ISRCTN16270209已完成未知
A randomised controlled trial of a conversational virtual avatar-led cognitive behavioural therapy app intervention for improving the quality of life and mental health of people with epilepsy
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Healios Ltd
- 入组人数
- 255
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36409536/ (added 22/11/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 16/05/2022:
- •1. Adult aged 18-65 years
- •2. UK resident
- •3. Fluent in English
- •4. Scoring =5 on the GAD-7 indicating at least mild anxiety at screen-in (incl. diagnosed/non-diagnosed)
- •5. The participant is willing and able to receive notifications and email messages
- •6. Have a confirmed Epilepsy diagnosis (6 months minimum time since diagnosis, suspected cases are not permitted). Diagnosis to be confirmed ideally by participant submitting a photograph of their current medication and/or letter/report from their healthcare provider
- •7. Stable epilepsy and anxiety/depression medication regime (anti-epileptic, antidepressant, anxiolytic drug etc. A stable medication regimen for the present study refers to no change in medication in the last 4 weeks. Questions to cover this at all data collection time points. Should participants change medication during the study period, this will not affect their inclusion, however, this will be explored in the analysis.
- •Previous inclusion criteria:
- •1. Adult aged 18-65 years
- •2. UK resident
- •3. Fluent in English
- •4. Clinical levels of anxiety (=10 on the GAD-7) at screen-in (incl. diagnosed/non-diagnosed)
- •5. The participant is willing and able to receive notifications and email messages
- •6. Have a confirmed Epilepsy diagnosis (6 months minimum time since diagnosis, suspected cases are not permitted). Diagnosis to be confirmed ideally by participant submitting a photograph of their current medication and/or letter/report from their healthcare provider
- •7. Stable epilepsy and anxiety/depression medication regime (anti-epileptic, antidepressant, anxiolytic drug etc. A stable medication regimen for the present study refers to no change in medication in the last 4 weeks. Questions to cover this at all data collection time points. Should participants change medication during the study period, this will not affect their inclusion, however, this will be explored in the analysis.
排除标准
- •1. Have a subclinical score on the GAD-7 at screening
- •2. Have a score =20 on the PHQ-9 indicating severe depression at screen in or if they answer ‘more than half of the days’ or ‘nearly every day’’ to the question ‘Over the last 2 weeks, how often have you been bothered by thoughts that you would be better off dead or of hurting yourself in some way?’
- •3. Sensitivity to mobile phone screen exposure
- •4. Currently receiving counselling or psychological therapy (however, will not be excluded if they seek support during the study)
- •5. Individuals involved in current or ongoing research
- •6. Pregnant or has given birth in the past 12 months
- •7. Diagnosis of a severe mental illness (severe depression including suicidal ideation, schizophrenia, bipolar, psychosis, personality disorder, PTSD, substance misuse)
- •8. Severe learning disability and individuals requiring a carer for their epilepsy
- •9. Does not have access to a smartphone (iPhone with iOS 9 or greater capabilities, or an Android with OS 7 or greater capabilities)
研究者
相似试验
进行中（未招募）
不适用
Effects of an e-health intervention ‘iSupport’ for reducing distress of dementia carersISRCTN17420703Bangor University352
进行中（未招募）
不适用
Does screening with the Galleri test in the NHS reduce the likelihood of a late-stage cancer diagnosis?Multi cancer early detection in people without symptomsCancerISRCTN91431511GRAIL Bio UK Ltd.140,000
进行中（未招募）
不适用
Perinatal emotional skills groups for women with borderline personality disorderMental and Behavioural DisordersBorderline personality disorderEmotionally unstable personality disorderISRCTN80470632niversity of Bristol48
已完成
不适用
iTEFORM light therapy effectiveness for oral mucositisCancerISRCTN14224600The Newcastle Upon Tyne Hospitals NHS Foundation Trust380
已完成
3 期
Trial investigating the effectiveness of a medical device (Alpha-Stim AID) for the treatment of depressive symptoms for patients in primary careISRCTN11853110niversity of Nottingham236