Therapeutic EngagementECTPNCT07902336
Empathy and Communication Training Program for Psychiatric Nurse Specialists in Saudi Arabia (ECTP)
A study testing Usual institutional training (Madinah) and ECTP (Dammam) in people with Therapeutic Engagement and Psychiatric Nursing, run by Lincoln University College at 2 sites in Saudi Arabia.
Trial summary
This study tests whether a five-day Empathy and Communication Training Program (ECTP) helps psychiatric nurse specialists in Saudi Arabia engage better with their patients. Good relationships between nurses and patients are central to mental health care, but structured training in empathy and communication is limited… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Engagement, Psychiatric Nursing, Nurse-Patient Relations
- What is being tested?
- Usual institutional training (Madinah) and ECTP (Dammam)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 1 Mar 2025to 30 Jul 2026
- 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
- Currently employed at one of the two study hospitals (Eradah Complex for Mental Health, Dammam, or Eradah Hospital for Mental Health, Madinah)
- Psychiatric nurse specialist assigned to a psychiatric ward or an outpatient psychiatric or addiction clinic, with direct patient care responsibilities
- At least six months of psychiatric nursing experience
- Written informed consent
Who cannot join
- Less than six months of psychiatric nursing experience
- Currently on extended leave (for example maternity leave, sick leave or other long-term absence)
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
Eradah Complex for Mental Health
Dammam, Eastern Province, 32253
Eradah Hospital for Mental Health
Madinah, Al Madinah Province, 42363
About this study
Official title: Effectiveness of an Empathy and Communication Training Program on Nurse-Reported Therapeutic Engagement Among Psychiatric Nurse Specialists in Saudi Arabia: A Two-Site Quasi-Experimental Study With an Explanatory Sequential Mixed-Methods Design
This study tests whether a five-day Empathy and Communication Training Program (ECTP) helps psychiatric nurse specialists in Saudi Arabia engage better with their patients. Good relationships between nurses and patients are central to mental health care, but structured training in empathy and communication is limited in Saudi psychiatric hospitals.
The ECTP is a face-to-face program of five two-hour sessions (10 hours in total). It covers empathy and communication, the work environment, language and cultural barriers, and emotional preparedness. Sessions use short lectures, role-play, case discussions and group reflection.
Read more
The study took place at two psychiatric hospitals. Nurses at the Eradah Complex for Mental Health in Dammam took the ECTP. Nurses at the Eradah Hospital for Mental Health in Madinah attended their usual hospital training sessions instead. Participants were not randomly assigned. The hospital they worked in decided which group they joined.
Nurses at both hospitals completed a 15-item questionnaire about therapeutic engagement before and after the training period. After the program, 15 nurses from the Dammam group were interviewed about how the training affected their work and what barriers remained.
The study aims to find out whether nurses' self-reported therapeutic engagement improves after the ECTP compared with usual training, and to understand nurses' own experiences of the program.
Read the detailed description
BACKGROUND The relationship between nurse and patient is a core part of effective psychiatric care. Empathy, active listening, trust and clear communication are its main building blocks. In Saudi Arabia, language and cultural differences within a diverse nursing workforce, together with heavy workloads, can make these relationships harder to build. Structured empathy and communication training for psychiatric nurses is scarce in Saudi hospitals and has rarely been evaluated.
DESIGN This is an explanatory sequential mixed-methods study. The first phase is a quasi-experimental, pre-test/post-test, non-equivalent control-group study. The second phase is a descriptive qualitative study using semi-structured interviews. Participants were assigned to conditions by hospital site rather than individually, because individual randomisation was not feasible (different institutional protocols, geographical separation, the need to keep routine clinical operations running) and to limit contamination between groups.
SETTING AND PARTICIPANTS The intervention site was the Eradah Complex for Mental Health in Dammam (Eastern Region). The control site was the Eradah Hospital for Mental Health in Madinah (Western Region). Both are tertiary psychiatric hospitals providing inpatient, outpatient and addiction services. All eligible psychiatric nurse specialists providing direct patient care at each site were invited to take part. Written informed consent was obtained from all participants.
INTERVENTION The ECTP was developed by the principal investigator with a panel of three experts in psychiatric nursing and nursing education. It was delivered 2 to 6 August 2026 by nurse educators and psychiatric nurse trainers with at least five years of experience in mental health education. Day 1 covered orientation and baseline assessment. Day 2 covered empathy and communication, Day 3 the work environment and training, Day 4 language and cultural barriers, and Day 5 emotional preparedness. Methods included short lectures, role-play, case-based discussion and reflective group activities.
COMPARATOR Control-group nurses attended usual institutional training sessions of their own choosing, lasting 5 to 8 hours, and submitted certificates of attendance. Because this content varied and could include material related to communication or de-escalation, the comparator is usual institutional training and not a no-training control.
DATA COLLECTION Participants completed a paper-based questionnaire in hospital classrooms during working hours, under researcher supervision. The 15-item questionnaire was adapted from the Therapeutic Engagement Questionnaire (used with permission from the developers at Kingston University London) and has four domains: empathy and communication, work environment and training, language and cultural barriers, and emotional preparedness. Items are rated 1 to 5. Three barrier-worded items are reverse-scored so that higher scores always mean more favourable engagement. The questionnaire was given at baseline and immediately after Day 5 for the intervention group, and at an equivalent interval for the control group. Participants created anonymous codes so that their before and after responses could be matched.
After the program, a purposive sample of intervention-group nurses took part in face-to-face interviews of 35 to 55 minutes, audio-recorded with separate written consent. Interviews continued until thematic saturation (15 participants).
SAMPLE SIZE A power analysis (independent-samples t-test, two-tailed, alpha 0.05, power 0.80, Cohen's d 0.50) gave a minimum of 64 participants per group. After finite population correction and a 15% allowance for attrition, the target samples were 66 (Dammam) and 61 (Madinah).
ANALYSIS Quantitative data are analysed with paired and independent-samples t-tests, with non-parametric tests as robustness checks, and with analysis of covariance using baseline score as the covariate. Effect sizes are reported as Cohen's d and partial eta squared. Interview transcripts are analysed with thematic analysis (Braun and Clarke) in NVivo. Quantitative and qualitative findings are integrated using a joint display.
REGISTRATION This study was registered retrospectively, after data collection had finished.
- Conditions
- Therapeutic Engagement, Psychiatric Nursing, Nurse-Patient Relations, Empathy, Communication
- Being tested
- Usual institutional training (Madinah), ECTP (Dammam)
- Keywords
- empathy training, communication training, therapeutic engagement, psychiatric nursing, mental health nursing, nurse education, quasi-experimental, Saudi Arabia
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual institutional training (Madinah)Other
Training sessions of the nurse's own choosing, offered as part of routine hospital education (for example on substance use, personality disorders or trauma-informed care), lasting 5-8 hours. Nurses submitted certificates of attendance.
ECTP (Dammam)Behavioural
Structured five-day, face-to-face training program, two hours per day (10 hours in total), delivered 2-6 August 2026 by nurse educators and psychiatric nurse trainers. Day 1: orientation and baseline assessment. Day 2: empathy and communication. Day 3: work environment and training. Day 4: language and cultural barriers. Day 5: emotional preparedness. Methods: short lectures, role-play, case-based discussion and reflective group activities.
| Study group | Role | What they receive |
|---|---|---|
| ECTP (Dammam) | Experimental | Psychiatric nurse specialists at the Eradah Complex for Mental Health, Dammam, who took part in the five-day ECTP. They completed the therapeutic engagement questionnaire at baseline (Day 1) and immediately after Day 5. Fifteen of these nurses were interviewed afterwards. Receives: Behavioral: ECTP (Dammam) |
| Usual institutional training (Madinah) | Active comparator | Psychiatric nurse specialists at the Eradah Hospital for Mental Health, Madinah, who did not receive the ECTP and attended usual institutional training sessions of their choice (5-8 hours). They completed the same questionnaire at baseline and at an equivalent interval later. Receives: Other: Usual institutional training (Madinah) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall nurse-reported patient therapeutic engagement (PTE) score
Overall score on the 15-item nurse-reported PTE questionnaire, adapted from the Therapeutic Engagement Questionnaire. Each item is rated from 1 (strongly disagree) to 5 (strongly agree). Items 5, 9 and 10 describe barriers and are reverse-scored (6 minus the original value). The overall score is the mean of all 15 items (range 1 to 5). Higher scores mean more favourable therapeutic engagement. The outcome is the change from baseline to post-test, compared between the intervention group (Dammam) and the control group (Madinah).
Measured: Baseline (Day 1) and immediately after Day 5 of the program (August 2026)
Secondary outcomes (4)
Change in Empathy and Communication domain score
Mean of items 1 to 3 of the PTE questionnaire (range 1 to 5). Higher scores mean more favourable engagement.
Measured: Baseline (Day 1) and immediately after Day 5 of the program (August 2026).
Change in Work Environment and Training domain score
Mean of items 4 to 8 of the PTE questionnaire (range 1 to 5), with item 5 reverse-scored. Higher scores mean more favourable engagement.
Measured: Baseline (Day 1) and immediately after Day 5 of the program (August 2026).
Change in Language and Cultural Barriers domain score
Mean of items 9 and 10 of the PTE questionnaire (range 1 to 5), both reverse-scored. Higher scores mean fewer perceived barriers.
Measured: Baseline (Day 1) and immediately after Day 5 of the program (August 2026).
Change in Emotional Preparedness domain score
Mean of items 11 to 15 of the PTE questionnaire (range 1 to 5). Higher scores mean more favourable engagement.
Measured: Baseline (Day 1) and immediately after Day 5 of the program (August 2026).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Mar 2025
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Therapeutic EngagementStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental, pre-test/post-test, non-equivalent control-group design followed by an explanatory sequential qualitative phase. Participants were assigned to the intervention or the control condition by hospital site (Dammam: ECTP; Madinah: usual institutional training), not individually. Fifteen intervention-group nurses were interviewed after the program.
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lincoln University College
- Sponsor type
- University, hospital or other
- Collaborators
- Lincoln University College Malaysia
- Responsible party
- Principal investigator, Amer Ahmed Amer Alammari, Lincoln University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902336
- Sponsor's protocol ID
- ECTP-DMM-2026
- Acronym
- ECTP
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified questionnaire data (anonymous participant codes, demographic variables and item-level responses) will be shared with qualified researchers on reasonable request to the corresponding author. Interview transcripts and audio recordings will not be shared, to protect participant confidentiality.
Publications
Hartley S, Raphael J, Lovell K, Berry K. Effective nurse-patient relationships in mental health care: A systematic review of interventions to improve the therapeutic alliance. Int J Nurs Stud. 2020 Feb;102:103490. doi: 10.1016/j.ijnurstu.2019.103490. Epub 2019 Nov 23.
PubMed 31862531Chambers M, McAndrew S, Nolan F, Thomas B, Watts P, Grant R, Kantaris X. The Therapeutic Engagement Questionnaire (TEQ): a service user-focused mental health nursing outcome metric. BMC Psychiatry. 2019 Dec 3;19(1):384. doi: 10.1186/s12888-019-2326-x.
PubMed 31796008
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Empathy and Communication Training Program on Nurse-Reported Therapeutic Engagement Among Psychiatric Nurse Specialists in Saudi Arabia: A Two-Site Quasi-Experimental Study With an Explanatory Sequential Mixed-Methods Design
- ClinicalTrials.gov ID
- NCT07902336
- Acronym / sponsor ID
- ECTP / ECTP-DMM-2026
- Conditions
- Therapeutic Engagement, Psychiatric Nursing, Nurse-Patient Relations, Empathy, Communication
- Keywords
- empathy training, communication training, therapeutic engagement, psychiatric nursing, mental health nursing, nurse education, quasi-experimental, Saudi Arabia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Lincoln University CollegeUniversity, hospital or other
- Collaborators
- Lincoln University College Malaysia
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 28 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.
This study tests whether a five-day Empathy and Communication Training Program (ECTP) helps psychiatric nurse specialists in Saudi Arabia engage better with their patients. Good relationships between nurses and patients are central to mental health care, but structured training in empathy and communication is limited in Saudi psychiatric hospitals.
The ECTP is a face-to-face program of five two-hour sessions (10 hours in total). It covers empathy and communication, the work environment, language and cultural barriers, and emotional preparedness. Sessions use short lectures, role-play, case discussions and group reflection.
The study took place at two psychiatric hospitals. Nurses at the Eradah Complex for Mental Health in Dammam took the ECTP. Nurses at the Eradah Hospital for Mental Health in Madinah attended their usual hospital training sessions instead. Participants were not randomly assigned. The hospital they worked in decided which group they joined.
Nurses at both hospitals completed a 15-item questionnaire about therapeutic engagement before and after the training period. After the program, 15 nurses from the Dammam group were interviewed about how the training affected their work and what barriers remained.
The study aims to find out whether nurses' self-reported therapeutic engagement improves after the ECTP compared with usual training, and to understand nurses' own experiences of the program.
Detailed description
BACKGROUND The relationship between nurse and patient is a core part of effective psychiatric care. Empathy, active listening, trust and clear communication are its main building blocks. In Saudi Arabia, language and cultural differences within a diverse nursing workforce, together with heavy workloads, can make these relationships harder to build. Structured empathy and communication training for psychiatric nurses is scarce in Saudi hospitals and has rarely been evaluated.
DESIGN This is an explanatory sequential mixed-methods study. The first phase is a quasi-experimental, pre-test/post-test, non-equivalent control-group study. The second phase is a descriptive qualitative study using semi-structured interviews. Participants were assigned to conditions by hospital site rather than individually, because individual randomisation was not feasible (different institutional protocols, geographical separation, the need to keep routine clinical operations running) and to limit contamination between groups.
SETTING AND PARTICIPANTS The intervention site was the Eradah Complex for Mental Health in Dammam (Eastern Region). The control site was the Eradah Hospital for Mental Health in Madinah (Western Region). Both are tertiary psychiatric hospitals providing inpatient, outpatient and addiction services. All eligible psychiatric nurse specialists providing direct patient care at each site were invited to take part. Written informed consent was obtained from all participants.
INTERVENTION The ECTP was developed by the principal investigator with a panel of three experts in psychiatric nursing and nursing education. It was delivered 2 to 6 August 2026 by nurse educators and psychiatric nurse trainers with at least five years of experience in mental health education. Day 1 covered orientation and baseline assessment. Day 2 covered empathy and communication, Day 3 the work environment and training, Day 4 language and cultural barriers, and Day 5 emotional preparedness. Methods included short lectures, role-play, case-based discussion and reflective group activities.
COMPARATOR Control-group nurses attended usual institutional training sessions of their own choosing, lasting 5 to 8 hours, and submitted certificates of attendance. Because this content varied and could include material related to communication or de-escalation, the comparator is usual institutional training and not a no-training control.
DATA COLLECTION Participants completed a paper-based questionnaire in hospital classrooms during working hours, under researcher supervision. The 15-item questionnaire was adapted from the Therapeutic Engagement Questionnaire (used with permission from the developers at Kingston University London) and has four domains: empathy and communication, work environment and training, language and cultural barriers, and emotional preparedness. Items are rated 1 to 5. Three barrier-worded items are reverse-scored so that higher scores always mean more favourable engagement. The questionnaire was given at baseline and immediately after Day 5 for the intervention group, and at an equivalent interval for the control group. Participants created anonymous codes so that their before and after responses could be matched.
After the program, a purposive sample of intervention-group nurses took part in face-to-face interviews of 35 to 55 minutes, audio-recorded with separate written consent. Interviews continued until thematic saturation (15 participants).
SAMPLE SIZE A power analysis (independent-samples t-test, two-tailed, alpha 0.05, power 0.80, Cohen's d 0.50) gave a minimum of 64 participants per group. After finite population correction and a 15% allowance for attrition, the target samples were 66 (Dammam) and 61 (Madinah).
ANALYSIS Quantitative data are analysed with paired and independent-samples t-tests, with non-parametric tests as robustness checks, and with analysis of covariance using baseline score as the covariate. Effect sizes are reported as Cohen's d and partial eta squared. Interview transcripts are analysed with thematic analysis (Braun and Clarke) in NVivo. Quantitative and qualitative findings are integrated using a joint display.
REGISTRATION This study was registered retrospectively, after data collection had finished.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental, pre-test/post-test, non-equivalent control-group design followed by an explanatory sequential qualitative phase. Participants were assigned to the intervention or the control condition by hospital site (Dammam: ECTP; Madinah: usual institutional training), not individually. Fifteen intervention-group nurses were interviewed after the program.
| Arm | Type | Receives |
|---|---|---|
| ECTP (Dammam) | Experimental | Behavioral: ECTP (Dammam)Psychiatric nurse specialists at the Eradah Complex for Mental Health, Dammam, who took part in the five-day ECTP. They completed the therapeutic engagement questionnaire at baseline (Day 1) and immediately after Day 5. Fifteen of these nurses were interviewed afterwards. |
| Usual institutional training (Madinah) | Active comparator | Other: Usual institutional training (Madinah)Psychiatric nurse specialists at the Eradah Hospital for Mental Health, Madinah, who did not receive the ECTP and attended usual institutional training sessions of their choice (5-8 hours). They completed the same questionnaire at baseline and at an equivalent interval later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Currently employed at one of the two study hospitals (Eradah Complex for Mental Health, Dammam, or Eradah Hospital for Mental Health, Madinah)
- Psychiatric nurse specialist assigned to a psychiatric ward or an outpatient psychiatric or addiction clinic, with direct patient care responsibilities
- At least six months of psychiatric nursing experience
- Written informed consent
Key exclusion criteria (2 listed)
- Less than six months of psychiatric nursing experience
- Currently on extended leave (for example maternity leave, sick leave or other long-term absence)
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 |
|---|---|---|
| Usual institutional training (Madinah)Training sessions of the nurse's own choosing, offered as part of routine hospital education (for example on substance use, personality disorders or trauma-informed care), lasting 5-8 hours. Nurses submitted certificates of attendance. | Other | Usual institutional training (Madinah) |
| ECTP (Dammam)Structured five-day, face-to-face training program, two hours per day (10 hours in total), delivered 2-6 August 2026 by nurse educators and psychiatric nurse trainers. Day 1: orientation and baseline assessment. Day 2: empathy and communication. Day 3: work environment and training. Day 4: language and cultural barriers. Day 5: emotional preparedness. Methods: short lectures, role-play, case-based discussion and reflective group activities. | Behavioural | ECTP (Dammam) |
Primary outcome
Change in overall nurse-reported patient therapeutic engagement (PTE) score
Time frame: Baseline (Day 1) and immediately after Day 5 of the program (August 2026)
Overall score on the 15-item nurse-reported PTE questionnaire, adapted from the Therapeutic Engagement Questionnaire. Each item is rated from 1 (strongly disagree) to 5 (strongly agree). Items 5, 9 and 10 describe barriers and are reverse-scored (6 minus the original value). The overall score is the mean of all 15 items (range 1 to 5). Higher scores mean more favourable therapeutic engagement. The outcome is the change from baseline to post-test, compared between the intervention group (Dammam) and the control group (Madinah).
4 secondary outcomes
Change in Empathy and Communication domain score
Time frame: Baseline (Day 1) and immediately after Day 5 of the program (August 2026).
Change in Work Environment and Training domain score
Time frame: Baseline (Day 1) and immediately after Day 5 of the program (August 2026).
Change in Language and Cultural Barriers domain score
Time frame: Baseline (Day 1) and immediately after Day 5 of the program (August 2026).
Change in Emotional Preparedness domain score
Time frame: Baseline (Day 1) and immediately after Day 5 of the program (August 2026).
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 28 Oct 2026.
- Background: PubMed 31862531Hartley S, Raphael J, Lovell K, Berry K. Effective nurse-patient relationships in mental health care: A systematic review of interventions to improve the therapeutic alliance. Int J Nurs Stud. 2020 Feb;102:103490. doi: 10.1016/j.ijnurstu.2019.103490. Epub 2019 Nov 23.
- Background: PubMed 31796008Chambers M, McAndrew S, Nolan F, Thomas B, Watts P, Grant R, Kantaris X. The Therapeutic Engagement Questionnaire (TEQ): a service user-focused mental health nursing outcome metric. BMC Psychiatry. 2019 Dec 3;19(1):384. doi: 10.1186/s12888-019-2326-x.
- Individual participant dataSharing planned: Yes. De-identified questionnaire data (anonymous participant codes, demographic variables and item-level responses) will be shared with qualified researchers on reasonable request to the corresponding author. Interview transcripts and audio recordings will not be shared, to protect participant confidentiality.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual institutional training (Madinah) and ECTP (Dammam) in people with Therapeutic Engagement and Psychiatric Nursing, run by Lincoln University College at 2 sites in Saudi Arabia.
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: finished, as of the sponsor's last update on 28 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 2 sites in Saudi Arabia. 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?
Change in overall nurse-reported patient therapeutic engagement (PTE) score (time frame: Baseline (Day 1) and immediately after Day 5 of the program (August 2026)). 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 NCT07902336, which also lists 2 linked publications.
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 28 Oct 2026.