An interventional study of Usual institutional training (Madinah) and ECTP (Dammam) in Therapeutic Engagement, Psychiatric Nursing and Nurse-Patient Relations, sponsored by Lincoln University College. Completed at 2 sites in Saudi Arabia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Lincoln University College · Not applicable, Interventional, and Health services research
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.
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.
719 studies on the registry are indexed under Communication; 159 are open to participants now.
This study's enrollment of 154 is close to the median of 144 across 571 interventional studies indexed under Communication.
Browse Communication studies →Lincoln University College is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: ECTP (Dammam)
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.
Other: 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.
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.
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).
Time frame: Baseline (Day 1) and immediately after Day 5 of the program (August 2026)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 1) and immediately after Day 5 of the program (August 2026).
Plan to share: 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.
Time frame: Data will be available after publication of the main results, on request, for 5 years.
Access criteria: Requests should be sent by email to the corresponding author (amer.phdscholar@lincoln.edu.my) with a brief description of the intended use. Access is subject to ethics requirements and to the licensing and permission requirements of the original Therapeutic Engagement Questionnaire.
Ran from Mar 2025 to primary completion in Jul 2026, 16 months.
Of 390 non-industry interventional studies with no phase under Communication, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's 16 months is below that.
Counting every sponsor, half of 394 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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