Exploratory Randomised Controlled Trial of an Artificial Intelligence Self Harm Application
试验速览
- 阶段
- 不适用
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Beck Scale for Suicide Ideation
研究概览
简要总结
This is a mixed-methods study. The quantitative component will comprise of a multicentre rater-blind, randomized controlled trial to evaluate the feasibility and acceptability of AISHA in addition to treatment as usual (TAU) compared to TAU alone in Pakistan.
In-depth interviews and focus groups with other stakeholders will take place to consider the wider implementation of AISHA in mental health services in Pakistan.
详细描述
Mental health resources in LMICs, including Pakistan, do not match the burden of mental illness, resulting in a massive mental health treatment gap. Interventions delivered on mobile platforms (M-Health) have the potential to overcome these barriers. Evidence supports the acceptability and efficacy of interventions delivered on digital platforms for a variety of mental disorders. Mobile-based interventions have been developed to target self-harm, however, there is paucity of research supporting their efficacy in LMIC.
To our knowledge there are currently no clinical trials examining the feasibility, acceptability and preliminary efficacy of a culturally adapted CBT informed problem solving intervention delivered on a digital platform for self-harm prevention.We have developed an Artificial Intelligence Self-Harm prevention Application (AISHA) to deliver an evidence-based problem solving intervention (CMAP) for people presenting with self-harm.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients presented to the participating family physicians, community health centres, emergency departments or admitted to a general hospital after an episode of self-harm at participating sites.
- •Age 16 to 25 years
- •Participants must be familiar with functioning of handheld mobile devices (mobile phones, tablets).
- •Able to read Urdu or English language.
- •Individuals able to provide written informed consent.
- •Have an android mobile phone/device
排除标准
- •Participants with ICD-I0 mental disorder; due to a general medical condition or substance misuse, dementia, delirium, alcohol or drug dependence, schizophrenia, bipolar disorder, learning disability which prevents participation.
- •Participants needing inpatient psychiatric treatment as determined by their clinical teams
研究组 & 干预措施
Intervention
干预措施: The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAP (Behavioral)
Standard Routine Care
Standard care for self-ham in Pakistan does not usually involve psychiatric or psychotherapy follow-up. Clinical teams in psychiatric departments or family medicine practices provide standard routine care according to their clinical judgment and available resources. We will obtain details of any treatment received by each participant
结局指标
主要结局
Beck Scale for Suicide Ideation
时间窗: Change in scores from baseline to 3-month follow up (end of intervention)
This is a self-report measure of current suicidal ideation. Higher scores (≥6) on the scale indicate greater risk. When measured against other instruments of suicidal ideation, the convergent validity of the BSI has been demonstrated, r= 0. We have used the Urdu translated version of this instrument in prior work from Pakistan and found the Cronbach's alpha to be 0.89 (M. O. Husain et al., 2019). Higher scores indicate greater severity of suicidal ideation
次要结局
- Beck Hopelessness Scale(Change in scores from baseline to 3-month follow up (end of intervention))
- The Problem Solving Inventory(Change in scores from baseline to 3-month follow up (end of intervention))
- Coping resource inventory(Change in scores from baseline to 3-month follow up (end of intervention))
- The Resilience Scale(Change in scores from baseline to 3-month follow up (end of intervention))
- Client Satisfaction Questionnaire(Level of satisfaction with the services received at end of intervention i.e., 3-month post-randomization)
- Client Service Receipt Inventory(Change in scores from baseline to 3-month follow up (end of intervention))
- Beck Depression Inventory(Change in scores from baseline to 3-month follow up (end of intervention))
- Euro-Qol Quality of Life Scale(Change in scores from baseline to 3-month follow up (end of intervention))