Mental IllnessNCT06258460
Multimodal Psychotherapy Training for Chinese Medical Students
A study testing psychotherapy training program intervention in people with Mental Illness, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
Providing evidence-based, well-designed psychotherapy teaching to train them to get a basic understanding of psychotherapy and to gain required skills for clinical practice would be fundamental to medical students, residency. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Illness
- What is being tested?
- psychotherapy training program intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2014to 15 Apr 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical student, residents, health care providers
- 18 years of age or older
- Expressing an interest in psychotherapy
- Willingness to received randomization
- Willing to provide informed consent to participate in the study
Who cannot join
- Not health care providers
- Below 18 years old
- Unwilling to be randomized
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yanhui Liao
Hangzhou, Zhejiang, 310016
Yanhui Liao, MD, 8615116225099, liaoyanhui@zju.edu.cn
About this study
Official title: Evaluating the Effectiveness of Multimodal Psychotherapy Training Program for Medical Students in China: Study Protocol for a Randomized Controlled Trial
Providing evidence-based, well-designed psychotherapy teaching to train them to get a basic understanding of psychotherapy and to gain required skills for clinical practice would be fundamental to medical students, residency. This study will be a two-arm randomized controlled trial (RCT) to evaluate the effectiveness of multimodal psychotherapy training program for medical students in China.
Read the detailed description
Background and aims: Providing evidence-based, well-designed psychotherapy teaching for medical students and residents is urgently needed. The aim of this project is to measure the effectiveness of a newly multimodal psychotherapy teaching program for medical students and residents in China.
Design: This study will be a two-arm randomized controlled trial (RCT). The intervention group will receive a two-day multimodal-based intensive educational intervention with 8 weeks follow-up (supervision based online teaching). The wait-list control group will not receive the intervention until the end of the study. Both groups will be followed up to 8 weeks.
Setting: This trial will be conduct at the Sir Run Run Shaw Hospital.
Participants: This study aims to recruit about 160 medical students and residents, with approximately 80 in each group.
Measurements: The primary outcome measure is the changes of the Facilitative Interpersonal Skills task (FIS) scores. Secondary outcome measures include: training program acceptability; trainees' psychotherapy knowledge; utilization of psychotherapy; and self-reported self-efficacy and self-reported motivation for psychotherapy.
Comments: If this CBT-based brief and short-term psychotherapy skill training program is proven effective, the mental health impact of its expansion nation-wide could be enormous.
- Conditions
- Mental Illness
- Being tested
- psychotherapy training program intervention, the wail-list control intervention
- Keywords
- Multimodal teaching, psychotherapy training, Chinese medical students, randomized controlled trial
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychotherapy training program interventionOther
The intervention group will receive a two-day multimodal-based intensive educational intervention of CBT with 8 weeks follow-up (supervision based online teaching).
the wail-list control interventionOther
The wail-list control group will receive a message encouraging them to complete all questionnaires from baseline to the last follow-up at 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| the two-day psychotherapy training program with 8-week follow-ups intervention group | Experimental | All participants from the intervention group will receive the two-day psychotherapy training program. They will receive a hard copy booklet of the psychotherapy training program at recruitment. In addition, supervision-based group meeting will be hold at week 1, 2, 4, and 8 during follow-ups, and each meeting will be lasted for approximately two hours. At each follow-up meeting, the teachers, including psychotherapists and psychiatrists, will be prepared to answer any psychotherapy related questions, encourage them to practice psychological interventions, and provide more information for participants' clinical application of psychotherapy. Receives: Other: psychotherapy training program intervention |
| the wail-list control group | Placebo comparator | After consent is given, participants who are allocated to the wail-list control group will receive a message encouraging them to complete all questionnaires from baseline to the last follow-up at 8 weeks. They will receive messages via WeChat to thank them for being in the study and reminding them of the time until the completion of the study at 8 weeks follow-up. They will receive a digital booklet of the psychotherapy training program via the WeChat individual messaging platform at recruitment, or a hard copy on request. After the trial ends, participants in the control arm will be able to receive the psychotherapy training program for free. Receives: Other: the wail-list control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facilitative Interpersonal Skills task (FIS)
FIS has eight dimensions: 1) verbal fluency, 2) hope and positive expectations, 3) persuasiveness; 4) emotional expression; 5) warmth, acceptance and understanding; 6) empathy; 7) alliance-bond capacity; and 8) alliance rupture-repair responsiveness. The items are rated on a 5-point Likert scale ranging from 1 (i.e., skill deficit) to 5 (i.e., optimal presence of skill), with high inter-rater agreement and excellent internal consistency. Research indicates that FIS is reliable measure to evaluate performance and psychotherapeutic outcomes in training and assessing therapists, high FIS indicate superior outcomes and better therapeutic processes. It measures therapists' demonstrated ability to convey psychotherapy's common factors, such as hopefulness, warmth, persuasiveness, and emotional engagement.
Measured: 8 weeks
Secondary outcomes (5)
Training program acceptability
program acceptability will be measured for participants from the intervention group by questions for assessing program acceptability
Measured: 2 days
Trainees' psychotherapy knowledge
Knowledge about psychotherapy before and after 8 weeks will be on a 5-point scale
Measured: 8 weeks
Utilization of psychotherapy
the utilization rate of psychotherapy interventions for patients during 8 weeks follow-up will be measured.
Measured: 8 weeks
Self-reported self-efficacy
the self-efficacy will be measured by the visual analog scale (VAS) on a 10-cm line that represents a continuum between "no self-efficacy" and "the strongest self-efficacy."
Measured: 8 weeks
Self-reported motivation
the motivation will be measured by the visual analog scale (VAS) on a 10-cm line that represents a continuum between "no motivation" and "the strongest motivation."
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Feb 2014
- Primary completion1 Apr 2024 (estimated)
- Study completion15 Apr 2024 (estimated)
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 Mental IllnessStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a two-arm randomized controlled trial (RCT). The intervention group will receive a two-day multimodal-based intensive educational intervention with 8 weeks follow-up (supervision based online teaching). The wait-list control group will not receive the intervention until the end of the study. Both groups will be followed up to 8 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhui Liao, Sir Run Run Shaw Hospital
- Investigators
- Tang Jinsong, MD, Study director, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258460
- Sponsor's protocol ID
- 2024-0066
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study data will be shared with other researchers by requirement.
Publications
Ding Y, Pei T, Peng P, Yao J, Tang J, Liao Y. Attitudes and knowledge for CBT-based psychotherapy among medical students and residents in China: a survey study. BMC Med Educ. 2025 Jan 15;25(1):68. doi: 10.1186/s12909-025-06641-w.
PubMed 39815284Pei T, Ding Y, Tang J, Liao Y. Evaluating the Effectiveness of a Multimodal Psychotherapy Training Program for Medical Students in China: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 3;14:e58037. doi: 10.2196/58037.
PubMed 39752191
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Multimodal Psychotherapy Training Program for Medical Students in China: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06258460
- Acronym / sponsor ID
- 2024-0066
- Conditions
- Mental Illness
- Keywords
- Multimodal teaching, psychotherapy training, Chinese medical students, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 14 Feb 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.
Providing evidence-based, well-designed psychotherapy teaching to train them to get a basic understanding of psychotherapy and to gain required skills for clinical practice would be fundamental to medical students, residency. This study will be a two-arm randomized controlled trial (RCT) to evaluate the effectiveness of multimodal psychotherapy training program for medical students in China.
Detailed description
Background and aims: Providing evidence-based, well-designed psychotherapy teaching for medical students and residents is urgently needed. The aim of this project is to measure the effectiveness of a newly multimodal psychotherapy teaching program for medical students and residents in China.
Design: This study will be a two-arm randomized controlled trial (RCT). The intervention group will receive a two-day multimodal-based intensive educational intervention with 8 weeks follow-up (supervision based online teaching). The wait-list control group will not receive the intervention until the end of the study. Both groups will be followed up to 8 weeks.
Setting: This trial will be conduct at the Sir Run Run Shaw Hospital.
Participants: This study aims to recruit about 160 medical students and residents, with approximately 80 in each group.
Measurements: The primary outcome measure is the changes of the Facilitative Interpersonal Skills task (FIS) scores. Secondary outcome measures include: training program acceptability; trainees' psychotherapy knowledge; utilization of psychotherapy; and self-reported self-efficacy and self-reported motivation for psychotherapy.
Comments: If this CBT-based brief and short-term psychotherapy skill training program is proven effective, the mental health impact of its expansion nation-wide could be enormous.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be a two-arm randomized controlled trial (RCT). The intervention group will receive a two-day multimodal-based intensive educational intervention with 8 weeks follow-up (supervision based online teaching). The wait-list control group will not receive the intervention until the end of the study. Both groups will be followed up to 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| the two-day psychotherapy training program with 8-week follow-ups intervention group | Experimental | Other: psychotherapy training program interventionAll participants from the intervention group will receive the two-day psychotherapy training program. They will receive a hard copy booklet of the psychotherapy training program at recruitment. In addition, supervision-based group meeting will be hold at week 1, 2, 4, and 8 during follow-ups, and each meeting will be lasted for approximately two hours. At each follow-up meeting, the teachers, including psychotherapists and psychiatrists, will be prepared to answer any psychotherapy related questions, encourage them to practice psychological interventions, and provide more information for participants' clinical application of psychotherapy. |
| the wail-list control group | Placebo comparator | Other: the wail-list control interventionAfter consent is given, participants who are allocated to the wail-list control group will receive a message encouraging them to complete all questionnaires from baseline to the last follow-up at 8 weeks. They will receive messages via WeChat to thank them for being in the study and reminding them of the time until the completion of the study at 8 weeks follow-up. They will receive a digital booklet of the psychotherapy training program via the WeChat individual messaging platform at recruitment, or a hard copy on request. After the trial ends, participants in the control arm will be able to receive the psychotherapy training program for free. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Medical student, residents, health care providers
- 18 years of age or older
- Expressing an interest in psychotherapy
- Willingness to received randomization
- Willing to provide informed consent to participate in the study
Key exclusion criteria (4 listed)
- Not health care providers
- Below 18 years old
- Unwilling to be randomized
- Unable to provide informed consent
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 |
|---|---|---|
| psychotherapy training program interventionThe intervention group will receive a two-day multimodal-based intensive educational intervention of CBT with 8 weeks follow-up (supervision based online teaching). | Other | the two-day psychotherapy training program with 8-week follow-ups intervention group |
| the wail-list control interventionThe wail-list control group will receive a message encouraging them to complete all questionnaires from baseline to the last follow-up at 8 weeks. | Other | the wail-list control group |
Primary outcome
Facilitative Interpersonal Skills task (FIS)
Time frame: 8 weeks
FIS has eight dimensions: 1) verbal fluency, 2) hope and positive expectations, 3) persuasiveness; 4) emotional expression; 5) warmth, acceptance and understanding; 6) empathy; 7) alliance-bond capacity; and 8) alliance rupture-repair responsiveness. The items are rated on a 5-point Likert scale ranging from 1 (i.e., skill deficit) to 5 (i.e., optimal presence of skill), with high inter-rater agreement and excellent internal consistency. Research indicates that FIS is reliable measure to evaluate performance and psychotherapeutic outcomes in training and assessing therapists, high FIS indicate superior outcomes and better therapeutic processes. It measures therapists' demonstrated ability to convey psychotherapy's common factors, such as hopefulness, warmth, persuasiveness, and emotional engagement.
5 secondary outcomes
Training program acceptability
Time frame: 2 days
Trainees' psychotherapy knowledge
Time frame: 8 weeks
Utilization of psychotherapy
Time frame: 8 weeks
Self-reported self-efficacy
Time frame: 8 weeks
Self-reported motivation
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 39815284Ding Y, Pei T, Peng P, Yao J, Tang J, Liao Y. Attitudes and knowledge for CBT-based psychotherapy among medical students and residents in China: a survey study. BMC Med Educ. 2025 Jan 15;25(1):68. doi: 10.1186/s12909-025-06641-w.
- Derived from this study: PubMed 39752191Pei T, Ding Y, Tang J, Liao Y. Evaluating the Effectiveness of a Multimodal Psychotherapy Training Program for Medical Students in China: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 3;14:e58037. doi: 10.2196/58037.
- Individual participant dataSharing planned: No. This study data will be shared with other researchers by requirement.
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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.
Tang Jinsong, MD study director
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychotherapy training program intervention in people with Mental Illness, run by Sir Run Run Shaw Hospital at 1 site in China.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luyao Zou, MS (8615869178144, ZouLuyao0000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facilitative Interpersonal Skills task (FIS) (time frame: 8 weeks). 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 NCT06258460, 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 20 Feb 2024.