Resilience Intervention for Older, HIV-Infected Women

Not Applicable

Completed

• Conditions: Resilience, Psychological
• Interventions: Behavioral: Relaxation Response Resiliency Program (3RP)

• Registration Number: NCT03071887
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-07
• Study Start: 2017-11-27
• Primary Completion: 2018-08-27
• Study Completion: 2018-08-27
• Results First Submitted: 2019-08-27
• Results First Submitted QC: 2019-09-19
• Results First Posted: 2019-09-20
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-24
• Last Update Posted: 2019-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Relaxation Response Resiliency Program (3RP)	Treatment arm - Relaxation Response Resiliency Program (3RP) (this is an open pilot; the treatment arm is the only arm)

Primary Outcome Measures

Name	Time	Method
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".

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States