Recruiting

Text Messaging Program

Sponsor:

Vincent Agyapong

Code:

NCT05411302

Conditions

Major Depressive Disorder

Generalized Anxiety Disorder

Mental Health Wellness 1

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Not accepted

Interventions

Mental health supportive text messages

Study Details

Brief 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.

Conditions

Major Depressive Disorder

Generalized Anxiety Disorder

Mental Health Wellness 1

Study ID

NCT05411302

Start date

Oct 3, 2022

Status verified date

Feb, 2024

Completion date

Sep 1, 2025

Anticipated

Primary completion date

Jul 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • Able to read English text messages.
  • Can provide informed written consent.

Exclusion Criteria:

  • Patients who are not capable of reading text messages in English.
  • Patients who are 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.

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Text4Support Arm

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.

no intervention: Care as usual arm

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.

Interventions

Mental health supportive text messages

Text4Support program was developed based on knowledge from randomized controlled trials conducted in Ireland and Alberta and from evaluations of the Text4Mood program. The diagnostic-specific approach is based on an analysis of service data, which suggested that diagnostic clusters for individuals accessing mental health services into 6 categories: mood disorders, anxiety disorders, schizophrenia and other psychotic disorders, substance use disorders, adjustment disorders and personality disorders. Thus, text message content will focus on 2 dimensions. General range includes messages of self-care, social support, hope, affirmation, and recovery. Specific content will focus on managing symptoms related to the conditions described above. As a component of scalability and inclusiveness, text message content can also be customized based on end-user characteristics. We will explore content that is sensitive to needs based on age group, cultural identity and gender identity.

Primary outcome measure

  • Change in Well-being [ Time Frame: Baseline, 6 weeks, 3, 6 and 12 months ]
  • Change in Recovery [ Time Frame: Baseline, 6 weeks, 3, 6 and 12 months ]
  • Change in Major Depressive Disorder [ Time Frame: Baseline, 6 weeks, 3, 6 and 12 months ]
  • Change in Generalized Anxiety Disorder [ Time Frame: Baseline, 6 weeks, 3, 6 and 12 months ]
  • Change in Suicidal Ideation and Behaviour [ Time Frame: Baseline, 6 weeks, 3, 6 and 12 months ]

Central Contacts and Locations

Central contacts

Vincent Agyapong

780-215-7771vincent.agyapong@nshealth.ca

Raquel Luz Dias

raquelL.dias@nshealth.ca

Locations

Nova Scotia Health - Abbie J. Lane Memorial Building QEII Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 2E2

Contacts

Vincent Agyapong

780-215-7771vincent.agyapong@nshealth.ca

Raquel Luz Dias

raquelL.dias@nshealth.ca

More Information

Sponsor

Vincent Agyapong

Last update posted

Feb 6, 2024

Last verified

Feb, 2024

Keywords

  • Mental Health
  • Text messages
  • e-health
  • Text4Support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vincent Agyapong on 2024-02-06.