Helping Urgent Care Users Cope With Distress About Physical Complaints: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 8
- 主要终点
- Health Anxiety Inventory: 14-Item Self Rated Short Form (Salkovskis 2002)
研究概览
简要总结
To determine the cost and clinical effectiveness of offering 6-10 sessions of remotely delivered cognitive behaviour therapy (CBT) via video calling or over the telephone for health anxiety in repeated utilisers of unscheduled/urgent care versus treatment as usual.
To optimise the delivery of CBT for health anxiety delivered remotely by systematically identifying and then acting on barriers and enablers to the intervention through a network of practice.
详细描述
Background: Health anxiety costs £3 billion per year in unnecessary expenditure, much of it on unscheduled care and in-patient admission. CCGs are incentivised to reduce emergency care use and the Department of Health is spending up to an additional £400 million per year to provide psychological treatment for this problem. Yet patients with health anxiety are reluctant to accept face to face psychological treatment. There is strong evidence that delivered in secondary acute care as a liaison psychiatry service psychological therapy it can be clinically and cost effective for two years. Government policy is to deliver this intervention in primary or community care where there is little evidence of clinical or cost effectiveness. Face to face delivery of this intervention through secondary care mental health and IAPT services has not been acceptable to these service users. Remotely delivered psychological treatment designed to assist coping with symptoms can be delivered by mental health services and may be both more acceptable to service users than face to face treatment in IAPT services and just as effective as in secondary acute care.
Aims: To determine the clinical and cost effectiveness of remotely delivered cognitive behaviour therapy for health anxiety in repeated users of unscheduled primary or secondary care for physical symptoms without a physical health cause. To determine barriers and drivers to delivering such remote treatment and how such treatment might fit into a wider care pathway to enhance patient experience of care.
Methods of research: Randomised controlled trial of 6-10 sessions of cognitive behaviour therapy for health anxiety delivered by telephone or through the internet versus treatment as usual. Primary outcome is change in health anxiety from baseline to 6 months; secondary outcomes are persisting change in health anxiety to 12 months, emergency care use, generalised anxiety, depression, somatic distress, work and social adjustment and quality of life. We will assess economic outcome and qualitative analysis of barriers and drivers to delivery of intervention and view the intervention as part of an overall care pathway to provide alternatives to emergency care use. This will help network leads, practitioners and service users to shape the research so that it can provide the most information to enable putting the intervention into practice.
Methods of implementation (putting into practice). A network lead, a networking practitioner and an associated network of practice will bridge work between the research team and practitioners, commissioners, strategic clinical networks, Health England (education) and the Academic Health Science Networks (AHSN) across the East Midlands to put the intervention into practice. The process will be iterative, identifying core features of the intervention that should not be varied and those parts of the intervention that may be adapted allowing a degree of adaptation to local requirements.
Research plan:
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two or more consultations, referrals or hospital admissions with any provider of unscheduled or emergency care (including urgent same day appointment with own general practice) in the last 12 months for common presentations not attributed to identified pathology such as: cardiac e.g. chest pain, respiratory e.g. breathlessness, neurological e.g. dizziness, gastrointestinal e.g. abdominal pain or genitourinary e.g. pain on passing urine.
- •Scores above the threshold for severe health anxiety of 18 or more on the 14 item short version of the Health Anxiety Inventory (HAI; Salkovskis et al, 2002).
- •The participant is aged 18 or over.
- •Sufficient understanding of English (spoken and written).
- •They give oral and written informed consent to participate in the study.
排除标准
- •Pathological medical condition requiring further assessment or acute management, or pregnancy.
- •Other severe mental illness (schizophrenia, bipolar disorder, severe major depressive episode, eating disorder) ascertained by the Structured Clinical Interview for DSM-IV Disorders (SCID, Spitzer et al., 2002) or anyone at immediate risk of harm to themselves or other people through their mental state
- •Organic mental disorder (dementia, delirium, substance use disorder, organic mood disorder).
- •They are already receiving specialist mental health intervention, including psychological treatment as part of specialist medical care e.g. pain clinic.
- •All of the above require a different clinical approach to the treatments being tested in the study. Unipolar mild to moderate depressive episodes, other anxiety disorders or stable physical illness are not exclusions to the study as they are readily addressed by the intervention and are necessary to include if the study is pragmatic and going to generalise to clinical practice.
研究组 & 干预措施
Remote Therapy Offered
Participants randomised to this arm receive 6-10 sessions of remote CBT
干预措施: (Remote) Cognitive Behaviour Therapy (Behavioral)
Treatment as Usual
Participants do not receive remote therapy and remain in usual care
结局指标
主要结局
Health Anxiety Inventory: 14-Item Self Rated Short Form (Salkovskis 2002)
时间窗: Baseline to 6 months
Self Rated
次要结局
- Generalised Anxiety Disorder: 7 Item (Spitzer et al 2006)(Baseline to 12 months)
- 5 item quality of life on the EQ5D-5L (EuroQol Group, 1990)(Baseline to 12 months)
- Health Anxiety Inventory: 14-Item Self Rated Short Form (Salkovskis 2002)(Baseline to 12 months)
- 8 item Work and Social Adjustment Scale for social function (WSAS; Mundt et al, 2002).(Baseline to 12 months)
- 9 item Patient Health Questionnaire for depression (PHQ-9; Kroenke et al, 2001).(Baseline to 12 months)
- Change in number of contacts with unscheduled or emergency care established through a totally adapted and stylised Client Service Receipt Inventory (CSRI; Beecham and Knapp 2001).(Baseline to 12 months)
- 36 item Short Form Health Survey (SF-36; Ware et al, 2000).(Baseline to 12 months)