StressQinisaNCT06548035
Developing a Resiliency Intervention to Support Healthcare Workers Engaged in the Provision of HIV Care
A study testing Adapted Relaxation Response Resiliency Program (3RP) in people with Stress and Burnout, Professional, run by Massachusetts General Hospital at 1 site in South Africa.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Burnout, Professional
- What is being tested?
- Adapted Relaxation Response Resiliency Program (3RP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Oct 2024to 29 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participation in cognitive behavioral therapy and/or a mind-body intervention in the past year.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
MatCh Research nit (MRU), a Division of Wits Health Consort
Durban, 4001
About this study
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.
Read the 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.
- Conditions
- Stress, Burnout, Professional
- Being tested
- Adapted Relaxation Response Resiliency Program (3RP)
- Keywords
- Nurses, HIV, Resiliency
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Relaxation Response Resiliency Program (3RP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Adapted Relaxation Response Resiliency Program (3RP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after the intervention
Acceptability of Study Procedures
Acceptability will also be assessed via qualitative exit interviews.
Measured: Immediately after the intervention
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 1-6 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Oct 2024
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Wits Health Consortium (Pty) Ltd
- Responsible party
- Principal investigator, Christina Psaros, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548035
- Sponsor's protocol ID
- 2024P001407
- Other IDs
- R34MH126753
- Acronym
- Qinisa
- Status last verified
- Oct 2025
- First submitted
- 30 Jul 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Psaros C, Smit JA, Mosery N, Traeger LN, Mngomezulu S, Qiya B, Maphumulo B, Stanton AM, Aoun ZR, Bedoya CA, Park ER. A Resiliency Intervention to Support Nurses Engaged in the Provision of HIV Care in KwaZulu-Natal, South Africa: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 25;15:e79777. doi: 10.2196/79777.
PubMed 42358082
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Resiliency Intervention to Support Healthcare Workers Engaged in the Provision of HIV Care
- ClinicalTrials.gov ID
- NCT06548035
- Acronym / sponsor ID
- Qinisa / 2024P001407
- Conditions
- Stress, Burnout, Professional
- Keywords
- Nurses, HIV, Resiliency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Wits Health Consortium (Pty) Ltd
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Adapted Relaxation Response Resiliency Program (3RP)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participation in cognitive behavioral therapy and/or a mind-body intervention in the past year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Relaxation Response Resiliency Program (3RP)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. | Behavioural | Intervention |
Primary outcome
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.
12 secondary outcomes
Resilience
Time frame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Perceived Stress
Time frame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Burnout
Time frame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Absenteeism
Time frame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention.
Compassion Fatigue
Time frame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Stigma
Time frame: Baseline
Anxiety
Time frame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Depression
Time frame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Social Support
Time frame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Optimism
Time frame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Distress Tolerance
Time frame: Baseline, pre-intervention; immediately after the intervention; 3 months after the intervention
Adherence to 3RP intervention skills
Time frame: Weeks 1-6 of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Derived from this study: PubMed 42358082Psaros C, Smit JA, Mosery N, Traeger LN, Mngomezulu S, Qiya B, Maphumulo B, Stanton AM, Aoun ZR, Bedoya CA, Park ER. A Resiliency Intervention to Support Nurses Engaged in the Provision of HIV Care in KwaZulu-Natal, South Africa: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 25;15:e79777. doi: 10.2196/79777.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Relaxation Response Resiliency Program (3RP) in people with Stress and Burnout, Professional, run by Massachusetts General Hospital at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06548035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.