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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06258460
Other study ID # 2024-0066
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2014
Est. completion date April 15, 2024

Study information

Verified date February 2024
Source Sir Run Run Shaw Hospital
Contact Luyao Zou, MS
Phone 8615869178144
Email ZouLuyao0000@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date April 15, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Medical student, residents, health care providers 2. 18 years of age or older 3. Expressing an interest in psychotherapy 4. Willingness to received randomization 5. Willing to provide informed consent to participate in the study Exclusion Criteria: 1. Not health care providers 2. Below 18 years old 3. Unwilling to be randomized 4. Unable to provide informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
psychotherapy training program intervention
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 intervention
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.

Locations

Country Name City State
China Yanhui Liao Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Training program acceptability program acceptability will be measured for participants from the intervention group by questions for assessing program acceptability 2 days
Secondary Trainees' psychotherapy knowledge Knowledge about psychotherapy before and after 8 weeks will be on a 5-point scale 8 weeks
Secondary Utilization of psychotherapy the utilization rate of psychotherapy interventions for patients during 8 weeks follow-up will be measured. 8 weeks
Secondary 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." 8 weeks
Secondary 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." 8 weeks
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