Outcome of Cognitive Behavior Therapy for Patients With Severe Health Anxiety Treated in Group Only. A Randomised Controlled Trial. The CHAG-Trial. Categorical and Dimensional Characteristics of Personality Pathology and Predictors of Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in degree of health anxiety on the questionnaire Whiteley Index 7 (WI-7) from baseline to 6 month after 12 weeks group-CBT intervention
研究概览
简要总结
Background:
The prevalence of severe health anxiety is reported to be 1-2% in Western communities. This functional disorder is difficult for medical doctors to treat, the course of the disorder is often chronic, and that is costly for the social and health care systems as well as for the patients. A Cochrane metaanalysis from 2009 finds evidence for effectiveness of individual cognitive behavior therapy (CBT) for patients with hypochondriasis. But no randomised controlled trials (RCT) of the effectiveness of classical CBT delivered only in groups for patients with severe health anxiety (hypochondriasis/illness anxiety disorder) has yet been conducted.
Aims:
- to examine the effectiveness of group-CBT for patients with severe health anxiety compared to a wait-list group receiving usual care, 2) to perform a categorical and dimensional assessment of personality, 3) to examine predictors of outcome especially comorbid personality disorders, 4) to examine the relation between personality, illness perception and treatment outcome, 5) to compare the cost-effectiveness of these two treatments, 6) at a 2 years follow up to examine the course and long-term effectiveness of group-CBT for patients with severe health anxiety and some also followed by psychological treatment for comorbid personality disorders.
Main hypothesis:
Patients with severe HA who have received group CBT will at 6-month follow-up compared to a wait-list group receiving usual care show a significantly reduction in health anxiety.
Methods:
84 patients referred from medical doctors during 2014-15 to the Clinic of Liaison Psychiatry in Koege, Region Zealand, Denmark, will be included and block randomised per 14 patients to either weekly group-CBT with 7 patients and 2 therapists for 3 hours a week in 12 weeks or wait-list with usual care for 9 months.
Inclusion: Severe health anxiety (dominant mental disorder), score on WI-7>21,4, age 18-65 years, Danish speaking, informed consent.
Exclusion: Another severe treatment demanding mental disorder, risk of suicide or psychosis, a serious somatic disease, pregnancy, dependency of drugs, alcohol or medication.
Diagnostic assessment:
The patients are included using research criteria for severe health anxiety (for ICD-11) and semi-structured interviews developed for DSM-IV, SCAN (general psychopathology) and SCID-II (personality disorders). Criteria for hypochondriasis from ICD-10 and illness anxiety disorder/somatic symptom disorder from DSM-5 are used for subcategorising. Dimensions and traits of personality are assessed by the questionnaire PID-5 included in DSM-5, section III.
Outcome measures:
The primary outcome measure is the questionnaire for health anxiety, Whiteley Index 7 (WI-7), with a cut-off for remission on 21,4 or a blinded diagnostic assessment of no severe health anxiety present 6 months after end of treatment.
The secondary outcome measures are questionnaires for health anxiety (HAI), general psychopathology (SCL-90-R), level of personality disorders (PID-5), level of functioning (SF-36), quality of life (WHO-5, EQ-5D), Illness perception (IPQ), alcohol consumption (CAGE) and register data for number of sick days and use of social and health care and a blinded global assessment of functioning (F-GAF).
Time frame:
Data wil be analysed, and results wil be disseminated from 2016.
详细描述
BACKGROUND
Classification and comorbidity
Hypochondriasis is broadly defined in the international classification systems for mental disorders ICD-10 (WHO) and DSM-IV (APA) under somatoform disorders as a preoccupation with fears and the belief of having a serious disease with the condition lasting for at least 6 months. It is non-delusional, and the symptoms are not better explained by another mental disorder, it causes distress or impairment of functioning and persists despite appropriate medical reassurance. Somatoform disorders are defined as syndromes with physical symptoms, which are not sufficiently explained by physical causes alone, defined somatic illnesses or comorbid mental disorders.
A less stigmatizing name: health anxiety has been suggested, and new research has reported more valid diagnostic criteria with continuous ruminations of fears and belief of having a serious disease lasting for at least 2 weeks and the presence of minimum one of five other symptoms: preoccupation with illness or body, preoccupation with medical information, suggestibility or autosuggestibility, fear of infection or contamination and fear of medication. A degree for severity has also been introduced here with either mild or severe health anxiety split by the presence of minimum one severely distressing symptom or a significant impairment of functioning [1]. Hypochondriasis and Health Anxiety (HA) are from now on used synonymously here.
HA like other somatoform disorders show high degree of mental comorbidity with depressive disorders between 15,3-45,2%, anxiety disorders between 22-52,4%, somatoform disorder between 8-21,4% and mental comorbidity in total between 54-78,6% [11,34,46]. HA also show a high degree of mental comorbidity with personality disorders (PD) between 63-76% [34,35] when using questionnaire for assessment, but they seem to overestimate the prevalence [36] and between 40-74% when using SCID-II, the semi-structured interview developed for DSM, that is the present golden standard for diagnosing PD [39,40].
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Whiteley-7 score of 21.4 or more (scale 0-100 score points)
- •Severe health anxiety (diagnosed by SCAN, according to the new health anxiety criteria [1]). In case of comorbid mental disorders, severe health anxiety must be dominant
- •Age 18-65 years
- •Patients who understand, read, and speak fluently danish
- •Given informed consent
排除标准
- •Another severe treatment demanding mental disorder, or risk of suicide
- •Current or previous episodes of psychosis, bipolar affective disorder or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
- •A serious somatic disease
- •Abuse or dependency of alcohol, drugs or (non-prescription) medication
结局指标
主要结局
Change in degree of health anxiety on the questionnaire Whiteley Index 7 (WI-7) from baseline to 6 month after 12 weeks group-CBT intervention
时间窗: Before 1. diagnostic assessment, baseline (2 weeks before), 0 months, 3 months, 6 months (primary measure), 24 months after 12 weeks group-CBT intervention
Questionnaire for degree of health anxiety (7 questions) by SurveyXact (online questionnaire). Outcome definition: Significant response= \> 1SD (standard deviation, 25 points on WI-7), Response= \> 1/2 SD, Cure= WI-7 score\<21,4 or no severe HA diagnosed by the blinded second investigator at the second diagnostic assessment at 6 month follow-up.
Cure from severe health anxiety
时间窗: At 6 months follow up
2. diagnostic assessment, here by the blinded second investigator at 6 month follow-up (after completing SurveyXact online questionnaire), using diagnostic criteria for severe health anxiety and questionnaire WI-7 at telephone interviewing.
次要结局
- Social level of Functioning (SF-36)(Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up)
- Change in degree of health anxiety on the questionnaire Health Anxiety Inventory-14/18 (HAI) from baseline to 6 months after 12 weeks group-CBT intervention(Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up)
- Illness Perception Questionnaire (IPQ)(Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up)
- Client Satisfaction Questionnaire (CSQ)(Baseline (2 weeks before), 6 months (primary measure), 24 months follow up)
- EQ-5D (EuroQol)(Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up)
- Resource Use from Register data for health and social care (cost/effectiveness)(From 9 and 27 months before baseline until 6 and 24 months follow up.)
- Personality Inventory for DSM-5 Total Score (PID-5)(Baseline (2 weeks before), 6 months (primary measure), 24 months follow up)
- WHO-5 Well-being Index(Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up)
- CAGE(Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up)
- Symptome Check List-90-Revised (SCL-90-R) subscales(Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up)
- Global Assessment of Functioning (F-GAF)(At 6 months follow up)