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Completed

NCT Number: NCT02404116

Metacognitive Therapy for Health Anxiety

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Lancashire, Preston, Lancashire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metacognitive Therapy

Other

Participants will receive treatment which focus's on helping reduce excessive thinking about health,

wait list

Other

Individuals are on a waiting list

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study title

Metacognitive Therapy for Health Anxiety: A Randomised Control Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2015
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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