Assessing Effectiveness of ThoughtFullChat Application in Improving Mental Well-Being

April 1, 2022 updated by: Lim Kean Ghee, International Medical University

Assessing Effectiveness of a Text-based Mental Health Coaching Application in Improving Mental Well-Being Among House Officers, IMU Faculty, IMU Corporate Staff and IMU Students in Malaysia

  • To determine the state of mental health among house officers, IMU corporate staff, IMU students and IMU faculty
  • To find out the effectiveness and user experience of text-based mental health coaching applications among house officers, IMU corporate staff, IMU students and IMU faculty

IMU - International Medical University

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The text-based mental health coaching application that the investigators are using is ThoughtFullChat Application. ThoughtFullChat Application provides mental health coaching through text by licensed mental health professionals. Participants of this research will be required to answer a set of questionnaires which consists of DASS-21, Satisfaction with Life Scale and Brief Resilience Scale at the start of the study. Participants will be randomly distributed into 2 groups which are intervention and control groups. Participants in the intervention group will be using the application for 3 months. Post-intervention questionnaires will be given to all participants after 3 months. Data collected from these 2 groups will be analyzed by using SPSS.

Study Type

Interventional

Enrollment (Actual)

353

Phase

  • 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 Locations

  • Malaysia
    • Negeri Sembilan
      • Seremban, Negeri Sembilan, Malaysia, 70300
        • IMU Clinical Campus

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • House Officers in Malaysia (UD41)
  • Corporate staff in IMU, IMU Faculty Members
  • All students who are currently studying in IMU who give their consent
  • Competent in English Language
  • Experiencing none to severe stress, anxiety or depression based on DASS-21 score

Exclusion Criteria:

  • Medical students, Medical Officers (UD44)
  • Contract staff, Outsourced staff or international staff in IMU campuses
  • Students who refuse to give their consent and those that have already or just graduated from IMU
  • Competent in other languages except English
  • Experiencing extremely severe stress, anxiety or depression based on the DASS-21 score

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Without ThoughtFullChat Application
Participants will not use the app during the 3 months
Experimental: With ThoughtFullChat Application
Participants will be using the app during the 3 months
Other: ThoughtFullChat Application
A subscription-based mobile platform that empowers users to proactively engage with their mental health via self-serve tools and 1-on-1 daily bite-sized coaching with certified mental health professionals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 3 months
Depression, Anxiety and Stress Scale - 21 Items (DASS-21), a self report scale is used to measure the participants' emotional states of depression, anxiety and stress. For anxiety component, it contains 7 items and scores from 0 to 3 for each item. The total scores of each subscale need to be multiplied by 2 and are categorized into 5 severity ranges: normal, mild, moderate, severe and extremely severe. The severity ranges for anxiety are: normal (0-7); mild (8-9); moderate (10-14); severe (15-19) and extremely severe (20+).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: 3 months
Depression, Anxiety and Stress Scale - 21 Items (DASS-21), a self report scale is used to measure the participants' emotional states of depression, anxiety and stress. For depression component, it contains 7 items and scores from 0 to 3 for each item. The total scores of each subscale need to be multiplied by 2 and are categorized into 5 severity ranges: normal, mild, moderate, severe and extremely severe. The severity ranges for depression are: normal (0-9); mild (10-13); moderate (14-20); severe (21-27) and extremely severe (28+).
3 months
Stress
Time Frame: 3 months
Depression, Anxiety and Stress Scale - 21 Items (DASS-21), a self report scale is used to measure the participants' emotional states of depression, anxiety and stress. For stress component, it contains 7 items and scores from 0 to 3 for each item. The total scores of each subscale need to be multiplied by 2 and are categorized into 5 severity ranges: normal, mild, moderate, severe and extremely severe. The severity ranges for stress are: normal (0-14); mild (15-18); moderate (1-25); severe (26-33) and extremely severe (34+).
3 months
Resilience
Time Frame: 3 months
Brief Resilience Scale is created to assess the perceived ability to bounce back or recover from stress. The scale was developed to assess a unitary construct of resilience, including both positively and negatively worded items. It consists of 6 items, each item scores from 1 to 5. Items 1, 3, 5 are positively worded while items 2, 4, 6 are negatively worded. The total score of Brief Resilience Scale will be the mean of the 6 items. The average score can be interpreted as follows: 1.00 to 2.99 (low resilience); 2.00 to 4.3 (normal resilience) and 4.31 to 5.00 (high resilience).
3 months
Satisfaction with Life
Time Frame: 3 months
Satisfaction with Life Scale is developed to assess satisfaction with people's lives as a whole. The scale has 5 items with each item ranges from 1 to 7. The total range of scores is 5-35 while 20 point is the neutral point in the scale. The scores can be interpreted as follows: 5-9 (extremely dissatisfied with life), 31-35 (extremely satisfied).
3 months

Collaborators and Investigators

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

Sponsor

International Medical University

Collaborators

ThoughtFull World Pte. Ltd.

Investigators

  • Principal Investigator: Kean Ghee Lim, FRCS, International MU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

June 15, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 19, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSc/Sem6(03)2021

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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