Comparing Cognitive-behavioural and Cognitive-analytic Guided Self-help for Anxiety; a Patient Preference Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Beck Anxiety Inventory
研究概览
简要总结
Supporting patients in exerting choice over their treatment is a central aspect of modern healthcare. In Improving Access to Psychological Therapies (IAPT) services, then patients treated at step 2 are only and always offered cognitive-behaviourally informed guided self-help (GSH), when they are deemed suitable for treatment at step 2 of IAPT services (termed CBT-GSH). Step 2 interventions are guided self-help (GSH) delivered by Psychological Wellbeing Practitioners (PWPs). Recently, a new type of GSH has been developed and found to be feasible and effective in IAPT services - this is called cognitive-analytic guided self-help (CAT-GSH). This research aims to test the efficacy of CAT-GSH by comparing outcomes over time achieved in both types of GSH and interviewing participants about their experience of the GSH. The methodology to support patient choice is a patient preference trial. In this method, then patients that meet inclusion criteria for the trial are offered and choose between either CAT-GSH and CBT-GSH. Those patients that are unconcerned with the type of treatment are randomised to either CAT-GSH or CBT-GSH. The primary outcome measure is the Beck Anxiety Inventory. No changes to the standard practice of the PWPs will occur during the trial, the trial will be situated in a standard IAPT service and be a therefore conducted in a routine practice setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients have self-referred or been referred by their GP or other health or social care professional for a step 2 intervention for treatment of a common mental health problem,
- •patients meet criteria for an anxiety disorder on MINI screening interview assessment and also met caseness on the BAI (as defined by a score of >10 on the BAI at assessment).
- •Patients want to engage in GSH to address the anxiety disorder
- •patients are motivated to engage in treatment and can attend six sessions of face-to-face GSH.
排除标准
- •engaging in any another IAPT step 2 interventions.
- •Do not meet criteria for an anxiety disorder as defined by the MINI and the BAI score.
- •Meet criteria for depression and a comorbid anxiety disorder, as identified by the BAI and MINI, where the depression is more severe and is the patient's main concern.
- •Have a severe/chronic mental health problem and are already involved in psychiatric or secondary care mental health services.
- •Have substance misuse issues that would interfere with engagement with the GSH.
- •Have a diagnosed learning disability that precludes engagement in GSH.
- •Have a diagnosis of social phobia or PTSD
结局指标
主要结局
Beck Anxiety Inventory
时间窗: Measured at screening, at 6 weeks, 12 weeks and 24 weeks
measuring change in anxiety at four time points
次要结局
- Generalised Anxiety Disorder - 7(Measured at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up)
- patient health questionnaire - 9(Measured at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up)
研究者
Emma Beattie-Edwards
Trainee Clinical Psychologist
University of Sheffield