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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Supportive Text Messaging Versus Supportive E-mail Messaging for Patients With Major Depressive Disorder - A Non-Inferiority Randomized Trial

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Other: Supportive messages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Text Message Group<br>This group will receive daily supportive messages through Short Messaging Service (SMS) on their mobile phones in addition to standard care | Other: Supportive messages<br>* Daily supportive messages via SMS or email<br>|
| Experimental: Email Message Group<br>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<br>* Daily supportive messages via SMS or email<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 6, 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Email messaging, Text messaging, Major Depressive Disorder