Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02404116
Other study ID # : z83hdhmg
Secondary ID
Status Completed
Phase N/A
First received March 23, 2015
Last updated February 6, 2017
Start date March 2015
Est. completion date January 2017

Study information

Verified date February 2017
Source University of Manchester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Metacognitive Therapy
Participants will receive treatment which focus's on helping reduce excessive thinking about health,
Wait List
Individuals are on a waiting list

Locations

Country Name City State
United Kingdom University of Manchester Manchester
United Kingdom University of Central Lancashire Preston Lancashire

Sponsors (1)

Lead Sponsor Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in health anxiety levels over 12weeks of treatment measured by the Whiteley Index 7 (WI7) Measures the presence of health anxiety. 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
Primary Change in health anxiety levels over 12weeks of treatment measured by the Bodily Perception Questionnaire (BP). Measures the presence of health anxiety. 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 Change in anxiety levels over 12weeks of treatment measured by the Beck Anxiety Inventory Will be used as a measure of anxiety 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 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. 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 Change in depression levels over 12weeks of treatment measured by the Beck Depression inventory Will be used as general mood measures 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 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 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 Change in dysfunctional beliefs over 12weeks of treatment measured by the Health cognition Questionnaire Dysfunctional beliefs associated with health anxiety 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
See also
  Status Clinical Trial Phase
Completed NCT01673035 - Internet Treatment for Health Anxiety N/A
Completed NCT00368212 - Integrated Treatment Program for Hypochondriasis in Primary Care Settings Phase 3
Completed NCT01158430 - Acceptance and Commitment Group Therapy (ACT) for Patients With Health Anxiety N/A
Completed NCT01119469 - Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis Phase 3
Completed NCT00339079 - Comparing Cognitive Behavioral Therapy, Antidepressant Medication, and Combined Treatment in Individuals With Hypochondriasis Phase 1/Phase 2
Recruiting NCT04900064 - Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial N/A
Completed NCT00828152 - Internet-delivered Cognitive Behavioral Therapy (CBT) for Health Anxiety Phase 2
Completed NCT00959452 - Follow up of Patients Treated With Cognitive Behavioural Therapy for Hypochondria From 1997 to 2007 N/A
Completed NCT02131883 - Outcome of Cognitive Behavioral Therapy for Patients With Severe Health Anxiety Treated in Group Only. A RCT. N/A
Completed NCT00208247 - KATHY:Cognitive-behavioural Therapy for Hypochondriasis Phase 2
Not yet recruiting NCT05942391 - Brief-intensive CBT Versus Once-weekly CBT in Anxiety-related Disorders N/A
Completed NCT02735434 - Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety N/A
Completed NCT04921280 - Effectiveness of ICBT for Severe Health Anxiety in Clinical Psychiatry.
Not yet recruiting NCT03024593 - An Examination of the Effects of Health-related Internet Use in Individuals With Pathological Health Anxiety N/A