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

NCT04638231 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

OTHER

Supportive messages

Daily supportive messages via SMS or email

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Vincent Agyapong, MD,PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-08
Primary Completion
2023-12-15
Completion
2023-12-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04638231 on ClinicalTrials.gov