Supportive Text Messaging for Mental Health Wellness

(Text4Support Trial)

Overseen By Raquel Luz Dias

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Vincent Agyapong

Disqualifiers: Non-English readers, No mobile phone, No consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

1500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on adding supportive text messaging to your usual care.

What data supports the effectiveness of the treatment Mental health supportive text messages, Text4Support, Supportive Text Messaging Program?

Research suggests that supportive text messaging programs like Text4Support can help improve mental well-being for people with mental health conditions, especially after they leave psychiatric care. These programs use text messages to provide support and have shown promise in helping people feel better and stay connected to their mental health care. ^{1 2 3 4 5}

Is supportive text messaging for mental health safe for humans?

Supportive text messaging programs like Text4Support and Text4Hope have been used safely by many people to help with mental health conditions, especially during the COVID-19 pandemic. These programs provide daily supportive messages and have not been associated with any reported safety issues. ^{1 2 6 7 8}

How is the Text4Support treatment different from other mental health treatments?

Text4Support is unique because it uses supportive text messages to help people with mental health issues, providing an easily accessible and scalable form of support that can be used after hospital discharge. Unlike traditional treatments, it leverages mobile technology to deliver cognitive behavioral therapy principles through daily messages, making it a novel approach to mental health care. ^{1 2 3 7 8}

Eligibility Criteria

This trial is for new or recently discharged patients from psychiatric care in Nova Scotia who own a mobile device, can read English text messages, and are willing to provide consent. It's not suitable for those unable to read texts in English or without a capable mobile phone.

Inclusion Criteria

Can provide informed written consent

Being a new patient (i.e. first-time user) of the TMHP, DH, RASP or MHCC, OR being a patient discharged from the ED or PIU (i.e. within a week period before discharge date)

Ownership of a mobile device capable of receiving text messages

Exclusion Criteria

I cannot read text messages in English.

Patients who do not own a mobile phone capable of receiving text messages

Patients who are not able/willing to provide consent to take part in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Informed Consent and Randomization

Participants provide informed consent and are randomized into intervention or control groups

1 week

1 visit (in-person or virtual)

Intervention

Participants in the intervention group receive daily supportive text messages for 12 months, while the control group receives usual care

12 months

Daily text messages

Follow-up

Participants complete online questionnaires at 6 weeks, 3, 6, and 12 months to assess mental health outcomes and satisfaction

12 months

4 online questionnaires

Qualitative Sub-study

A sub-sample of participants is invited to participate in individual interviews and focus groups to discuss their experiences

End of Year 2

1-2 visits (in-person or virtual)

Treatment Details

Interventions

• Mental health supportive text messages

Trial Overview The study tests if supportive daily text messages based on cognitive-behavioural therapy can improve mental health outcomes compared to usual care alone. Participants will be randomly assigned to receive either the text message program plus usual care or just the usual care.

Participant Groups

Group I: Text4Support Arm Experimental Treatment 1 Intervention

Patients in the intervention (Text4Support) arm of the study will receive the usual care (i.e. community care, follow-up appointments), plus daily automated supportive text messages from an online application.

Group II: Care as usual arm Active Control 1 Intervention

Patients in the control arm of the study will receive the usual care, which includes the freely accessible Health Authority approved low-intensity e-mental health services. They will receive a single text message informing and encouraging them to utilize current MHAP resources on the NS Health website. They will not receive automated daily supportive text messages.

Mental health supportive text messages is already approved in Canada for the following indications:

Approved in Canada as Text4Support for:

• Mental health support
• Psychological distress management

Who Is Running the Clinical Trial?

Vincent Agyapong

Lead Sponsor

Trials

1

Recruited

1,500+

Nova Scotia Health Authority

Collaborator

Trials

302

Recruited

95,300+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Findings from Research

The Text4Support service, which provides supportive text messages to patients after discharge from psychiatric care, was well received by 40% of participants who reported high satisfaction with the service's impact on their mental well-being.

Participants suggested that future iterations of the service could benefit from more personalized messages and opportunities for interaction with healthcare personnel, indicating a desire for enhanced engagement in their mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Expectations and Experiences With a Mental Health-Focused Supportive Text Messaging Program: Mixed Methods Evaluation. Shalaby, R., Vuong, W., Eboreime, E., et al.[2022]

SMS (text messaging) is a widely accessible communication tool that can be effectively utilized for health-related messaging, particularly in mental health care.

Technology-delivered interventions like SMS can support mental health patients in their treatment and recovery, providing a valuable resource for both patients and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short message service can be a promising tool for psychiatric patients and clinicians. Vernig, PM., Repique, RJ.[2015]

The Text4Support program, a text-messaging intervention based on cognitive behavioral therapy, aims to improve mental well-being for individuals dealing with addiction or mental health issues, and was evaluated over a 6-month period with surveys at baseline, 12 weeks, and 6 months.

Although the study did not have a large enough sample size to achieve statistical significance, it highlights the potential of digital technologies like text messaging to support mental health interventions and suggests areas for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text4Support Mobile-Based Programming for Individuals Accessing Addictions and Mental Health Services-Retroactive Program Analysis at Baseline, 12 Weeks, and 6 Months. Noble, JM., Vuong, W., Surood, S., et al.[2021]

The Text4Hope texting service significantly improved mental health outcomes for male subscribers during the COVID-19 pandemic, with lower perceived stress, anxiety, and depression scores in those receiving daily supportive messages compared to those who did not.

Among the 286 male participants, those in the intervention group showed a lower prevalence of likely major depressive disorder (MDD) and generalized anxiety disorder (GAD), indicating that the service effectively supports mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naturalistic randomized controlled trial demonstrating effectiveness of Text4Hope in supporting male population mental health during the COVID-19 pandemic. Shalaby, R., Agyapong, B., Vuong, W., et al.[2023]

Patients often feel vulnerable when accessing community mental health programs, leading to low adherence and dissatisfaction with treatment, which can result in recurrent hospitalizations.

The proposed Text4Support service, based on cognitive-behavioral therapy principles, aims to improve mental health outcomes and patient satisfaction for those attending or discharged from psychiatric care, potentially reducing the burden on the health care system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmenting Mental Health Support for Patients Accessing Different Degrees of Formal Psychiatric Care through a Supportive Text Messaging Program: Protocol for a Randomized Controlled Trial. Dias, RDL., Shalaby, R., Agyapong, B., et al.[2023]

The Text4Hope service, which provided daily mental health text messages for six weeks, significantly reduced levels of moderate/high stress, generalized anxiety disorder (GAD), and major depressive disorder (MDD) among its subscribers compared to those who had not yet received messages.

Participants in the intervention group reported a 20.9% improvement in overall mental health scores, demonstrating that Text4Hope is an effective tool for alleviating mental health issues during the COVID-19 pandemic and suggesting that similar services could be beneficial in future crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental Health Outreach via Supportive Text Messages during the COVID-19 Pandemic: Improved Mental Health and Reduced Suicidal Ideation after Six Weeks in Subscribers of Text4Hope Compared to a Control Population. Agyapong, VIO., Shalaby, R., Hrabok, M., et al.[2021]

The Text4Mood program, launched by Alberta Health Services during the COVID-19 pandemic, provided free daily supportive text messages to over 32,000 subscribers within the first week, demonstrating a rapid response to mental health needs.

Crafted by mental health professionals, the program aimed to support individuals during quarantine and isolation, and has garnered interest from other regions looking to implement similar mental health initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronavirus Disease 2019 Pandemic: Health System and Community Response to a Text Message (Text4Hope) Program Supporting Mental Health in Alberta. Agyapong, VIO.[2021]

After 3 months of using the Text4Hope program, participants (n = 373) reported significant reductions in anxiety (22.7%), depressive symptoms (10.3%), and perceived stress (5.7%), indicating its effectiveness in alleviating psychological distress during the pandemic.

The program also led to a notable decrease in the prevalence of moderate to high anxiety symptoms, suggesting that Text4Hope is a convenient and accessible intervention for improving mental health on a population level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text4Hope: Receiving Daily Supportive Text Messages for 3 Months During the COVID-19 Pandemic Reduces Stress, Anxiety, and Depression. Agyapong, VIO., Hrabok, M., Shalaby, R., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Patients' Expectations and Experiences With a Mental Health-Focused Supportive Text Messaging Program: Mixed Methods Evaluation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Short message service can be a promising tool for psychiatric patients and clinicians. [2015]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Text4Support Mobile-Based Programming for Individuals Accessing Addictions and Mental Health Services-Retroactive Program Analysis at Baseline, 12 Weeks, and 6 Months. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Naturalistic randomized controlled trial demonstrating effectiveness of Text4Hope in supporting male population mental health during the COVID-19 pandemic. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Augmenting Mental Health Support for Patients Accessing Different Degrees of Formal Psychiatric Care through a Supportive Text Messaging Program: Protocol for a Randomized Controlled Trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Mental Health Outreach via Supportive Text Messages during the COVID-19 Pandemic: Improved Mental Health and Reduced Suicidal Ideation after Six Weeks in Subscribers of Text4Hope Compared to a Control Population. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Coronavirus Disease 2019 Pandemic: Health System and Community Response to a Text Message (Text4Hope) Program Supporting Mental Health in Alberta. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Text4Hope: Receiving Daily Supportive Text Messages for 3 Months During the COVID-19 Pandemic Reduces Stress, Anxiety, and Depression. [2022]