Trial Outcomes & Findings for Resilience Intervention for Older, HIV-Infected Women (NCT NCT03071887)

NCT ID: NCT03071887

Last Updated: 2019-10-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: Approximately 10 weeks after baseline
• Results posted on: 2019-10-28

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	13
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Resilience Intervention for Older, HIV-Infected Women

Baseline characteristics by cohort

Measure	Treatment: Relaxation Response Resiliency Program (3RP) n=13 Participants 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.
Age, Continuous	57.6 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	8 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Education Less than high school degree	5 Participants n=5 Participants
Education High school graduate/GED	1 Participants n=5 Participants
Education College/graduate school partial/degree	7 Participants n=5 Participants
Current Employment Status Full-Time	1 Participants n=5 Participants
Current Employment Status Part-Time	2 Participants n=5 Participants
Current Employment Status Disabled/retired	9 Participants n=5 Participants
Current Employment Status Other	1 Participants n=5 Participants
Relationship Status Single	5 Participants n=5 Participants
Relationship Status Married/Partnered	3 Participants n=5 Participants
Relationship Status Separated/Divorced	5 Participants n=5 Participants
Monthly Income $10,000 or less	9 Participants n=5 Participants
Monthly Income More than $10,000	4 Participants n=5 Participants
Years since diagnosis More than 5 years ago	12 Participants n=5 Participants
Years since diagnosis Less than 5 years ago	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 10 weeks after baseline

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

Outcome measures

Measure	Treatment: Relaxation Response Resiliency Program (3RP) n=13 Participants 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.
Number of Participants Completing Treatment Sessions Attended at least half of group sessions	4 Participants
Number of Participants Completing Treatment Sessions Attended fewer than half of group sessions	9 Participants

PRIMARY outcome

Timeframe: 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".

Outcome measures

Measure	Treatment: Relaxation Response Resiliency Program (3RP) n=7 Participants 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.
Participant Satisfaction With Study Procedures Very satisfied	6 Participants
Participant Satisfaction With Study Procedures Mostly satisfied	1 Participants

Adverse Events

Treatment: Relaxation Response Resiliency Program (3RP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christina Psaros

Massachusetts General Hospital

Phone: 617.726.7458

Email: cpsaros@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place