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

NCT02131883 | Completed

• 1 other identifier: SJ-374
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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 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

Keywords

Health Anxiety; Hypochondriasis; Illness Anxiety Disorder; Somatic Symptom Disorder; Personality Disorders; Cognitive Behavioral Therapy; Group-CBT; Illness Perception; Cost-effectiveness

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Before 1. diagnostic assessment, baseline (2 weeks before), 0 months, 3 months, 6 months (primary measure), 24 months after 12 weeks group-CBT intervention

• Cure from severe health anxiety

  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.

  At 6 months follow up

Secondary Outcomes (11)

• 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

• Personality Inventory for DSM-5 Total Score (PID-5)

  Baseline (2 weeks before), 6 months (primary measure), 24 months follow up

• Social level of Functioning (SF-36)

  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

• WHO-5 Well-being Index

  Before 1. diagnostic assessment, baseline, 0 months, 3 months, 6 months (primary), 24 months follow up

Study Arms (2)

Group-Cognitive Behavioral Therapy

EXPERIMENTAL

Group-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

Behavioral: Group-Cognitive Behavioral Therapy

Wait-List with treatment as usual

OTHER

Wait-List with treatment as usual waiting in 9 months for the intervention with group-CBT

Other: Wait-List with treatment as usual

Interventions

Group-Cognitive Behavioral Therapy BEHAVIORAL

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

Group-Cognitive Behavioral Therapy

Wait-List with treatment as usual OTHER

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

Wait-List with treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnancy

Sponsors & Collaborators

• Psychiatric Research Unit, Region Zealand, Denmark: lead
• The Clinic for Liaison Psychiatry in Koege, Department of Special Functions, Psychiatry Region Zealand: collaborator
• The Regional Fund for Health Sciences in Region Zealand: collaborator

Study Sites (1)

The Clinic of Liaison Psychiatry

Koege, 4600, Denmark

Location

MeSH Terms

Conditions

Hypochondriasis; Personality Disorders

Interventions

Waiting Lists; Therapeutics

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Erik Simonsen, MD PhD

  Psychiatric Research Unit, Region Zealand, Denmark

  STUDY DIRECTOR

• Ulf Soegaard, MD

  Department of Special Functions, Psychiatry Region Zealand, Denmark

  STUDY CHAIR

• Per Fink, DMSc

  Clinic for Functional Disorders in Aarhus

  STUDY DIRECTOR

• Brian Fallon, MD

  Columbia University in New York

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: May 6, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

DK (1)