Supportive Text Messaging Versus Supportive E-mail Messaging for Patients with Major Depressive Disorder

NCT04638231 | Completed

• 1 other identifier: Pro00105429
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In 2012, over 3.2 million Canadians over 15 (11.3%) years reported symptoms of major depressive disorder (MDD), and barriers such as lack of readily available care system, stigma and affordability of health care services were reported by millions of Canadians who expressed they had unmet or partially met mental health care needs. There is the need to develop innovative psychological interventions which are not human resource intensive, are easily accessible, cost-effective, are geographic location independent, scalable, and can be offered to thousands of people simultaneously. Supportive text messaging has been proven in clinical trials to be effective in alleviating depression symptoms but are limited in their ability support those without active cell phones. Objective: The objective of this study is to evaluate the feasibility, comparative effectiveness and user satisfaction with daily supportive e-mail messaging as an intervention to treat patients with MDD when compared to daily supportive text messaging. Method: In this innovative two-arm randomized non-inferiority pilot trial, patients with MDD receiving usual care would be randomized to receive either daily supportive email messaging or daily supportive text messaging of the same content for six months. The Patient Health Questionnaire (PHQ)-9 scale will be utilized to record depression symptom scores, the Generalized Anxiety Disorder (GAD)-7 scale would be used to record the anxiety symptoms and quality of life will be measured using the WHO (Five) Well-Being Index (WHO-5) at baseline, 6, 12 and 24 weeks. Primary outcomes would be the mean difference in change scores on the PHQ-9 and WHO-5 scales from baseline to 6, 12 and 24 weeks for the two study arms. Secondary outcomes include changed scores on the GAD7 scale from baseline to 6, 12 and 24 weeks for the two study arms, the dropout rates and the satisfaction rates at 12 and 24 weeks for participants in the two treatment arms. All outcome measures would be analyzed using descriptive and inferential statistics. Qualitative data will be analyzed using thematic analysis aided by NVIVO software. Results: We expect the study results to be available within 18 months of study commencement. Conclusion: The results of this study will shed light on the feasibility, acceptability and effectiveness of using automated email supportive message interventions in the management of patients with MDD.

Conditions

Major Depressive Disorder

Keywords

Email messaging; Text messaging; Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Change in Patient Health Questionnaire (PHQ)-9 scores

  The Patient Health Questionnaire (PHQ) 9 is a self-administered diagnostic instrument for depression, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Minimal depression (score 0-4); Mild depression (score 5-9); Moderate depression (Score 10-14); Moderately severe depression (Score 15-19); Severe depression (score 20-27). We will monitor the change in this outcome measure at various intervals.

  Baseline, 6, 12 and 24 weeks

• Change in the WHO (Five) Well-Being Index (WHO-5)

  The World Health Organization- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing. Raw score: 0 represents worst possible quality of life and 25 represents best possible quality of life. Percentage score: 0 represents worst possible quality of life and 100 represents best possible quality of life. We will monitor the change in this outcome measure at various intervals.

  Baseline, 6, 12 and 24 weeks

Secondary Outcomes (1)

• Change in the Generalized Anxiety Disorder Assessment (GAD-7) score

  Baseline, 6, 12 and 24 weeks

Study Arms (2)

Text Message Group

ACTIVE COMPARATOR

This group will receive daily supportive messages through Short Messaging Service (SMS) on their mobile phones in addition to standard care

Other: Supportive messages

Email Message Group

EXPERIMENTAL

This group will receive same supportive message as the Text Message group but through their email addresses, in addition to receiving standard care

Other: Supportive messages

Interventions

Supportive messages OTHER

Daily supportive messages via SMS or email

Email Message Group; Text Message Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons aged 18 years and over who have the capacity to provide informed consent.
• Patients who have been assessed using structured clinical interviews for DSM 5and diagnosed with a Major Depressive Disorder.
• Patients who have a cell phone with an active line and a functional email address and can access both E-mail messages and Text messages
• Patients who accept willingly to be enrolled in the trial and agrees to sign the consent form

You may not qualify if:

• Active psychotic disorders
• Residing outside of regular cell phone and internet connection areas
• Already subscribed to Text4Hope, Text4Mood, Text4Support or another supportive text messaging program.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Urgent Psychiatric Clinic

Edmonton, Alberta, T6R 3P5, Canada

Location

Related Publications (30)

• Agyapong VIO. Coronavirus Disease 2019 Pandemic: Health System and Community Response to a Text Message (Text4Hope) Program Supporting Mental Health in Alberta. Disaster Med Public Health Prep. 2020 Oct;14(5):e5-e6. doi: 10.1017/dmp.2020.114. Epub 2020 Apr 22.

  PMID: 32317038 BACKGROUND

• Agyapong VI, Ahern S, McLoughlin DM, Farren CK. Supportive text messaging for depression and comorbid alcohol use disorder: single-blind randomised trial. J Affect Disord. 2012 Dec 10;141(2-3):168-76. doi: 10.1016/j.jad.2012.02.040. Epub 2012 Mar 29.

  PMID: 22464008 BACKGROUND

• Agyapong VIO, Juhas M, Ohinmaa A, Omeje J, Mrklas K, Suen VYM, Dursun SM, Greenshaw AJ. Randomized controlled pilot trial of supportive text messages for patients with depression. BMC Psychiatry. 2017 Aug 2;17(1):286. doi: 10.1186/s12888-017-1448-2.

  PMID: 28768493 BACKGROUND

• Agyapong VI, Mrklas K, Juhas M, Omeje J, Ohinmaa A, Dursun SM, Greenshaw AJ. Cross-sectional survey evaluating Text4Mood: mobile health program to reduce psychological treatment gap in mental healthcare in Alberta through daily supportive text messages. BMC Psychiatry. 2016 Nov 8;16(1):378. doi: 10.1186/s12888-016-1104-2.

  PMID: 27821096 BACKGROUND

• Agyapong VI, Milnes J, McLoughlin DM, Farren CK. Perception of patients with alcohol use disorder and comorbid depression about the usefulness of supportive text messages. Technol Health Care. 2013;21(1):31-9. doi: 10.3233/THC-120707.

  PMID: 23358057 BACKGROUND

• Becker KD, Buckingham SL, Rith-Najarian L, Kline ER. The Common Elements of treatment engagement for clinically high-risk youth and youth with first-episode psychosis. Early Interv Psychiatry. 2016 Dec;10(6):455-467. doi: 10.1111/eip.12283. Epub 2015 Oct 20.

  PMID: 26486257 BACKGROUND

• Berrouiguet S, Baca-Garcia E, Brandt S, Walter M, Courtet P. Fundamentals for Future Mobile-Health (mHealth): A Systematic Review of Mobile Phone and Web-Based Text Messaging in Mental Health. J Med Internet Res. 2016 Jun 10;18(6):e135. doi: 10.2196/jmir.5066.

  PMID: 27287668 BACKGROUND

• Broom MA, Ladley AS, Rhyne EA, Halloran DR. Feasibility and Perception of Using Text Messages as an Adjunct Therapy for Low-Income, Minority Mothers With Postpartum Depression. JMIR Ment Health. 2015 Mar 16;2(1):e4. doi: 10.2196/mental.4074. eCollection 2015 Jan-Mar.

  PMID: 26543910 BACKGROUND

• Chisholm D, Sweeny K, Sheehan P, Rasmussen B, Smit F, Cuijpers P, Saxena S. Scaling-up treatment of depression and anxiety: a global return on investment analysis. Lancet Psychiatry. 2016 May;3(5):415-24. doi: 10.1016/S2215-0366(16)30024-4. Epub 2016 Apr 12.

  PMID: 27083119 BACKGROUND

• Garcia-Lizana F, Munoz-Mayorga I. Telemedicine for depression: a systematic review. Perspect Psychiatr Care. 2010 Apr;46(2):119-26. doi: 10.1111/j.1744-6163.2010.00247.x.

  PMID: 20377799 BACKGROUND

• Hall AK, Cole-Lewis H, Bernhardt JM. Mobile text messaging for health: a systematic review of reviews. Annu Rev Public Health. 2015 Mar 18;36:393-415. doi: 10.1146/annurev-publhealth-031914-122855.

  PMID: 25785892 BACKGROUND

• Iyer S, Jordan G, MacDonald K, Joober R, Malla A. Early intervention for psychosis: a Canadian perspective. J Nerv Ment Dis. 2015 May;203(5):356-64. doi: 10.1097/NMD.0000000000000288.

  PMID: 25900548 BACKGROUND

• Kerst A, Zielasek J, Gaebel W. Smartphone applications for depression: a systematic literature review and a survey of health care professionals' attitudes towards their use in clinical practice. Eur Arch Psychiatry Clin Neurosci. 2020 Mar;270(2):139-152. doi: 10.1007/s00406-018-0974-3. Epub 2019 Jan 3.

  PMID: 30607530 BACKGROUND

• Lal S, Malla A. Service Engagement in First-Episode Psychosis: Current Issues and Future Directions. Can J Psychiatry. 2015 Aug;60(8):341-5. doi: 10.1177/070674371506000802.

  PMID: 26454555 BACKGROUND

• Lowe B, Kroenke K, Herzog W, Grafe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004 Jul;81(1):61-6. doi: 10.1016/S0165-0327(03)00198-8.

  PMID: 15183601 BACKGROUND

• Mohr DC, Tomasino KN, Lattie EG, Palac HL, Kwasny MJ, Weingardt K, Karr CJ, Kaiser SM, Rossom RC, Bardsley LR, Caccamo L, Stiles-Shields C, Schueller SM. IntelliCare: An Eclectic, Skills-Based App Suite for the Treatment of Depression and Anxiety. J Med Internet Res. 2017 Jan 5;19(1):e10. doi: 10.2196/jmir.6645.

  PMID: 28057609 BACKGROUND

• Nolin M, Malla A, Tibbo P, Norman R, Abdel-Baki A. Early Intervention for Psychosis in Canada: What Is the State of Affairs? Can J Psychiatry. 2016 Mar;61(3):186-94. doi: 10.1177/0706743716632516.

  PMID: 27254094 BACKGROUND

• Pratt LA, Brody DJ. Depression in the United States household population, 2005-2006. NCHS Data Brief. 2008 Sep;(7):1-8.

  PMID: 19389321 BACKGROUND

• Singla DR, Raviola G, Patel V. Scaling up psychological treatments for common mental disorders: a call to action. World Psychiatry. 2018 Jun;17(2):226-227. doi: 10.1002/wps.20532. No abstract available.

  PMID: 29856556 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Sucala M, Schnur JB, Constantino MJ, Miller SJ, Brackman EH, Montgomery GH. The therapeutic relationship in e-therapy for mental health: a systematic review. J Med Internet Res. 2012 Aug 2;14(4):e110. doi: 10.2196/jmir.2084.

  PMID: 22858538 BACKGROUND

• Sunderland A, Findlay LC. Perceived need for mental health care in Canada: Results from the 2012 Canadian Community Health Survey-Mental Health. Health Rep. 2013 Sep;24(9):3-9.

  PMID: 24258361 BACKGROUND

• Versluis A, Verkuil B, Spinhoven P, van der Ploeg MM, Brosschot JF. Changing Mental Health and Positive Psychological Well-Being Using Ecological Momentary Interventions: A Systematic Review and Meta-analysis. J Med Internet Res. 2016 Jun 27;18(6):e152. doi: 10.2196/jmir.5642.

  PMID: 27349305 BACKGROUND

• Wang PS, Lane M, Olfson M, Pincus HA, Wells KB, Kessler RC. Twelve-month use of mental health services in the United States: results from the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):629-40. doi: 10.1001/archpsyc.62.6.629.

  PMID: 15939840 BACKGROUND

• Wells KB, Stewart A, Hays RD, Burnam MA, Rogers W, Daniels M, Berry S, Greenfield S, Ware J. The functioning and well-being of depressed patients. Results from the Medical Outcomes Study. JAMA. 1989 Aug 18;262(7):914-9.

  PMID: 2754791 BACKGROUND

• Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 9;382(9904):1575-86. doi: 10.1016/S0140-6736(13)61611-6. Epub 2013 Aug 29.

  PMID: 23993280 BACKGROUND

• Wu Z, Penning MJ, Schimmele CM. Immigrant status and unmet health care needs. Can J Public Health. 2005 Sep-Oct;96(5):369-73. doi: 10.1007/BF03404035.

  PMID: 16238157 BACKGROUND

• Zhou X, Snoswell CL, Harding LE, Bambling M, Edirippulige S, Bai X, Smith AC. The Role of Telehealth in Reducing the Mental Health Burden from COVID-19. Telemed J E Health. 2020 Apr;26(4):377-379. doi: 10.1089/tmj.2020.0068. Epub 2020 Mar 23. No abstract available.

  PMID: 32202977 BACKGROUND

• Adu MK, Eboreime O, Shalaby R, Eboreime E, Agyapong B, da Luz Dias R, Sapara AO, Agyapong VIO. Comparing Email Versus Text Messaging as Delivery Platforms for Supporting Patients With Major Depressive Disorder: Noninferiority Randomized Controlled Trial. JMIR Form Res. 2024 Sep 9;8:e59003. doi: 10.2196/59003.

  PMID: 39250182 DERIVED

• Adu MK, Shalaby R, Eboreime E, Sapara A, Nkire N, Chawla R, Chima C, Achor M, Osiogo F, Chue P, Greenshaw AJ, Agyapong VI. Text Messaging Versus Email Messaging to Support Patients With Major Depressive Disorder: Protocol for a Randomized Hybrid Type II Effectiveness-Implementation Trial. JMIR Res Protoc. 2021 Oct 13;10(10):e29495. doi: 10.2196/29495.

  PMID: 34643541 DERIVED

Related Links

• E-mail communication: Issues for mental health counselors
• Personalized treatment for functional outcome in depression
• The Global burden of disease : a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020 : summary / edited by Christopher J. L. Murray, Alan D. Lopez

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Vincent Agyapong, MD,PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: We will use block randomization with a series of computer-generated random numbers to ensure balance (1:1) between the two treatment groups. The randomisation codes will be transmitted by an independent statistician via text message directly to the blinded researcher's password-protected phone line with a secure online backup
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-arm randomized non-inferiority pilot trial in which patients with MDD receiving usual care are randomized to receive either daily supportive email messaging or daily supportive text messaging of the same content.

Study Record Dates

• First Submitted: November 7, 2020
• First Posted: November 20, 2020
• Study Start: April 8, 2021
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Throughout the study duration, up to 5 years after the data is collected
• Access Criteria: Involved in data collection, analyses or report writing

Locations

CA (1)