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Metacognitive Therapy for Health Anxiety

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ClinicalTrials.gov Identifier: NCT02404116
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Robin Bailey, University of Manchester

Brief Summary:
The study involves a comparing a new psychological treatment- Metacognitive Therapy (MCT) which has shown promising results in the treatment of health anxiety to no treatment at all- a waiting list.

Condition or disease Intervention/treatment Phase
Hypochondriasis Other: Metacognitive Therapy Other: Wait List Not Applicable

Detailed Description:

Hypochondriasis or severe health anxiety is characterised by excessive, disproportionate and persistent thoughts, behaviour and emotion focused on physical symptoms and/or fear of developing a serious illness. There is often excessive worry about illness or disease in the absence of supporting medical evidence and contrary to continual medical reassurance.

The most effective psychological treatments are cognitive and behavioural therapies (CBT). However, CBT has failed to demonstrate consistent gains in the treatment of this disorder.

A newer form of psychological therapy, Metacognitive Therapy (MCT) has shown to be more effective than CBT in the treatment of anxiety disorders and depression. MCT is based on the principle that health anxiety is caused by a pattern of extended thinking, this pattern is called the Cognitive Attentional Syndrome (CAS). The CAS is made up of chains of verbal thought in the form of excessive worry about having an illness; a pattern of focusing attention on threat, such as scanning the body for signs of illness and excessive body checking; and coping strategies that have negative effects, such as internet searching for illnesses or trying to block out thoughts of illness. Rather than stopping negative thinking the CAS extends it and leads to the belief that illness is present. To help reduce these symptoms MCT teaches specific techniques that help people develop new ways of experiencing negative thoughts about illnesses, allow them to abandon worry and learn to disengage from unhelpful coping attempts.

A recent small study has provided some limited evidence that metacognitive therapy (MCT) can be applied to cases of hypochondriasis and demonstrated that the therapy was associated with improvement in symptoms.

To provide future evaluation of MCT in this client group a more definitive trial will be carried out to ascertain the effects of MCT in a larger group when compared to a control group.

If the results are positive this will provide a rationale for a larger research study, which will compare MCT with evidence based treatment such as CBT.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metacognitive Therapy for Health Anxiety: A Randomised Control Trial
Study Start Date : March 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Metacognitive Therapy
12 weeks of Metacognitive Therapy
Other: Metacognitive Therapy
Participants will receive treatment which focus's on helping reduce excessive thinking about health,

Wait List Control
The Waiting list control will control for time and repeated assessments during an initial 12 week period
Other: Wait List
Individuals are on a waiting list




Primary Outcome Measures :
  1. Change in health anxiety levels over 12weeks of treatment measured by the Whiteley Index 7 (WI7) [ Time Frame: This will be administered in the first and last treatment session (week 1 and week 12) by the study investigators, and once at 6 months follow up following treatment completion ]
    Measures the presence of health anxiety.

  2. Change in health anxiety levels over 12weeks of treatment measured by the Bodily Perception Questionnaire (BP). [ Time Frame: This will be administered in the first and last treatment session (week 1 and week 12) by the study investigators, and once at 6 months follow up following treatment completion ]
    Measures the presence of health anxiety.


Secondary Outcome Measures :
  1. Change in anxiety levels over 12weeks of treatment measured by the Beck Anxiety Inventory [ Time Frame: This will be administered in the first and last treatment session (week 1 and week 12) by the study investigators, and once at 6 months follow up following treatment completion ]
    Will be used as a measure of anxiety

  2. Change in general metacognition levels over 12weeks of treatment measured by the The Metacognitions Questionaire-30 (MCQ-30) [ Time Frame: This will be administered in the first and last treatment session (week 1 and week 12) by the study investigators, and once at 6 months follow up following treatment completion ]
    will be used to examine general positive and negative beliefs about worrying thoughts, attitudes & processes.

  3. Change in depression levels over 12weeks of treatment measured by the Beck Depression inventory [ Time Frame: This will be administered in the first and last treatment session (week 1 and week 12) by the study investigators, and once at 6 months follow up following treatment completion ]
    Will be used as general mood measures

  4. Change in health anxious metacognition levels over 12weeks of treatment measured by the The Meta-Cognitions about Health Questionnaire (MCHQ) [ Time Frame: This will be administered in the first and last treatment session (week 1 and week 12) by the study investigators, and once at 6 months follow up following treatment completion ]
    Specific metacognitive beliefs associated with health anxiety

  5. Change in dysfunctional beliefs over 12weeks of treatment measured by the Health cognition Questionnaire [ Time Frame: This will be administered in the first and last treatment session (week 1 and week 12) by the study investigators, and once at 6 months follow up following treatment completion ]
    Dysfunctional beliefs associated with health anxiety



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be over 18.
  • Exceed cut off on BP and WI
  • Not undergoing any other form of psychological therapy during treatment.
  • If on medication must be stable six weeks prior to treatment onset.
  • Willing to undergo randomisation
  • Provide written consent

Exclusion Criteria:

  • Be under 18
  • Not exceeding cut off on BP and WI
  • Undergone CBT for health anxiety over the past three months.
  • Having started medication less than four weeks before assessment
  • Not willing to undergo randomisation
  • Not willing to provide written consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404116


Locations
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United Kingdom
University of Central Lancashire
Preston, Lancashire, United Kingdom, PR12HE
University of Manchester
Manchester, United Kingdom, M13 9PL
Sponsors and Collaborators
University of Manchester
Investigators
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Principal Investigator: Robin Bailey, MSc University of Manchester

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Responsible Party: Robin Bailey, Principal Investigator, University of Manchester
ClinicalTrials.gov Identifier: NCT02404116     History of Changes
Other Study ID Numbers: : z83hdhmg
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Hypochondriasis
Somatoform Disorders
Mental Disorders