Augmenting Mental Health Support for Patients Accessing Different Degrees of Formal Psychiatric Care Through a Supportive Text Messaging Program: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Change in Generalized Anxiety Disorder
研究概览
简要总结
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.
详细描述
In this study, the investigators are testing the Text4Support program, which is a daily supportive text message intervention, developed using cognitive-behavioural therapy (CBT) principles. The Text4Support program will be implemented in Nova Scotia/Canada, to augment mental health support for patients accessing different degrees of psychiatric care in the province.
The main goal is to evaluate how patients participating in community mental health programs or being discharged from psychiatric units will progress in terms of mental well-being and health services utilization if they receive daily automated supportive text messages from an online application, plus the usual care (i.e. community care, follow-up appointments). The results of this evaluation will be compared to the results from the patients who receive the usual care only. The prediction is that daily supportive text messages will result in a 20% greater reduction in the mean Patient Health Questionnaire 9 (PHQ-9), Generalized Anxiety Disorder 7 (GAD-7) scale, and Columbia Suicidal Rating Scale (CSRS) scores and a 20% greater increase in the Recovery Assessment Scale (RAS) and the World Health Organization 5 (WHO 5) Well-Being Index scores at 6 weeks, 3, 6 and 12 months from baseline compared to control interventions. It is also expected a reduction of 10-25% in services utilization (i.e. psychiatric readmissions and ED visits) among participants of the Text4Support arm, compared to the usual care group.
The length of this study for participants is 12 months. The entire study is expected to take about 3 years to complete. Results of this study are expected to be available within 3 years of project commencement. It is anticipated that about 1500 people will participate in this study throughout all zones of Nova Scotia.
Study procedures will include the following steps:
Screening:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 16 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Generalized Anxiety Disorder
时间窗: Baseline, 6 weeks, 3, 6 and 12 months
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.
Change in Well-being
时间窗: Baseline, 6 weeks, 3, 6 and 12 months
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.
Change in Recovery
时间窗: Baseline, 6 weeks, 3, 6 and 12 months
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.
Change in Major Depressive Disorder
时间窗: Baseline, 6 weeks, 3, 6 and 12 months
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).
Change in Suicidal Ideation and Behaviour
时间窗: Baseline, 6 weeks, 3, 6 and 12 months
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.
次要结局
- Health services utilization (lenght of stay - LOS)(12 months)
- Patient retention(12 months)
- Health services utilization (Emergency Department visits)(12 months)
- Health services utilization (crisis calls)(12 months)
- Health services utilization (hospital readmissions - i.e. admissions before 30 days os the last admission)(12 months)
- Health services utilization (hospital admissions)(12 months)
- Patient satisfaction(12 months)
研究者
Vincent Agyapong
Psychiatrist
Nova Scotia Health Authority
