Major Depressive DisorderSTEMNCT04638231
Supportive Text Messaging Versus Supportive E-mail Messaging for Patients With Major Depressive Disorder
A study testing Supportive messages in people with Major Depressive Disorder, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Supportive messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- 8 Apr 2021to 15 Dec 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supportive Text Messaging Versus Supportive E-mail Messaging for Patients With Major Depressive Disorder - A Non-Inferiority Randomized Trial
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.
Read more
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.
Read the detailed description
Depression is a debilitating condition which is characterized by changes in mood, self-attitude, cognitive functioning, sleep, appetite, and energy levels. Depression causes a decrease in quality of life that leads to impairment in occupational and social functioning. In 2010, it was estimated that mental and substance use disorders were the leading cause of years lived with disability worldwide, with Depressive disorders in particular accounting for 40·5% of disability-adjusted life-years caused by mental and substance use disorders. Depression is thus a major contributor to the overall global burden of disease and it is projected by the World Health Organization, that by 2030, Major Depressive Disorder (MDD) will be the leading cause of disability worldwide.
In 2012, over 3.2 million Canadians over 15 (11.3%) years reported symptoms of major depression and a higher health and service utilization amongst patients with depression have been reported compared to other patients. Psycho-social interventions and pharmacotherapy is the preferred first-line treatment for severe mental health problems including major depression. Psychotherapies, such as cognitive behavior therapy, interpersonal psychotherapy, problem-solving and behavioral activation are common and effective forms of treatment for depression. However, access to these psychotherapies are often limited by human resource capacity constraints and most people with depressive disorders do not receive treatment. Psychosocial services are also mostly found in cities and towns, with reduced access for rural inhabitants. Even in cities and towns these services are mostly only available during the working days and day time business hours, with caregivers often dealing with double the recommended number of clients, further restricting appointment availability. Long wait times to access counselling services and the stigma associated with seeking mental health counselling also compound the problem. In the 2012 Canadian Community Health Survey on Mental Health, barriers such as lack of readily available care system, stigma and affordability of health care services, were reported by 2.3 million Canadians who expressed they had unmet or partially met mental health care needs. It is clear, that traditional ways of providing mental healthcare alone will not be able to meet the demands for services given that the prevalence of depression is so high and not likely to decrease any time soon. There is, therefore, 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.
Digital technologies for the provision of health care interventions have advanced significantly in the last decade and further development of this field looks very promising. The new technologies may enhance access to mental healthcare and contribute to closing the treatment gap that has existed over the years. Current evidence supports the efficacy and cost-effectiveness of tele mental health, especially in the context of treating depressive disorders. Useful communication methods for the delivery of mental health services includes smartphone apps, text messages and e-mails.
Supportive text messages have become an appropriate and acceptable means of delivering psychological care to patients with mental health issues. It is estimated that 99% of received mobile text messages are opened, and 90% of all text messages are read within three minutes of reception and present an opportunity to aid in the closure of the psychological treatment gap for patients with depression. In three randomized controlled trials conducted in Ireland and Canada, patients with MDD who received twice-daily supportive text messages had significantly greater reductions in their depression symptom scores compared to patients who received the usual treatment. In the first of two studies conducted in Ireland, after three months, the mean difference in change Becks Depression Inventory (BID)-II scores between the intervention and the control group was -7.9 (95% CI -13.06 to -2.76, Cohen'sd=0.85) in favor of the intervention group. Similar results were reported in another Irish study with larger sample size and in a Canadian study, a significant difference was found in the 3 months mean BDI scores between the intervention and control groups: (20.8 (SD = 11.7) vs. 24.9 (SD = 11.5), respectively, F (1, 60) = 4.83, p = 0.03, ηp2 = 0.07) with an effect size (Cohen's d) of 0.67. literature review of studies conducted on the effectiveness of text messaging as an adjunct therapy for mothers with postpartum depression living in low-income countries also reported a positive outcome and the mothers noted that they would love to receive psychological care via the text messaging. Several studies have also reported high user satisfaction of the supportive text message intervention and in one of these studies, 83% of subscribers to the Text4Mood program reported that the daily messages contributed to improving their overall mental wellbeing.
Anecdotally, some people have not been able to subscribe to supportive text messaging programs such as Text4Hope and Text4Mood because they do not have active cell phone numbers, with several individuals for whom these programs have been recommended in Addiction and Mental Health clinics in Edmonton enquiring if the messages could be sent to them via email. In the participants' satisfaction survey for the Text4Hope program, majority of respondents (64%), even though they had access to cell phones, were in favor of Email messaging for as part of their health care interventions during crisis periods.
In this technological period where faster, accessible and efficient communication medium is of outmost importance, e-mail has emerged and professionals have continued to used e-mail as a medium of communication, including communication between physicians with patients. The uniqueness of E-mail can be linked to its special characteristics, such as asynchronous communication and rapid message delivery. Electronic-therapy has been rapidly expanding in the last decades, with evidence suggesting that the provision of mental health services over the internet is both clinically efficacious and cost-effective even though its effects remain underutilized by the medical fraternity as a viable medium of communication. Given this introduction, the goal 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.
Our specific objectives include:
- To compare the mean the difference/change in Patient Health Questionnaire (PHQ)-9 scores from baseline at 6, 12 and 24 weeks for patients with MDD receiving standard care plus daily supportive Email messages to those receiving standard care plus daily supportive text messages.
- To compare the mean the difference/change in the WHO (Five) Well-Being Index (WHO-5) scores from baseline at 6, 12 and 24 week for patients with MDD receiving standard care plus daily supportive Email messages to those receiving standard care plus daily supportive text messages.
- To compare the mean the difference/change in the Generalized Anxiety Disorder (GAD)-7 scale scores from baseline at 6, 12 and 24 week for patients with MDD receiving standard care plus daily supportive Email messages to those receiving standard care plus daily supportive text messages.
- To compare the dropout and satisfaction rates between patients in the two treatment arms.
- To explore the perspectives of beneficiaries and opt-out patients on their perceptions about the interventions
Intervention:
A research coordinator will assist participants who have provided written informed consent to enrol on either the email messaging or text messaging program by inputting their email address or phone numbers into online email messaging or text messaging applications which would be used to deliver the daily messages. Starting a day after enrollments, participants will receive either daily supportive text messages or daily supportive email messages. Both the email and text messages have the same content and have been crafted by mental health therapists, clinical psychologists, psychiatrists and mental health service users based on Cognitive Behaviour Therapy (CBT) principles. Each message would be scheduled to be delivered to participants cell phone or email address at 10 AM MT and each participant would receive the messages for 6 months.
- Conditions
- Major Depressive Disorder
- Being tested
- Supportive messages
- Keywords
- Email messaging, Text messaging, Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive messagesOther
Daily supportive messages via SMS or email
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Supportive messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6, 12 and 24 weeks
Secondary outcomes (1)
Change in the Generalized Anxiety Disorder Assessment (GAD-7) score
The Generalised Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day". Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
When used as a screening tool, further evaluation is recommended when the score is 10 or greater. We will monitor the change in this outcome measure at various intervals.
Measured: Baseline, 6, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start8 Apr 2021
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Agyapong, MD,PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638231
- Sponsor's protocol ID
- Pro00105429
- Acronym
- STEM
- Status last verified
- Mar 2024
- First submitted
- 7 Nov 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available to the other members of the research team including Dr Ejemai Eboreime, Dr Reham Shalaby, Medard Adu
Publications
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.
PubMed 26486257Singla 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.
PubMed 29856556Whiteford 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.
PubMed 23993280Wu 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.
PubMed 16238157Zhou 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.
PubMed 32202977Agyapong 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.
PubMed 32317038Agyapong 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.
PubMed 22464008Agyapong 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.
PubMed 28768493Agyapong 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.
PubMed 27821096Agyapong 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.
PubMed 23358057Berrouiguet 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.
PubMed 27287668Broom 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.
PubMed 26543910Chisholm 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.
PubMed 27083119Garcia-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.
PubMed 20377799Hall 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.
PubMed 25785892
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Text Messaging Versus Supportive E-mail Messaging for Patients With Major Depressive Disorder - A Non-Inferiority Randomized Trial
- ClinicalTrials.gov ID
- NCT04638231
- Acronym / sponsor ID
- STEM / Pro00105429
- Conditions
- Major Depressive Disorder
- Keywords
- Email messaging, Text messaging, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Depression is a debilitating condition which is characterized by changes in mood, self-attitude, cognitive functioning, sleep, appetite, and energy levels. Depression causes a decrease in quality of life that leads to impairment in occupational and social functioning. In 2010, it was estimated that mental and substance use disorders were the leading cause of years lived with disability worldwide, with Depressive disorders in particular accounting for 40·5% of disability-adjusted life-years caused by mental and substance use disorders. Depression is thus a major contributor to the overall global burden of disease and it is projected by the World Health Organization, that by 2030, Major Depressive Disorder (MDD) will be the leading cause of disability worldwide.
In 2012, over 3.2 million Canadians over 15 (11.3%) years reported symptoms of major depression and a higher health and service utilization amongst patients with depression have been reported compared to other patients. Psycho-social interventions and pharmacotherapy is the preferred first-line treatment for severe mental health problems including major depression. Psychotherapies, such as cognitive behavior therapy, interpersonal psychotherapy, problem-solving and behavioral activation are common and effective forms of treatment for depression. However, access to these psychotherapies are often limited by human resource capacity constraints and most people with depressive disorders do not receive treatment. Psychosocial services are also mostly found in cities and towns, with reduced access for rural inhabitants. Even in cities and towns these services are mostly only available during the working days and day time business hours, with caregivers often dealing with double the recommended number of clients, further restricting appointment availability. Long wait times to access counselling services and the stigma associated with seeking mental health counselling also compound the problem. In the 2012 Canadian Community Health Survey on Mental Health, barriers such as lack of readily available care system, stigma and affordability of health care services, were reported by 2.3 million Canadians who expressed they had unmet or partially met mental health care needs. It is clear, that traditional ways of providing mental healthcare alone will not be able to meet the demands for services given that the prevalence of depression is so high and not likely to decrease any time soon. There is, therefore, 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.
Digital technologies for the provision of health care interventions have advanced significantly in the last decade and further development of this field looks very promising. The new technologies may enhance access to mental healthcare and contribute to closing the treatment gap that has existed over the years. Current evidence supports the efficacy and cost-effectiveness of tele mental health, especially in the context of treating depressive disorders. Useful communication methods for the delivery of mental health services includes smartphone apps, text messages and e-mails.
Supportive text messages have become an appropriate and acceptable means of delivering psychological care to patients with mental health issues. It is estimated that 99% of received mobile text messages are opened, and 90% of all text messages are read within three minutes of reception and present an opportunity to aid in the closure of the psychological treatment gap for patients with depression. In three randomized controlled trials conducted in Ireland and Canada, patients with MDD who received twice-daily supportive text messages had significantly greater reductions in their depression symptom scores compared to patients who received the usual treatment. In the first of two studies conducted in Ireland, after three months, the mean difference in change Becks Depression Inventory (BID)-II scores between the intervention and the control group was -7.9 (95% CI -13.06 to -2.76, Cohen'sd=0.85) in favor of the intervention group. Similar results were reported in another Irish study with larger sample size and in a Canadian study, a significant difference was found in the 3 months mean BDI scores between the intervention and control groups: (20.8 (SD = 11.7) vs. 24.9 (SD = 11.5), respectively, F (1, 60) = 4.83, p = 0.03, ηp2 = 0.07) with an effect size (Cohen's d) of 0.67. literature review of studies conducted on the effectiveness of text messaging as an adjunct therapy for mothers with postpartum depression living in low-income countries also reported a positive outcome and the mothers noted that they would love to receive psychological care via the text messaging. Several studies have also reported high user satisfaction of the supportive text message intervention and in one of these studies, 83% of subscribers to the Text4Mood program reported that the daily messages contributed to improving their overall mental wellbeing.
Anecdotally, some people have not been able to subscribe to supportive text messaging programs such as Text4Hope and Text4Mood because they do not have active cell phone numbers, with several individuals for whom these programs have been recommended in Addiction and Mental Health clinics in Edmonton enquiring if the messages could be sent to them via email. In the participants' satisfaction survey for the Text4Hope program, majority of respondents (64%), even though they had access to cell phones, were in favor of Email messaging for as part of their health care interventions during crisis periods.
In this technological period where faster, accessible and efficient communication medium is of outmost importance, e-mail has emerged and professionals have continued to used e-mail as a medium of communication, including communication between physicians with patients. The uniqueness of E-mail can be linked to its special characteristics, such as asynchronous communication and rapid message delivery. Electronic-therapy has been rapidly expanding in the last decades, with evidence suggesting that the provision of mental health services over the internet is both clinically efficacious and cost-effective even though its effects remain underutilized by the medical fraternity as a viable medium of communication. Given this introduction, the goal 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.
Our specific objectives include:
- To compare the mean the difference/change in Patient Health Questionnaire (PHQ)-9 scores from baseline at 6, 12 and 24 weeks for patients with MDD receiving standard care plus daily supportive Email messages to those receiving standard care plus daily supportive text messages.
- To compare the mean the difference/change in the WHO (Five) Well-Being Index (WHO-5) scores from baseline at 6, 12 and 24 week for patients with MDD receiving standard care plus daily supportive Email messages to those receiving standard care plus daily supportive text messages.
- To compare the mean the difference/change in the Generalized Anxiety Disorder (GAD)-7 scale scores from baseline at 6, 12 and 24 week for patients with MDD receiving standard care plus daily supportive Email messages to those receiving standard care plus daily supportive text messages.
- To compare the dropout and satisfaction rates between patients in the two treatment arms.
- To explore the perspectives of beneficiaries and opt-out patients on their perceptions about the interventions
Intervention:
A research coordinator will assist participants who have provided written informed consent to enrol on either the email messaging or text messaging program by inputting their email address or phone numbers into online email messaging or text messaging applications which would be used to deliver the daily messages. Starting a day after enrollments, participants will receive either daily supportive text messages or daily supportive email messages. Both the email and text messages have the same content and have been crafted by mental health therapists, clinical psychologists, psychiatrists and mental health service users based on Cognitive Behaviour Therapy (CBT) principles. Each message would be scheduled to be delivered to participants cell phone or email address at 10 AM MT and each participant would receive the messages for 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Text Message Group | Active comparator | Other: Supportive messagesThis group will receive daily supportive messages through Short Messaging Service (SMS) on their mobile phones in addition to standard care |
| Email Message Group | Experimental | Other: Supportive messagesThis group will receive same supportive message as the Text Message group but through their email addresses, in addition to receiving standard care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive messagesDaily supportive messages via SMS or email | Other | Email Message Group, Text Message Group |
Primary outcome
Change in Patient Health Questionnaire (PHQ)-9 scores
Time frame: Baseline, 6, 12 and 24 weeks
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.
Change in the WHO (Five) Well-Being Index (WHO-5)
Time frame: Baseline, 6, 12 and 24 weeks
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.
1 secondary outcome
Change in the Generalized Anxiety Disorder Assessment (GAD-7) score
Time frame: Baseline, 6, 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 26486257Becker 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.
- Background: PubMed 29856556Singla 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.
- Background: PubMed 23993280Whiteford 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.
- Background: PubMed 16238157Wu 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.
- Background: PubMed 32202977Zhou 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.
- Results publication: PubMed 32317038Agyapong 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.
- Results publication: PubMed 22464008Agyapong 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.
- Results publication: PubMed 28768493Agyapong 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.
- Results publication: PubMed 27821096Agyapong 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.
- Results publication: PubMed 23358057Agyapong 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.
- Results publication: PubMed 27287668Berrouiguet 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.
- Results publication: PubMed 26543910Broom 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.
- Personalized treatment for functional outcome in depressionLink provided by the sponsor.
- 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. LopezLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD will be available to the other members of the research team including Dr Ejemai Eboreime, Dr Reham Shalaby, Medard Adu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Agyapong, MD,PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive messages in people with Major Depressive Disorder, run by University of Alberta at 1 site in Canada.
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 4 inclusion and 3 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 19 Sep 2024. 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 Canada. 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?
Change in Patient Health Questionnaire (PHQ)-9 scores (time frame: Baseline, 6, 12 and 24 weeks). The study lists 2 primary outcomes in all. 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 NCT04638231, which also lists 30 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 19 Sep 2024.