Assessing Effectiveness of ThoughtFullChat Application in Improving Mental Well-Being

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944277
• Other study ID #: CSc/Sem6(03)2021
• Status: Completed
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2022
• Source: International Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 University

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: February 28, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Resilience
• Stress

Intervention

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.

Locations

Country	Name	City	State
Malaysia	IMU Clinical Campus	Seremban	Negeri Sembilan

Sponsors (2)

Lead Sponsor	Collaborator
International Medical University	ThoughtFull World Pte. Ltd.

Country where clinical trial is conducted

Malaysia, 

References & Publications (30)

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. — View Citation

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. — View Citation

Aboalshamat K, Hou XY, Strodl E. The impact of a self-development coaching programme on medical and dental students' psychological health and academic performance: a randomised controlled trial. BMC Med Educ. 2015 Aug 19;15:134. doi: 10.1186/s12909-015-0412-4. — View Citation

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. — View Citation

Andrews B, Wilding JM. The relation of depression and anxiety to life-stress and achievement in students. Br J Psychol. 2004 Nov;95(Pt 4):509-21. — View Citation

Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80. — View Citation

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. — View Citation

Aysan F, Thompson D, Hamarat E. Test anxiety, coping strategies, and perceived health in a group of high school students: a Turkish sample. J Genet Psychol. 2001 Dec;162(4):402-11. — View Citation

Bangasser DA, Curtis A, Reyes BA, Bethea TT, Parastatidis I, Ischiropoulos H, Van Bockstaele EJ, Valentino RJ. Sex differences in corticotropin-releasing factor receptor signaling and trafficking: potential role in female vulnerability to stress-related psychopathology. Mol Psychiatry. 2010 Sep;15(9):877, 896-904. doi: 10.1038/mp.2010.66. Epub 2010 Jun 15. — View Citation

Bayram N, Bilgel N. The prevalence and socio-demographic correlations of depression, anxiety and stress among a group of university students. Soc Psychiatry Psychiatr Epidemiol. 2008 Aug;43(8):667-72. doi: 10.1007/s00127-008-0345-x. Epub 2008 Apr 8. — View Citation

Boyd CP, Hayes L, Nurse S, Aisbett DL, Francis K, Newnham K, Sewell J. Preferences and intention of rural adolescents toward seeking help for mental health problems. Rural Remote Health. 2011;11(1):1582. Epub 2011 Feb 14. — View Citation

Dahlin M, Joneborg N, Runeson B. Stress and depression among medical students: a cross-sectional study. Med Educ. 2005 Jun;39(6):594-604. — View Citation

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. Review. — View Citation

Gopalakrishnan V, Umabalan T, Affan M, Zamri AA, Kamal A, Sandheep S. Stress perceived by houseman in a hospital in northern Malaysia. Med J Malaysia. 2016 Feb;71(1):8-11. — View Citation

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. — View Citation

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. — View Citation

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;10:1b. Print 2013. — View Citation

Huberty J, Green J, Glissmann C, Larkey L, Puzia M, Lee C. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 25;7(6):e14273. doi: 10.2196/14273. — View Citation

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. — View Citation

Kajitani K, Higashijima I, Kaneko K, Matsushita T, Fukumori H, Kim D. Short-term effect of a smartphone application on the mental health of university students: A pilot study using a user-centered design self-monitoring application for mental health. PLoS One. 2020 Sep 25;15(9):e0239592. doi: 10.1371/journal.pone.0239592. eCollection 2020. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Musiat P, Conrod P, Treasure J, Tylee A, Williams C, Schmidt U. Targeted prevention of common mental health disorders in university students: randomised controlled trial of a transdiagnostic trait-focused web-based intervention. PLoS One. 2014 Apr 15;9(4):e93621. doi: 10.1371/journal.pone.0093621. eCollection 2014. — View Citation

Patel V, Flisher AJ, Hetrick S, McGorry P. Mental health of young people: a global public-health challenge. Lancet. 2007 Apr 14;369(9569):1302-1313. doi: 10.1016/S0140-6736(07)60368-7. Review. — View Citation

Puthran R, Zhang MW, Tam WW, Ho RC. Prevalence of depression amongst medical students: a meta-analysis. Med Educ. 2016 Apr;50(4):456-68. doi: 10.1111/medu.12962. Review. — View Citation

Rashid AA, Ghazali SS, Mohamad I, Mawardi M, Musa H, Roslan D. The effectiveness of a Malaysian House Officer (HO) preparatory course for medical graduates on self-perceived confidence and readiness: A quasi-experimental study. PLoS One. 2020 Jul 17;15(7):e0235685. doi: 10.1371/journal.pone.0235685. eCollection 2020. — View Citation

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. — View Citation

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. — View Citation

Yeoh CM, Thong KS, Seed HF, Nur Iwana AT, Maruzairi H. Psychological morbidities amongst house officers in Sarawak General Hospital Kuching. Med J Malaysia. 2019 Aug;74(4):307-311. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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+).	3 months
Secondary	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+).	3 months
Secondary	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+).	3 months
Secondary	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).	3 months
Secondary	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).	3 months

External Links

•   A Preliminary Study of Talkspace's Text-based Psychotherapy
•   A qualitative exploration of the perspectives of mental health professionals on stigma and discrimination of mental illness in Malaysia. Int J Ment Health Syst 9, 10 (2015).
•   A Study of BetterHelp Text-Based Counseling
•   Accommodating students.
•   Adolescents coping with poverty-related family stress: prospective predictors of coping and psychological symptoms
•   An Empathy-Driven, Conversational Artificial Intelligence Agent (Wysa) for Digital Mental Well-Being: Real-World Data Evaluation Mixed-Methods Study
•   Application of Synchronous Text-Based Dialogue Systems in Mental Health Interventions: Systematic Review
•   Building your resilience
•   Common Mental Health Disorders: Identification and Pathways to Care.
•   Coping Skills and Burnout among Medical Officers in a Malaysian Tertiary Hospital
•   Doctors still see own mental health problems as sign of weakness, research finds
•   Doctors' Mental Health in the Midst of COVID-19 Pandemic: The Roles of Work Demands and Recovery Experiences
•   Dr. Pitt is adjunct clinical assistant professor. Mental Health Services for Residents: More Important Than...
•   Evolutionary approaches to psychopathology: The role of natural defenses.
•   Impact of a mobile phone and web program on symptom and functional outcomes for people with mild-to-moderate depression, anxiety and stress: a randomised controlled trial
•   Information about Mental Illness and the Brain.
•   Life satisfaction among university students in a Canadian Prairie City: a multivariate analysis
•   Long-Term Outcomes of a Therapist-Supported, Smartphone-Based Intervention for Elevated Symptoms of Depression and Anxiety: Quasiexperimental, Pre-Postintervention Study
•   Malaysian Healthcare Performance Unit, Malaysian Healthcare Performance: Technical Report 2016, Ministry of Health Malaysia, Putrajaya
•   Mental Health and Coping Response among Malaysian Adults during COVID-19 Pandemic Movement Control Order
•   Mental Health of the world
•   National Centre for Education Statistics. Nontraditional Undergraduates / Definitions and Data
•   Researching protective and promotive factors in mental health
•   Resilience: A definition in context. Australian Community Psychologist
•   Road to resilience: a systematic review and meta-analysis of resilience training programmes and interventions
•   Single young professionals and shared household living.
•   Stress among Medical Students and Its Association with Substance Use and Academic Performance
•   The APEC Digital Hub-WONCA Collaborative Framework on Integration of Mental Health into Primary Care in the Asia Pacific
•   The Burden of Mental Illness: An Emerging Global Disaster. Sungai Buloh
•   The challenges and mental health issues of academic trainees.
•   The economic cost of mental disorders in Malaysia
•   The efficacy of app-supported smartphone interventions for mental health problems: a meta-analysis of randomized controlled trials. World Psychiatry
•   The Global Prevalence of Anxiety Among Medical Students: A Meta-Analysis
•   The mental health of university students in the United Kingdom.
•   The Prevalence and Associated Factors of Depression, Anxiety and Stress of First Year Undergraduate Students in a Public Higher Learning Institution in Malaysia.
•   The prevalence of psychological distress and its association with coping strategies among medical interns in Malaysia: A national-level cross-sectional study
•   The use and effectiveness of mobile mental health apps for treating anxiety and depression. Australian & New Zealand Journal of Psychiatry
•   Two-way messaging therapy for depression and anxiety: longitudinal response trajectories
•   Uses and abuses of recovery: implementing recovery-oriented practices in mental health systems