Developing a Resiliency Intervention to Support Healthcare Workers Engaged in the Provision of HIV Care
Overview
- Phase
- N/A
- Intervention
- Control
- Conditions
- Stress
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals.
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
The purpose of this study is to pilot an adapted resiliency-based mind-body intervention (the Relaxation Response Resiliency Program; the 3RP) for nurses that care for people with HIV (PWH) in the public sector in South Africa (SA). In Phase 1 [NIH Grant Number: R34MH131426; Human Research Ethics Committee (HREC) Ethics Reference Number: 220813], the investigators conducted focus group discussions to solicit feedback on: the role of culture and perceptions of stress; the lived experiences of stress; sources of stress (e.g. occupational, trauma related); how stress impacts job functioning (specifically patient care); current coping strategies; and the intervention modules (content, number of sessions, session duration, program length, mode of delivery (e.g., virtual, in-person, hybrid approaches, use of coaches), etc.). In this phase 2, the investigators will conduct a small proof-of-concept study (N = 8-10), followed by a randomized pilot (N = 60) of nurses that care for PWH in the public sector in South Africa (SA) to test the feasibility and acceptability of the adapted intervention.
Detailed Description
This study will pilot test an adapted version of an existing stress management and resiliency-enhancing intervention (the Relaxation Response Resiliency Program; the 3RP) for nurses that care for PWH in the public sector in SA, to test the feasibility and acceptability of all study procedures. This intervention was adapted and refined from its original format (which consisted of eight, 90-minute weekly group sessions) following focus group discussions (FGDs) that explored nurses' preferences and desired modifications to the intervention (Phase 1 of this study). This trial will involve a randomized pilot study (N = 60) to test the feasibility and acceptability of the adapted intervention among nurses that care for PWH in the public sector in SA. Additionally, the randomized control trial (RCT) will collect anonymous clinic client data on demographics, satisfaction with care, client-provider trust, and likelihood of returning to care. We will also collect clinic-level data to understand how to measure client-related outcomes and clinic metrics of HIV care engagement, such as expected patient return rates/measures of retention, percentage of patients with suppressed viral load, frequency of viral load collection, and percentage of patients initiating second line treatment to best understand how to measure these variables in a larger trial testing the efficacy of the intervention.
Investigators
Christina Psaros
Associate Director, Behavioral Medicine Program
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Providing at least some primary HIV care in a public sector clinic (at the level of professional nurse) for at least one year;
- •IsiZulu or English speaking;
- •Able and willing to sign informed consent.
Exclusion Criteria
- •\- Participation in cognitive behavioral therapy and/or a mind-body intervention in the past year.
Arms & Interventions
Control
The control condition will be a one-time, \~90-minute, didactic stress management session (with no interventionist follow-up). The session will provide information on the four-component model of stress and the energy battery exercise (asks participants to reflect on stressors and things that offset stress).
Intervention
The intervention condition will consist of six one-hour group sessions. The sessions will provide information on topics including relaxation response, the components of stress, recuperative sleep, mindful awareness, resilience, and social support. Sessions will also include practice-based exercises (e.g., breathing exercises, mindfulness exercises). Participants will also have the option of accessing a closed WhatsApp group moderated by the interventionist. The interventionist will initiate chats in between group sessions to provide support to participants in practicing stress management skills. All intervention sessions will be delivered by a trained professional nurse, who will be trained and closely supervised by the study team members. Individual supervision will be provided at least bi-weekly, with opportunities for group supervision with US interventionists using the 3RP intervention in other studies as needed.
Intervention: Adapted Relaxation Response Resiliency Program (3RP)
Outcomes
Primary Outcomes
Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals.
Time Frame: Through study completion, approximately 12 months after initiation
To assess feasibility, the investigators will track the number of participants screened, eligible, and enrolled; the number of treatment and assessment sessions completed; and reasons for declining enrollment and for prematurely leaving the trial.
Acceptability of Study Procedures, as Assessed by the Client Satisfaction Questionnaire
Time Frame: Immediately after the intervention
Acceptability will be measured through the Client Satisfaction Questionnaire (CSQ-8): 8-item measure of how much one values an intervention. Items scored from 1 (poor) to 4 (excellent); higher scores indicate greater satisfaction. Totals range from 8 to 32; with scores between 26 and 32 indicating 'excellent acceptability' and scores between 20 and 25 indicating 'good acceptability'. High internal consistency (alpha = 0.84-0.93) and used in HIV intervention research and resource-limited settings.
Acceptability of Study Procedures
Time Frame: Immediately after the intervention
Acceptability will also be assessed via qualitative exit interviews.
Secondary Outcomes
- Perceived Stress(Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention)
- Social Support(Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention)
- Adherence to 3RP intervention skills(Weeks 1-6 of intervention)
- Burnout(Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention)
- Absenteeism(Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention.)
- Compassion Fatigue(Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention)
- Depression(Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention)
- Optimism(Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention)
- Resilience(Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention)
- Stigma(Baseline)
- Anxiety(Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention)
- Distress Tolerance(Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention)