StratCare Trial 2: Evaluating the Clinical and Cost-effectiveness of AI-driven Stratified Care for Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,252
- 试验地点
- 10
- 主要终点
- Change in depressive symptoms from enrolment, as measured by the Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
Depression and anxiety are common mental health problems affecting around one in six adults. Treatments include therapy, telephone or group-based activities delivered by therapists. Treatment uses a "stepped care" model where most patients start with very brief treatments. If they remain unwell after this, they access longer and more intensive therapy. This model does not always work, as only one out of two patients fully recover.
The researchers have developed an artificial intelligence tool called "StratCare". It is designed to help health services to offer the best available treatment for each patient. StratCare is a computerised system that guides therapists on how to assess new patients. It asks a few questions about their symptoms, personality, and background. The system makes a recommendation about which treatment might be most effective for that person. This is either starting with brief therapy or starting with intensive therapy. The treatments are already used with depression in the National health Service (NHS). The patient can discuss with their therapist and decide whether to accept the recommendation. Otherwise, they can discuss trying other options. Previous research found that StratCare can help more people to recover from depression compared to the usual stepped care model.
The researchers will investigate if the StratCare tool works on a large scale in the NHS and if it helps patients in the long-term. The researchers will run a trial involving 1252 participants using NHS Talking Therapies services. Half will use the StratCare tool to make a treatment recommendation. The other half will follow the stepped care approach. The researchers will contact participants in the trial after 6, 12 and 18 months to see if their mood and quality of life has improved. The researchers will also interview therapists and participants to see what they think about treatment being guided by the StratCare tool.
Hypotheses:
- Stratified care will result in lower mean depression scores compared to usual stepped care (USC).
- Stratified care will result in a statistically significant higher proportion of cases with reliable and clinically significant improvement in depression symptoms, compared to USC.
Primary Outcome:
Depressive symptoms, as measured by change on the Patient Health Questionnaire (PHQ-9), at 12 months post-enrolment.
详细描述
Trial Design: A pragmatic, single-blind, multi-site, parallel group cluster Randomised Controlled Trial (RCT), with an internal pilot and stop/go criteria for progression to the full RCT. The researchers will recruit 1252 adult participants seeking treatment for common mental health problems who present with case-level depression symptoms on the Patient Health Questionnaire (PHQ-9) measure. They will be recruited from 16 services in the National Health Service (NHS) Talking Therapies programme across England.
Enrolment: Cluster randomisation will be used to allocate Talking Therapies Teams and their patients to either StratCare or Usual Stepped Care (USC) arms. Sites may have one or more Talking Therapies Teams participating in the trial.
After General Practitioner (GP) or self-referral for treatment, participants will undergo a standard clinical assessment by Talking Therapies clinicians, during which a treatment option will be selected. In the experimental arm, treatment selection will be guided by an Artificial Intelligence (AI) tool (StratCare app). In the USC arm, treatment will be selected following usual clinical practice and guidelines. Participants will then follow their selected treatment option.
NHS Trusts will be recruited through a Practice Research Network, NHS data service provider (PCMIS), and other means, attending to considerations of diversity and generalisability outlined in section seven. Within trusts, individual Talking Therapies teams will be recruited to participate in the trial. Randomisation will occur at team level rather than individual level, to reduce the risk of potential contamination from clinicians becoming aware of how the StratCare app makes treatment decisions.
Participants are adult patients seeking and eligible for treatment for common mental health problems in NHS Talking Therapies services. Patients who are eligible for treatment in the Talking Therapies service will be offered the opportunity to take part in the trial at the point of initial suitability assessment by the service, if seen by a team and clinician participating in StratCare-2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Trial statisticians will be blinded to allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In addition to the criteria, participants must be under the treatment of a participating Talking Therapies service.
- •Inclusion criteria:
- •18 years of age or older.
- •Patients who consent to share their de-identified clinical records for research purposes.
- •Patients assessed as eligible for psychological care in Talking Therapies based on clinical guidelines.
- •Patients with case-level depression symptoms (PHQ-9 ≥ 10).
排除标准
- •Those who are ineligible for treatment in Talking Therapies services according to standard treatment guidelines.
研究组 & 干预措施
StratCare
Treatment recommendation made by the StratCare-2 App using stratified care principles.
干预措施: StratCare (Device)
Usual Stepped Care
Treatment recommendation made using usual stepped care principles.
结局指标
主要结局
Change in depressive symptoms from enrolment, as measured by the Patient Health Questionnaire (PHQ-9)
时间窗: 12 months post-enrolment.
The PHQ-9 is a brief measure of depression symptoms, where each of 9 items is rated on a Likert scale from 0 to 3 representing symptom frequency in the last two weeks, yielding an overall severity score between 0 and 27. The cut-off ≥10 is recommended to screen for clinically significant depression symptoms, and a change of ≥6 points is indicative of statistically reliable change. The PHQ-9 has been extensively validated in primary care populations, with adequate sensitivity (88%) and specificity (88%) estimates for the detection of major depressive disorder using a cut-off score ≥10.
次要结局
- Change in anxiety symptoms from enrolment, as measured by the Generalised Anxiety Disorder Questionnaire (GAD-7)(6, 12 and 18 months post-enrolment.)
- Change in Quality of Life (to derive Quality Adjusted Life Years) from enrolment, as measured by the EQ-5D-5L(6, 12 and 18 months post-enrolment.)
- Change in Quality of Life from enrolment, as measured by the Recovering Quality of Life Scale 10 item version (ReQoL-10)(6, 12 and 18 months post-enrolment.)
- Resource use across the trial duration, measured using an adapted Adult Service Use Schedule (AD-SUS)(6, 12 and 18 months post-enrolment.)
- Change in depressive symptoms from enrolment, as measured by the Patient Health Questionnaire (PHQ-9)(6 and 18-months post enrolment.)