NCT06258460

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

10.2 years

First QC Date

February 6, 2024

Last Update Submit

February 15, 2024

Conditions

Keywords

Multimodal teachingpsychotherapy trainingChinese medical studentsrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (5)

  • Training program acceptability

    2 days

  • Trainees' psychotherapy knowledge

    8 weeks

  • Utilization of psychotherapy

    8 weeks

  • Self-reported self-efficacy

    8 weeks

  • Self-reported motivation

    8 weeks

Study Arms (2)

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.

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.

Other: the wail-list control intervention

Interventions

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 two-day psychotherapy training program with 8-week follow-ups intervention group

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.

the wail-list control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical student, residents, health care providers
  • years of age or older
  • Expressing an interest in psychotherapy
  • Willingness to received randomization
  • Willing to provide informed consent to participate in the study

You may not qualify if:

  • Not health care providers
  • Below 18 years old
  • Unwilling to be randomized
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yanhui Liao

Hangzhou, Zhejiang, 310016, China

RECRUITING

Related Publications (2)

  • 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.

  • Pei 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.

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Tang Jinsong, MD

    Sir Run Run Shaw Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data will be blinded to intervention assignment by the trial statistician using R software
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Psychiatrist

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 14, 2024

Study Start

February 1, 2014

Primary Completion

April 1, 2024

Study Completion

April 15, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

This study data will be shared with other researchers by requirement.

Locations