- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02404116
Metacognitive Therapy for Health Anxiety
Metacognitive Therapy for Health Anxiety: A Randomised Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manchester, United Kingdom, M13 9PL
- University of Manchester
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Lancashire
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Preston, Lancashire, United Kingdom, PR12HE
- University of Central Lancashire
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metacognitive Therapy
12 weeks of Metacognitive Therapy
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Participants will receive treatment which focus's on helping reduce excessive thinking about health,
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Other: Wait List Control
The Waiting list control will control for time and repeated assessments during an initial 12 week period
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Individuals are on a waiting list
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Measures the presence of health anxiety.
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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
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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
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Measures the presence of health anxiety.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Will be used as a measure of anxiety
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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
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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
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will be used to examine general positive and negative beliefs about worrying thoughts, attitudes & processes.
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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
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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
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Will be used as general mood measures
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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
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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
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Specific metacognitive beliefs associated with health anxiety
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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
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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
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Dysfunctional beliefs associated with health anxiety
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robin Bailey, MSc, University of Manchester
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- : z83hdhmg
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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