Moral InjuryICU-RESILIENCENCT07896447
Mobile-Based Resilience Intervention for Moral Injury, Compassion Fatigue, and Distress in ICU Nurses
A study testing Behavioral in people with Moral Injury, run by Alexandria University at 1 site in Egypt.
Trial summary
Critical care nurses are routinely exposed to high acuity, mortality, end-of-life decisions, and long rotating shifts, which can lead to moral injury, compassion fatigue (burnout and secondary traumatic stress), and psychological distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moral Injury
- What is being tested?
- Behavioral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently working as a full-time staff nurse in one of the study intensive care units (General, Trauma, Neurosurgical, Medical, or Chest ICU) of Beni-Suef University Hospitals for at least 6 months.
- Owns and routinely uses a smartphone.
- Willing to download and engage with the mobile application.
- Written informed consent.
Who cannot join
- Extended leave (sick or maternity) overlapping the 12-week trial window.
- Current receipt of formal psychotherapy or psychotropic medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Alexandria University Hospital, Faculty of Nursing
Alexandria, Alexandria Governorate, 21511
About this study
Official title: Effectiveness of a Mobile-Based Workplace Resilience Intervention in Mitigating Moral Injury, Compassion Fatigue, and Psychological Distress Among Critical Care Nurses: A Randomized Controlled Trial
Critical care nurses are routinely exposed to high acuity, mortality, end-of-life decisions, and long rotating shifts, which can lead to moral injury, compassion fatigue (burnout and secondary traumatic stress), and psychological distress. This randomized controlled trial will test the effectiveness of ICU Resilience, an 8-week, self-paced, Arabic-language mobile-based workplace resilience intervention, in reducing these outcomes among full-time nurses working in the intensive care units of Beni-Suef University Hospitals, Egypt.
One hundred sixty nurses will be randomly allocated 1:1 to the intervention or a control arm. The intervention is grounded in Conservation of Resources theory and an integrated cognitive-reappraisal and psycho-spiritual resilience framework, organized around psychological, emotional, social, and professional resources. Each weekly module includes a micro-learning video, an audio-guided exercise, an interactive digital tool, and a daily one-minute micro-practice, covering psychoeducation, mindfulness and somatic regulation, cognitive reappraisal, self-compassion, meaning-making, social support, practical coping, and relapse prevention. Control participants receive usual workplace orientation and routine hospital support and are offered the app after the final assessment.
Moral injury, burnout, secondary traumatic stress, psychological distress, and resilience will be measured with self-report scales at baseline, immediately after the intervention (week 8), and at one-month follow-up (week 12).
- Conditions
- Moral Injury
- Being tested
- Behavioral
- Keywords
- Mobile health
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehavioralBehavioural
Eight weekly modules delivered individually and asynchronously through a web-based mobile application in Arabic, with no facilitator. Each module includes a micro-learning video (5-7 minutes), an audio-guided exercise (3-10 minutes), an interactive digital tool, and a daily 1-minute micro-practice. Weekly topics: psychoeducation; mindfulness and somatic regulation; cognitive reappraisal; self-compassion and emotion regulation; meaning-making and values; social support; practical coping and shift micro-drills; integration and relapse prevention. Grounded in Conservation of Resources theory and a cognitive-reappraisal and psycho-spiritual resilience framework. Automated reminders prompt module and daily practice completion.
| Study group | Role | What they receive |
|---|---|---|
| ICU Resilience App | Experimental | Participants use the ICU Resilience mobile application for 8 consecutive weeks (one module per week plus daily one-minute micro-practices) in addition to usual workplace orientation and routine hospital support. Receives: Behavioral: Behavioral |
| Usual Support Control | No intervention | Participants receive usual workplace orientation and routine hospital support, with no access to the app during the trial. They complete the same assessments at the same time points and are offered the app after the follow-up assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moral injury: Moral Injury Symptom Scale-Healthcare Professionals (MISS-HP) total score
Moral injury symptoms measured with the Moral Injury Symptom Scale-Healthcare Professionals (MISS-HP; Mantri et al., 2020), a 10-item self-report questionnaire. Items are rated from 1 (strongly disagree) to 10 (strongly agree); items 5, 6, 7, and 10 are reverse-coded. Minimum total score 10, maximum 100. Higher scores indicate greater moral injury (worse outcome). Unit of measure: score on a scale.
Measured: Baseline (T0), immediately after the 8-week intervention (T1, week 8), and one-month follow-up (T2, week 12)
urnout: Professional Quality of Life Scale version 5 (ProQOL-5), Burnout subscale score
Burnout measured with the 10-item Burnout subscale of the Professional Quality of Life Scale version 5 (ProQOL-5; Stamm, 2009), one of two subscales used to operationalize compassion fatigue. Items are rated from 1 (never) to 5 (very often) for the past 30 days; items 1, 4, 15, 17, and 29 are reverse-scored. Minimum subscale score 10, maximum 50. Higher scores indicate greater burnout (worse outcome). Unit of measure: score on a scale.
Measured: Baseline (T0), immediately after the 8-week intervention (T1, week 8), and one-month follow-up (T2, week 12)
Secondary traumatic stress: Professional Quality of Life Scale version 5 (ProQOL-5), Secondary Traumatic Stress subscale score
Secondary traumatic stress measured with the 10-item Secondary Traumatic Stress subscale of the Professional Quality of Life Scale version 5 (ProQOL-5; Stamm, 2009), one of two subscales used to operationalize compassion fatigue. Items are rated from 1 (never) to 5 (very often) for the past 30 days. Minimum subscale score 10, maximum 50. Higher scores indicate greater secondary traumatic stress (worse outcome). Unit of measure: score on a scale.
Measured: Baseline (T0), immediately after the 8-week intervention (T1, week 8), and one-month follow-up (T2, week 12)
Psychological distress: Kessler Psychological Distress Scale (K10) total score
Non-specific psychological distress (anxiety and depressive symptoms) measured with the Kessler Psychological Distress Scale (K10; Kessler et al., 2002), a 10-item self-report questionnaire covering the preceding four weeks. Items are rated from 1 (none of the time) to 5 (all of the time). Minimum total score 10, maximum 50. Higher scores indicate greater psychological distress (worse outcome). Unit of measure: score on a scale.
Measured: Baseline (T0), immediately after the 8-week intervention (T1, week 8), and one-month follow-up (T2, week 12)
Secondary outcomes (1)
Resilience: 10-item Connor-Davidson Resilience Scale (CD-RISC-10) total score
Resilience measured with the 10-item Connor-Davidson Resilience Scale (CD-RISC-10; Campbell-Sills and Stein, 2007), a self-report questionnaire covering the past month. Items are rated from 0 (not true at all) to 4 (true nearly all the time). Minimum total score 0, maximum 40. Higher scores indicate greater resilience (better outcome). Unit of measure: score on a scale.
Measured: Baseline (T0), immediately after the 8-week intervention (T1, week 8), and one-month follow-up (T2, week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moral InjuryStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group, individually randomized controlled trial with 1:1 allocation comparing an 8-week mobile-based workplace resilience intervention with usual workplace orientation and routine hospital support. Outcomes are measured at baseline, immediately after the intervention (week 8), and at one-month follow-up (week 12). Control participants are offered the app after the follow-up assessment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fakhry Ahmed Salem, Alexandria University
- Investigators
- Mohamed Fakhry Salem, PHD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896447
- Sponsor's protocol ID
- FNBSURECP/25082026236
- Acronym
- ICU-RESILIENCE
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mobile-Based Workplace Resilience Intervention in Mitigating Moral Injury, Compassion Fatigue, and Psychological Distress Among Critical Care Nurses: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07896447
- Acronym / sponsor ID
- ICU-RESILIENCE / FNBSURECP/25082026236
- Conditions
- Moral Injury
- Keywords
- Mobile health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 27 Oct 2026 (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.
Critical care nurses are routinely exposed to high acuity, mortality, end-of-life decisions, and long rotating shifts, which can lead to moral injury, compassion fatigue (burnout and secondary traumatic stress), and psychological distress. This randomized controlled trial will test the effectiveness of ICU Resilience, an 8-week, self-paced, Arabic-language mobile-based workplace resilience intervention, in reducing these outcomes among full-time nurses working in the intensive care units of Beni-Suef University Hospitals, Egypt.
One hundred sixty nurses will be randomly allocated 1:1 to the intervention or a control arm. The intervention is grounded in Conservation of Resources theory and an integrated cognitive-reappraisal and psycho-spiritual resilience framework, organized around psychological, emotional, social, and professional resources. Each weekly module includes a micro-learning video, an audio-guided exercise, an interactive digital tool, and a daily one-minute micro-practice, covering psychoeducation, mindfulness and somatic regulation, cognitive reappraisal, self-compassion, meaning-making, social support, practical coping, and relapse prevention. Control participants receive usual workplace orientation and routine hospital support and are offered the app after the final assessment.
Moral injury, burnout, secondary traumatic stress, psychological distress, and resilience will be measured with self-report scales at baseline, immediately after the intervention (week 8), and at one-month follow-up (week 12).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, individually randomized controlled trial with 1:1 allocation comparing an 8-week mobile-based workplace resilience intervention with usual workplace orientation and routine hospital support. Outcomes are measured at baseline, immediately after the intervention (week 8), and at one-month follow-up (week 12). Control participants are offered the app after the follow-up assessment.
| Arm | Type | Receives |
|---|---|---|
| ICU Resilience App | Experimental | Behavioral: BehavioralParticipants use the ICU Resilience mobile application for 8 consecutive weeks (one module per week plus daily one-minute micro-practices) in addition to usual workplace orientation and routine hospital support. |
| Usual Support Control | No intervention | –Participants receive usual workplace orientation and routine hospital support, with no access to the app during the trial. They complete the same assessments at the same time points and are offered the app after the follow-up assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Currently working as a full-time staff nurse in one of the study intensive care units (General, Trauma, Neurosurgical, Medical, or Chest ICU) of Beni-Suef University Hospitals for at least 6 months.
- Owns and routinely uses a smartphone.
- Willing to download and engage with the mobile application.
- Written informed consent.
Key exclusion criteria (2 listed)
- Extended leave (sick or maternity) overlapping the 12-week trial window.
- Current receipt of formal psychotherapy or psychotropic medication.
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 |
|---|---|---|
| BehavioralEight weekly modules delivered individually and asynchronously through a web-based mobile application in Arabic, with no facilitator. Each module includes a micro-learning video (5-7 minutes), an audio-guided exercise (3-10 minutes), an interactive digital tool, and a daily 1-minute micro-practice. Weekly topics: psychoeducation; mindfulness and somatic regulation; cognitive reappraisal; self-compassion and emotion regulation; meaning-making and values; social support; practical coping and shift micro-drills; integration and relapse prevention. Grounded in Conservation of Resources theory and a cognitive-reappraisal and psycho-spiritual resilience framework. Automated reminders prompt module and daily practice completion. | Behavioural | ICU Resilience App |
Primary outcome
Moral injury: Moral Injury Symptom Scale-Healthcare Professionals (MISS-HP) total score
Time frame: Baseline (T0), immediately after the 8-week intervention (T1, week 8), and one-month follow-up (T2, week 12)
Moral injury symptoms measured with the Moral Injury Symptom Scale-Healthcare Professionals (MISS-HP; Mantri et al., 2020), a 10-item self-report questionnaire. Items are rated from 1 (strongly disagree) to 10 (strongly agree); items 5, 6, 7, and 10 are reverse-coded. Minimum total score 10, maximum 100. Higher scores indicate greater moral injury (worse outcome). Unit of measure: score on a scale.
urnout: Professional Quality of Life Scale version 5 (ProQOL-5), Burnout subscale score
Time frame: Baseline (T0), immediately after the 8-week intervention (T1, week 8), and one-month follow-up (T2, week 12)
Burnout measured with the 10-item Burnout subscale of the Professional Quality of Life Scale version 5 (ProQOL-5; Stamm, 2009), one of two subscales used to operationalize compassion fatigue. Items are rated from 1 (never) to 5 (very often) for the past 30 days; items 1, 4, 15, 17, and 29 are reverse-scored. Minimum subscale score 10, maximum 50. Higher scores indicate greater burnout (worse outcome). Unit of measure: score on a scale.
Secondary traumatic stress: Professional Quality of Life Scale version 5 (ProQOL-5), Secondary Traumatic Stress subscale score
Time frame: Baseline (T0), immediately after the 8-week intervention (T1, week 8), and one-month follow-up (T2, week 12)
Secondary traumatic stress measured with the 10-item Secondary Traumatic Stress subscale of the Professional Quality of Life Scale version 5 (ProQOL-5; Stamm, 2009), one of two subscales used to operationalize compassion fatigue. Items are rated from 1 (never) to 5 (very often) for the past 30 days. Minimum subscale score 10, maximum 50. Higher scores indicate greater secondary traumatic stress (worse outcome). Unit of measure: score on a scale.
Psychological distress: Kessler Psychological Distress Scale (K10) total score
Time frame: Baseline (T0), immediately after the 8-week intervention (T1, week 8), and one-month follow-up (T2, week 12)
Non-specific psychological distress (anxiety and depressive symptoms) measured with the Kessler Psychological Distress Scale (K10; Kessler et al., 2002), a 10-item self-report questionnaire covering the preceding four weeks. Items are rated from 1 (none of the time) to 5 (all of the time). Minimum total score 10, maximum 50. Higher scores indicate greater psychological distress (worse outcome). Unit of measure: score on a scale.
1 secondary outcome
Resilience: 10-item Connor-Davidson Resilience Scale (CD-RISC-10) total score
Time frame: Baseline (T0), immediately after the 8-week intervention (T1, week 8), and one-month follow-up (T2, week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
Mohamed Fakhry Salem, PHD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral in people with Moral Injury, run by Alexandria University at 1 site in Egypt.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 27 Oct 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Fakhry Salem, PhD (01286038014, Mohamed.Fakhry@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moral injury: Moral Injury Symptom Scale-Healthcare Professionals (MISS-HP) total score (time frame: Baseline (T0), immediately after the 8-week intervention (T1, week 8), and one-month follow-up (T2, week 12)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.