Web-based Single-session Intervention of Mindset for Improving Pre-practicum Anxiety and Coping

July 15, 2024 updated by: The Hong Kong Polytechnic University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Hong Kong Polytechnic University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Pre-practicum students in social work and/or counselling programmes are eligible.

  • Inclusion Criteria: students who

    1. are about to start the practicum soon;
    2. can read and write Chinese;
    3. consent to participate.

  • Exclusion Criteria: students who

    1. do not consent to participate;
    2. cannot concentrate for at least 45 minutes to complete the intervention and questionnaires;
    3. have a disability or serious physical or mental illness resulting in poor condition;
    4. do not participate in the practicum.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Web-based Single-session Intervention of Mindset on Intelligence, Failure, and Emotion (We-SMILE)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shimin Zhu, PhD, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20240512001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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