Assessed up to 3 months post-baseline
Includes the number of individuals who enrolled, but did not take part in group sessions (N=2) and the reasons for not participating.
Feasibility as Assessed by Reasons for Withdrawing From the Study
Time frame: Assessed up to 6 months post-baseline
Includes the number of individuals who withdrew from the study, despite participating in group sessions (N=7), and the reasons for withdrawing.
Feasibility as Assessed by Participants Lost to Follow-Up
Time frame: Assessed up to 6 months post-baseline
Includes the number of individuals who were lost to follow-up and unable to be traced (N=5).
Acceptability of Study Procedures, as Assessed by the Client Satisfaction Questionnaire
Time frame: Assessed up to 6 months post-baseline
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.
Acceptability of Study Procedures, as Assessed by the Perception of Study Assessments Questionnaire
Time frame: Assessed up to 6 months post-baseline
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Christina, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted 3RP in people with Resilience, Psychological, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Study Procedures, as Assessed by Number of Individuals Screened and Eligible for Participation in the Study (time frame: Assessed at screening (pre-baseline)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.