- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06258460
Multimodal Psychotherapy Training for Chinese Medical Students
Evaluating the Effectiveness of Multimodal Psychotherapy Training Program for Medical Students in China: Study Protocol for a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luyao Zou, MS
- Phone Number: 8615869178144
- Email: ZouLuyao0000@163.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310016
- Recruiting
- Yanhui Liao
-
Contact:
- Yanhui Liao, MD
- Phone Number: 8615116225099
- Email: liaoyanhui@zju.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not health care providers
- Below 18 years old
- Unwilling to be randomized
- Unable to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: the two-day psychotherapy training program with 8-week follow-ups intervention group
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.
|
The intervention group will receive a two-day multimodal-based intensive educational intervention of CBT with 8 weeks follow-up (supervision based online teaching).
|
Placebo Comparator: the wail-list control group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Training program acceptability
Time Frame: 2 days
|
program acceptability will be measured for participants from the intervention group by questions for assessing program acceptability
|
2 days
|
Trainees' psychotherapy knowledge
Time Frame: 8 weeks
|
Knowledge about psychotherapy before and after 8 weeks will be on a 5-point scale
|
8 weeks
|
Utilization of psychotherapy
Time Frame: 8 weeks
|
the utilization rate of psychotherapy interventions for patients during 8 weeks follow-up will be measured.
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8 weeks
|
Self-reported self-efficacy
Time Frame: 8 weeks
|
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."
|
8 weeks
|
Self-reported motivation
Time Frame: 8 weeks
|
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."
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tang Jinsong, MD, Sir Run Run Shaw Hospital, Zhejiang University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-0066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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