Clinical trial NCT03673098: The BRIgHT Program: Building Resilience in HIV Together
Official title: Developing a Resilience Intervention for Older, HIV-Infected Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resilience, Psychological
Keywords: Resilience
Women
HIV/AIDS
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2018-09-17
Enrollment: 44
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention: 10 weekly sessions of the adapted Relaxation Response Resiliency Program (3RP) Control: 10 weekly sessions of a supportive psychotherapy program
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Study Procedures, as Assessed by Number of Individuals Screened and Eligible for Participation in the Study
timeFrame: Assessed at screening (pre-baseline)
measure: Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals.
timeFrame: Assessed up to 6 months post-baseline
measure: Feasibility of Study Procedures, as Assessed by Time Required for Screening and Enrollment
timeFrame: Assessed after completion of all baseline assessments
measure: Feasibility of Study Procedures, as Assessed by Time Required to Complete Study Procedures
timeFrame: Assessed up to 6 months post-baseline
measure: Feasibility as Assessed by Reasons for Declining Enrollment
timeFrame: Assessed at screening (pre-baseline)
measure: Feasibility as Assessed by Reasons for Enrolling But Not Taking Part in Group Sessions
timeFrame: Assessed up to 3 months post-baseline
measure: Feasibility as Assessed by Reasons for Withdrawing From the Study
timeFrame: Assessed up to 6 months post-baseline
measure: Feasibility as Assessed by Participants Lost to Follow-Up
timeFrame: Assessed up to 6 months post-baseline
measure: Acceptability of Study Procedures, as Assessed by the Client Satisfaction Questionnaire
timeFrame: Assessed up to 6 months post-baseline
measure: Acceptability of Study Procedures, as Assessed by the Perception of Study Assessments Questionnaire
timeFrame: Assessed up to 6 months post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christina Christina, PhD
role: PRINCIPAL_INVESTIGATOR
References: