Augmenting Mental Health Support Through a Supportive Text Messaging Program

NCT05411302 | Recruiting

• 1 other identifier: Text4Support-NS47476
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Keywords

Mental Health; Text messages; e-health; Text4Support

Outcome Measures

Primary Outcomes (5)

• Change in Well-being

  Change from Baseline to 6 weeks, 3, 6 and 12 months for the mean scores for the quality life, assessed through the World Health Organization 5 Well-Being Index (WHO-5) in both groups. WHO-5-Well-Being Index is a short 5-item generic global rating scale measuring subjective well-being. The scale was derived from the WHO-10, which in turn was derived from a 28-item rating scale. The scale has adequate validity both as a screening tool for depression and as an outcome measure in clinical trials. The raw score is calculated by totaling the figures of the five answers. The raw score ranges from 0 (zero) to 25, 0 (zero) representing worst possible and 25 representing best possible quality of life.To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 (zero) represents worst possible, whereas a score of 100 represents best possible quality of life.

  Baseline, 6 weeks, 3, 6 and 12 months

• Change in Recovery

  Change from Baseline to 6 weeks, 3, 6 and 12 months for the mean scores for recovery, assessed through the Recovery Assessment Scale (RAS), in both groups. RAS is a 20-item measure developed based on a process model of recovery. The RAS evaluates various aspects of recovery with a special focus on hope and self-determination.

  Baseline, 6 weeks, 3, 6 and 12 months

• Change in Major Depressive Disorder

  Change from Baseline to 6 weeks, 3, 6 and 12 months for the mean scores for moderate to high depression (likely Major Depressive Disorder) assessed through the Patient Health Questionnaire (PHQ-9), in both groups. The PHQ-9 is a 9-item validated instrument used to diagnose and measure the severity of depression in general medical and mental health settings. PHQ-9 scores are: 0 - 4 None-minimal (patient may not need depression treatment); 5 - 9 Mild (use clinical judgment about treatment, based on patient's duration of symptoms and functional impairment); 10 - 14 Moderate (use clinical judgment about treatment, based on patient's duration of symptoms and functional impairment); 15 - 19 Moderately severe (treat using antidepressants, psychotherapy or a combination of treatment); 20 - 27 Severe (treat using antidepressants with or without psychotherapy).

  Baseline, 6 weeks, 3, 6 and 12 months

• Change in Generalized Anxiety Disorder

  Change from Baseline to 6 weeks, 3, 6 and 12 months in prevalence for moderate to high anxiety (likely Generalized Anxiety Disorder), assessed through the Generalized Anxiety Disorder (GAD-7) scale, in both groups. GAD-7 is a validated 7-item questionnaire used to assess the self-reported levels of anxiety in respondents. This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety.

  Baseline, 6 weeks, 3, 6 and 12 months

• Change in Suicidal Ideation and Behaviour

  Change from Baseline to 6 weeks, 3, 6 and 12 months in the mean score for suicidal ideation and behaviour, assessed through the Columbia-Suicide Severity Rating Scale, in both groups. C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. The two initial questions have binary responses (yes/no), which lead to 10 different categories: 1) Wish to be Dead; 2) Non-specific Active Suicidal Thoughts; 3) Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; 4) Active Suicidal Ideation with Some Intent to Act, without Specific Plan; 5) Active Suicidal Ideation with Specific Plan and Intent; 6) Preparatory Acts or Behavior; 7) Aborted Attempt; 8) Interrupted Attempt; 9) Actual Attempt (non-fatal); 10) Completed suicide.

  Baseline, 6 weeks, 3, 6 and 12 months

Secondary Outcomes (7)

• Health services utilization (crisis calls)

  12 months

• Health services utilization (Emergency Department visits)

  12 months

• Health services utilization (hospital admissions)

  12 months

• Health services utilization (hospital readmissions - i.e. admissions before 30 days os the last admission)

  12 months

• Health services utilization (lenght of stay - LOS)

  12 months

Other Outcomes (5)

• Implementation (reach)

  6 weeks, 3, 6 and 12 months after enrollment

• Implementation (acceptability)

  12 months after enrollment

• Implementation (appropriateness)

  6 months after enrollment

Study Arms (2)

Text4Support Arm

EXPERIMENTAL

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.

Other: Mental health supportive text messages

Care as usual arm

NO 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.

Interventions

Mental health supportive text messages OTHER

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.

Text4Support Arm

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vincent Agyapong: lead
• Dalhousie University: collaborator
• Nova Scotia Health Authority: collaborator

Study Sites (1)

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

Halifax, Nova Scotia, B3H 2E2, Canada

RECRUITING

Related Publications (1)

• Obuobi-Donkor G, Shalaby R, Agyapong B, Nkrumah SO, Adu MK, Eboreime E, Wozney L, Agyapong VIO. Impact of a supportive text messaging program (Text4Support) for mitigating psychological problems in patients receiving formal mental health services: A randomized controlled trial. Digit Health. 2025 Jul 23;11:20552076251361236. doi: 10.1177/20552076251361236. eCollection 2025 Jan-Dec.

  PMID: 40727620 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Generalized Anxiety Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Anxiety Disorders; Personal Satisfaction; Behavior

Central Study Contacts

Vincent Agyapong

CONTACT

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

Raquel Luz Dias

CONTACT

raquelL.dias@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Administrative data outcome assessors will be blinded to treatment group allocation by not involving them in discussions about study participants and not granting them access to the randomization code database.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: October 3, 2022
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

CA (1)