Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Whiteley-7 index
研究概览
简要总结
Health anxiety is a prevalent, disabling disorder associated with extensive health care expenditures. The lack of easily accessible, evidence-based psychological treatment combined with delayed diagnostic recognition constitute barriers to receiving treatment.
Aim
- To develop an internet-delivered treatment program, based on 'Acceptance and Commitment Therapy' (ACT), for patients with health anxiety.
- To test the feasibility and effectiveness of the treatment programme in a randomized, controlled trial, comparing the treatment with an active control condition.
Methods 150 patients aged 18 years and older can self-refer through a web-page to apply for participation. Before inclusion patients will undergo a video-diagnostic interview. Patients are randomly assigned to 12 weeks of either, 1) active treatment: consisting of internet-based ACT (iACT) with 7 therapist-guided modules of self-help text, exercises, patient videos and audio-files, or 2) active control condition: consisting of an internet-based discussion forum (iFORUM) with 7 topics of discussion.
All patients will complete self-report questionnaires at baseline, before randomization, at 4 and 8 weeks into treatment, after end of treatment, and at 6-month follow-up.
详细描述
Severe health anxiety (illness anxiety disorder) or hypochondriasis, according to the psychiatric classification system ICD-10, is characterized by preoccupation with fear of having a serious illness, which interferes with daily functions and persists despite medical reassurance. Clinical significant health anxiety is prevalent in primary care with 0.8-9.5%, and has a lifetime prevalence of 5.7% in the general population. It is a disabling disorder, associated with extensive use of health care services and occupational disability.
Earlier, health anxiety has been considered a chronic disease with poor treatment outcomes. A recent review found effect of both medicine and psychotherapy, but patients may prefer psychotherapeutic treatments. Despite the high prevalence, health anxiety is rarely diagnosed within primary care, and there is limited access to evidence-based treatment for health anxiety.
An easily accessible, evidence-based treatment is needed for this debilitating condition.
Internet-based treatment is a new approach where patients receive access to a guided self-help program. A meta-analysis has shown equal treatment effects of internet-based treatment compared to "face-to-face" treatment for depressive- and anxiety disorders. Internet-based cognitive behavioral therapy for health anxiety has shown to be cost-effective. ACT is a new effective generation of cognitive-behavioral therapy, with an emphasis on acceptance and value-based exposure that has shown good results for treating health anxiety in a group setting. Internet-based Cognitive behavioral therapy (CBT) for health anxiety has shown promising results but low treatment completion. This may be due to the comprehensive treatment modules and the text-based format. ACT is an experiential behavioral therapy, and aims to activate patients with exercises, videos, audio-files and less text material.
Most persons with health anxiety have high health care expenditure. However, some patients with health anxiety avoid contact to the health care system, and may not receive proper treatment. Patient self-referral is a new approach that may facilitate access to treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe health anxiety > 6 months
- •Whiteley-7 score (scale 0-100 score points) corresponding to 21,4 or more.
- •Age above 18 years old
- •In case of a comorbid functional or other psychiatric disorder health anxiety must be the dominant problem
- •Patients who speak, read and write Danish
- •Access to a computer and internet access
- •Residence in Denmark
- •Exclusion criteria:
- •Acute suicidal risk
- •Abuse of narcotics or alcohol and (non-prescribed) medicine
- •Lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
- •Unstable psychopharmacological treatment within last 2 months
- •Former treatment at the Research Clinic for Functional Disorders and Psychosomatics
- •Not providing informed consent
排除标准
- 未提供
结局指标
主要结局
Whiteley-7 index
时间窗: At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation
Health anxiety symptoms
次要结局
- Health anxiety symptoms measured with the Short Health Anxiety Inventory (SHAI)(At baseline (i.e. at self-referral), and 3 and 9 months after randomisation)
- Quality of life measured with the visual analogue scale (VAS question) from Youth profile, National Institute of Public Health(At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation)
- Somatisation measured with the Bodily Distress Syndrome Checklist (BDS Checklist)(At baseline (i.e. at self-referral))
- General health status and functioning measured with the Short Form 12 Health Survey (SF-12)(At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline), 3 and 9 months after randomisation)
- Diagnosed somatic illnesses measured with questions from the Danish study for Functional Disorders (DanFund)(At baseline (i.e. at self-referral))
- Demographic questions measured with questions from the Danish study for Functional Disorders (DanFund)(At baseline (i.e. at self-referral))
- Quality of life measured with the World Health Organisation Well-being Index-Five (WHO-5)(At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation)
- Stress measured with questions from the survey Youth stress, Danish Health Authority(At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation)
- Anxiety, depression, obsessive-compulsive and physical symptoms measured with subscales from the Symptom Checklist (SCL-92)(At baseline (i.e. at self-referral), and 3 and 9 months after randomisation)