Developing a Resiliency Intervention to Support Healthcare Workers Engaged in the Provision of HIV Care (Qinisa)

Mass General Brigham

Status: Completed

Conditions: Burnout, Professional; Stress

Treatments: Behavioral: Adapted Relaxation Response Resiliency Program (3RP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06548035

2024P001407

R34MH126753 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Behavioral: Adapted Relaxation Response Resiliency Program (3RP)