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Metacognitive Therapy for Health Anxiety

Primary Purpose

Hypochondriasis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Metacognitive Therapy
Wait List
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypochondriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Central Lancashire
  • University of Manchester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Metacognitive Therapy

Wait List Control

Arm Description

12 weeks of Metacognitive Therapy

The Waiting list control will control for time and repeated assessments during an initial 12 week period

Outcomes

Primary Outcome Measures

Change in health anxiety levels over 12weeks of treatment measured by the Whiteley Index 7 (WI7)
Measures the presence of health anxiety.
Change in health anxiety levels over 12weeks of treatment measured by the Bodily Perception Questionnaire (BP).
Measures the presence of health anxiety.

Secondary Outcome Measures

Change in anxiety levels over 12weeks of treatment measured by the Beck Anxiety Inventory
Will be used as a measure of anxiety
Change in general metacognition levels over 12weeks of treatment measured by the The Metacognitions Questionaire-30 (MCQ-30)
will be used to examine general positive and negative beliefs about worrying thoughts, attitudes & processes.
Change in depression levels over 12weeks of treatment measured by the Beck Depression inventory
Will be used as general mood measures
Change in health anxious metacognition levels over 12weeks of treatment measured by the The Meta-Cognitions about Health Questionnaire (MCHQ)
Specific metacognitive beliefs associated with health anxiety
Change in dysfunctional beliefs over 12weeks of treatment measured by the Health cognition Questionnaire
Dysfunctional beliefs associated with health anxiety

Full Information

First Posted
March 23, 2015
Last Updated
February 6, 2017
Sponsor
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT02404116
Brief Title
Metacognitive Therapy for Health Anxiety
Official Title
Metacognitive Therapy for Health Anxiety: A Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypochondriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metacognitive Therapy
Arm Type
Experimental
Arm Description
12 weeks of Metacognitive Therapy
Arm Title
Wait List Control
Arm Type
Other
Arm Description
The Waiting list control will control for time and repeated assessments during an initial 12 week period
Intervention Type
Other
Intervention Name(s)
Metacognitive Therapy
Intervention Description
Participants will receive treatment which focus's on helping reduce excessive thinking about health,
Intervention Type
Other
Intervention Name(s)
Wait List
Intervention Description
Individuals are on a waiting list
Primary Outcome Measure Information:
Title
Change in health anxiety levels over 12weeks of treatment measured by the Whiteley Index 7 (WI7)
Description
Measures the presence of health anxiety.
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
Title
Change in health anxiety levels over 12weeks of treatment measured by the Bodily Perception Questionnaire (BP).
Description
Measures the presence of health anxiety.
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
Secondary Outcome Measure Information:
Title
Change in anxiety levels over 12weeks of treatment measured by the Beck Anxiety Inventory
Description
Will be used as a measure of anxiety
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
Title
Change in general metacognition levels over 12weeks of treatment measured by the The Metacognitions Questionaire-30 (MCQ-30)
Description
will be used to examine general positive and negative beliefs about worrying thoughts, attitudes & processes.
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
Title
Change in depression levels over 12weeks of treatment measured by the Beck Depression inventory
Description
Will be used as general mood measures
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
Title
Change in health anxious metacognition levels over 12weeks of treatment measured by the The Meta-Cognitions about Health Questionnaire (MCHQ)
Description
Specific metacognitive beliefs associated with health anxiety
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
Title
Change in dysfunctional beliefs over 12weeks of treatment measured by the Health cognition Questionnaire
Description
Dysfunctional beliefs associated with health anxiety
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Bailey, MSc
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Central Lancashire
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR12HE
Country
United Kingdom
Facility Name
University of Manchester
City
Manchester
ZIP/Postal Code
M13 9PL
Country
United Kingdom

12. IPD Sharing Statement

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Metacognitive Therapy for Health Anxiety

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