Developing a Resiliency Intervention to Support Healthcare Workers Engaged in the Provision of HIV Care
NCT Number: NCT06548035
Acronym: Qinisa
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Burnout, Professional
Interventions: BEHAVIORAL: Adapted Relaxation Response Resiliency Program (3RP)
Sponsor: Massachusetts General Hospital
Collaborators: Wits Health Consortium (Pty) Ltd|National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2025-09

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.

Primary Outcome Measures: 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 Outcome Measures: Resilience, Measure of Current Status (MOCS-A): 13-item measure of stress reactivity and coping; statements are rated from 0 (I cannot do this at all) to 4 (I can do this extremely well); total score ranges from 0-52; higher scores suggest better coping skills. Current Experiences Scale (CES): 25-item measure of resiliency domains; scores range from 0-125; higher scores reflect greater resilience., Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention|Perceived Stress, Perceived Stress Scale (PSS-10): 10-item measure of the extent to which past month life situations are appraised as stressful. Scores range from 0-40; higher scores indicate higher perceived stress., Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention|Burnout, Maslach Burnout Inventory Human Services Survey for Medical Personnel (MBI-HSS \[MP\]): 22-item measure of job burnout in medical professionals. The MBI-HSS comprised 22 questions across 3 subscales; Emotional Exhaustion (EE)-9 questions, Depersonalization (DP)-5 questions, and self-perceived lack of Personal Accomplishment (PA)-8 questions.

High scores on the emotional exhaustion and depersonalization dimensions correspond to higher levels of burnout and high scores on the personal accomplishment dimension refer to lower levels of burnout., Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention|Absenteeism, Absenteeism will be measured by assessing unplanned days off from work in the prior 30 days., Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention.|Compassion Fatigue, Professional Quality of Life Scale (ProQOL) Version 5: 20-item burnout and secondary traumatic stress subscales from larger 30-item measure. Subscale scores range from 10-50; higher scores represent greater burnout and secondary traumatic stress., Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention|Stigma, Measuring HIV Stigma and Discrimination Among Health Facility Staff: Standardized Brief Questionnaire (BL). Higher score represent greater stigma., Baseline|Anxiety, Generalized Anxiety Disorder (GAD-7) scale: 7- item measure of the severity of anxiety symptoms over the past two weeks. Scores range from 0-21; cutoff scores of 5, 10, and 15 indicate mild, moderate, and severe anxiety., Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention|Depression, Patient Health Questionnaire (PHQ-9): 9-item tool to evaluate the presence and frequency of depressive symptoms in the past two weeks. Scores range from 0-27; cutoffs of 5, 10, 15, and 20 indicate mild, moderate, moderately severe, and severe depression., Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention|Social Support, Coping Orientation to Problems Experienced (COPE) Inventory: Two 4-item subscales of the 53-item COPE Inventory (use of emotional support, use of instrumental support) to assess frequency of use of social support to cope with stress. Subscale scores range from 4-16, with higher scores indicating greater use of emotional or instrumental support., Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention|Optimism, Life Orientation Test - Revised (LOT-R): 10-item measure of generalized optimism vs. pessimism about the future. Total scores range from 0-24; higher scores indicate greater optimism., Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention|Distress Tolerance, Distress Tolerance Scale (DTS): 15-item measure. Total scores range from 15-75; higher scores indicate greater distress tolerance.

of emotional distress tolerance., Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention|Adherence to 3RP intervention skills, Practice notes have been developed to correspond with each module of the 3RP treatment.

Participants will be asked to keep brief daily diaries of their out-of-session practice of core skills, which will be used to generate a rating of adherence to out-of-session practice guidelines. Note, completion will be encouraged but is not required., Weeks 1-6 of intervention