Clinical Trial: Acceptance and Commitment Group Therapy (ACT) for Patients With Health Anxiety

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Patients With Health Anxiety. A Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) Group Treatment Compared to a Waiting List

Brief Summary: The purpose of this study is to determine the effect of Acceptance and Commitment Therapy (ACT) in groups on functional level, emotional problems, and use of health care in patients with severe health anxiety in a randomized, controlled design.

Detailed Summary:

Health anxiety disorder or Hypochondriasis is a prevalent somatoform disorder, but a rarely used diagnosis in clinical practice despite studies having reported prevalence between 0.8-9.5% in primary care (Fink et al, 2004). As a consequence, the disorder is rarely treated.

The lack of valid, reliable, and generally accepted diagnostic criteria has been a major obstacle in clinical practice and Hypochondriasis studies, which causes problems particularly in distinguishing Hypochondriasis patients from other patients presenting with medically unexplained symptoms or functional symptoms.

In 2004, the investigators introduced a radically revised definition of Hypochondriasis. Hypochondriasis is viewed as a stigmatizing label, and the designation health anxiety has been suggested as replacement. This new diagnosis is empirically established. The essential feature of health anxiety is that the patients present with cognitive symptoms such as unfounded worrying about their health. In contrast to other somatoform disorders, the patients are not necessarily plagued by physical symptoms.

The new diagnostic criteria include the symptom 'obsessive rumination about illness' plus at least one of the symptoms 'worry or preoccupation with fears of harboring an illness or with bodily functions', 'suggestibility or autosuggestibility', 'an unrealistic fear of being infected or contaminated', 'an excessive fascination with medical information', or 'fear of taking prescribed medication'.

In the current study, health anxiety is diagnosed by use of newly introduced empirically established positive criteria for Health anxiety (Fink et al, 2004).

Most patients with health anxiety disorder receive the
Sponsor: University of Aarhus

Current Primary Outcome: Health anxiety measured by the Whiteley-7 index [ Time Frame: 9 months (2nd follow-up) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Social level of functioning measured with Short Form health status questionnaire from the medical outcome status (SF-36) [ Time Frame: 9 months (2nd follow-up) ]
  • Social level of functioning, emotional disorders measured with relevant sub-scales from Symptom Check List, 90 items (SCL 90) [ Time Frame: 9 months (2nd follow-up) ]
  • Social level of functioning measured with an alcohol dependency questionnaire (CAGE) [ Time Frame: 9 months (2nd follow-up) ]
  • Illness perception measured with Illness Perception Questionnaire (IPQ) [ Time Frame: 9 months (2nd follow-up) ]
  • Physical symptoms measured with somatisation subscales from Symptom Check List, 90 items (SCL 90) [ Time Frame: 9 months (2nd follow-up) ]
  • Health care use (National Patient Register & National Health Service Register (general practitioner (GP) contacts/consultations, specialists, physiotherapists, dentists, GPs' emergency service), The Danish Medicine Agency (medicine consumption)). [ Time Frame: 9 months (2nd follow-up) ]
  • Sick days (the DREAM database - the register-based evaluation of the extent of marginalization) [ Time Frame: 9 months (2nd follow-up) ]
  • ACT process measures measured with Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 9 months (2nd follow-up) ]
  • ACT process measures measured with Acceptance and Action Questionnaire - II (AAQ II) [ Time Frame: 9 months (2nd follow-up) ]


Original Secondary Outcome: Same as current

Information By: University of Aarhus

Dates:
Date Received: February 16, 2010
Date Started: March 2010
Date Completion:
Last Updated: April 12, 2013
Last Verified: April 2013