Text4Support Arm for Psychosis, Involutional

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nova Scotia Health - Abbie J. Lane Memorial Building QEII Health Sciences Centre, Halifax, Canada
Psychosis, Involutional+6 More
Mental health supportive text messages - Other
Eligibility
Any Age
All Sexes
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Study Summary

Patients seeking mental health care and those being discharged from psychiatric units frequently express psychological distress. A lack of routine follow-up and tailored support during these critical stages of a patient's journey can weaken the patient's connection to the health care system, resulting in low adherence and dissatisfaction with treatment, and the need for more intensive therapies. These unfavourable outcomes may result in deterioration of the patient's mental health, readmissions, recurrent emergency department (ED) visits, and extended length of stay (LOS). The investigators propose implementing an add-on supportive text messaging service (Text4Support), developed using cognitive-behavioural therapy (CBT) principles to augment mental health support for patients accessing different degrees of psychiatric care in Nova Scotia. The primary objective is to investigate the effectiveness of Text4Support, compared to usual care, in improving clinical mental health outcomes and overall mental wellbeing among participants. Secondary objective is to examine the impact of Text4Support on health services utilization and patient satisfaction. Lastly, investigators will explore Text4Support implementation outcomes. This will be a multicenter, mixed-methods, longitudinal, prospective, parallel, two-arm, rater-blinded randomized controlled trial. Participants will be randomized into two arms: the intervention arm will receive the usual care, plus daily automated supportive text messages from an online application, and the control arm will receive the usual care, which includes the freely accessible Health Authority approved e-mental health services. It is planned to enrol at least 1500 participants. Quantitative data will be analyzed using repeated measures mixed-effects modelling, effect size analysis, and correlational analysis between measures at each time point on an intention-to-treat basis. Qualitative data analysis will be guided by the six-phase thematic analysis framework. The analysis of the implementation outcomes will be guided by the RE-AIM framework. The results of the study will provide important information with respect to a comprehensive evaluation of outcomes of a supportive daily text message program; comparability of a supportive daily text message program compared with care as usual; and the impact of a supportive daily text message program on clinical outcomes, patient satisfaction and health services utilization.

Eligible Conditions

  • Psychosis, Involutional
  • Major Depressive Disorder (MDD)
  • Generalized Anxiety Disorder
  • Mental Health Wellness 1

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 7 Secondary · Reporting Duration: 6 weeks, 3, 6 and 12 months.

12 months
Health services utilization (Emergency Department visits)
Health services utilization (crisis calls)
Health services utilization (hospital admissions)
Health services utilization (hospital readmissions - i.e. admissions before 30 days os the last admission)
Health services utilization (lenght of stay - LOS)
Patient retention
Patient satisfaction
12 months after enrollment
Implementation (acceptability)
6 months after enrollment
Implementation (appropriateness)
Month 12
Implementation (reach)
Month 12
Implementation (cost-effectiveness)
Implementation (fidelity)
Month 12
Change in Generalized Anxiety Disorder
Change in Major Depressive Disorder
Change in Recovery
Change in Well-being

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Care as usual arm
1 of 2
Text4Support Arm
1 of 2
Active Control
Experimental Treatment

1500 Total Participants · 2 Treatment Groups

Primary Treatment: Text4Support Arm · No Placebo Group · N/A

Text4Support Arm
Other
Experimental Group · 1 Intervention: Mental health supportive text messages · Intervention Types: Other
Care as usual armNoIntervention Group · 1 Intervention: Care as usual arm · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks, 3, 6 and 12 months.
Closest Location: Nova Scotia Health - Abbie J. Lane Memorial Building QEII Health Sciences Centre · Halifax, Canada
N/AFirst Recorded Clinical Trial
0 TrialsResearching Psychosis, Involutional
0 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a new patient of the TMHP, DH, RASP or MHCC, OR you are a patient discharged from the ED or PIU (i.e

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.