Tailored Internet-delivered Cognitive Behavioural Therapy for Depression and Anxiety in Patients With a Long-term Condition (Chronic Pain, COPD and Diabetes).
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Depression (as measured by the Patient Health Questionnaire)
研究概览
简要总结
SilverCloud provides internet-delivered interventions for depression and anxiety in NHS Mental Health Services. The interventions have proved successful in the management of depression and anxiety for clients presenting to mental health services, with recovery rates exceeding the national standard. Recently SilverCloud has embarked on tailoring the interventions for patients with long-term conditions including COPD, pain and diabetes. The purpose of the customisation is to make the interventions more meaningful and relevant to patients with LTCs, but all the while having the same goal of addressing depression and anxiety disorders. In doing so it would be expected that individuals might be in a better position to effectively self-manage their LTC. The current study, therefore, seeks to assess the possible effectiveness of implementing customised internet-delivered interventions for depression and anxiety for people with long-term conditions presenting to NHS mental health services.
详细描述
iCBT is the delivery of a tailored structured cognitive and behaviour therapy based programme, with support, to individuals with mild to moderate symptoms of depression and anxiety. There is now a substantial body of research evidence that supports the efficacy and effectiveness of internet-delivered cognitive behaviour therapy for depression and anxiety (Richards & Richardson, 2012; Andersson and Cuijpers, 2009). Historically, a number of iCBT interventions have been used in clinical practice in IAPT services. However, they have often suffered from poor engagement and consequently poor clinical outcomes. More recent developments in the field have produced more robust technological platforms, where content is delivered through a variety of media that enhance productivity, increase engagement and produce better clinical outcomes. The SilverCloud intervention has been demonstrated to be a clinical effective evidence-based cognitive behavioural treatment option (Richards et al., 2015).
Chronic illnesses can have profound effects on well-being, functional capacity and quality of life. Psychological comorbidities with an LTC can further contribute to the distress that is caused by these symptoms. Patients with comorbid depression and anxiety disorders and a long-term condition are associated with significantly higher health care utilisation, poorer outcomes from treatment and increased costs of care (Moussavi et al., 2007; Naylor et al., 2012). The IAPT programme in the UK provides effective treatments for depression and anxiety but these have been underutilized by people with LTCs and partially this is due to an underrecognition; one reason for this has been the traditional precedence set on managing the physical aspects of any LTC and effectively paying little attention to psychological comorbidity (Coventry et al., 2011).
Several pathfinders sites are currently involved in providing psychological treatment for long-term conditions, but to date, results have been limited due to several factors, such as delays in commencing programmes and funding issues. To this extent, SilverCloud wishes to implement their tailored "Space from..." series of programmes for long-term conditions - chronic pain, COPD and Diabetes. The purpose of the tailoring is to make the interventions more meaningful and relevant to patients with LTCs, but all the while having the same goal of addressing depression and anxiety disorders. In doing so it would be expected that individuals might be in a better position to effectively self-manage their LTC. The current study, therefore, seeks to assess the clinical feasibility of implementing customised internet-delivered interventions for depression and anxiety for people with LTCS presenting to IAPT services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age
- •English language speakers
- •Have capacity to consent
- •Has a chronic condition (Diabetes, COPD, Chronic Pain) with comorbid depression and/or anxiety.
- •Suitable for step 2 intervention in NHS IAPT Services.
排除标准
- •Exceed cut-off score for risk in terms of self-harm on the screening questionnaires.
- •Receiving an intervention (therapeutic or biological) that is not a part of treatment as usual, or another trial.
研究组 & 干预措施
Space in Diabetes
The SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. Psychoeducational content in the diabetes programme focusses on the impact that mood can have on self-management and self-care when living with diabetes.
干预措施: Space in Diabetes (Behavioral)
Space in COPD
The SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. Additional content on panic has been included in the COPD programme. Symptoms of COPD and anxiety can be closely linked, and this content provides CBT-based strategies for dealing with symptoms of panic and anxiety.
干预措施: Space in COPD (Behavioral)
Space in Chronic Pain
The SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. A module on health anxiety, titled "Anxiety and your Health", has been added to the chronic pain programme. This module provides psychoeducational content on health anxiety, the unhelpful behaviours that accompany it and how these can negatively impact on the experience of pain.
干预措施: Space in Chronic Pain (Behavioral)
结局指标
主要结局
Depression (as measured by the Patient Health Questionnaire)
时间窗: Weekly for up to 8 weeks
The Patient Health Questionnaire-9 (PHQ-9;(Kroenke, Spitzer, \& Williams, 2001; Spitzer, Kroenke, \& Williams, 1999) is a self-report measure of depression that has been widely used in screening, primary care, and research. The PHQ-9 items reflect the diagnostic criteria for depression outlined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) (American Psychiatric Association \[APA\], 2000). Summary scores range from 0-27, where larger scores reflect a greater severity of depressive symptoms. The PHQ-9 has been found to discriminated well between depressed and non-depressed individuals using the clinical cut-off of total score ≥10, with good sensitivity (88.0%), specificity (88.0%) and reliability (.89) (Kroenke et al., 2001; Spitzer et al., 1999).
Anxiety (as measured by the 7 item Generalised Anxiety Disorder inventory)
时间窗: Weekly for up to 8 weeks
The Generalized Anxiety Disorder-7 (GAD-7; (Spitzer, Kroenke, Williams, \& Löwe, 2006) GAD-7 comprises 7 items measuring symptoms and severity of GAD based on the DSM-IV diagnostic criteria for GAD. The GAD-7 has good internal consistency (α = .92) and good convergent validity with other anxiety scales (Spitzer et al., 2006). Higher scores indicate greater severity of symptoms. The GAD-7 has increasingly been used in large-scale studies as a generic measure of change in anxiety symptomatology, using a cut-off score of 8 (D. A. Richards \& Suckling, 2009).
次要结局
- Quality of Life (As measured by the EuroQOL 5D5L)(Baseline (week 0) and end of treatment (week 8))
- Diabetes Distress (As measured by the Diabetes Distress Scale)(Baseline (week 0) and end of treatment (week 8))
- Clinical COPD Symptoms (As measured by the Clinical COPD Questionnaire)(Baseline (week 0) and end of treatment (week 8))
- Work and Social Adjustment (as measured by the Work and Social Adjustment Scale)(Baseline (week 0) and end of treatment (week 8))
- Patient Experience (As measured by the Patient Experience Questionnaire)(End of treatment (week 8))
- Pain Acceptance (As measured by the Pain Acceptance Questionnaire - revised)(Baseline (week 0) and end of treatment (week 8))
研究者
Derek Richards
Director of Clinical Research and Innovation
Silver Cloud Health