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

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 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.

Conditions

• Severe Health Anxiety
• Hypochondriasis
• Illness Anxiety Disorder
• Somatic Symptom Disorder
• Personality Disorders

Interventions

BEHAVIORAL

Group-Cognitive Behavioral Therapy

psychoeducation, stress management, cognitive restructuring, response prevention, exposure, relapse prevention

OTHER

Wait-List with treatment as usual

Intervention typical supportive talks from general practitioner. No restrictions for interventions for patients here.

Sponsors & Collaborators

• The Clinic for Liaison Psychiatry in Koege, Department of Special Functions, Psychiatry Region Zealand

  collaborator UNKNOWN

• The Regional Fund for Health Sciences in Region Zealand

  collaborator UNKNOWN

• Psychiatric Research Unit, Region Zealand, Denmark

  lead OTHER

Principal Investigators

• Erik Simonsen, MD PhD · Psychiatric Research Unit, Region Zealand, Denmark

• Ulf Soegaard, MD · Department of Special Functions, Psychiatry Region Zealand, Denmark

• Per Fink, DMSc · Clinic for Functional Disorders in Aarhus

• Brian Fallon, MD · Columbia University in New York

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2019-01-31

Completion

2019-01-31

Countries

• Denmark