Resilience, Psychological
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is an open pilot of the adapted Relaxation Response Resiliency Program (3RP).
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* biologically born women who endorse a female identity * HIV-infected * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Completing Treatment Sessions | Approximately 10 weeks after baseline | The investigators will assess feasibility by collecting data on the number of completed treatment sessions. |
| Participant Satisfaction With Study Procedures | Approximately 10 weeks after baseline | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Treatment: Relaxation Response Resiliency Program (3RP) |
|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 5.2 |
| Current Employment Status Disabled/retired | 9 Participants |
| Current Employment Status Full-Time | 1 Participants |
| Current Employment Status Other | 1 Participants |
| Current Employment Status Part-Time | 2 Participants |
| Education College/graduate school partial/degree | 7 Participants |
| Education High school graduate/GED | 1 Participants |
| Education Less than high school degree | 5 Participants |
| Monthly Income $10,000 or less | 9 Participants |
| Monthly Income More than $10,000 | 4 Participants |
| Race/Ethnicity, Customized Black/African American | 8 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 4 Participants |
| Relationship Status Married/Partnered | 3 Participants |
| Relationship Status Separated/Divorced | 5 Participants |
| Relationship Status Single | 5 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 0 Participants |
| Years since diagnosis Less than 5 years ago | 1 Participants |
| Years since diagnosis More than 5 years ago | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Number of Participants Completing Treatment Sessions
The investigators will assess feasibility by collecting data on the number of completed treatment sessions.
Time frame: Approximately 10 weeks after baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment: Relaxation Response Resiliency Program (3RP) | Number of Participants Completing Treatment Sessions | Attended at least half of group sessions | 4 Participants |
| Treatment: Relaxation Response Resiliency Program (3RP) | Number of Participants Completing Treatment Sessions | Attended fewer than half of group sessions | 9 Participants |
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.
Time frame: Approximately 10 weeks after baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment: Relaxation Response Resiliency Program (3RP) | Participant Satisfaction With Study Procedures | Very satisfied | 6 Participants |
| Treatment: Relaxation Response Resiliency Program (3RP) | Participant Satisfaction With Study Procedures | Mostly satisfied | 1 Participants |