Clinical Trial: Outcome of Cognitive Behavioral Therapy for Patients With Severe Health Anxiety Treated in Group Only. A RCT.

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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 Perso

Brief Summary:

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:

1) 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 Liais

Detailed Summary:

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 wit
Sponsor: Psychiatric Research Unit, Region Zealand, Denmark

Current Primary Outcome:

  • 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 [ Time Frame: 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 [ Time Frame: 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.


Original Primary Outcome:

  • 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 [ Time Frame: 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: Response= > 1SD (standard deviation, 25 points on WI-7), 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 [ Time Frame: 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.


Current Secondary Outcome:

  • 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 [ Time Frame: Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up ]
    Degree of health anxiety measured by the questionnaire Health Anxiety Inventory with 14 and 18-items (HAI). SurveyXact, online questionnaire.
  • Personality Inventory for DSM-5 Total Score (PID-5) [ Time Frame: Baseline (2 weeks before), 6 months (primary measure), 24 months follow up ]
    Degree of pathology of comorbid personality disorders measured by the total score on the questionnaire PID-5
  • Social level of Functioning (SF-36) [ Time Frame: Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up ]
    Social level of functioning and emotional distress measured with relevant sub-scales from the questionnaire SF-36
  • Symptome Check List-90-Revised (SCL-90-R) subscales [ Time Frame: Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up ]
    General psychopathology measured with selected subscales from the questionnaire SCL-90-R (somatisation, depression, anxiety, OCD)
  • WHO-5 Well-being Index [ Time Frame: Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up ]
    Health related quality of life measured with the questionnaire WHO-5 (5 questions)
  • EQ-5D (EuroQol) [ Time Frame: Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up ]
    Health related quality of life measured with the questionnaire EQ-5D (5 questions)
  • CAGE [ Time Frame: Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up ]
    Alcohol consumption measured with the questionnaire CAGE (4 questions)
  • Illness Perception Questionnaire (IPQ) [ Time Frame: Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up ]
    Illness perception measured with the questionnaire IPQ
  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: Baseline (2 weeks before), 6 months (primary measure), 24 months follow up ]
    Satisfaction with treatment measured with Client Satisfaction Questionnaire (CSQ)
  • Global Assessment of Functioning (F-GAF) [ Time Frame: At 6 months follow up ]
    F-GAF for global functioning assessed by the blinded second investigator at the 2. diagnostic assessment at 6 months follow-up at telephone interviewing
  • Resource Use from Register data for health and social care (cost/effectiveness) [ Time Frame: From 9 and 27 months before baseline until 6 and 24 months follow up. ]
    Health care use, DRG charges and sick days measured by data extraction from the National Patient Register (Landspatientregistret), and the Central Psychiatric Register (Det Psykiatriske Centralregister) [admissions and outpatient contacts to the hospital-based health care system and DRG charges], The National Health Service Register (Sygesikringen) [family physician contacts/consultations, specialists, physiotherapists, dentists, family physician emergency service and unit costs], The Danish Medicine Agency (Lægemiddelstyrelsen) [medicine consumption and unit costs] and the DREAM database (The register-based evaluation of the extent of marginalization).


Original Secondary Outcome: Same as current

Information By: Psychiatric Research Unit, Region Zealand, Denmark

Dates:
Date Received: April 2, 2014
Date Started: February 2014
Date Completion: April 2019
Last Updated: March 28, 2017
Last Verified: March 2017