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AzTrials

AnxietyNCT04944277

Assessing Effectiveness of ThoughtFullChat Application in Improving Mental Well-Being

A study testing ThoughtFullChat Application in people with Anxiety and Depression, run by IMU University, Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety, Depression, Stress
What is being tested?
ThoughtFullChat Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
353 participants
Where
1 siteMalaysia
Study dates
15 Jun 2021to 28 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • IMU Clinical Campus

    Seremban, Negeri Sembilan, 70300

Other trials in Malaysia

About this study

Official title: 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

Read the 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.

Being tested
ThoughtFullChat Application
Keywords
Mental Health Wellbeing, Text-based Mental Health Coaching Application
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThoughtFullChat ApplicationOther

    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.

Study groups in NCT04944277
Study groupRoleWhat they receive
Without ThoughtFullChat ApplicationNo interventionParticipants will not use the app during the 3 months
With ThoughtFullChat ApplicationExperimentalParticipants will be using the app during the 3 months
Receives: Other: ThoughtFullChat Application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety

    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+).

    Measured: 3 months

Secondary outcomes (4)

  1. Depression

    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+).

    Measured: 3 months

  2. Stress

    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+).

    Measured: 3 months

  3. Resilience

    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).

    Measured: 3 months

  4. Satisfaction with Life

    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).

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2021
  2. Study start15 Jun 2021
  3. Primary completion31 Jan 2022
  4. Study completion28 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04944277
Sponsor's protocol ID
CSc/Sem6(03)2021
Status last verified
Apr 2022
First submitted
10 Jun 2021
Last updated
11 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Khan TM, Sulaiman SA, Hassali MA. Mental health literacy towards depression among non-medical students at a Malaysian university. Ment Health Fam Med. 2010 Mar;7(1):27-35.

    PubMed 22477920

  • Marshall JM, Dunstan DA, Bartik W. Effectiveness of Using Mental Health Mobile Apps as Digital Antidepressants for Reducing Anxiety and Depression: Protocol for a Multiple Baseline Across-Individuals Design. JMIR Res Protoc. 2020 Jul 5;9(7):e17159. doi: 10.2196/17159.

    PubMed 32623368

  • Kelders SM, Bohlmeijer ET, Pots WT, van Gemert-Pijnen JE. Comparing human and automated support for depression: Fractional factorial randomized controlled trial. Behav Res Ther. 2015 Sep;72:72-80. doi: 10.1016/j.brat.2015.06.014. Epub 2015 Jul 6.

    PubMed 26196078

  • Haider II, Tiwana F, Tahir SM. Impact of the COVID-19 Pandemic on Adult Mental Health. Pak J Med Sci. 2020 May;36(COVID19-S4):S90-S94. doi: 10.12669/pjms.36.COVID19-S4.2756.

    PubMed 32582321

  • Donker T, Petrie K, Proudfoot J, Clarke J, Birch MR, Christensen H. Smartphones for smarter delivery of mental health programs: a systematic review. J Med Internet Res. 2013 Nov 15;15(11):e247. doi: 10.2196/jmir.2791.

    PubMed 24240579

  • Hoyt R, Adler K, Ziesemer B, Palombo G. Evaluating the usability of a free electronic health record for training. Perspect Health Inf Manag. 2013 Apr 1;10(Spring):1b. Print 2013.

    PubMed 23805062

  • Teo AR, Choi H, Andrea SB, Valenstein M, Newsom JT, Dobscha SK, Zivin K. Does Mode of Contact with Different Types of Social Relationships Predict Depression in Older Adults? Evidence from a Nationally Representative Survey. J Am Geriatr Soc. 2015 Oct;63(10):2014-22. doi: 10.1111/jgs.13667. Epub 2015 Oct 6.

    PubMed 26437566

  • Abdul Latiff L, Tajik E, Ibrahim N, Abubakar AS, Ali SS. DEPRESSION AND ITS ASSOCIATED FACTORS AMONG SECONDARY SCHOOL STUDENTS IN MALAYSIA. Southeast Asian J Trop Med Public Health. 2016 Jan;47(1):131-41.

    PubMed 27086434

  • Adlina S, Suthahar A, Ramli M, Edariah AB, Soe SA, Mohd Ariff F, Narimah AH, Nuraliza AS, Karuthan C. Pilot study on depression among secondary school students in Selangor. Med J Malaysia. 2007 Aug;62(3):218-22.

    PubMed 18246911

  • Shamsuddin K, Fadzil F, Ismail WS, Shah SA, Omar K, Muhammad NA, Jaffar A, Ismail A, Mahadevan R. Correlates of depression, anxiety and stress among Malaysian university students. Asian J Psychiatr. 2013 Aug;6(4):318-23. doi: 10.1016/j.ajp.2013.01.014. Epub 2013 Mar 1.

    PubMed 23810140

  • Auerbach RP, Mortier P, Bruffaerts R, Alonso J, Benjet C, Cuijpers P, Demyttenaere K, Ebert DD, Green JG, Hasking P, Murray E, Nock MK, Pinder-Amaker S, Sampson NA, Stein DJ, Vilagut G, Zaslavsky AM, Kessler RC; WHO WMH-ICS Collaborators. WHO World Mental Health Surveys International College Student Project: Prevalence and distribution of mental disorders. J Abnorm Psychol. 2018 Oct;127(7):623-638. doi: 10.1037/abn0000362. Epub 2018 Sep 13.

    PubMed 30211576

  • Abdulghani HM, AlKanhal AA, Mahmoud ES, Ponnamperuma GG, Alfaris EA. Stress and its effects on medical students: a cross-sectional study at a college of medicine in Saudi Arabia. J Health Popul Nutr. 2011 Oct;29(5):516-22. doi: 10.3329/jhpn.v29i5.8906.

    PubMed 22106758

  • Dahlin M, Joneborg N, Runeson B. Stress and depression among medical students: a cross-sectional study. Med Educ. 2005 Jun;39(6):594-604. doi: 10.1111/j.1365-2929.2005.02176.x.

    PubMed 15910436

  • Hardeman RR, Przedworski JM, Burke SE, Burgess DJ, Phelan SM, Dovidio JF, Nelson D, Rockwood T, van Ryn M. Mental Well-Being in First Year Medical Students: A Comparison by Race and Gender: A Report from the Medical Student CHANGE Study. J Racial Ethn Health Disparities. 2015 Sep;2(3):403-13. doi: 10.1007/s40615-015-0087-x.

    PubMed 26413458

  • Jafari N, Loghmani A, Montazeri A. Mental health of Medical Students in Different Levels of Training. Int J Prev Med. 2012 Mar;3(Suppl 1):S107-12.

    PubMed 22826751

Questions about this trial

What is this clinical trial studying?

A study testing ThoughtFullChat Application in people with Anxiety and Depression, run by IMU University, Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04944277, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.

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