HypochondriasisNCT02404116
Metacognitive Therapy for Health Anxiety
A study testing Metacognitive Therapy and Wait List in people with Hypochondriasis, run by University of Manchester at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypochondriasis
- What is being tested?
- Metacognitive Therapy and Wait List
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Manchester
Manchester, Manchester, M13 9PL
University of Central Lancashire
Preston, Lancashire, PR12HE
About this study
Official title: Metacognitive Therapy for Health Anxiety: A Randomised Control Trial
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.
Read the 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.
- Conditions
- Hypochondriasis
- Being tested
- Metacognitive Therapy, Wait List
- Medical subject headings
- Hypochondriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive TherapyOther
Participants will receive treatment which focus's on helping reduce excessive thinking about health,
Wait ListOther
Individuals are on a waiting list
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive Therapy | Experimental | 12 weeks of Metacognitive Therapy Receives: Other: Metacognitive Therapy |
| Wait List Control | Other | The Waiting list control will control for time and repeated assessments during an initial 12 week period Receives: Other: Wait List |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health anxiety levels over 12weeks of treatment measured by the Whiteley Index 7 (WI7)
Measures the presence of health anxiety.
Measured: 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
Change in health anxiety levels over 12weeks of treatment measured by the Bodily Perception Questionnaire (BP).
Measures the presence of health anxiety.
Measured: 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 outcomes (5)
Change in anxiety levels over 12weeks of treatment measured by the Beck Anxiety Inventory
Will be used as a measure of anxiety
Measured: 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
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.
Measured: 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
Change in depression levels over 12weeks of treatment measured by the Beck Depression inventory
Will be used as general mood measures
Measured: 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
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
Measured: 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
Change in dysfunctional beliefs over 12weeks of treatment measured by the Health cognition Questionnaire
Dysfunctional beliefs associated with health anxiety
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypochondriasisStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Bailey, University of Manchester
- Investigators
- Robin Bailey, MSc, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404116
- Sponsor's protocol ID
- : z83hdhmg
- Status last verified
- Feb 2017
- First submitted
- 23 Mar 2015
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Therapy for Health Anxiety: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT02404116
- Acronym / sponsor ID
- : z83hdhmg
- Conditions
- Hypochondriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metacognitive Therapy | Experimental | Other: Metacognitive Therapy12 weeks of Metacognitive Therapy |
| Wait List Control | Other | Other: Wait ListThe Waiting list control will control for time and repeated assessments during an initial 12 week period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive TherapyParticipants will receive treatment which focus's on helping reduce excessive thinking about health, | Other | Metacognitive Therapy |
| Wait ListIndividuals are on a waiting list | Other | Wait List Control |
Primary outcome
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.
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
Related trials for Hypochondriasis
Active, not recruiting
Brief-intensive CBT Versus Once-weekly CBT in Anxiety-related Disorders
Anxiety Disorders, Obsessive-Compulsive Disorder
Recruiting
Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial
Panic Disorder, Social Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Bailey, MSc principal investigator
University of Manchester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Therapy and Wait List in people with Hypochondriasis, run by University of Manchester at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.