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

NCT06548035 | Completed DMC

• 2 other identifiers: 2024P001407R34MH126753
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Burnout, Professional

Keywords

Nurses; HIV; Resiliency

Outcome Measures

Primary Outcomes (3)

• Feasibility of Study Procedures, as Assessed by Number of Individuals Enrolled and Number of Assessments and Sessions Completed by Enrolled Individuals.

  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.

  Through study completion, approximately 12 months after initiation

• Acceptability of Study Procedures, as Assessed by the Client Satisfaction Questionnaire

  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.

  Immediately after the intervention

• Acceptability of Study Procedures

  Acceptability will also be assessed via qualitative exit interviews.

  Immediately after the intervention

Secondary Outcomes (12)

• Resilience

  Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention

• Perceived Stress

  Baseline, pre-intervention; immediately after the intervention; 3 months after the 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

Study Arms (2)

Control

NO INTERVENTION

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

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.

Behavioral: Adapted Relaxation Response Resiliency Program (3RP)

Interventions

Adapted Relaxation Response Resiliency Program (3RP) BEHAVIORAL

The 3RP intervention is an integrated program of relaxation response (RR) eliciting meditation and mindfulness exercises, social support, cognitive skills training, and positive psychology focused on developing skills to reduce the stress response, elicit the relaxation response and enhance resiliency.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Participation in cognitive behavioral therapy and/or a mind-body intervention in the past year.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator
• Wits Health Consortium (Pty) Ltd: collaborator

Study Sites (1)

MatCh Research nit (MRU), a Division of Wits Health Consort

Durban, 4001, South Africa

Location

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Burnout, Psychological; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Behavioral Medicine Program

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 12, 2024
• Study Start: October 1, 2024
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: February 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)