Severe Health Anxiety | Outcome of Cognitive Behavioral Therapy for Patients With Severe Health Anxiety Treated in Group Only. A RCT.
Severe Health Anxiety research study
What is the primary objective of this study?
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 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.
Who is eligible to participate?
Inclusion Criteria: 1. Whiteley-7 score of 21.4 or more (scale 0-100 score points) 2. Severe health anxiety (diagnosed by SCAN, according to the new health anxiety criteria ). In case of comorbid mental disorders, severe health anxiety must be dominant 3. Age 18-65 years 4. Patients who understand, read, and speak fluently danish 5. Given informed consent Exclusion Criteria: 1. Another severe treatment demanding mental disorder, or risk of suicide 2. Current or previous episodes of psychosis, bipolar affective disorder or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3) 3. A serious somatic disease 4. Abuse or dependency of alcohol, drugs or (non-prescription) medication 5. Pregnancy
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Severe Health Anxiety
Illness Anxiety Disorder
Somatic Symptom Disorder
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Behavioral:Group-Cognitive Behavioral Therapypsychoeducation, stress management, cognitive restructuring, response prevention, exposure, relapse prevention
Other:Wait-List with treatment as usualIntervention typical supportive talks from general practitioner. No restrictions for interventions for patients here.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Group-Cognitive Behavioral TherapyGroup-Cognitive Behavioral Therapy for 7 patients and 2 therapists, 3 hours sessions a week in 12 weeks and a 3 hours booster session 12 weeks after
Wait-List with treatment as usualWait-List with treatment as usual waiting in 9 months for the intervention with group-CBT
Active, not recruiting
Start Date: February 2014
Completed Date: April 2019
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
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
Study sponsors, principal investigator, and references
Principal Investigator: Erik Simonsen, MD PhD
Lead Sponsor: Psychiatric Research Unit, Region Zealand, Denmark
Collaborator: The Clinic for Liaison Psychiatry in Koege, Department of Special Functions, Psychiatry Region Zealand