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临床试验/NCT03062202
NCT03062202已完成不适用

The Potential Impact of Using Internet-delivered CBT (iCBT) for People in IAPT Services as a Prequel to High Intensity Therapy (HIT) for Depression and Anxiety Disorders.

Derek Richards2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2016年12月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
2
主要终点
Changes in depression symptoms (as measured by the 9 item Patient Health Questionnaire)

研究概览

简要总结

This study will explore the potential impacts of internet-delivered cognitive behavioural therapy (ICBT) at step 3 of the IAPT model. To do this, interventions administered as a prequel to face-to-face therapy will be analysed and compared based on their impacts in regards to access, outcomes (psychological) and costs. A qualitative segment will also be conducted in order to investigate the acceptability and usability of the platform for clinicians and the possibility of developing a therapeutic alliance through an online medium.

详细描述

Depression and anxiety disorders (panic disorder, social anxiety disorder, specific phobias and generalized anxiety disorder) have been ranked high among the leading causes of disease burden throughout the world, displaying high rates of lifetime incidence, early age onset, high chronicity, and role impairment. Depression and anxiety are associated with impairment in several areas of functioning including social, occupational and personal. The cost to the person and the economy is great, for instance, 105 billion pounds is the estimated cost of depression in the UK with 30% of that being consumed through occupational costs. This has consequently had to be augmented through unemployment benefit to the tune of 7-10 billion.

Improving Access to Psychological Therapies (IAPT):

In 2007 the Department of Health UK announced the introduction of the Improving Access to Psychological Therapies (IAPT) programme. The aim of the programme was to extend access to clinically approved psychological interventions for depression and anxiety. In doing this, the hope was to be able to tackle and help alleviate the burden of psychological distress and its associated costs. In accordance with the model, a five-step approach to psychological care for people with depression and anxiety was introduced and implemented within NHS mental health services The model can be interpreted as a hierarchical care model of mental health, where each step is catered to provide treatment based on the severity of symptoms presented by the patient. This includes watchful waiting by general practitioners care at step 1, step 2 relates to low-intensity psychological interventions, step 3 involves high-intensity psychological interventions, step 4 comprises of specialist mental health care, and step 5 consists of inpatient treatment for mental health problems.

The use of cCBT in IAPT As recommended by the National Institute for Health and Clinical Excellence the IAPT programme offers computerised cognitive behaivoural therapy (cCBT) as a low-intensity, Step 2 intervention for individuals presenting with mild to moderate symptoms of depression and/or anxiety. cCBT and internet-delivered cognitive behavior therapy (iCBT) are delivered by PWPs and support is offered through electronic communication means or by telephone support. However, traditionally they have often suffered with 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 increase engagement, enhance productivity, and produce better clinical effectiveness. In accordance with what has been utilised in the IAPT model, research has demonstrated the effectiveness of cCBT and iCBT in treating symptoms of depression and anxiety . There is now a substantial body of research evidence that supports the efficacy and effectiveness of online delivered cognitive behavior therapy for depression and anxiety.

Alongside the use of antidepressants, patients at Step 3 IAPT are commonly treated using face-to-face psychological interventions include cognitive behavior therapy, interpersonal therapy, and behavioural activation. In practice, online delivered interventions have been used in some cases for those at step 3 and also as a facilitator for those who are stepping down from Step 3. However, to date, there have not been studies conducted that have examined the potential of online interventions at step 3 and their impact on access rates, clinical and functional outcomes, and costs.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Deemed suitable for an initial Step 3 intervention at IAPT.
  • 18 years old and above.
  • Able to read English.
  • Have capacity to consent.
  • Willing to consent.

排除标准

  • Flag a risk as per IAPT regulations. (e.g. indicating self-harm on the PHQ-9)
  • Receiving an intervention or treatment that is not a part of TAU or another trial.
  • Specific communication needs.
  • Screened and require an intervention for traumatic stress.
  • Do not meet the requirements for step 3 treatment.

研究组 & 干预措施

Depression group

Experimental

SilverCloud iCBT for depression.

干预措施: SilverCloud (Behavioral)

Anxiety group

Experimental

SilverCloud iCBT anxiety disorders.

干预措施: SilverCloud (Behavioral)

Comorbid Depression and Anxiety group

Experimental

SilverCloud iCBT for comorbid depression and anxiety.

干预措施: SilverCloud (Behavioral)

结局指标

主要结局

Changes in depression symptoms (as measured by the 9 item Patient Health Questionnaire)

时间窗: Baseline and post-treatment - 8 weeks

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).

Changes in anxiety symptoms (as measured by the 7 item Generalised Anxiety Disorder inventory)

时间窗: Baseline and post-treatment - 8 weeks

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 (Richards \& Suckling, 2009).

次要结局

  • Usability and Acceptability of the iCBT platforms for clinicians.(At the end of the treatment 2 months)
  • Therapeutic Alliance for clinicians(continuous during treatment after each session for 8 weeks)
  • Qualitative Investigation into Therapeutic Alliance for Clinicians(1 month post study.)
  • Work and Social Adjustment(Baseline and post-treatment - 8 weeks)
  • Social Phobia(Baseline and post-treatment - 8 weeks)
  • Obsessive Compulsive Tendencies(Baseline and post-treatment - 8 weeks)
  • Heath Anxiety(Baseline and post-treatment - 8 weeks)
  • Avoidance Behaviours(Baseline and post-treatment - 8 weeks)
  • Responses to Traumatic Events(Baseline and post-treatment - 8 weeks)
  • Patient Experience(At the end of the treatment - week 8)
  • Therapeutic Alliance for patients(continuous during treatment after each session for 8 weeks)

研究者

发起方
Derek Richards
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Derek Richards

Director of Clinical Research and Innovation

Silver Cloud Health

研究点 (2)

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