- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06509802
Web-based Single-session Intervention of Mindset for Improving Pre-practicum Anxiety and Coping
Efficacy of an Integrated Growth Mindset Intervention on Reducing Anxiety for Social Work and/or Counselling Practicum Trainees: Study Protocol for a Two-Arm Randomised Controlled Trial
Practicum is an essential educational component of professional training, however, the process can be challenging and sometimes frustrating, with obstacles such as the rigorous training process and mental distress. Being adequately prepared to confront the challenges and difficulties in practicum is crucial for the learning outcomes and psychological well-being of social work and/or counselling trainees. At the same time, mindset is found to be a modifiable factor in intervention, which is essential in clinical psychology, therapy, prevention, and early intervention. Instilling growth mindsets regarding intelligence, emotion, and failure-is-enhancing mindsets, respectively, is worthwhile in easing anxiety and stress coping. However, the existing intervention approaches lack of mindset integration, low intensity, distinctions of employees and interns, more objective and reliable outcome indictors and well-designed randomised controlled trials.
Using a two-arm randomised controlled trial, the proposed study will examine the efficacy of a Web-based Single-session Intervention of Mindset on Intelligence, Failure, and Emotion (We-SMILE) on reducing anxiety related to practicum and improving mental health and practicum-related outcomes.
A total of 117 students will be recruited from the social work and/or counselling programmes, and randomly assigned to existing pre-practicum training (Training As Usual, TAU) or that plus the We-SMILE. The intervention is 45 minutes in length. Participants will be assessed at three timepoints: baseline (T1), two weeks post-intervention (T2), and eight weeks post-intervention (T3). Patient and public involvement is adopted in the intervention design and implementation strategies. It is expected that the We-SMILE group will present lower anxiety related to practicum and more positive secondary outcomes (depression, anxiety, stress, psychological well-being, learning and performance orientation, academic self-efficacy, and confidence) compared to the TAU group. The intention-to-treat principle and linear-regression-based maximum likelihood multi-level models will be used for data analysis.
The study will not only provide evidence on integrated mindset intervention for trainees' mental health and learning outcomes, but also benefit social work and/or counselling supervisors and programmes as an accessible module.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shimin Zhu, PhD
- Phone Number: +852 2766 5787
- Email: jasmine.zhu@polyu.edu.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- The Hong Kong Polytechnic University
-
Contact:
- Shimin Zhu, PhD
- Phone Number: +852 2766 5787
- Email: jasmine.zhu@polyu.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Pre-practicum students in social work and/or counselling programmes are eligible.
Inclusion Criteria: students who
- are about to start the practicum soon;
- can read and write Chinese;
- consent to participate.
Exclusion Criteria: students who
- do not consent to participate;
- cannot concentrate for at least 45 minutes to complete the intervention and questionnaires;
- have a disability or serious physical or mental illness resulting in poor condition;
- do not participate in the practicum.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Web-based Single-session Intervention of Mindset on Intelligence, Failure, and Emotion (We-SMILE)
We-SMILE introduces growth mindsets about intelligence, failure, and negative emotions to pre-practicum trainees, consisting of five components: (a) an introduction to a proactive mindset, including neuroplasticity, the malleability of intelligence and emotion, and the importance of failure and feedback in the learning process; (b) stories and testimonials during practicum which emphasise the belief in change; (c) short videos about allegories of developing intelligence, emotion, and failure mindsets; (d) common questions and misconceptions about growth mindsets; and (e) self-persuasive writing exercises in which participants write down their thoughts and suggestions for others about growth mindsets.
|
This study will be a two-arm randomised controlled trial to examine the efficacy of the We-SMILE for pre-practicum social work and/or counselling students by comparing to the We-SMILE intervention group and the no-intervention training-as-usual group.
|
|
No Intervention: Training as usual group
The training-as-usual group will continue the normal training and will be provided with repeated assessments at the same timeframe as the intervention group.
Participants in training-as-usual group will receive the intervention course after finishing the eight-week follow-up questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety related to practicum
Time Frame: Baseline
|
Anxiety related to practicum will be measured by four items, including "level of anxiety about starting the practicum", "how much your anxiety will interfere with their learning", "how prepared you are for the practicum" and "how excited you are to participate in the practicum".
Each statement will be rated on a 10-point Likert scale, ranging from 1=completely not anxious, very small, completely unprepared, and completely unexcited to 10=extremely anxious, very great, perfectly prepared, and extremely excited.
|
Baseline
|
|
Anxiety related to practicum
Time Frame: Two-week post-intervention
|
Anxiety related to practicum will be measured by four items, including "level of anxiety about starting the practicum", "how much your anxiety will interfere with their learning", "how prepared you are for the practicum" and "how excited you are to participate in the practicum".
Each statement will be rated on a 10-point Likert scale, ranging from 1=completely not anxious, very small, completely unprepared, and completely unexcited to 10=extremely anxious, very great, perfectly prepared, and extremely excited.
|
Two-week post-intervention
|
|
Anxiety related to practicum
Time Frame: Eight-week post-intervention
|
Anxiety related to practicum will be measured by four items, including "level of anxiety about starting the practicum", "how much your anxiety will interfere with their learning", "how prepared you are for the practicum" and "how excited you are to participate in the practicum".
Each statement will be rated on a 10-point Likert scale, ranging from 1=completely not anxious, very small, completely unprepared, and completely unexcited to 10=extremely anxious, very great, perfectly prepared, and extremely excited.
|
Eight-week post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression, anxiety and stress
Time Frame: Baseline
|
Depression, anxiety, and stress will be assessed by the simplified 12-item Depression Anxiety Stress Scales (DASS-12).
The items of DASS-12 were shortlisted from the DASS-21 such as "I found it hard to wind down.".
Each item will be rated from 0=never to 4=almost always according to the participant's status over the past week.
|
Baseline
|
|
Depression, anxiety and stress
Time Frame: Two-week post-intervention
|
Depression, anxiety, and stress will be assessed by the simplified 12-item Depression Anxiety Stress Scales (DASS-12).
The items of DASS-12 were shortlisted from the DASS-21 such as "I found it hard to wind down.".
Each item will be rated from 0=never to 4=almost always according to the participant's status over the past week.
|
Two-week post-intervention
|
|
Depression, anxiety and stress
Time Frame: Eight-week post-intervention
|
Depression, anxiety, and stress will be assessed by the simplified 12-item Depression Anxiety Stress Scales (DASS-12).
The items of DASS-12 were shortlisted from the DASS-21 such as "I found it hard to wind down.".
Each item will be rated from 0=never to 4=almost always according to the participant's status over the past week.
|
Eight-week post-intervention
|
|
Psychological well-being
Time Frame: Baseline
|
Psychological well-being will be measured using the seven-item Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS).
One example item is "I've been feeling optimistic about the future.".
Each item is rated from 1 (None of the time) to 5 (All of the time).
|
Baseline
|
|
Psychological well-being
Time Frame: Two-week post-intervention
|
Psychological well-being will be measured using the seven-item Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS).
One example item is "I've been feeling optimistic about the future.".
Each item is rated from 1 (None of the time) to 5 (All of the time).
|
Two-week post-intervention
|
|
Psychological well-being
Time Frame: Eight-week post-intervention
|
Psychological well-being will be measured using the seven-item Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS).
One example item is "I've been feeling optimistic about the future.".
Each item is rated from 1 (None of the time) to 5 (All of the time).
|
Eight-week post-intervention
|
|
Learning and performance orientation
Time Frame: Baseline
|
Learning and performance orientation will be assessed by eleven adapted items, with five items measuring the learning orientation (e.g., "I like to learn new knowledge in practicums.") and six items measuring performance orientation (e.g., "I like to seek rewards in short term for my efforts.").
Each item will be rated by a five-point Likert scale from 1=strongly disagree to 5=strongly agree.
|
Baseline
|
|
Learning and performance orientation
Time Frame: Two-week post-intervention
|
Learning and performance orientation will be assessed by eleven adapted items, with five items measuring the learning orientation (e.g., "I like to learn new knowledge in practicums.") and six items measuring performance orientation (e.g., "I like to seek rewards in short term for my efforts.").
Each item will be rated by a five-point Likert scale from 1=strongly disagree to 5=strongly agree.
|
Two-week post-intervention
|
|
Learning and performance orientation
Time Frame: Eight-week post-intervention
|
Learning and performance orientation will be assessed by eleven adapted items, with five items measuring the learning orientation (e.g., "I like to learn new knowledge in practicums.") and six items measuring performance orientation (e.g., "I like to seek rewards in short term for my efforts.").
Each item will be rated by a five-point Likert scale from 1=strongly disagree to 5=strongly agree.
|
Eight-week post-intervention
|
|
Academic self-efficacy
Time Frame: Baseline
|
Academic self-efficacy will be measured by five adapted items.
Example items are "I believe that as long as I study diligently, I will be able to master practical skills."
and "As long as I am diligent, I can master all of the skills learned during the internship.".
The items will be scored from 1=strongly disagree to 5=strongly agree.
|
Baseline
|
|
Academic self-efficacy
Time Frame: Two-week post-intervention
|
Academic self-efficacy will be measured by five adapted items.
Example items are "I believe that as long as I study diligently, I will be able to master practical skills."
and "As long as I am diligent, I can master all of the skills learned during the internship.".
The items will be scored from 1=strongly disagree to 5=strongly agree.
|
Two-week post-intervention
|
|
Academic self-efficacy
Time Frame: Eight-week post-intervention
|
Academic self-efficacy will be measured by five adapted items.
Example items are "I believe that as long as I study diligently, I will be able to master practical skills."
and "As long as I am diligent, I can master all of the skills learned during the internship.".
The items will be scored from 1=strongly disagree to 5=strongly agree.
|
Eight-week post-intervention
|
|
Confidence related to practicum
Time Frame: Baseline
|
Confidence related to practicum will be assessed by a six-item self-developed scale.
Items generated from interviews with social work students, such as "I am confident that I can listen to comments from supervisors/colleagues/service users with an open mind."
and "I am confident that I can manage my time well and cope with my practicum work and schoolwork at the same time.".
Each item needs to be rated from 1=strongly disagree to 5=strongly agree.
|
Baseline
|
|
Confidence related to practicum
Time Frame: Two-week post-intervention
|
Confidence related to practicum will be assessed by a six-item self-developed scale.
Items generated from interviews with social work students, such as "I am confident that I can listen to comments from supervisors/colleagues/service users with an open mind."
and "I am confident that I can manage my time well and cope with my practicum work and schoolwork at the same time.".
Each item needs to be rated from 1=strongly disagree to 5=strongly agree.
|
Two-week post-intervention
|
|
Confidence related to practicum
Time Frame: Eight-week post-intervention
|
Confidence related to practicum will be assessed by a six-item self-developed scale.
Items generated from interviews with social work students, such as "I am confident that I can listen to comments from supervisors/colleagues/service users with an open mind."
and "I am confident that I can manage my time well and cope with my practicum work and schoolwork at the same time.".
Each item needs to be rated from 1=strongly disagree to 5=strongly agree.
|
Eight-week post-intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Shimin Zhu, PhD, The Hong Kong Polytechnic 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20240512001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Anxiety
-
University of CalabriaNot yet recruitingAnxiety | Anxiety Disease | Anxiety and Distress | Public Speaking AnxietyItaly
-
Clinica Alemana de SantiagoUniversidad del DesarrolloRecruitingAnxiety | Induction of Anesthesia | Anxiety Preoperative | Technology Use | Child Anxiety | Anesthesia Care | Anxiety After SurgeryChile
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedAnxiety Disorders | Anxiety | Anxiety Symptoms | Child Anxiety | Anxiety, Mild to Moderate | Pediatric Anxiety DisordersUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Abant Izzet Baysal UniversityRecruitingAnxiety | Parental AnxietyTurkey (Türkiye)
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiActive, not recruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruitingAnxiety Disorders | Anxiety | Anxiety and FearFrance
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
Clinical Trials on Web-based Single-session Intervention of Mindset on Intelligence, Failure, and Emotion (We-SMILE)
-
The Hong Kong Polytechnic UniversityNot yet recruiting
-
The Hong Kong Polytechnic UniversityNot yet recruiting
-
University of Massachusetts, WorcesterNational Cancer Institute (NCI)CompletedSmoking Cessation | Tobacco Use DisorderUnited States