NCT03071887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

November 27, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 20, 2019

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

9 months

First QC Date

February 22, 2017

Results QC Date

August 27, 2019

Last Update Submit

October 24, 2019

Conditions

Resilience, Psychological

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Completing Treatment Sessions

    The investigators will assess feasibility by collecting data on the number of completed treatment sessions.

    Approximately 10 weeks after baseline

  • 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".

    Approximately 10 weeks after baseline

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Relaxation Response Resiliency Program (3RP)

Interventions

Relaxation Response Resiliency Program (3RP)BEHAVIORAL

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.

Intervention

Eligibility Criteria

Age50 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe investigators will recruit biologically born women who endorse a female gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • biologically born women who endorse a female identity
  • HIV-infected
  • age 50 or older
  • English speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • Stanton AM, Goodman GR, Blyler A, Kirakosian N, Labbe AK, Robbins GK, Park ER, Psaros C. Mental Health, Social Connectedness, and Fear During the COVID-19 Pandemic: A Qualitative Perspective from Older Women with HIV. AIDS Behav. 2023 Jul;27(7):2176-2189. doi: 10.1007/s10461-022-03950-9. Epub 2022 Dec 20.

    PMID: 36538139DERIVED

Results Point of Contact

Title
Dr. Christina Psaros
Organization
Massachusetts General Hospital
cpsaros@mgh.harvard.edu
617.726.7458

Study Officials

  • Christina Psaros, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This is an open pilot of the adapted Relaxation Response Resiliency Program (3RP).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

February 22, 2017

First Posted

March 7, 2017

Study Start

November 27, 2017

Primary Completion

August 27, 2018

Study Completion

August 27, 2018

Last Updated

October 28, 2019

Results First Posted

September 20, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)