CommunicationNCT07333781
Effects of Communication Training for Mental Health Occupational Therapy Interns
A study testing iCOT in people with Communication, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to develop and test a new communication skills training program for occupational therapy (OT) interns in mental health practice, called the Intervention Protocol for Communication Skills of Occupational Therapy Interns (iCOT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication
- What is being tested?
- iCOT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2022to 30 Sep 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Occupational therapy interns: willing to participate; no additional inclusion or exclusion criteria.
- Clinical supervisors (occupational therapists): willing to participate; no additional inclusion or exclusion criteria.
- Patients:
- Diagnosed with any DSM-5 mental disorder
- Age 20 years or older
- Able to provide informed consent
- Adequate verbal communication ability
Who cannot join
- Patients: severe cognitive impairment (e.g., aphasia or inability to follow three-step commands).
- Interns and supervisors: none.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Communication Skills Training Program for Occupational Therapy Interns in Mental Health
The goal of this clinical trial is to develop and test a new communication skills training program for occupational therapy (OT) interns in mental health practice, called the Intervention Protocol for Communication Skills of Occupational Therapy Interns (iCOT). The main questions are:
Does iCOT improve interns' communication skills in the short term?
Read more
The study has two parts. First, researchers will develop the iCOT program using expert input, feedback from recent graduates, and feasibility testing with interns, supervisors, and patients. Second, the study will test iCOT using a single-blind design. Expert raters, who do not know which group each intern belongs to, will evaluate communication skills using the Gap-Kalamazoo Communication Skills Assessment Form (GKCSAF).
The intervention group will receive iCOT training. The comparison group will use data from a previous study of interns, supervisors, and patients. Communication skills will be rated by experts (primary outcome) and by supervisors, patients, and interns (secondary outcomes).
Read the detailed description
Communication skills are essential for occupational therapy (OT) practitioners working in mental health settings. Strong communication skills improve treatment quality, therapeutic relationships, and clinical outcomes. However, there is currently no evidence-based communication training specifically designed for OT interns in mental health. This gap limits both clinical education and research in the field.
This study aims to develop and evaluate a structured communication skills training program for mental-health OT interns, called the Intervention Protocol for Communication Skills of Occupational Therapy Interns (iCOT). The study has two phases and uses a single-blind clinical trial design, in which expert raters are blinded to group assignment.
Phase 1: Development of the iCOT Program
In Phase 1, researchers will create the iCOT training program through several steps:
Teaching content: Materials will be designed based on established models of therapist-patient communication in mental health.
Teaching methods: Instructional strategies will be developed to fit OT interns' learning needs.
Procedure design: The training sequence will align with internship schedules and clinical workflow.
Expert validation: Three clinical experts, two university instructors, and five recent graduates will review and validate the initial version.
Feasibility testing: Five interns, their clinical supervisors, and patients will pilot-test the program to refine the final version.
Phase 2: Evaluation of iCOT Effectiveness
In Phase 2, the finalized iCOT program will be tested. The intervention group will include OT interns, clinical supervisors, and patients participating in the current study. The comparison group will consist of previously collected data from 44 interns, 9 supervisors, and 97 patients.
The primary outcome is interns' communication performance evaluated by blinded expert raters using the Gap-Kalamazoo Communication Skills Assessment Form (GKCSAF). Secondary outcomes include GKCSAF ratings completed by clinical supervisors, patients, and the interns themselves.
This study will provide the first evidence-based communication skills training protocol tailored to OT interns in mental health and may support future improvements in clinical education and quality of care.
- Conditions
- Communication
- Being tested
- iCOT, Active Control
- Keywords
- communication skills, communication skills training, occupational therapy
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCOTBehavioural
Also called An intervention protocol for communication skills of occupational therapy interns in in the field of mental health clinical practice
The intervention group receives the iCOT program, which includes:
- Online training through Moodle with instructional videos, expert demonstrations, and scenario-based quizzes requiring full completion; and
- Multi-source feedback from patients, clinical supervisors, and experts using structured communication assessment tools. The program aims to improve communication skills during mental health clinical practice.
Active ControlBehavioural
Also called Standard Communication Training
The active control group receives the standard communication training used in routine internship education. Interns complete three recorded patient interviews during the internship, followed by supervisor feedback using the GKCSAF. The control group does not receive the iCOT online modules, expert demonstrations, scenario-based training, or patient feedback. Total training time is approximately 2.5 hours shorter than the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| iCOT Communication Training | Experimental | Participants receive the iCOT (Intervention Protocol for Communication Skills of Occupational Therapy Interns) communication skills training program. The program includes structured instructional content based on therapist-patient communication models, teaching strategies designed for OT interns, and a training sequence integrated into internship schedules. Training is delivered during the internship period. Receives: Behavioral: iCOT |
| Active Control (Historical Data) | Active comparator | This arm uses historical data from a previous cohort of occupational therapy interns, clinical supervisors, and patients. The cohort includes 44 interns, 9 supervisors, and 97 patients who completed standard internship training without the iCOT program. Their communication performance, measured with the Gap-Kalamazoo Communication Skills Assessment Form (GKCSAF), serves as the comparison group. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expert-rated communication skills performance
Blinded expert raters evaluate interns' communication skills using the Gap-Kalamazoo Communication Skills Assessment Form (GKCSAF).
Measured: Baseline and immediately after completion of the intervention.
Secondary outcomes (3)
clinical supervisor-rated communication skills performance
Clinical supervisors evaluate interns' communication skills using the Gap-Kalamazoo Communication Skills Assessment Form (GKCSAF).
Measured: Baseline and immediately after completion of the intervention.
Patient-rated communication skills performance
Patients evaluate interns' communication behavior using the Gap-Kalamazoo Communication Skills Assessment Form (GKCSAF).
Measured: Baseline and immediately after completion of the intervention.
Intern self-rated communication skills performance
Interns complete a self-assessment using the Gap-Kalamazoo Communication Skills Assessment Form (GKCSAF).
Measured: Baseline and immediately after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jul 2022
- Primary completion31 Dec 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group receives the iCOT program; comparison group uses historical active control data.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333781
- Sponsor's protocol ID
- 202200268B0
- Status last verified
- Jul 2022
- First submitted
- 24 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Communication Skills Training Program for Occupational Therapy Interns in Mental Health
- ClinicalTrials.gov ID
- NCT07333781
- Acronym / sponsor ID
- 202200268B0
- Conditions
- Communication
- Keywords
- communication skills, communication skills training, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 12 Jan 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.
The goal of this clinical trial is to develop and test a new communication skills training program for occupational therapy (OT) interns in mental health practice, called the Intervention Protocol for Communication Skills of Occupational Therapy Interns (iCOT). The main questions are:
Does iCOT improve interns' communication skills in the short term?
The study has two parts. First, researchers will develop the iCOT program using expert input, feedback from recent graduates, and feasibility testing with interns, supervisors, and patients. Second, the study will test iCOT using a single-blind design. Expert raters, who do not know which group each intern belongs to, will evaluate communication skills using the Gap-Kalamazoo Communication Skills Assessment Form (GKCSAF).
The intervention group will receive iCOT training. The comparison group will use data from a previous study of interns, supervisors, and patients. Communication skills will be rated by experts (primary outcome) and by supervisors, patients, and interns (secondary outcomes).
Detailed description
Communication skills are essential for occupational therapy (OT) practitioners working in mental health settings. Strong communication skills improve treatment quality, therapeutic relationships, and clinical outcomes. However, there is currently no evidence-based communication training specifically designed for OT interns in mental health. This gap limits both clinical education and research in the field.
This study aims to develop and evaluate a structured communication skills training program for mental-health OT interns, called the Intervention Protocol for Communication Skills of Occupational Therapy Interns (iCOT). The study has two phases and uses a single-blind clinical trial design, in which expert raters are blinded to group assignment.
Phase 1: Development of the iCOT Program
In Phase 1, researchers will create the iCOT training program through several steps:
Teaching content: Materials will be designed based on established models of therapist-patient communication in mental health.
Teaching methods: Instructional strategies will be developed to fit OT interns' learning needs.
Procedure design: The training sequence will align with internship schedules and clinical workflow.
Expert validation: Three clinical experts, two university instructors, and five recent graduates will review and validate the initial version.
Feasibility testing: Five interns, their clinical supervisors, and patients will pilot-test the program to refine the final version.
Phase 2: Evaluation of iCOT Effectiveness
In Phase 2, the finalized iCOT program will be tested. The intervention group will include OT interns, clinical supervisors, and patients participating in the current study. The comparison group will consist of previously collected data from 44 interns, 9 supervisors, and 97 patients.
The primary outcome is interns' communication performance evaluated by blinded expert raters using the Gap-Kalamazoo Communication Skills Assessment Form (GKCSAF). Secondary outcomes include GKCSAF ratings completed by clinical supervisors, patients, and the interns themselves.
This study will provide the first evidence-based communication skills training protocol tailored to OT interns in mental health and may support future improvements in clinical education and quality of care.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group receives the iCOT program; comparison group uses historical active control data.
| Arm | Type | Receives |
|---|---|---|
| iCOT Communication Training | Experimental | Behavioral: iCOTParticipants receive the iCOT (Intervention Protocol for Communication Skills of Occupational Therapy Interns) communication skills training program. The program includes structured instructional content based on therapist-patient communication models, teaching strategies designed for OT interns, and a training sequence integrated into internship schedules. Training is delivered during the internship period. |
| Active Control (Historical Data) | Active comparator | Behavioral: Active ControlThis arm uses historical data from a previous cohort of occupational therapy interns, clinical supervisors, and patients. The cohort includes 44 interns, 9 supervisors, and 97 patients who completed standard internship training without the iCOT program. Their communication performance, measured with the Gap-Kalamazoo Communication Skills Assessment Form (GKCSAF), serves as the comparison group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Occupational therapy interns: willing to participate; no additional inclusion or exclusion criteria.
- Clinical supervisors (occupational therapists): willing to participate; no additional inclusion or exclusion criteria.
- Diagnosed with any DSM-5 mental disorder
- Age 20 years or older
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Patients: severe cognitive impairment (e.g., aphasia or inability to follow three-step commands).
- Interns and supervisors: none.
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 |
|---|---|---|
| iCOTAlso: An intervention protocol for communication skills of occupational therapy interns in in the field of mental health clinical practiceThe intervention group receives the iCOT program, which includes: 1. Online training through Moodle with instructional videos, expert demonstrations, and scenario-based quizzes requiring full completion; and 2. Multi-source feedback from patients, clinical supervisors, and experts using structured communication assessment tools. The program aims to improve communication skills during mental health clinical practice. | Behavioural | iCOT Communication Training |
| Active ControlAlso: Standard Communication TrainingThe active control group receives the standard communication training used in routine internship education. Interns complete three recorded patient interviews during the internship, followed by supervisor feedback using the GKCSAF. The control group does not receive the iCOT online modules, expert demonstrations, scenario-based training, or patient feedback. Total training time is approximately 2.5 hours shorter than the intervention group. | Behavioural | Active Control (Historical Data) |
Primary outcome
Expert-rated communication skills performance
Time frame: Baseline and immediately after completion of the intervention.
Blinded expert raters evaluate interns' communication skills using the Gap-Kalamazoo Communication Skills Assessment Form (GKCSAF).
3 secondary outcomes
clinical supervisor-rated communication skills performance
Time frame: Baseline and immediately after completion of the intervention.
Patient-rated communication skills performance
Time frame: Baseline and immediately after completion of the intervention.
Intern self-rated communication skills performance
Time frame: Baseline and immediately after completion of the 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 12 Jan 2026.
- 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 iCOT in people with Communication, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 7 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 12 Jan 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 Taiwan. 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?
Expert-rated communication skills performance (time frame: Baseline and immediately after completion of the intervention.). 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 12 Jan 2026.